Pediatric News

Nearly 90% of diabetes management in the United States is provided by primary care clinicians; diabetes is the fifth most common reason for a primary care visit. State-of-the-art technology such as continuous glucose monitors (CGMs) will inevitably transform the management of diabetes in primary care. Clinicians and staff must be ready to educate, counsel, and support primary care patients in the use of CGMs.

CGMs (also called glucose sensors) are small, minimally invasive devices that attach to the skin of the upper arm or trunk. A tiny electrode in the subcutaneous space prompts an enzyme reaction that measures the interstitial (rather than blood) glucose concentration, typically every 5 minutes. The results are displayed on an accompanying reader or transmitted to an app on the user’s mobile phone.

CGMs could eliminate the need for finger-stick blood glucose testing, which until now, has been the much-despised gold standard for self-monitoring of glucose levels in diabetes. Despite being relatively inexpensive and accurate, finger-stick glucose tests are inconvenient and often painful. But of greater significance is this downside: Finger-stick monitoring reveals the patient’s blood glucose concentration at a single point in time, which can be difficult to interpret. Is the blood glucose rising or falling? Multiple finger-stick tests are required to determine the trend of a patient’s glucose levels or the response to food or exercise.

In contrast, the graphic display from a CGM sensor is more like a movie, telling a story as it unfolds. Uninterrupted data provide valuable feedback to patients about the effects of diet, physical activity, stress, or pain on their glucose levels. And for the first time, it’s easy to determine the proportion of time the patient spends in or out of the target glucose range.

Incorporating new technology into your practice may seem like a burden, but the reward is better information that leads to better management of diabetes. If you’re new to glucose sensors, many excellent resources are available to learn how to use them.

I recommend starting with a website called diabeteswise.org, which has both a patient-facing and clinician-facing version. This unbranded site serves as a kind of Consumer Reports for diabetes technology, allowing both patients and professionals to compare and contrast currently available CGM devices.

DiabetesWisePro  has information ranging from CGM device fundamentals and best practices to CGM prescribing and reimbursement.

Clinical Diabetes also provides multiple tools to help incorporate these devices into primary care clinical practice, including:

• Continuous Glucose Monitoring: Optimizing Diabetes Care (CME course).

• Diabetes Technology in Primary Care.

The next article in this series will cover two types of CGMs used in primary care: professional and personal devices.

Dr. Shubrook is a professor in the department of primary care, Touro University California College of Osteopathic Medicine, Vallejo, Calif., and director of diabetes services, Solano County Family Health Services, Fairfield, Calif. He disclosed ties with Abbott, Astra Zeneca, Bayer, Nevro, and Novo Nordisk.

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

Nearly 90% of diabetes management in the United States is provided by primary care clinicians; diabetes is the fifth most common reason for a primary care visit. State-of-the-art technology such as continuous glucose monitors (CGMs) will inevitably transform the management of diabetes in primary care. Clinicians and staff must be ready to educate, counsel, and support primary care patients in the use of CGMs.

CGMs (also called glucose sensors) are small, minimally invasive devices that attach to the skin of the upper arm or trunk. A tiny electrode in the subcutaneous space prompts an enzyme reaction that measures the interstitial (rather than blood) glucose concentration, typically every 5 minutes. The results are displayed on an accompanying reader or transmitted to an app on the user’s mobile phone.

CGMs could eliminate the need for finger-stick blood glucose testing, which until now, has been the much-despised gold standard for self-monitoring of glucose levels in diabetes. Despite being relatively inexpensive and accurate, finger-stick glucose tests are inconvenient and often painful. But of greater significance is this downside: Finger-stick monitoring reveals the patient’s blood glucose concentration at a single point in time, which can be difficult to interpret. Is the blood glucose rising or falling? Multiple finger-stick tests are required to determine the trend of a patient’s glucose levels or the response to food or exercise.

In contrast, the graphic display from a CGM sensor is more like a movie, telling a story as it unfolds. Uninterrupted data provide valuable feedback to patients about the effects of diet, physical activity, stress, or pain on their glucose levels. And for the first time, it’s easy to determine the proportion of time the patient spends in or out of the target glucose range.

Incorporating new technology into your practice may seem like a burden, but the reward is better information that leads to better management of diabetes. If you’re new to glucose sensors, many excellent resources are available to learn how to use them.

I recommend starting with a website called diabeteswise.org, which has both a patient-facing and clinician-facing version. This unbranded site serves as a kind of Consumer Reports for diabetes technology, allowing both patients and professionals to compare and contrast currently available CGM devices.

DiabetesWisePro  has information ranging from CGM device fundamentals and best practices to CGM prescribing and reimbursement.

Clinical Diabetes also provides multiple tools to help incorporate these devices into primary care clinical practice, including:

• Continuous Glucose Monitoring: Optimizing Diabetes Care (CME course).

• Diabetes Technology in Primary Care.

The next article in this series will cover two types of CGMs used in primary care: professional and personal devices.

Dr. Shubrook is a professor in the department of primary care, Touro University California College of Osteopathic Medicine, Vallejo, Calif., and director of diabetes services, Solano County Family Health Services, Fairfield, Calif. He disclosed ties with Abbott, Astra Zeneca, Bayer, Nevro, and Novo Nordisk.

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

Nearly 90% of diabetes management in the United States is provided by primary care clinicians; diabetes is the fifth most common reason for a primary care visit. State-of-the-art technology such as continuous glucose monitors (CGMs) will inevitably transform the management of diabetes in primary care. Clinicians and staff must be ready to educate, counsel, and support primary care patients in the use of CGMs.

CGMs (also called glucose sensors) are small, minimally invasive devices that attach to the skin of the upper arm or trunk. A tiny electrode in the subcutaneous space prompts an enzyme reaction that measures the interstitial (rather than blood) glucose concentration, typically every 5 minutes. The results are displayed on an accompanying reader or transmitted to an app on the user’s mobile phone.

CGMs could eliminate the need for finger-stick blood glucose testing, which until now, has been the much-despised gold standard for self-monitoring of glucose levels in diabetes. Despite being relatively inexpensive and accurate, finger-stick glucose tests are inconvenient and often painful. But of greater significance is this downside: Finger-stick monitoring reveals the patient’s blood glucose concentration at a single point in time, which can be difficult to interpret. Is the blood glucose rising or falling? Multiple finger-stick tests are required to determine the trend of a patient’s glucose levels or the response to food or exercise.

In contrast, the graphic display from a CGM sensor is more like a movie, telling a story as it unfolds. Uninterrupted data provide valuable feedback to patients about the effects of diet, physical activity, stress, or pain on their glucose levels. And for the first time, it’s easy to determine the proportion of time the patient spends in or out of the target glucose range.

Incorporating new technology into your practice may seem like a burden, but the reward is better information that leads to better management of diabetes. If you’re new to glucose sensors, many excellent resources are available to learn how to use them.

I recommend starting with a website called diabeteswise.org, which has both a patient-facing and clinician-facing version. This unbranded site serves as a kind of Consumer Reports for diabetes technology, allowing both patients and professionals to compare and contrast currently available CGM devices.

DiabetesWisePro  has information ranging from CGM device fundamentals and best practices to CGM prescribing and reimbursement.

Clinical Diabetes also provides multiple tools to help incorporate these devices into primary care clinical practice, including:

• Continuous Glucose Monitoring: Optimizing Diabetes Care (CME course).

• Diabetes Technology in Primary Care.

The next article in this series will cover two types of CGMs used in primary care: professional and personal devices.

Dr. Shubrook is a professor in the department of primary care, Touro University California College of Osteopathic Medicine, Vallejo, Calif., and director of diabetes services, Solano County Family Health Services, Fairfield, Calif. He disclosed ties with Abbott, Astra Zeneca, Bayer, Nevro, and Novo Nordisk.

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

In Colorado and Wyoming, nearly every baby born since 2020 is tested for signs of a mutation in the SMN1 gene, an indicator of spinal muscular atrophy (SMA). And in 4 years, genetic counselor Melissa Gibbons has seen 24 positive results. She has prepped 24 different pediatricians and family doctors to deliver the news: A seemingly perfect newborn likely has a lethal genetic disease.

Most of these clinicians had never cared for a child with SMA before, nor did they know that lifesaving gene therapy for the condition now exists. Still, the physicians were foundational to getting babies emergency treatment and monitoring the child’s safety after the fact.

“They are boots on the ground for this kind of [work],” Ms. Gibbons, who is the newborn screen coordinator for SMA in both states, told this news organization. “I’m not even sure they realize it.” As of today, the U.S. Food and Drug Administration has approved 16 gene therapies for the treatment of rare and debilitating diseases once considered lethal, such as SMA and cerebral adrenoleukodystrophy.

The newest addition to the list of approvals is Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD). These conditions can now be mitigated, abated for years at a time, and even cured using treatments that tweak a patient’s DNA or RNA.

Hundreds of treatments are under development using the same mechanism. Viruses, liposomes, and other vectors of all kinds are being used to usher new genes into cells, correcting faulty copies or equipping a cell to fight disease. Cells gain the ability to make lifesaving proteins – proteins that heal wounds, restore muscle function, and fight cancer.

Within the decade, a significant fraction of the pediatric population will have gone through gene therapy, experts told this news organization. And primary care stands to be a linchpin in the scale-up of this kind of precision genetic medicine. Pediatricians and general practitioners will be central to finding and monitoring the patients that need these treatments. But the time and support doctors will need to fill that role remain scarce.

“This is a world we are creating right now, quite literally,” said Stanley Nelson, MD, director of the center for Duchenne muscular dystrophy at the University of California, Los Angeles. These cases – some before gene therapy and some after – will show up in primary care offices before the textbook is written.
 

Unknown side effects, new diseases

Even now, gene therapy is sequestered away in large academic medical research centers. The diagnosis, decision-making, and aftercare are handled by subspecialists working on clinical trials. While the research is ongoing, trial sponsors are keeping a close eye on enrolled patients. But that’s only until these drugs get market approval, Phil Beales, MD, chief medical officer at Congenica, a digital health company specializing in genome analysis support, said. Afterward, “the trialists will no longer have a role in looking after those patients.”

At that point, the role of primary care clinicians will be critically important. Although they probably will not manage gene-therapy patients on their own – comanaging them instead with subspecialists – they will be involved in the ordering and monitoring of safety labs and other tests.

General practitioners “need to know side effects because they are going to deal with side effects when someone calls them in the middle of the night,” said Dr. Beales, who also is chief executive officer of Axovia Therapeutics, a biotech company developing gene therapies.

Some of the side effects that come with gene therapy are established. Adeno-associated virus (AAV) or AAV-mediated gene therapies carry an increased risk for damage to the heart and liver, Dr. Nelson said. Other side effects are less well known and could be specific to the treatment and the tissue it targets. Primary care will be critical in detecting these unexpected side effects and expediting visits with subspecialists, he said.

In rural Wyoming, pediatricians and family doctors are especially important, Ms. Gibbons said. In the 30-90 days after gene therapy, patients need a lot of follow-up for safety reasons.

But aftercare for gene therapy will be more than just monitoring and managing side effects. The diseases themselves will change. Patients will be living with conditions that once were lethal.

In some cases, gene therapy may largely eliminate the disease. The data suggest that thalassemia, for example, can be largely cured for decades with one infusion of a patient’s genetically modified hematopoietic stem cells made using bluebird bio’s Zynteglo, according to Christy Duncan, MD, medical director of clinical research at the gene therapy program at Boston Children’s Hospital.

But other gene therapies, like the one for DMD, will offer a “spectrum of benefits,” Dr. Nelson said. They will be lifesaving, but the signs of the disease will linger. Clinicians will be learning alongside specialists what the new disease state for DMD and other rare diseases looks like after gene therapy.

“As we get hundreds of such therapies, [post–gene therapy] will amount to a substantial part of the pediatric population,” Dr. Nelson said.
 

Finding patients

Many of these rare diseases that plague young patients are unmistakable. Children with moderate or severe dystrophic epidermolysis bullosa, for instance, carry a mutation that prevents them from making type VII collagen. The babies suffer wounds and excessive bleeding and tend to receive a quick diagnosis within the first 6 months of life, according to Andy Orth, chief commercial officer at Krystal Bio, manufacturer of a new wound-healing gene therapy, Vyjuvek, for the disorder.

Other rare neurologic or muscular diseases can go undiagnosed for years. Until recently, drug companies and researchers have had little motivation to speed up the timeline because early diagnosis of a disease like DMD would not change the outcome, Dr. Nelson said.

But with gene therapy, prognoses are changing. And finding diseases early could soon mean preserving muscular function or preventing neurologic damage, Dr. Duncan said.

Newborn sequencing “is not standard of care yet, but it’s certainly coming,” Josh Peterson, MD, MPH, director of the center for precision medicine at Vanderbilt University Medical Center, in Nashville, Tenn., told this news organization.

A recent survey of 238 specialists in rare diseases found that roughly 90% believe whole-genome sequencing should be available to all newborns. And 80% of those experts endorse 42 genes as disease predictors. Screening for rare diseases at birth could reveal a host of conditions in the first week of life and expedite treatment. But this strategy will often rely on primary care and pediatricians interpreting the results.

Most pediatricians think sequencing is a great idea, but they do not feel comfortable doing it themselves, Dr. Peterson said. The good news, he said, is that manufacturers have made screening tests straightforward. Some drug companies even offer free screenings for gene therapy candidates.

Dr. Peterson predicts pediatricians will need to be equipped to deliver negative results on their own, which will be the case for around 97%-99% of patients. They also will need to be clear on whether a negative result is definitive or if more testing is warranted.

Positive results are more nuanced. Genetic counseling is the ideal resource when delivering this kind of news to patients, but counselors are a scarce resource nationally – and particularly in rural areas, Dr. Nelson said. Physicians likely will have to rely on their own counseling training to some degree.

“I feel very strongly that genetic counselors are in short supply,” Ms. Gibbons in Colorado said. Patients need a friendly resource who can talk them through the disease and how it works. And that discussion is not a one-off, she said.

The number of board-certified genetic counselors in the United States has doubled to more than 6,000 in the past 10 years – a pace that is expected to continue, according to the National Society of Genetic Counselors. “However, the geographical distribution of genetic counselors is most concentrated in urban centers.”

Equally important to the counseling experience, according to Dr. Duncan at Boston Children’s, is a primary care physician’s network of connections. The best newborn screening rollouts across the country have succeeded because clinicians knew where to send people next and how to get families the help they needed, she said.

But she also cautioned that this learning curve will soon be overwhelming. As gene therapy expands, it may be difficult for primary care doctors to keep up with the science, treatment studies, and commercially available therapies. “It’s asking too much,” Dr. Duncan said.

The structure of primary care already stretches practitioners thin and will “affect how well precision medicine can be adopted and disseminated,” Dr. Peterson said. “I think that is a key issue.”

Artificial intelligence may offer a partial solution. Some genetic counseling models already exist, but their utility for clinicians so far is limited, Dr. Beales said. But he said he expects these tools to improve rapidly to help clinicians and patients. On the patient’s end, they may be able to answer questions and supplement basic genetic counseling. On the physician’s end, algorithms could help triage patients and help move them along to the next steps in the care pathway for these rare diseases.
 

The whole patient

Primary care physicians will not be expected to be experts in gene therapy or solely in charge of patient safety. They will have support from industry and subspecialists leading the development of these treatments, experts agreed.

But generalists should expect to be drawn into multidisciplinary care teams, be the sounding boards for patients making decisions about gene therapy, help arrange insurance coverage, and be the recipients of late-night phone calls about side effects.

All that, while never losing sight of the child’s holistic health. In children so sick, specialists, subspecialists, and even parents tend to focus only on the rare disease. The team can “get distracted from good normal routine care,” Dr. Nelson said. But these children aren’t exempt from check-ups, vaccine regimens, or the other diseases of childhood.

“In a world where we mitigate that core disease,” he said, “we need a partner in the general pediatrics community” investing in their long-term health.

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

In Colorado and Wyoming, nearly every baby born since 2020 is tested for signs of a mutation in the SMN1 gene, an indicator of spinal muscular atrophy (SMA). And in 4 years, genetic counselor Melissa Gibbons has seen 24 positive results. She has prepped 24 different pediatricians and family doctors to deliver the news: A seemingly perfect newborn likely has a lethal genetic disease.

Most of these clinicians had never cared for a child with SMA before, nor did they know that lifesaving gene therapy for the condition now exists. Still, the physicians were foundational to getting babies emergency treatment and monitoring the child’s safety after the fact.

“They are boots on the ground for this kind of [work],” Ms. Gibbons, who is the newborn screen coordinator for SMA in both states, told this news organization. “I’m not even sure they realize it.” As of today, the U.S. Food and Drug Administration has approved 16 gene therapies for the treatment of rare and debilitating diseases once considered lethal, such as SMA and cerebral adrenoleukodystrophy.

The newest addition to the list of approvals is Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD). These conditions can now be mitigated, abated for years at a time, and even cured using treatments that tweak a patient’s DNA or RNA.

Hundreds of treatments are under development using the same mechanism. Viruses, liposomes, and other vectors of all kinds are being used to usher new genes into cells, correcting faulty copies or equipping a cell to fight disease. Cells gain the ability to make lifesaving proteins – proteins that heal wounds, restore muscle function, and fight cancer.

Within the decade, a significant fraction of the pediatric population will have gone through gene therapy, experts told this news organization. And primary care stands to be a linchpin in the scale-up of this kind of precision genetic medicine. Pediatricians and general practitioners will be central to finding and monitoring the patients that need these treatments. But the time and support doctors will need to fill that role remain scarce.

“This is a world we are creating right now, quite literally,” said Stanley Nelson, MD, director of the center for Duchenne muscular dystrophy at the University of California, Los Angeles. These cases – some before gene therapy and some after – will show up in primary care offices before the textbook is written.
 

Unknown side effects, new diseases

Even now, gene therapy is sequestered away in large academic medical research centers. The diagnosis, decision-making, and aftercare are handled by subspecialists working on clinical trials. While the research is ongoing, trial sponsors are keeping a close eye on enrolled patients. But that’s only until these drugs get market approval, Phil Beales, MD, chief medical officer at Congenica, a digital health company specializing in genome analysis support, said. Afterward, “the trialists will no longer have a role in looking after those patients.”

At that point, the role of primary care clinicians will be critically important. Although they probably will not manage gene-therapy patients on their own – comanaging them instead with subspecialists – they will be involved in the ordering and monitoring of safety labs and other tests.

General practitioners “need to know side effects because they are going to deal with side effects when someone calls them in the middle of the night,” said Dr. Beales, who also is chief executive officer of Axovia Therapeutics, a biotech company developing gene therapies.

Some of the side effects that come with gene therapy are established. Adeno-associated virus (AAV) or AAV-mediated gene therapies carry an increased risk for damage to the heart and liver, Dr. Nelson said. Other side effects are less well known and could be specific to the treatment and the tissue it targets. Primary care will be critical in detecting these unexpected side effects and expediting visits with subspecialists, he said.

In rural Wyoming, pediatricians and family doctors are especially important, Ms. Gibbons said. In the 30-90 days after gene therapy, patients need a lot of follow-up for safety reasons.

But aftercare for gene therapy will be more than just monitoring and managing side effects. The diseases themselves will change. Patients will be living with conditions that once were lethal.

In some cases, gene therapy may largely eliminate the disease. The data suggest that thalassemia, for example, can be largely cured for decades with one infusion of a patient’s genetically modified hematopoietic stem cells made using bluebird bio’s Zynteglo, according to Christy Duncan, MD, medical director of clinical research at the gene therapy program at Boston Children’s Hospital.

But other gene therapies, like the one for DMD, will offer a “spectrum of benefits,” Dr. Nelson said. They will be lifesaving, but the signs of the disease will linger. Clinicians will be learning alongside specialists what the new disease state for DMD and other rare diseases looks like after gene therapy.

“As we get hundreds of such therapies, [post–gene therapy] will amount to a substantial part of the pediatric population,” Dr. Nelson said.
 

Finding patients

Many of these rare diseases that plague young patients are unmistakable. Children with moderate or severe dystrophic epidermolysis bullosa, for instance, carry a mutation that prevents them from making type VII collagen. The babies suffer wounds and excessive bleeding and tend to receive a quick diagnosis within the first 6 months of life, according to Andy Orth, chief commercial officer at Krystal Bio, manufacturer of a new wound-healing gene therapy, Vyjuvek, for the disorder.

Other rare neurologic or muscular diseases can go undiagnosed for years. Until recently, drug companies and researchers have had little motivation to speed up the timeline because early diagnosis of a disease like DMD would not change the outcome, Dr. Nelson said.

But with gene therapy, prognoses are changing. And finding diseases early could soon mean preserving muscular function or preventing neurologic damage, Dr. Duncan said.

Newborn sequencing “is not standard of care yet, but it’s certainly coming,” Josh Peterson, MD, MPH, director of the center for precision medicine at Vanderbilt University Medical Center, in Nashville, Tenn., told this news organization.

A recent survey of 238 specialists in rare diseases found that roughly 90% believe whole-genome sequencing should be available to all newborns. And 80% of those experts endorse 42 genes as disease predictors. Screening for rare diseases at birth could reveal a host of conditions in the first week of life and expedite treatment. But this strategy will often rely on primary care and pediatricians interpreting the results.

Most pediatricians think sequencing is a great idea, but they do not feel comfortable doing it themselves, Dr. Peterson said. The good news, he said, is that manufacturers have made screening tests straightforward. Some drug companies even offer free screenings for gene therapy candidates.

Dr. Peterson predicts pediatricians will need to be equipped to deliver negative results on their own, which will be the case for around 97%-99% of patients. They also will need to be clear on whether a negative result is definitive or if more testing is warranted.

Positive results are more nuanced. Genetic counseling is the ideal resource when delivering this kind of news to patients, but counselors are a scarce resource nationally – and particularly in rural areas, Dr. Nelson said. Physicians likely will have to rely on their own counseling training to some degree.

“I feel very strongly that genetic counselors are in short supply,” Ms. Gibbons in Colorado said. Patients need a friendly resource who can talk them through the disease and how it works. And that discussion is not a one-off, she said.

The number of board-certified genetic counselors in the United States has doubled to more than 6,000 in the past 10 years – a pace that is expected to continue, according to the National Society of Genetic Counselors. “However, the geographical distribution of genetic counselors is most concentrated in urban centers.”

Equally important to the counseling experience, according to Dr. Duncan at Boston Children’s, is a primary care physician’s network of connections. The best newborn screening rollouts across the country have succeeded because clinicians knew where to send people next and how to get families the help they needed, she said.

But she also cautioned that this learning curve will soon be overwhelming. As gene therapy expands, it may be difficult for primary care doctors to keep up with the science, treatment studies, and commercially available therapies. “It’s asking too much,” Dr. Duncan said.

The structure of primary care already stretches practitioners thin and will “affect how well precision medicine can be adopted and disseminated,” Dr. Peterson said. “I think that is a key issue.”

Artificial intelligence may offer a partial solution. Some genetic counseling models already exist, but their utility for clinicians so far is limited, Dr. Beales said. But he said he expects these tools to improve rapidly to help clinicians and patients. On the patient’s end, they may be able to answer questions and supplement basic genetic counseling. On the physician’s end, algorithms could help triage patients and help move them along to the next steps in the care pathway for these rare diseases.
 

The whole patient

Primary care physicians will not be expected to be experts in gene therapy or solely in charge of patient safety. They will have support from industry and subspecialists leading the development of these treatments, experts agreed.

But generalists should expect to be drawn into multidisciplinary care teams, be the sounding boards for patients making decisions about gene therapy, help arrange insurance coverage, and be the recipients of late-night phone calls about side effects.

All that, while never losing sight of the child’s holistic health. In children so sick, specialists, subspecialists, and even parents tend to focus only on the rare disease. The team can “get distracted from good normal routine care,” Dr. Nelson said. But these children aren’t exempt from check-ups, vaccine regimens, or the other diseases of childhood.

“In a world where we mitigate that core disease,” he said, “we need a partner in the general pediatrics community” investing in their long-term health.

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

In Colorado and Wyoming, nearly every baby born since 2020 is tested for signs of a mutation in the SMN1 gene, an indicator of spinal muscular atrophy (SMA). And in 4 years, genetic counselor Melissa Gibbons has seen 24 positive results. She has prepped 24 different pediatricians and family doctors to deliver the news: A seemingly perfect newborn likely has a lethal genetic disease.

Most of these clinicians had never cared for a child with SMA before, nor did they know that lifesaving gene therapy for the condition now exists. Still, the physicians were foundational to getting babies emergency treatment and monitoring the child’s safety after the fact.

“They are boots on the ground for this kind of [work],” Ms. Gibbons, who is the newborn screen coordinator for SMA in both states, told this news organization. “I’m not even sure they realize it.” As of today, the U.S. Food and Drug Administration has approved 16 gene therapies for the treatment of rare and debilitating diseases once considered lethal, such as SMA and cerebral adrenoleukodystrophy.

The newest addition to the list of approvals is Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD). These conditions can now be mitigated, abated for years at a time, and even cured using treatments that tweak a patient’s DNA or RNA.

Hundreds of treatments are under development using the same mechanism. Viruses, liposomes, and other vectors of all kinds are being used to usher new genes into cells, correcting faulty copies or equipping a cell to fight disease. Cells gain the ability to make lifesaving proteins – proteins that heal wounds, restore muscle function, and fight cancer.

Within the decade, a significant fraction of the pediatric population will have gone through gene therapy, experts told this news organization. And primary care stands to be a linchpin in the scale-up of this kind of precision genetic medicine. Pediatricians and general practitioners will be central to finding and monitoring the patients that need these treatments. But the time and support doctors will need to fill that role remain scarce.

“This is a world we are creating right now, quite literally,” said Stanley Nelson, MD, director of the center for Duchenne muscular dystrophy at the University of California, Los Angeles. These cases – some before gene therapy and some after – will show up in primary care offices before the textbook is written.
 

Unknown side effects, new diseases

Even now, gene therapy is sequestered away in large academic medical research centers. The diagnosis, decision-making, and aftercare are handled by subspecialists working on clinical trials. While the research is ongoing, trial sponsors are keeping a close eye on enrolled patients. But that’s only until these drugs get market approval, Phil Beales, MD, chief medical officer at Congenica, a digital health company specializing in genome analysis support, said. Afterward, “the trialists will no longer have a role in looking after those patients.”

At that point, the role of primary care clinicians will be critically important. Although they probably will not manage gene-therapy patients on their own – comanaging them instead with subspecialists – they will be involved in the ordering and monitoring of safety labs and other tests.

General practitioners “need to know side effects because they are going to deal with side effects when someone calls them in the middle of the night,” said Dr. Beales, who also is chief executive officer of Axovia Therapeutics, a biotech company developing gene therapies.

Some of the side effects that come with gene therapy are established. Adeno-associated virus (AAV) or AAV-mediated gene therapies carry an increased risk for damage to the heart and liver, Dr. Nelson said. Other side effects are less well known and could be specific to the treatment and the tissue it targets. Primary care will be critical in detecting these unexpected side effects and expediting visits with subspecialists, he said.

In rural Wyoming, pediatricians and family doctors are especially important, Ms. Gibbons said. In the 30-90 days after gene therapy, patients need a lot of follow-up for safety reasons.

But aftercare for gene therapy will be more than just monitoring and managing side effects. The diseases themselves will change. Patients will be living with conditions that once were lethal.

In some cases, gene therapy may largely eliminate the disease. The data suggest that thalassemia, for example, can be largely cured for decades with one infusion of a patient’s genetically modified hematopoietic stem cells made using bluebird bio’s Zynteglo, according to Christy Duncan, MD, medical director of clinical research at the gene therapy program at Boston Children’s Hospital.

But other gene therapies, like the one for DMD, will offer a “spectrum of benefits,” Dr. Nelson said. They will be lifesaving, but the signs of the disease will linger. Clinicians will be learning alongside specialists what the new disease state for DMD and other rare diseases looks like after gene therapy.

“As we get hundreds of such therapies, [post–gene therapy] will amount to a substantial part of the pediatric population,” Dr. Nelson said.
 

Finding patients

Many of these rare diseases that plague young patients are unmistakable. Children with moderate or severe dystrophic epidermolysis bullosa, for instance, carry a mutation that prevents them from making type VII collagen. The babies suffer wounds and excessive bleeding and tend to receive a quick diagnosis within the first 6 months of life, according to Andy Orth, chief commercial officer at Krystal Bio, manufacturer of a new wound-healing gene therapy, Vyjuvek, for the disorder.

Other rare neurologic or muscular diseases can go undiagnosed for years. Until recently, drug companies and researchers have had little motivation to speed up the timeline because early diagnosis of a disease like DMD would not change the outcome, Dr. Nelson said.

But with gene therapy, prognoses are changing. And finding diseases early could soon mean preserving muscular function or preventing neurologic damage, Dr. Duncan said.

Newborn sequencing “is not standard of care yet, but it’s certainly coming,” Josh Peterson, MD, MPH, director of the center for precision medicine at Vanderbilt University Medical Center, in Nashville, Tenn., told this news organization.

A recent survey of 238 specialists in rare diseases found that roughly 90% believe whole-genome sequencing should be available to all newborns. And 80% of those experts endorse 42 genes as disease predictors. Screening for rare diseases at birth could reveal a host of conditions in the first week of life and expedite treatment. But this strategy will often rely on primary care and pediatricians interpreting the results.

Most pediatricians think sequencing is a great idea, but they do not feel comfortable doing it themselves, Dr. Peterson said. The good news, he said, is that manufacturers have made screening tests straightforward. Some drug companies even offer free screenings for gene therapy candidates.

Dr. Peterson predicts pediatricians will need to be equipped to deliver negative results on their own, which will be the case for around 97%-99% of patients. They also will need to be clear on whether a negative result is definitive or if more testing is warranted.

Positive results are more nuanced. Genetic counseling is the ideal resource when delivering this kind of news to patients, but counselors are a scarce resource nationally – and particularly in rural areas, Dr. Nelson said. Physicians likely will have to rely on their own counseling training to some degree.

“I feel very strongly that genetic counselors are in short supply,” Ms. Gibbons in Colorado said. Patients need a friendly resource who can talk them through the disease and how it works. And that discussion is not a one-off, she said.

The number of board-certified genetic counselors in the United States has doubled to more than 6,000 in the past 10 years – a pace that is expected to continue, according to the National Society of Genetic Counselors. “However, the geographical distribution of genetic counselors is most concentrated in urban centers.”

Equally important to the counseling experience, according to Dr. Duncan at Boston Children’s, is a primary care physician’s network of connections. The best newborn screening rollouts across the country have succeeded because clinicians knew where to send people next and how to get families the help they needed, she said.

But she also cautioned that this learning curve will soon be overwhelming. As gene therapy expands, it may be difficult for primary care doctors to keep up with the science, treatment studies, and commercially available therapies. “It’s asking too much,” Dr. Duncan said.

The structure of primary care already stretches practitioners thin and will “affect how well precision medicine can be adopted and disseminated,” Dr. Peterson said. “I think that is a key issue.”

Artificial intelligence may offer a partial solution. Some genetic counseling models already exist, but their utility for clinicians so far is limited, Dr. Beales said. But he said he expects these tools to improve rapidly to help clinicians and patients. On the patient’s end, they may be able to answer questions and supplement basic genetic counseling. On the physician’s end, algorithms could help triage patients and help move them along to the next steps in the care pathway for these rare diseases.
 

The whole patient

Primary care physicians will not be expected to be experts in gene therapy or solely in charge of patient safety. They will have support from industry and subspecialists leading the development of these treatments, experts agreed.

But generalists should expect to be drawn into multidisciplinary care teams, be the sounding boards for patients making decisions about gene therapy, help arrange insurance coverage, and be the recipients of late-night phone calls about side effects.

All that, while never losing sight of the child’s holistic health. In children so sick, specialists, subspecialists, and even parents tend to focus only on the rare disease. The team can “get distracted from good normal routine care,” Dr. Nelson said. But these children aren’t exempt from check-ups, vaccine regimens, or the other diseases of childhood.

“In a world where we mitigate that core disease,” he said, “we need a partner in the general pediatrics community” investing in their long-term health.

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

Like hundreds of other medical experts, Leana Wen, MD, an emergency physician and former Baltimore health commissioner, was an early and avid supporter of COVID vaccines and their ability to prevent severe disease, hospitalization, and death from SARS-CoV-2 infections.

When 51-year-old Scott Eli Harris, of Aubrey, Tex., heard of Dr. Wen’s stance in July 2021, the self-described “fifth-generation U.S. Army veteran and a sniper” sent Dr. Wen an electronic invective laden with racist language and very specific threats to shoot her.

Mr. Harris pled guilty to transmitting threats via interstate commerce last February and began serving 6 months in federal prison in the fall of 2022, but his threats wouldn’t be the last for Dr. Wen. Just 2 days after Mr. Harris was sentenced, charges were unsealed against another man in Massachusetts, who threatened that Dr. Wen would “end up in pieces” if she continued “pushing” her thoughts publicly.’

Dr. Wen has plenty of company. In an August 2022 survey of emergency doctors conducted by the American College of Emergency Physicians, 85% of respondents said violence against them is increasing. One in four doctors said they’re being assaulted by patients and their family and friends multiple times a week, compared with just 8% of doctors who said as much in 2018. About 64% of emergency physicians reported receiving verbal assaults and threats of violence; 40% reported being hit or slapped, and 26% were kicked.

This uptick of violence and threats against physicians didn’t come out of nowhere; violence against health care workers has been gradually increasing over the past decade. Health care providers can attest to the hostility that particular topics have sparked for years: vaccines in pediatrics, abortion in ob.gyn., and gender-affirming care in endocrinology.

But the pandemic fueled the fire. While there have always been hot-button issues in medicine, the ire they arouse today is more intense than ever before. The proliferation of misinformation (often via social media) and the politicization of public health and medicine are at the center of the problem.
 

‘The people attacking are themselves victims’

The misinformation problem first came to a head in one area of public health: vaccines. The pandemic accelerated antagonism in medicine – thanks, in part, to decades of antivaccine activism.

The antivaccine movement, which has ebbed and flowed in the United States and across the globe since the first vaccine, experienced a new wave in the early 2000s with the combination of concerns about thimerosal in vaccines and a now disproven link between autism and the MMR vaccine. But that movement grew. It picked up steam when activists gained political clout after a 2014 measles outbreak at Disneyland led California schools to tighten up policies regarding vaccinations for kids who enrolled. These stronger public school vaccination laws ran up against religious freedom arguments from antivaccine advocates.

Use of social media continues to grow, and with it, the spread of misinformation. A recent study found that Facebook “users’ social media habits doubled, and in some cases, tripled the amount of fake news they shared.”

In the face of growing confusion, health care providers and public health experts have often struggled to treat their patients – and communicate to the public – without appearing political.

“The people that are doing the attacking are in some ways themselves victims,” said Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, Houston. “They’re victims of the antiscience, antihealth ecosystem coming out of Fox News, the House Freedom Caucus, the CPAC conference, coming out of contrarian intellectuals.”

Many of Dr. Hotez’s colleagues don’t want to talk about the political right as an enabler of scientific disinformation, he said, but that doesn’t change what the evidence shows. The vast majority of state and national bills opposing vaccination, gender-affirming care, comprehensive reproductive care, and other evidence-based medical care often come from Republican legislators.
 

When politics and health care collide

“We’re in an incredible status quo,” said William Schaffner, MD, the previous director of the Infectious Diseases Society of America and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “You can’t get away from the politics, because you have [political] candidates espousing certain concepts that are antithetical to good public health.”

In March 2023, Florida Gov. Ron DeSantis’s surgeon general, Joseph Ladapo, MD, PhD, warned that COVID vaccines are harmful to young men, prompting rebukes from federal health authorities. It later came out that Dr. Ladapo had changed some of the results of the study before issuing his warning. But long before 2023, there emerged an increasing gap in COVID deaths between red states and blue states, mirroring the vaccination rates in those states. The redder the state, the higher the death toll.

It’s not just Republican Party culture warriors; medical misinformation is also finding increasing purchase on the far left. Robert F. Kennedy Jr. and Marianne Williamson, both of whom have launched long-shot challenges to President Biden for the 2024 Democratic nomination, had promoted antivaccine ideas long before the COVID pandemic. Mr. Kennedy continues to spread misinformation.

In June 2023, Joe Rogan hosted Mr. Kennedy, on his podcast. During the episode, Mr. Rogan listened uncritically as Mr. Kennedy told his millions of listeners that vaccines cause autism and that 5G causes cancer, among other fringe, often-debunked theories.

Dr. Hotez, a prominent misinformation debunker who was also part of a team that designed a low-cost COVID-19 vaccine, wrote on Twitter that the episode was “just awful.”

The backlash began almost immediately. Mr. Rogan, who has over 11 million followers on Twitter, responded with a public challenge for Dr. Hotez to debate Mr. Kennedy on Mr. Rogan’s show, with a reward of $100,000 to the charity of Dr. Hotez’s choice. More offers streamed in, including from Elon Musk, who tweeted that Dr. Hotez was “afraid of a public debate, because he knows he’s wrong.” More supporters of Mr. Kennedy and Mr. Rogan piled on.

Vaccine skeptics even showed up at Dr. Hotez’s house, filming him as he was returning from buying a Father’s Day cake and taunting him to debate Mr. Kennedy.
 

A turn in the pandemic

For a precious few weeks at the start of the pandemic, it felt as though the country was all in this together. There were arguments against closing schools and shutting down businesses, but for the most part, the nation had about 4 solid weeks of solidarity.

As masking mandates changed and the public health establishment lost the confidence of Americans, the veneer of solidarity began to chip away.

“Things were changing so rapidly during the pandemic that it was very hard for staff and patients to understand the changing guidelines, whether it was visitor constraints or masking,” said Carrie Nelson, the chief medical officer at the telehealth company AmWell, who worked as a supervisor at a large health care system in the Midwest until 2021.

In the midst of the public health crisis, former President Trump was downplaying the severity of the disease and was silencing officials from the Centers for Disease Control and Prevention, such as Nancy Messonier, who warned from the very beginning of the pandemic’s potential.

When the vaccines came out, the latent antivaccine movement flared up once again. And this time – unlike in decades past – the debate over vaccines had become partisan.

“Before the pandemic,” said Christopher Thomas, an emergency physician on the West Coast who requested that a pseudonym be used because of personal threats he has received, “patients wouldn’t really challenge me or throw out weird questions.” It’s not that he never encountered pushback, but the stakes felt lower, and people largely deferred to his medical expertise. “If we got a parent who had not vaccinated their child, I would totally engage back then,” Dr. Thomas said.

But the pandemic – and America’s response to it – changed the conversation. “The rhetoric ... switched from downplaying the virus to demonizing the vaccines,” Dr. Thomas said.
 

The toll on health care professionals

By the time vaccines were available, the public had begun to conflate doctors with public health experts, since both were “pushing” the vaccine.

“Most people probably don’t really know the difference between clinical medicine and public health,” said Richard Pan, MD, MPH, a pediatrician and California legislator who sponsored two bills – now laws – that strengthened state childhood vaccination requirements.

At first, it was clearly public health officials, such as Anthony Fauci, MD, who were the face of measures to mitigate the virus. But as doctors became the enforcers of those measures, the line between physicians and public health officials blurred.

A lot of the anger then shifted toward doctors, nurses, and other health care professionals, Dr. Pan said, “because we were, of course, the ones who would be administering the vaccines. They don’t really think of their doctor as a government person until your doctor is carrying a [government] message.”

Given the pressures and struggles of the past few years, it’s no surprise that burnout among health care professionals is high. According to an April 2023 study by the National Council of State Boards of Nursing and the National Forum of State Nursing Workforce Centers, an estimated 800,000 nurses expect to leave the profession by 2027, driven first and foremost by “stress and burnout.”

All of these departures in medicine’s “great resignation” have left hospitals and health care organizations even more short staffed, thereby increasing even more the pressure and burnout on those left.

The pandemic had already badly exacerbated the already widespread problem of burnout in the medical field, which Ms. Nelson said has contributed to the tension.

“The burnout problem that we have in health care is not a good basis for the development of a good therapeutic relationship,” Ms. Nelson said. “Burnout is fraught with apathy and desensitization to human emotions. It takes away the empathy that we once had for people that we see.”
 

What comes next?

Almost exactly 3 years after the world learned about SARS-CoV-2, Biden declared an end to the coronavirus public health emergency in April 2023. Yet, Americans continue to die from COVID, and the anger that bloomed and spread has not abated.

“I think we’re in a new steady state of violence in health care settings,” Ms. Nelson said. “It’s not gone down, because people are still very distressed.” That’s evident from the high prevalence of mental health conditions, the financial strain of first the pandemic and then inflation, and the overall traumatic impact the pandemic had on people, whether they recognize it or not.

The first step to solving any problem is, as the saying goes, to admit that there is a problem.

“I think people need to start stepping out of their comfort bubbles and start to look at things that make them uncomfortable,” Dr. Thomas said, but he doesn’t see that happening any time soon. “I’ve been very let down by physicians and embarrassed by the American physician organizations.”

The medical board in his state, he said, has stood by as some doctors continue misrepresenting medical evidence. “That’s been really, really hard on me. I didn’t think that the medical boards would go so far as to look the other way for something that was this tremendously bad.”

There are others who can take the lead – if they’re willing.

“There are some things the medical societies and academic health centers can do,” Dr. Hotez said, “starting with building up a culture of physicians and health care providers feeling comfortable in the public domain.” He said the messaging when he was getting his degrees was not to engage the public and not to talk to journalists because that was “self-promotion” or “grandstanding.” But the world is different now. Health care professionals need training in public engagement and communication, he said, and the culture needs to change so that health care providers feel comfortable speaking out without feeling “the sword of Damocles over their heads” every time they talk to a reporter, Dr. Hotez said.

There may be no silver bullet to solve the big-picture trust problem in medicine and public health. No TV appearance or quote in an article can solve it. But on an individual level — through careful relationship building with patients – doctors can strengthen that trust.

Telehealth may help with that, but there’s a fine balance there, Ms. Nelson cautioned. On the one hand, with the doctor and the patient each in their own private spaces, where they feel safe and comfortable, the overall experience can be more therapeutic and less stressful. At the same time, telehealth can pile on change-management tasks that can exacerbate burnout, “so it’s a delicate thing we have to approach.”

One very thin silver lining that could emerge from the way in which patients have begun to try to take charge of their care.

“They should fully understand the reasoning behind the recommendations that physicians are making,” Ms. Nelson said. “I’d like to see us get to a happy medium where it’s a partnership. We can’t go back to the old school where the doctor knows best and you don’t ever question him.

“What we need is the partnership, and I would love to see that as the silver lining, but the anger has got to settle down in order for that kind of productive thing to happen.”

As for the big picture? There’s a limit to what even society’s “miracle workers” can do. “The biggest priority right now for the health system is to protect their staff whatever way they can and do some training in deescalation,” Ms. Nelson said. “But I don’t think health care can solve the societal issues that seem to be creating this.”

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

Like hundreds of other medical experts, Leana Wen, MD, an emergency physician and former Baltimore health commissioner, was an early and avid supporter of COVID vaccines and their ability to prevent severe disease, hospitalization, and death from SARS-CoV-2 infections.

When 51-year-old Scott Eli Harris, of Aubrey, Tex., heard of Dr. Wen’s stance in July 2021, the self-described “fifth-generation U.S. Army veteran and a sniper” sent Dr. Wen an electronic invective laden with racist language and very specific threats to shoot her.

Mr. Harris pled guilty to transmitting threats via interstate commerce last February and began serving 6 months in federal prison in the fall of 2022, but his threats wouldn’t be the last for Dr. Wen. Just 2 days after Mr. Harris was sentenced, charges were unsealed against another man in Massachusetts, who threatened that Dr. Wen would “end up in pieces” if she continued “pushing” her thoughts publicly.’

Dr. Wen has plenty of company. In an August 2022 survey of emergency doctors conducted by the American College of Emergency Physicians, 85% of respondents said violence against them is increasing. One in four doctors said they’re being assaulted by patients and their family and friends multiple times a week, compared with just 8% of doctors who said as much in 2018. About 64% of emergency physicians reported receiving verbal assaults and threats of violence; 40% reported being hit or slapped, and 26% were kicked.

This uptick of violence and threats against physicians didn’t come out of nowhere; violence against health care workers has been gradually increasing over the past decade. Health care providers can attest to the hostility that particular topics have sparked for years: vaccines in pediatrics, abortion in ob.gyn., and gender-affirming care in endocrinology.

But the pandemic fueled the fire. While there have always been hot-button issues in medicine, the ire they arouse today is more intense than ever before. The proliferation of misinformation (often via social media) and the politicization of public health and medicine are at the center of the problem.
 

‘The people attacking are themselves victims’

The misinformation problem first came to a head in one area of public health: vaccines. The pandemic accelerated antagonism in medicine – thanks, in part, to decades of antivaccine activism.

The antivaccine movement, which has ebbed and flowed in the United States and across the globe since the first vaccine, experienced a new wave in the early 2000s with the combination of concerns about thimerosal in vaccines and a now disproven link between autism and the MMR vaccine. But that movement grew. It picked up steam when activists gained political clout after a 2014 measles outbreak at Disneyland led California schools to tighten up policies regarding vaccinations for kids who enrolled. These stronger public school vaccination laws ran up against religious freedom arguments from antivaccine advocates.

Use of social media continues to grow, and with it, the spread of misinformation. A recent study found that Facebook “users’ social media habits doubled, and in some cases, tripled the amount of fake news they shared.”

In the face of growing confusion, health care providers and public health experts have often struggled to treat their patients – and communicate to the public – without appearing political.

“The people that are doing the attacking are in some ways themselves victims,” said Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, Houston. “They’re victims of the antiscience, antihealth ecosystem coming out of Fox News, the House Freedom Caucus, the CPAC conference, coming out of contrarian intellectuals.”

Many of Dr. Hotez’s colleagues don’t want to talk about the political right as an enabler of scientific disinformation, he said, but that doesn’t change what the evidence shows. The vast majority of state and national bills opposing vaccination, gender-affirming care, comprehensive reproductive care, and other evidence-based medical care often come from Republican legislators.
 

When politics and health care collide

“We’re in an incredible status quo,” said William Schaffner, MD, the previous director of the Infectious Diseases Society of America and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “You can’t get away from the politics, because you have [political] candidates espousing certain concepts that are antithetical to good public health.”

In March 2023, Florida Gov. Ron DeSantis’s surgeon general, Joseph Ladapo, MD, PhD, warned that COVID vaccines are harmful to young men, prompting rebukes from federal health authorities. It later came out that Dr. Ladapo had changed some of the results of the study before issuing his warning. But long before 2023, there emerged an increasing gap in COVID deaths between red states and blue states, mirroring the vaccination rates in those states. The redder the state, the higher the death toll.

It’s not just Republican Party culture warriors; medical misinformation is also finding increasing purchase on the far left. Robert F. Kennedy Jr. and Marianne Williamson, both of whom have launched long-shot challenges to President Biden for the 2024 Democratic nomination, had promoted antivaccine ideas long before the COVID pandemic. Mr. Kennedy continues to spread misinformation.

In June 2023, Joe Rogan hosted Mr. Kennedy, on his podcast. During the episode, Mr. Rogan listened uncritically as Mr. Kennedy told his millions of listeners that vaccines cause autism and that 5G causes cancer, among other fringe, often-debunked theories.

Dr. Hotez, a prominent misinformation debunker who was also part of a team that designed a low-cost COVID-19 vaccine, wrote on Twitter that the episode was “just awful.”

The backlash began almost immediately. Mr. Rogan, who has over 11 million followers on Twitter, responded with a public challenge for Dr. Hotez to debate Mr. Kennedy on Mr. Rogan’s show, with a reward of $100,000 to the charity of Dr. Hotez’s choice. More offers streamed in, including from Elon Musk, who tweeted that Dr. Hotez was “afraid of a public debate, because he knows he’s wrong.” More supporters of Mr. Kennedy and Mr. Rogan piled on.

Vaccine skeptics even showed up at Dr. Hotez’s house, filming him as he was returning from buying a Father’s Day cake and taunting him to debate Mr. Kennedy.
 

A turn in the pandemic

For a precious few weeks at the start of the pandemic, it felt as though the country was all in this together. There were arguments against closing schools and shutting down businesses, but for the most part, the nation had about 4 solid weeks of solidarity.

As masking mandates changed and the public health establishment lost the confidence of Americans, the veneer of solidarity began to chip away.

“Things were changing so rapidly during the pandemic that it was very hard for staff and patients to understand the changing guidelines, whether it was visitor constraints or masking,” said Carrie Nelson, the chief medical officer at the telehealth company AmWell, who worked as a supervisor at a large health care system in the Midwest until 2021.

In the midst of the public health crisis, former President Trump was downplaying the severity of the disease and was silencing officials from the Centers for Disease Control and Prevention, such as Nancy Messonier, who warned from the very beginning of the pandemic’s potential.

When the vaccines came out, the latent antivaccine movement flared up once again. And this time – unlike in decades past – the debate over vaccines had become partisan.

“Before the pandemic,” said Christopher Thomas, an emergency physician on the West Coast who requested that a pseudonym be used because of personal threats he has received, “patients wouldn’t really challenge me or throw out weird questions.” It’s not that he never encountered pushback, but the stakes felt lower, and people largely deferred to his medical expertise. “If we got a parent who had not vaccinated their child, I would totally engage back then,” Dr. Thomas said.

But the pandemic – and America’s response to it – changed the conversation. “The rhetoric ... switched from downplaying the virus to demonizing the vaccines,” Dr. Thomas said.
 

The toll on health care professionals

By the time vaccines were available, the public had begun to conflate doctors with public health experts, since both were “pushing” the vaccine.

“Most people probably don’t really know the difference between clinical medicine and public health,” said Richard Pan, MD, MPH, a pediatrician and California legislator who sponsored two bills – now laws – that strengthened state childhood vaccination requirements.

At first, it was clearly public health officials, such as Anthony Fauci, MD, who were the face of measures to mitigate the virus. But as doctors became the enforcers of those measures, the line between physicians and public health officials blurred.

A lot of the anger then shifted toward doctors, nurses, and other health care professionals, Dr. Pan said, “because we were, of course, the ones who would be administering the vaccines. They don’t really think of their doctor as a government person until your doctor is carrying a [government] message.”

Given the pressures and struggles of the past few years, it’s no surprise that burnout among health care professionals is high. According to an April 2023 study by the National Council of State Boards of Nursing and the National Forum of State Nursing Workforce Centers, an estimated 800,000 nurses expect to leave the profession by 2027, driven first and foremost by “stress and burnout.”

All of these departures in medicine’s “great resignation” have left hospitals and health care organizations even more short staffed, thereby increasing even more the pressure and burnout on those left.

The pandemic had already badly exacerbated the already widespread problem of burnout in the medical field, which Ms. Nelson said has contributed to the tension.

“The burnout problem that we have in health care is not a good basis for the development of a good therapeutic relationship,” Ms. Nelson said. “Burnout is fraught with apathy and desensitization to human emotions. It takes away the empathy that we once had for people that we see.”
 

What comes next?

Almost exactly 3 years after the world learned about SARS-CoV-2, Biden declared an end to the coronavirus public health emergency in April 2023. Yet, Americans continue to die from COVID, and the anger that bloomed and spread has not abated.

“I think we’re in a new steady state of violence in health care settings,” Ms. Nelson said. “It’s not gone down, because people are still very distressed.” That’s evident from the high prevalence of mental health conditions, the financial strain of first the pandemic and then inflation, and the overall traumatic impact the pandemic had on people, whether they recognize it or not.

The first step to solving any problem is, as the saying goes, to admit that there is a problem.

“I think people need to start stepping out of their comfort bubbles and start to look at things that make them uncomfortable,” Dr. Thomas said, but he doesn’t see that happening any time soon. “I’ve been very let down by physicians and embarrassed by the American physician organizations.”

The medical board in his state, he said, has stood by as some doctors continue misrepresenting medical evidence. “That’s been really, really hard on me. I didn’t think that the medical boards would go so far as to look the other way for something that was this tremendously bad.”

There are others who can take the lead – if they’re willing.

“There are some things the medical societies and academic health centers can do,” Dr. Hotez said, “starting with building up a culture of physicians and health care providers feeling comfortable in the public domain.” He said the messaging when he was getting his degrees was not to engage the public and not to talk to journalists because that was “self-promotion” or “grandstanding.” But the world is different now. Health care professionals need training in public engagement and communication, he said, and the culture needs to change so that health care providers feel comfortable speaking out without feeling “the sword of Damocles over their heads” every time they talk to a reporter, Dr. Hotez said.

There may be no silver bullet to solve the big-picture trust problem in medicine and public health. No TV appearance or quote in an article can solve it. But on an individual level — through careful relationship building with patients – doctors can strengthen that trust.

Telehealth may help with that, but there’s a fine balance there, Ms. Nelson cautioned. On the one hand, with the doctor and the patient each in their own private spaces, where they feel safe and comfortable, the overall experience can be more therapeutic and less stressful. At the same time, telehealth can pile on change-management tasks that can exacerbate burnout, “so it’s a delicate thing we have to approach.”

One very thin silver lining that could emerge from the way in which patients have begun to try to take charge of their care.

“They should fully understand the reasoning behind the recommendations that physicians are making,” Ms. Nelson said. “I’d like to see us get to a happy medium where it’s a partnership. We can’t go back to the old school where the doctor knows best and you don’t ever question him.

“What we need is the partnership, and I would love to see that as the silver lining, but the anger has got to settle down in order for that kind of productive thing to happen.”

As for the big picture? There’s a limit to what even society’s “miracle workers” can do. “The biggest priority right now for the health system is to protect their staff whatever way they can and do some training in deescalation,” Ms. Nelson said. “But I don’t think health care can solve the societal issues that seem to be creating this.”

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

Like hundreds of other medical experts, Leana Wen, MD, an emergency physician and former Baltimore health commissioner, was an early and avid supporter of COVID vaccines and their ability to prevent severe disease, hospitalization, and death from SARS-CoV-2 infections.

When 51-year-old Scott Eli Harris, of Aubrey, Tex., heard of Dr. Wen’s stance in July 2021, the self-described “fifth-generation U.S. Army veteran and a sniper” sent Dr. Wen an electronic invective laden with racist language and very specific threats to shoot her.

Mr. Harris pled guilty to transmitting threats via interstate commerce last February and began serving 6 months in federal prison in the fall of 2022, but his threats wouldn’t be the last for Dr. Wen. Just 2 days after Mr. Harris was sentenced, charges were unsealed against another man in Massachusetts, who threatened that Dr. Wen would “end up in pieces” if she continued “pushing” her thoughts publicly.’

Dr. Wen has plenty of company. In an August 2022 survey of emergency doctors conducted by the American College of Emergency Physicians, 85% of respondents said violence against them is increasing. One in four doctors said they’re being assaulted by patients and their family and friends multiple times a week, compared with just 8% of doctors who said as much in 2018. About 64% of emergency physicians reported receiving verbal assaults and threats of violence; 40% reported being hit or slapped, and 26% were kicked.

This uptick of violence and threats against physicians didn’t come out of nowhere; violence against health care workers has been gradually increasing over the past decade. Health care providers can attest to the hostility that particular topics have sparked for years: vaccines in pediatrics, abortion in ob.gyn., and gender-affirming care in endocrinology.

But the pandemic fueled the fire. While there have always been hot-button issues in medicine, the ire they arouse today is more intense than ever before. The proliferation of misinformation (often via social media) and the politicization of public health and medicine are at the center of the problem.
 

‘The people attacking are themselves victims’

The misinformation problem first came to a head in one area of public health: vaccines. The pandemic accelerated antagonism in medicine – thanks, in part, to decades of antivaccine activism.

The antivaccine movement, which has ebbed and flowed in the United States and across the globe since the first vaccine, experienced a new wave in the early 2000s with the combination of concerns about thimerosal in vaccines and a now disproven link between autism and the MMR vaccine. But that movement grew. It picked up steam when activists gained political clout after a 2014 measles outbreak at Disneyland led California schools to tighten up policies regarding vaccinations for kids who enrolled. These stronger public school vaccination laws ran up against religious freedom arguments from antivaccine advocates.

Use of social media continues to grow, and with it, the spread of misinformation. A recent study found that Facebook “users’ social media habits doubled, and in some cases, tripled the amount of fake news they shared.”

In the face of growing confusion, health care providers and public health experts have often struggled to treat their patients – and communicate to the public – without appearing political.

“The people that are doing the attacking are in some ways themselves victims,” said Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, Houston. “They’re victims of the antiscience, antihealth ecosystem coming out of Fox News, the House Freedom Caucus, the CPAC conference, coming out of contrarian intellectuals.”

Many of Dr. Hotez’s colleagues don’t want to talk about the political right as an enabler of scientific disinformation, he said, but that doesn’t change what the evidence shows. The vast majority of state and national bills opposing vaccination, gender-affirming care, comprehensive reproductive care, and other evidence-based medical care often come from Republican legislators.
 

When politics and health care collide

“We’re in an incredible status quo,” said William Schaffner, MD, the previous director of the Infectious Diseases Society of America and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “You can’t get away from the politics, because you have [political] candidates espousing certain concepts that are antithetical to good public health.”

In March 2023, Florida Gov. Ron DeSantis’s surgeon general, Joseph Ladapo, MD, PhD, warned that COVID vaccines are harmful to young men, prompting rebukes from federal health authorities. It later came out that Dr. Ladapo had changed some of the results of the study before issuing his warning. But long before 2023, there emerged an increasing gap in COVID deaths between red states and blue states, mirroring the vaccination rates in those states. The redder the state, the higher the death toll.

It’s not just Republican Party culture warriors; medical misinformation is also finding increasing purchase on the far left. Robert F. Kennedy Jr. and Marianne Williamson, both of whom have launched long-shot challenges to President Biden for the 2024 Democratic nomination, had promoted antivaccine ideas long before the COVID pandemic. Mr. Kennedy continues to spread misinformation.

In June 2023, Joe Rogan hosted Mr. Kennedy, on his podcast. During the episode, Mr. Rogan listened uncritically as Mr. Kennedy told his millions of listeners that vaccines cause autism and that 5G causes cancer, among other fringe, often-debunked theories.

Dr. Hotez, a prominent misinformation debunker who was also part of a team that designed a low-cost COVID-19 vaccine, wrote on Twitter that the episode was “just awful.”

The backlash began almost immediately. Mr. Rogan, who has over 11 million followers on Twitter, responded with a public challenge for Dr. Hotez to debate Mr. Kennedy on Mr. Rogan’s show, with a reward of $100,000 to the charity of Dr. Hotez’s choice. More offers streamed in, including from Elon Musk, who tweeted that Dr. Hotez was “afraid of a public debate, because he knows he’s wrong.” More supporters of Mr. Kennedy and Mr. Rogan piled on.

Vaccine skeptics even showed up at Dr. Hotez’s house, filming him as he was returning from buying a Father’s Day cake and taunting him to debate Mr. Kennedy.
 

A turn in the pandemic

For a precious few weeks at the start of the pandemic, it felt as though the country was all in this together. There were arguments against closing schools and shutting down businesses, but for the most part, the nation had about 4 solid weeks of solidarity.

As masking mandates changed and the public health establishment lost the confidence of Americans, the veneer of solidarity began to chip away.

“Things were changing so rapidly during the pandemic that it was very hard for staff and patients to understand the changing guidelines, whether it was visitor constraints or masking,” said Carrie Nelson, the chief medical officer at the telehealth company AmWell, who worked as a supervisor at a large health care system in the Midwest until 2021.

In the midst of the public health crisis, former President Trump was downplaying the severity of the disease and was silencing officials from the Centers for Disease Control and Prevention, such as Nancy Messonier, who warned from the very beginning of the pandemic’s potential.

When the vaccines came out, the latent antivaccine movement flared up once again. And this time – unlike in decades past – the debate over vaccines had become partisan.

“Before the pandemic,” said Christopher Thomas, an emergency physician on the West Coast who requested that a pseudonym be used because of personal threats he has received, “patients wouldn’t really challenge me or throw out weird questions.” It’s not that he never encountered pushback, but the stakes felt lower, and people largely deferred to his medical expertise. “If we got a parent who had not vaccinated their child, I would totally engage back then,” Dr. Thomas said.

But the pandemic – and America’s response to it – changed the conversation. “The rhetoric ... switched from downplaying the virus to demonizing the vaccines,” Dr. Thomas said.
 

The toll on health care professionals

By the time vaccines were available, the public had begun to conflate doctors with public health experts, since both were “pushing” the vaccine.

“Most people probably don’t really know the difference between clinical medicine and public health,” said Richard Pan, MD, MPH, a pediatrician and California legislator who sponsored two bills – now laws – that strengthened state childhood vaccination requirements.

At first, it was clearly public health officials, such as Anthony Fauci, MD, who were the face of measures to mitigate the virus. But as doctors became the enforcers of those measures, the line between physicians and public health officials blurred.

A lot of the anger then shifted toward doctors, nurses, and other health care professionals, Dr. Pan said, “because we were, of course, the ones who would be administering the vaccines. They don’t really think of their doctor as a government person until your doctor is carrying a [government] message.”

Given the pressures and struggles of the past few years, it’s no surprise that burnout among health care professionals is high. According to an April 2023 study by the National Council of State Boards of Nursing and the National Forum of State Nursing Workforce Centers, an estimated 800,000 nurses expect to leave the profession by 2027, driven first and foremost by “stress and burnout.”

All of these departures in medicine’s “great resignation” have left hospitals and health care organizations even more short staffed, thereby increasing even more the pressure and burnout on those left.

The pandemic had already badly exacerbated the already widespread problem of burnout in the medical field, which Ms. Nelson said has contributed to the tension.

“The burnout problem that we have in health care is not a good basis for the development of a good therapeutic relationship,” Ms. Nelson said. “Burnout is fraught with apathy and desensitization to human emotions. It takes away the empathy that we once had for people that we see.”
 

What comes next?

Almost exactly 3 years after the world learned about SARS-CoV-2, Biden declared an end to the coronavirus public health emergency in April 2023. Yet, Americans continue to die from COVID, and the anger that bloomed and spread has not abated.

“I think we’re in a new steady state of violence in health care settings,” Ms. Nelson said. “It’s not gone down, because people are still very distressed.” That’s evident from the high prevalence of mental health conditions, the financial strain of first the pandemic and then inflation, and the overall traumatic impact the pandemic had on people, whether they recognize it or not.

The first step to solving any problem is, as the saying goes, to admit that there is a problem.

“I think people need to start stepping out of their comfort bubbles and start to look at things that make them uncomfortable,” Dr. Thomas said, but he doesn’t see that happening any time soon. “I’ve been very let down by physicians and embarrassed by the American physician organizations.”

The medical board in his state, he said, has stood by as some doctors continue misrepresenting medical evidence. “That’s been really, really hard on me. I didn’t think that the medical boards would go so far as to look the other way for something that was this tremendously bad.”

There are others who can take the lead – if they’re willing.

“There are some things the medical societies and academic health centers can do,” Dr. Hotez said, “starting with building up a culture of physicians and health care providers feeling comfortable in the public domain.” He said the messaging when he was getting his degrees was not to engage the public and not to talk to journalists because that was “self-promotion” or “grandstanding.” But the world is different now. Health care professionals need training in public engagement and communication, he said, and the culture needs to change so that health care providers feel comfortable speaking out without feeling “the sword of Damocles over their heads” every time they talk to a reporter, Dr. Hotez said.

There may be no silver bullet to solve the big-picture trust problem in medicine and public health. No TV appearance or quote in an article can solve it. But on an individual level — through careful relationship building with patients – doctors can strengthen that trust.

Telehealth may help with that, but there’s a fine balance there, Ms. Nelson cautioned. On the one hand, with the doctor and the patient each in their own private spaces, where they feel safe and comfortable, the overall experience can be more therapeutic and less stressful. At the same time, telehealth can pile on change-management tasks that can exacerbate burnout, “so it’s a delicate thing we have to approach.”

One very thin silver lining that could emerge from the way in which patients have begun to try to take charge of their care.

“They should fully understand the reasoning behind the recommendations that physicians are making,” Ms. Nelson said. “I’d like to see us get to a happy medium where it’s a partnership. We can’t go back to the old school where the doctor knows best and you don’t ever question him.

“What we need is the partnership, and I would love to see that as the silver lining, but the anger has got to settle down in order for that kind of productive thing to happen.”

As for the big picture? There’s a limit to what even society’s “miracle workers” can do. “The biggest priority right now for the health system is to protect their staff whatever way they can and do some training in deescalation,” Ms. Nelson said. “But I don’t think health care can solve the societal issues that seem to be creating this.”

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

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

Choosing the right partner to add to your practice takes planning and strategic decision-making. When the match is right, the benefits can be significant: more hands to share the load of running a medical practice, and increased revenue and expanded patient population. A partner can bring in new, complementary strengths and skills. Adding a partner is also a way to prepare for the future by setting your practice up for a smooth transition if you or another partner is looking toward retirement.

But a mismatched partnership can cost you time and money, not to mention endless amount of conflict, dysfunction, and liability. Mutual trust and a long-term commitment on both sides are critical.

“Just like with marriage, it can be very difficult, traumatic, and expensive to break up with a partner,” said Clifton Straughn, MD, partner at Direct Access MD, a concierge-service model family practice in Anderson, S.C. “So, do your due diligence and take your time.” Picking the right partner is essential.
 

The basics

Before you begin the process of partnership with a physician, be sure you know what you need, the skill sets you’re looking for to complement your practice, and the personality characteristics and values that are important to you so the person you choose can check all the boxes and not just add a name to the letterhead.

“A lot of times, doctors go into this with just a general idea that they need more doctors or that they would like to be bigger or have more clout,” said Tim Boden, a certified medical practice executive with over 40 years of experience. “But you have to understand that to a certain degree, if you’re bringing somebody in who has basically an identical clinical profile to yours, you’re going to be sacrificing a bit of your lunch for a while until that person builds a name for himself or herself. A new partner’s skill set should match the need that you’re trying to fill.”

Figure out and discuss with your current partners how much it will cost to bring in a partner between their compensation and additional practice expenses. How much revenue will you expect the partner to generate? Will your practice break even the first year or the second? And how will you cover any shortfall?

It’s also essential to understand how the day-to-day operation of your practice will change after you add another partner.

• Will the new partner’s percentage of ownership be the same as that of the other partners?
• Will their ownership include a percentage of the facility, equipment, supplies, and accounts receivable?
• How will you split call and work hours?
• How will decision-making work?
• How would buyout work if a partner were to leave the practice, and is there a minimum obligation, such as a 5-year commitment?

As a team, you may also want to discuss “soft skills,” or the way you’d hope a partner would represent your practice to patients and the community.

“These can be harder to quantify,” said Dr. Straughn. “Evaluating them can take artful questions and simple observation over time.”
 

It’s a slow process

Many practices offer paths to partnership rather than bringing in a partner straight away. With this process, an incoming physician works toward that goal. If you’re going this route, discuss this during the hiring process, so that both sides are clear about the process. Rule No. 1 is to make sure that new hires understand that partnership is possible, although it’s not a given. The typical partnership track is 2-3 years, but you can set the timeline that works best for your practice.

Mr. Boden recommends at least a year for this period so as to allow you the opportunity to evaluate the new member, how they work, and how they fit with your team. The partnership track method is typically for young or fairly new physicians.

“I would avoid ever promising an ownership position to a recruit,” said Mr. Boden. “I would only show them how it can happen and what it would look like if they qualify.”
 

Consider professional help

If you want to be sure you weigh all the pros and cons of your new partner, a medical practice consultant may be the way to go. A consultant can identify many situations that you might overlook.

Some services offer a medical practice assessment to help you see where you need the most help and what skills might be best to bring to the table. They might also be able to take over some of the administrative work of a new hire if you like, so you and the other partners can focus solely on interacting with and observing the clinical abilities of a potential partner.

A health care attorney can help you build a sound agreement regarding decision-making and how the fees/costs will be divided and can put legal protections in place for everyone involved.

You’ll need a buy-sell agreement (also called a partnership or shareholder agreement) that spells out the terms and conditions, including buying into and selling out of the practice. A fair agreement respects all parties, while a poor one that offers the new partner a minority share or lessor profit may favor the practice’s current partners but could breed resentment, undermining the practice’s culture and morale.
 

Takeaway

Ideally, you’ll select someone with excellent credentials and experience with similar goals for the practice who blends well with your staff. It’s best to find someone who fits well culturally with your office and who practices medicine with a similar patient philosophy.

To that end, Mr. Boden encourages out-of-the-box questions for interviews, such as what a potential partner wants to make sure they have room for in their life, or what their ideal work and family life looks like. The more you can assess components such as emotional intelligence, =the fuller picture you’ll get.

“You’re going to be spending major hours every week with this person, and your destiny is going to be tied up with theirs to some degree,” said Mr. Boden. You can teach somebody the job, but if you don’t genuinely like and respect them and want to work with them daily, it may not be the right fit.

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

The U.S. Preventive Services Task Force has again determined that current evidence is insufficient to recommend screening for lipid disorders among asymptomatic children and patients aged 20 years or younger.

The group’s final recommendation and corresponding evidence report were published  in the Journal of the American Medical Association, following a draft recommendation in January.

The organization reached a similar conclusion following its evaluation in 2016.

“There’s just not enough evidence to determine whether or not screening all children for high cholesterol improves their heart health into adulthood,” said Katrina Donahue, MD, MPH, a USPSTF member and a professor in the department of family medicine at the University of North Carolina at Chapel Hill. “We’re calling for additional research on the effectiveness of screening for and treatment of high cholesterol in children and adolescents to prevent heart attacks, strokes, and death in adulthood.”

The task force recommended other evidence-based strategies to promote heart health, such as screening for obesity and interventions to prevent tobacco use.

The recommendation was the result of a review of 43 studies from MEDLINE and the Cochrane Central Register of Controlled Trials through May 16, 2022. No randomized controlled trial directly addressed the effectiveness or harms of lipid screening for children and adolescents. The task force continued to use article alerts and targeted journal searches through March 24, 2023.

Conditions such as familial hypercholesterolemia and multifactorial dyslipidemia can cause abnormally high lipid levels in children, potentially leading to premature cardiovascular events such as myocardial infarction, stroke, and death in adulthood. According to the USPSTF, the prevalence of FH in U.S. children and adolescents ranges from 0.2% to 0.4% (one in every 250-500 youth). Multifactorial dyslipidemia is more common – the prevalence in children and adolescents ranges from 7.1% to 9.4%.

In an editorial response to the task force’s statement, the authors, including Sarah D. de Ferranti, MD, department of pediatrics at Harvard Medical School, Boston, question the impact of not screening children to identify FH and other conditions and caution against the subsequent delay in treatment.

“Treating FH during childhood slows the progression of vascular finding in atherosclerosis,” the authors write.

They note that the recommendation “leaves a void for clinicians seeking to provide care for patients today” while additional research is conducted.

Sarah Nosal, MD, a member of the board of directors of the American Academy of Family Physicians, said that despite the lack of a recommendation, primary care clinicians can still encourage proper nutrition and physical activity for patients.

Dr. Nosal said that even without clear recommendations from the USPSTF, in the rare case of a patient with a family history of FH, she would order a lipid test and discuss treatment plans with the patient and family, if needed.

“We really don’t want to do tests that we don’t know what to do with the information,” she said.

One USPSTF member reported receiving grants from Healthwise, a nonprofit organization, outside the submitted work.

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

The U.S. Preventive Services Task Force has again determined that current evidence is insufficient to recommend screening for lipid disorders among asymptomatic children and patients aged 20 years or younger.

The group’s final recommendation and corresponding evidence report were published  in the Journal of the American Medical Association, following a draft recommendation in January.

The organization reached a similar conclusion following its evaluation in 2016.

“There’s just not enough evidence to determine whether or not screening all children for high cholesterol improves their heart health into adulthood,” said Katrina Donahue, MD, MPH, a USPSTF member and a professor in the department of family medicine at the University of North Carolina at Chapel Hill. “We’re calling for additional research on the effectiveness of screening for and treatment of high cholesterol in children and adolescents to prevent heart attacks, strokes, and death in adulthood.”

The task force recommended other evidence-based strategies to promote heart health, such as screening for obesity and interventions to prevent tobacco use.

The recommendation was the result of a review of 43 studies from MEDLINE and the Cochrane Central Register of Controlled Trials through May 16, 2022. No randomized controlled trial directly addressed the effectiveness or harms of lipid screening for children and adolescents. The task force continued to use article alerts and targeted journal searches through March 24, 2023.

Conditions such as familial hypercholesterolemia and multifactorial dyslipidemia can cause abnormally high lipid levels in children, potentially leading to premature cardiovascular events such as myocardial infarction, stroke, and death in adulthood. According to the USPSTF, the prevalence of FH in U.S. children and adolescents ranges from 0.2% to 0.4% (one in every 250-500 youth). Multifactorial dyslipidemia is more common – the prevalence in children and adolescents ranges from 7.1% to 9.4%.

In an editorial response to the task force’s statement, the authors, including Sarah D. de Ferranti, MD, department of pediatrics at Harvard Medical School, Boston, question the impact of not screening children to identify FH and other conditions and caution against the subsequent delay in treatment.

“Treating FH during childhood slows the progression of vascular finding in atherosclerosis,” the authors write.

They note that the recommendation “leaves a void for clinicians seeking to provide care for patients today” while additional research is conducted.

Sarah Nosal, MD, a member of the board of directors of the American Academy of Family Physicians, said that despite the lack of a recommendation, primary care clinicians can still encourage proper nutrition and physical activity for patients.

Dr. Nosal said that even without clear recommendations from the USPSTF, in the rare case of a patient with a family history of FH, she would order a lipid test and discuss treatment plans with the patient and family, if needed.

“We really don’t want to do tests that we don’t know what to do with the information,” she said.

One USPSTF member reported receiving grants from Healthwise, a nonprofit organization, outside the submitted work.

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

The U.S. Preventive Services Task Force has again determined that current evidence is insufficient to recommend screening for lipid disorders among asymptomatic children and patients aged 20 years or younger.

The group’s final recommendation and corresponding evidence report were published  in the Journal of the American Medical Association, following a draft recommendation in January.

The organization reached a similar conclusion following its evaluation in 2016.

“There’s just not enough evidence to determine whether or not screening all children for high cholesterol improves their heart health into adulthood,” said Katrina Donahue, MD, MPH, a USPSTF member and a professor in the department of family medicine at the University of North Carolina at Chapel Hill. “We’re calling for additional research on the effectiveness of screening for and treatment of high cholesterol in children and adolescents to prevent heart attacks, strokes, and death in adulthood.”

The task force recommended other evidence-based strategies to promote heart health, such as screening for obesity and interventions to prevent tobacco use.

The recommendation was the result of a review of 43 studies from MEDLINE and the Cochrane Central Register of Controlled Trials through May 16, 2022. No randomized controlled trial directly addressed the effectiveness or harms of lipid screening for children and adolescents. The task force continued to use article alerts and targeted journal searches through March 24, 2023.

Conditions such as familial hypercholesterolemia and multifactorial dyslipidemia can cause abnormally high lipid levels in children, potentially leading to premature cardiovascular events such as myocardial infarction, stroke, and death in adulthood. According to the USPSTF, the prevalence of FH in U.S. children and adolescents ranges from 0.2% to 0.4% (one in every 250-500 youth). Multifactorial dyslipidemia is more common – the prevalence in children and adolescents ranges from 7.1% to 9.4%.

In an editorial response to the task force’s statement, the authors, including Sarah D. de Ferranti, MD, department of pediatrics at Harvard Medical School, Boston, question the impact of not screening children to identify FH and other conditions and caution against the subsequent delay in treatment.

“Treating FH during childhood slows the progression of vascular finding in atherosclerosis,” the authors write.

They note that the recommendation “leaves a void for clinicians seeking to provide care for patients today” while additional research is conducted.

Sarah Nosal, MD, a member of the board of directors of the American Academy of Family Physicians, said that despite the lack of a recommendation, primary care clinicians can still encourage proper nutrition and physical activity for patients.

Dr. Nosal said that even without clear recommendations from the USPSTF, in the rare case of a patient with a family history of FH, she would order a lipid test and discuss treatment plans with the patient and family, if needed.

“We really don’t want to do tests that we don’t know what to do with the information,” she said.

One USPSTF member reported receiving grants from Healthwise, a nonprofit organization, outside the submitted work.

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

It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?

First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.

Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.

Many employers like PTO because there is less paperwork involved and less abuse of sick leave – and they don’t have to make any decisions about whether an employee is actually sick. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.

Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)

Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.

Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.

The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.

When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.

What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.

When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.

What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?

First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.

Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.

Many employers like PTO because there is less paperwork involved and less abuse of sick leave – and they don’t have to make any decisions about whether an employee is actually sick. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.

Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)

Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.

Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.

The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.

When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.

What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.

When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.

What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?

First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.

Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.

Many employers like PTO because there is less paperwork involved and less abuse of sick leave – and they don’t have to make any decisions about whether an employee is actually sick. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.

Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)

Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.

Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.

The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.

When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.

What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.

When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.

What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It’s “summertime and the livin’ is easy” according to the lyric from an old George Gershwin song. But sometimes, summer activities can lead to illnesses that can disrupt a child’s easy living.

Case: An otherwise healthy 11-year-old presents with four to five loose stools per day, mild nausea, excess flatulence, and cramps for 12 days with a 5-pound weight loss. His loose-to-mushy stools have no blood or mucous but smell worse than usual. He has had no fever, vomiting, rashes, or joint symptoms. A month ago, he went hiking/camping on the Appalachian Trail, drank boiled stream water. and slept in a common-use semi-enclosed shelter. He waded through streams and shared “Trail Magic” (soft drinks being cooled in a fresh mountain stream). Two other campers report similar symptoms.

Differential diagnosis: Broadly, we should consider bacteria, viruses, and parasites. But generally, bacteria are likely to produce more systemic symptoms and usually do not last 12 days. That said, this could be Clostridioides difficile, yet that seems unlikely because he is otherwise healthy and has no apparent risk factors. Salmonella spp., Campylobacter spp. and some Escherichia coli infections may drag on for more than a week but the lack of systemic symptoms or blood/mucous lowers the likelihood. Viral agents (rotavirus, norovirus, adenovirus, astrovirus, calicivirus, or sapovirus) seem unlikely because of the long symptom duration and the child’s preteen age.

The history and presentation seem more likely attributable to a parasite. Uncommonly detected protozoa include Microsporidium (mostly Enterocytozoon bieneusi) and amoeba. Microsporidium is very rare and seen mostly in immune compromised hosts, for example, those living with HIV. Amebiasis occurs mostly after travel to endemic areas, and stools usually contain blood or mucous. Some roundworm or tapeworm infestations cause abdominal pain and abnormal stools, but the usual exposures are absent. Giardia spp., Cryptosporidium spp., Cyclospora cayetanensis, and/or Cystoisospora belli best fit this presentation given his hiking/camping trip.
 

Workup. Laboratory testing of stool is warranted (because of weight loss and persistent diarrhea) despite a lack of systemic signs. Initially, bacterial culture, C. difficile testing, and viral testing seem unwarranted. The best initial approach, given our most likely suspects, is protozoan/parasite testing.

The Centers for Disease Control and Prevention recommends testing up to three stools collected on separate days.¹ Initially, stool testing for giardia and cryptosporidium antigens by EIA assays could be done as a point-of-care test. Such antigen tests are often the first step because of their ease of use, relatively low expense, reasonably high sensitivity and specificity, and rapid turnaround (as little as 1 hour). Alternatively, direct examination of three stools for ova and parasites (O&P) and acid-fast stain or direct fluorescent antibody testing can usually detect our main suspects (giardia, cryptosporidium, cyclospora, and cystoisospora) along with other less likely parasites.

Some laboratories, however, use syndromic stool testing approaches (multiplex nucleic acid panels) that detect over 20 different bacteria, viruses, and select parasites. Multiplex testing has yielded increased detection rates, compared with microscopic examination alone in some settings. Further, they also share ease-of-use and rapid turnaround times with parasite antigen assays while requiring less hands-on time by laboratory personnel, compared with direct microscopic examination. However, multiplex assays are expensive and more readily detect commensal organisms, so they are not necessarily the ideal test in all diarrheal illnesses.

Diagnosis. You decide to first order giardia and cryptosporidium antigen testing because you are highly suspicious that giardia is the cause, based on wild-water exposure, the presentation, and symptom duration. You also order full microscopic O&P examination because you know that parasites can “run in packs.” Results of testing the first stool are positive for giardia. Microscopic examination on each of three stools is negative except for giardia trophozoites (the noninfectious form) in stools two and three.

Giardia overview. Giardia is the most common protozoan causing diarrhea in the United States, is fecal-oral spread, and like Shigella spp., is a low-inoculum infection (ingestion of as few as 10-100 cysts). Acquisition in the United States has been estimated as being 75% from contaminated water (streams are a classic source.² Other sources are contaminated food (fresh produce is classic) and in some cases sexual encounters (mostly in men who have sex with men). Most detections are sporadic, but outbreaks can occur with case numbers usually below 20; 40% of outbreaks are attributable to contaminated water or food.³ Evaluating symptomatic household members can be important as transmission in families can occur.

After ingestion, the cysts uncoat and form trophozoites, which reside mostly in the small bowel (Figure), causing inflammation and altering gut membrane permeability, thereby reducing nutrient absorption and circulating amino acids. Along with decreased food intake, altered absorption can lead to weight loss and potentially reduce growth in young children. Some trophozoites replicate while others encyst, eventually passing into stool. The cysts can survive for months in water or the environment (lakes, swimming pools, and clear mountain streams). Giardia has been linked to beavers’ feces contaminating wild-water sources, hence the moniker “Beaver fever” and warnings about stream water related to wilderness hiking.⁴

CDC / Science Direct

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital–Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].

References

1. Diagnosis and Treatment Information for Medical Professionals, Giardia, Parasites. CDC.

2. Krumrie S et al. Curr Res Parasitol Vector Borne Dis. 2022;2:100084. doi: 10.1016/j.crpvbd.2022.100084.

3. Baldursson S and Karanis P. Water Res. 2011 Dec 15. doi: 10.1016/j.watres.2011.10.013.

4. “Water on the Appalachian Trail” AppalachianTrail.com.

5. Giardiasis: Treatment and prevention. UpToDate.

6. Kimberlin D et al. Red Book: 2021-2024 Report of the Committee on Infectious Diseases (Itasca, Ill.: American Academy of Pediatrics, 2021. 32nd ed.) Giardia duodenalis infections. pp. 335-8; and p. 961 (Table 4.11).

It’s “summertime and the livin’ is easy” according to the lyric from an old George Gershwin song. But sometimes, summer activities can lead to illnesses that can disrupt a child’s easy living.

Case: An otherwise healthy 11-year-old presents with four to five loose stools per day, mild nausea, excess flatulence, and cramps for 12 days with a 5-pound weight loss. His loose-to-mushy stools have no blood or mucous but smell worse than usual. He has had no fever, vomiting, rashes, or joint symptoms. A month ago, he went hiking/camping on the Appalachian Trail, drank boiled stream water. and slept in a common-use semi-enclosed shelter. He waded through streams and shared “Trail Magic” (soft drinks being cooled in a fresh mountain stream). Two other campers report similar symptoms.

Differential diagnosis: Broadly, we should consider bacteria, viruses, and parasites. But generally, bacteria are likely to produce more systemic symptoms and usually do not last 12 days. That said, this could be Clostridioides difficile, yet that seems unlikely because he is otherwise healthy and has no apparent risk factors. Salmonella spp., Campylobacter spp. and some Escherichia coli infections may drag on for more than a week but the lack of systemic symptoms or blood/mucous lowers the likelihood. Viral agents (rotavirus, norovirus, adenovirus, astrovirus, calicivirus, or sapovirus) seem unlikely because of the long symptom duration and the child’s preteen age.

The history and presentation seem more likely attributable to a parasite. Uncommonly detected protozoa include Microsporidium (mostly Enterocytozoon bieneusi) and amoeba. Microsporidium is very rare and seen mostly in immune compromised hosts, for example, those living with HIV. Amebiasis occurs mostly after travel to endemic areas, and stools usually contain blood or mucous. Some roundworm or tapeworm infestations cause abdominal pain and abnormal stools, but the usual exposures are absent. Giardia spp., Cryptosporidium spp., Cyclospora cayetanensis, and/or Cystoisospora belli best fit this presentation given his hiking/camping trip.
 

Workup. Laboratory testing of stool is warranted (because of weight loss and persistent diarrhea) despite a lack of systemic signs. Initially, bacterial culture, C. difficile testing, and viral testing seem unwarranted. The best initial approach, given our most likely suspects, is protozoan/parasite testing.

The Centers for Disease Control and Prevention recommends testing up to three stools collected on separate days.¹ Initially, stool testing for giardia and cryptosporidium antigens by EIA assays could be done as a point-of-care test. Such antigen tests are often the first step because of their ease of use, relatively low expense, reasonably high sensitivity and specificity, and rapid turnaround (as little as 1 hour). Alternatively, direct examination of three stools for ova and parasites (O&P) and acid-fast stain or direct fluorescent antibody testing can usually detect our main suspects (giardia, cryptosporidium, cyclospora, and cystoisospora) along with other less likely parasites.

Some laboratories, however, use syndromic stool testing approaches (multiplex nucleic acid panels) that detect over 20 different bacteria, viruses, and select parasites. Multiplex testing has yielded increased detection rates, compared with microscopic examination alone in some settings. Further, they also share ease-of-use and rapid turnaround times with parasite antigen assays while requiring less hands-on time by laboratory personnel, compared with direct microscopic examination. However, multiplex assays are expensive and more readily detect commensal organisms, so they are not necessarily the ideal test in all diarrheal illnesses.

Diagnosis. You decide to first order giardia and cryptosporidium antigen testing because you are highly suspicious that giardia is the cause, based on wild-water exposure, the presentation, and symptom duration. You also order full microscopic O&P examination because you know that parasites can “run in packs.” Results of testing the first stool are positive for giardia. Microscopic examination on each of three stools is negative except for giardia trophozoites (the noninfectious form) in stools two and three.

Giardia overview. Giardia is the most common protozoan causing diarrhea in the United States, is fecal-oral spread, and like Shigella spp., is a low-inoculum infection (ingestion of as few as 10-100 cysts). Acquisition in the United States has been estimated as being 75% from contaminated water (streams are a classic source.² Other sources are contaminated food (fresh produce is classic) and in some cases sexual encounters (mostly in men who have sex with men). Most detections are sporadic, but outbreaks can occur with case numbers usually below 20; 40% of outbreaks are attributable to contaminated water or food.³ Evaluating symptomatic household members can be important as transmission in families can occur.

After ingestion, the cysts uncoat and form trophozoites, which reside mostly in the small bowel (Figure), causing inflammation and altering gut membrane permeability, thereby reducing nutrient absorption and circulating amino acids. Along with decreased food intake, altered absorption can lead to weight loss and potentially reduce growth in young children. Some trophozoites replicate while others encyst, eventually passing into stool. The cysts can survive for months in water or the environment (lakes, swimming pools, and clear mountain streams). Giardia has been linked to beavers’ feces contaminating wild-water sources, hence the moniker “Beaver fever” and warnings about stream water related to wilderness hiking.⁴

CDC / Science Direct

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital–Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].

References

1. Diagnosis and Treatment Information for Medical Professionals, Giardia, Parasites. CDC.

2. Krumrie S et al. Curr Res Parasitol Vector Borne Dis. 2022;2:100084. doi: 10.1016/j.crpvbd.2022.100084.

3. Baldursson S and Karanis P. Water Res. 2011 Dec 15. doi: 10.1016/j.watres.2011.10.013.

4. “Water on the Appalachian Trail” AppalachianTrail.com.

5. Giardiasis: Treatment and prevention. UpToDate.

6. Kimberlin D et al. Red Book: 2021-2024 Report of the Committee on Infectious Diseases (Itasca, Ill.: American Academy of Pediatrics, 2021. 32nd ed.) Giardia duodenalis infections. pp. 335-8; and p. 961 (Table 4.11).

It’s “summertime and the livin’ is easy” according to the lyric from an old George Gershwin song. But sometimes, summer activities can lead to illnesses that can disrupt a child’s easy living.

Case: An otherwise healthy 11-year-old presents with four to five loose stools per day, mild nausea, excess flatulence, and cramps for 12 days with a 5-pound weight loss. His loose-to-mushy stools have no blood or mucous but smell worse than usual. He has had no fever, vomiting, rashes, or joint symptoms. A month ago, he went hiking/camping on the Appalachian Trail, drank boiled stream water. and slept in a common-use semi-enclosed shelter. He waded through streams and shared “Trail Magic” (soft drinks being cooled in a fresh mountain stream). Two other campers report similar symptoms.

Differential diagnosis: Broadly, we should consider bacteria, viruses, and parasites. But generally, bacteria are likely to produce more systemic symptoms and usually do not last 12 days. That said, this could be Clostridioides difficile, yet that seems unlikely because he is otherwise healthy and has no apparent risk factors. Salmonella spp., Campylobacter spp. and some Escherichia coli infections may drag on for more than a week but the lack of systemic symptoms or blood/mucous lowers the likelihood. Viral agents (rotavirus, norovirus, adenovirus, astrovirus, calicivirus, or sapovirus) seem unlikely because of the long symptom duration and the child’s preteen age.

The history and presentation seem more likely attributable to a parasite. Uncommonly detected protozoa include Microsporidium (mostly Enterocytozoon bieneusi) and amoeba. Microsporidium is very rare and seen mostly in immune compromised hosts, for example, those living with HIV. Amebiasis occurs mostly after travel to endemic areas, and stools usually contain blood or mucous. Some roundworm or tapeworm infestations cause abdominal pain and abnormal stools, but the usual exposures are absent. Giardia spp., Cryptosporidium spp., Cyclospora cayetanensis, and/or Cystoisospora belli best fit this presentation given his hiking/camping trip.
 

Workup. Laboratory testing of stool is warranted (because of weight loss and persistent diarrhea) despite a lack of systemic signs. Initially, bacterial culture, C. difficile testing, and viral testing seem unwarranted. The best initial approach, given our most likely suspects, is protozoan/parasite testing.

The Centers for Disease Control and Prevention recommends testing up to three stools collected on separate days.¹ Initially, stool testing for giardia and cryptosporidium antigens by EIA assays could be done as a point-of-care test. Such antigen tests are often the first step because of their ease of use, relatively low expense, reasonably high sensitivity and specificity, and rapid turnaround (as little as 1 hour). Alternatively, direct examination of three stools for ova and parasites (O&P) and acid-fast stain or direct fluorescent antibody testing can usually detect our main suspects (giardia, cryptosporidium, cyclospora, and cystoisospora) along with other less likely parasites.

Some laboratories, however, use syndromic stool testing approaches (multiplex nucleic acid panels) that detect over 20 different bacteria, viruses, and select parasites. Multiplex testing has yielded increased detection rates, compared with microscopic examination alone in some settings. Further, they also share ease-of-use and rapid turnaround times with parasite antigen assays while requiring less hands-on time by laboratory personnel, compared with direct microscopic examination. However, multiplex assays are expensive and more readily detect commensal organisms, so they are not necessarily the ideal test in all diarrheal illnesses.

Diagnosis. You decide to first order giardia and cryptosporidium antigen testing because you are highly suspicious that giardia is the cause, based on wild-water exposure, the presentation, and symptom duration. You also order full microscopic O&P examination because you know that parasites can “run in packs.” Results of testing the first stool are positive for giardia. Microscopic examination on each of three stools is negative except for giardia trophozoites (the noninfectious form) in stools two and three.

Giardia overview. Giardia is the most common protozoan causing diarrhea in the United States, is fecal-oral spread, and like Shigella spp., is a low-inoculum infection (ingestion of as few as 10-100 cysts). Acquisition in the United States has been estimated as being 75% from contaminated water (streams are a classic source.² Other sources are contaminated food (fresh produce is classic) and in some cases sexual encounters (mostly in men who have sex with men). Most detections are sporadic, but outbreaks can occur with case numbers usually below 20; 40% of outbreaks are attributable to contaminated water or food.³ Evaluating symptomatic household members can be important as transmission in families can occur.

After ingestion, the cysts uncoat and form trophozoites, which reside mostly in the small bowel (Figure), causing inflammation and altering gut membrane permeability, thereby reducing nutrient absorption and circulating amino acids. Along with decreased food intake, altered absorption can lead to weight loss and potentially reduce growth in young children. Some trophozoites replicate while others encyst, eventually passing into stool. The cysts can survive for months in water or the environment (lakes, swimming pools, and clear mountain streams). Giardia has been linked to beavers’ feces contaminating wild-water sources, hence the moniker “Beaver fever” and warnings about stream water related to wilderness hiking.⁴

CDC / Science Direct

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital–Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].

References

1. Diagnosis and Treatment Information for Medical Professionals, Giardia, Parasites. CDC.

2. Krumrie S et al. Curr Res Parasitol Vector Borne Dis. 2022;2:100084. doi: 10.1016/j.crpvbd.2022.100084.

3. Baldursson S and Karanis P. Water Res. 2011 Dec 15. doi: 10.1016/j.watres.2011.10.013.

4. “Water on the Appalachian Trail” AppalachianTrail.com.

5. Giardiasis: Treatment and prevention. UpToDate.

6. Kimberlin D et al. Red Book: 2021-2024 Report of the Committee on Infectious Diseases (Itasca, Ill.: American Academy of Pediatrics, 2021. 32nd ed.) Giardia duodenalis infections. pp. 335-8; and p. 961 (Table 4.11).

According to the World Health Organization (WHO), approximately 5% of adults (or 280 million people) suffer from depression globally. Although depression is more common in women, it can affect anyone. It is seen in all socioeconomic classes, ages, and races. In response, the WHO developed the Mental Health Gap Action Programme to bring mental health care services to those in need.

Depression can lead to severe consequences, such as loss of employment, relationships difficulties, and suicide. In fact, suicide is the 10th leading cause of death in the United States.

The U.S. Preventive Services Task Force (USPSTF), in past years, concluded that there was insufficient evidence to screen adolescents and adults for depression, However, new guidelines were issued this year in which the task force concluded there was a moderate benefit to screening adults for depression but insufficient evidence to screen for suicide risk. The agency now recommends screening for depression in all adults, even in the absence of risk factors, by using brief screening instruments such as the PHQ (Patient Health Questionnaire).

As family doctors, we have witnessed the burden of depression in our practices. The previous recommendations neglected the fact that mental health disorders were often purposely hidden because of stigma. Many patients do not readily come for treatment for mental illness and sometimes do not even accept these diagnoses. It is good that screening is now recommended, but we need to do more to tear down the stigma attached to mental illness.

These new guidelines do not address the effect that the lack of available mental health services has on treatment. It can take months to get an appointment for a patient with a mental health disorder, even if that person is potentially suicidal. Primary care physicians are often left treating these disorders; sometimes we are treating mental illness whether we feel comfortable doing so or not. Patients may not receive the best care but it is better than no care at all.

Although treating anxiety and depression is common for primary care doctors, specialists should be contacted when cases get more complicated. Even a call to crisis intervention can lead to an emergency department visit with discharge back to the family doctor because there is nowhere else to send the patient. The burden falls on us when we are already burdened by many other things, such as the rising rates of obesity with the resultant consequences of diabetes and heart disease. We simply do not have the time or expertise to treat complicated mental illness.

Creating guidelines to diagnose more undetected cases of depression without increasing the infrastructure to handle it is only going to lead to more pressure on family doctors. Many of us are already burnt out and at our limits. Yes, we want to diagnose every case of depression we can and to treat these patients for these disorders, but we need help.

Another problem with the guidelines is the recommendation to screen for depression and not suicide risk. As family doctors, we ask all patients who are depressed if they have thoughts of hurting themselves or others. Also, some people who commit suicide are not clinically depressed. These questions are simple to ask on an intake form.

Screening for depression is a pretty simple process. A patient can complete a screening tool or the clinician can directly ask the questions. It is a quick, noninvasive process. The Diagnostic and Statistical Manual of Mental Disorders criteria for diagnosing depression are pretty rigid and straightforward so misdiagnoses are not likely to be common.

The new guidelines do not make recommendations for treatment. In the real world, we often see patients unable to get the medications we prescribe because their insurance won’t cover it. Having guidelines supporting medication use would be very helpful.

In the area where I practice, it is difficult to refer a patient for counseling despite there being a plethora of counselors, therapists, and psychologists. These mental health providers often take only cash-paying patients, which eliminates access for many patients.

If we truly want to address the ever-increasing rates of depression in our country, we need to do much more than create new screening guidelines (screening that many family doctors were already doing). We must remove stigma, especially in the health care setting, fund mental health services, make them more readily available, and provide care that is affordable and covered by insurance. Until then, we are just going to add to the load of family doctors until we either break or leave our profession. Patients deserve better.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

According to the World Health Organization (WHO), approximately 5% of adults (or 280 million people) suffer from depression globally. Although depression is more common in women, it can affect anyone. It is seen in all socioeconomic classes, ages, and races. In response, the WHO developed the Mental Health Gap Action Programme to bring mental health care services to those in need.

Depression can lead to severe consequences, such as loss of employment, relationships difficulties, and suicide. In fact, suicide is the 10th leading cause of death in the United States.

The U.S. Preventive Services Task Force (USPSTF), in past years, concluded that there was insufficient evidence to screen adolescents and adults for depression, However, new guidelines were issued this year in which the task force concluded there was a moderate benefit to screening adults for depression but insufficient evidence to screen for suicide risk. The agency now recommends screening for depression in all adults, even in the absence of risk factors, by using brief screening instruments such as the PHQ (Patient Health Questionnaire).

As family doctors, we have witnessed the burden of depression in our practices. The previous recommendations neglected the fact that mental health disorders were often purposely hidden because of stigma. Many patients do not readily come for treatment for mental illness and sometimes do not even accept these diagnoses. It is good that screening is now recommended, but we need to do more to tear down the stigma attached to mental illness.

These new guidelines do not address the effect that the lack of available mental health services has on treatment. It can take months to get an appointment for a patient with a mental health disorder, even if that person is potentially suicidal. Primary care physicians are often left treating these disorders; sometimes we are treating mental illness whether we feel comfortable doing so or not. Patients may not receive the best care but it is better than no care at all.

Although treating anxiety and depression is common for primary care doctors, specialists should be contacted when cases get more complicated. Even a call to crisis intervention can lead to an emergency department visit with discharge back to the family doctor because there is nowhere else to send the patient. The burden falls on us when we are already burdened by many other things, such as the rising rates of obesity with the resultant consequences of diabetes and heart disease. We simply do not have the time or expertise to treat complicated mental illness.

Creating guidelines to diagnose more undetected cases of depression without increasing the infrastructure to handle it is only going to lead to more pressure on family doctors. Many of us are already burnt out and at our limits. Yes, we want to diagnose every case of depression we can and to treat these patients for these disorders, but we need help.

Another problem with the guidelines is the recommendation to screen for depression and not suicide risk. As family doctors, we ask all patients who are depressed if they have thoughts of hurting themselves or others. Also, some people who commit suicide are not clinically depressed. These questions are simple to ask on an intake form.

Screening for depression is a pretty simple process. A patient can complete a screening tool or the clinician can directly ask the questions. It is a quick, noninvasive process. The Diagnostic and Statistical Manual of Mental Disorders criteria for diagnosing depression are pretty rigid and straightforward so misdiagnoses are not likely to be common.

The new guidelines do not make recommendations for treatment. In the real world, we often see patients unable to get the medications we prescribe because their insurance won’t cover it. Having guidelines supporting medication use would be very helpful.

In the area where I practice, it is difficult to refer a patient for counseling despite there being a plethora of counselors, therapists, and psychologists. These mental health providers often take only cash-paying patients, which eliminates access for many patients.

If we truly want to address the ever-increasing rates of depression in our country, we need to do much more than create new screening guidelines (screening that many family doctors were already doing). We must remove stigma, especially in the health care setting, fund mental health services, make them more readily available, and provide care that is affordable and covered by insurance. Until then, we are just going to add to the load of family doctors until we either break or leave our profession. Patients deserve better.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

According to the World Health Organization (WHO), approximately 5% of adults (or 280 million people) suffer from depression globally. Although depression is more common in women, it can affect anyone. It is seen in all socioeconomic classes, ages, and races. In response, the WHO developed the Mental Health Gap Action Programme to bring mental health care services to those in need.

Depression can lead to severe consequences, such as loss of employment, relationships difficulties, and suicide. In fact, suicide is the 10th leading cause of death in the United States.

The U.S. Preventive Services Task Force (USPSTF), in past years, concluded that there was insufficient evidence to screen adolescents and adults for depression, However, new guidelines were issued this year in which the task force concluded there was a moderate benefit to screening adults for depression but insufficient evidence to screen for suicide risk. The agency now recommends screening for depression in all adults, even in the absence of risk factors, by using brief screening instruments such as the PHQ (Patient Health Questionnaire).

As family doctors, we have witnessed the burden of depression in our practices. The previous recommendations neglected the fact that mental health disorders were often purposely hidden because of stigma. Many patients do not readily come for treatment for mental illness and sometimes do not even accept these diagnoses. It is good that screening is now recommended, but we need to do more to tear down the stigma attached to mental illness.

These new guidelines do not address the effect that the lack of available mental health services has on treatment. It can take months to get an appointment for a patient with a mental health disorder, even if that person is potentially suicidal. Primary care physicians are often left treating these disorders; sometimes we are treating mental illness whether we feel comfortable doing so or not. Patients may not receive the best care but it is better than no care at all.

Although treating anxiety and depression is common for primary care doctors, specialists should be contacted when cases get more complicated. Even a call to crisis intervention can lead to an emergency department visit with discharge back to the family doctor because there is nowhere else to send the patient. The burden falls on us when we are already burdened by many other things, such as the rising rates of obesity with the resultant consequences of diabetes and heart disease. We simply do not have the time or expertise to treat complicated mental illness.

Creating guidelines to diagnose more undetected cases of depression without increasing the infrastructure to handle it is only going to lead to more pressure on family doctors. Many of us are already burnt out and at our limits. Yes, we want to diagnose every case of depression we can and to treat these patients for these disorders, but we need help.

Another problem with the guidelines is the recommendation to screen for depression and not suicide risk. As family doctors, we ask all patients who are depressed if they have thoughts of hurting themselves or others. Also, some people who commit suicide are not clinically depressed. These questions are simple to ask on an intake form.

Screening for depression is a pretty simple process. A patient can complete a screening tool or the clinician can directly ask the questions. It is a quick, noninvasive process. The Diagnostic and Statistical Manual of Mental Disorders criteria for diagnosing depression are pretty rigid and straightforward so misdiagnoses are not likely to be common.

The new guidelines do not make recommendations for treatment. In the real world, we often see patients unable to get the medications we prescribe because their insurance won’t cover it. Having guidelines supporting medication use would be very helpful.

In the area where I practice, it is difficult to refer a patient for counseling despite there being a plethora of counselors, therapists, and psychologists. These mental health providers often take only cash-paying patients, which eliminates access for many patients.

If we truly want to address the ever-increasing rates of depression in our country, we need to do much more than create new screening guidelines (screening that many family doctors were already doing). We must remove stigma, especially in the health care setting, fund mental health services, make them more readily available, and provide care that is affordable and covered by insurance. Until then, we are just going to add to the load of family doctors until we either break or leave our profession. Patients deserve better.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

Over the past few years, there has been rampant misinformation regarding gender-affirming care for transgender youth. In particular, there has been confusion regarding how care is administered, and what types of care are considered at various stages of development. This primer will help you understand the developmental approach to supporting transgender youth.

Gender-affirming care is a broad term that can encapsulate many different domains: social, legal, medical, and surgical affirmation. While people generally think of medical and surgical aspects of gender-affirming care, other domains can be just as important. For example, a 2020 publication in The Lancet Public Health found that access to gender-congruent government identification documents was associated with lower odds of severe psychological distress and suicidality.¹ 

Stanford Lucille Packard Children's Hospital.

Considerations for prepubertal children

The youngest developmental stage at which a young person may seek care regarding gender diversity is the prepubertal childhood stage. Guidelines set forth by The Endocrine Society and The World Professional Association for Transgender Health make it clear that no medical or surgical interventions are considered at this developmental stage.^2,3 However, some young people may choose to pursue a “social transition.” Though this may sound like one thing, social transition can mean very different things for different people. It may include any combination of adopting a new name, pronouns, hairstyle, clothing, etc. Young people may also choose to pursue these various aspects of social transition in all settings, or sometimes only in some settings (for example, only at home if they don’t yet feel comfortable doing so at school). Research so far shows that prepubertal children who are allowed to socially transition have levels of anxiety and depression nearly indistinguishable from their cisgender peers.⁴ While some in the past have raised the question of whether a social transition increases a child’s degree of gender incongruence and thus their likelihood to “persist” in a transgender identity, research has suggested this is not the case, and that gender identity does not meaningfully differ before and after a social transition.⁵ It’s worth noting, that “desistance” of a young person’s transgender identity is generally not considered an ethical goal and that gender identity conversion efforts (that is, attempts to force transgender people to be cisgender) have been labeled unethical by the American Academy of Child & Adolescent Psychiatry.

Sadly, transgender children are victims of bullying at high rates in their schools and communities. Creating safe and affirming school and community environments can be some of the highest yield ways in which providers can support the mental health of gender-diverse youth at this stage. Gender Spectrum is an excellent nonprofit that provides resources to help families and communities with some of these nonmedical supports.

 

Early adolescence and pubertal suppression

The earliest gender-affirming medical intervention that may be considered is pubertal suppression. Pubertal suppression is achieved with gonadotropin-releasing hormone agonists. This class of medications is Food and Drug Administration approved in pediatrics for precocious puberty – a condition in which young people enter puberty much earlier than expected (sometimes as early as age 3). For that condition, the rationale is to delay puberty until the patient reaches a more developmentally normative age for puberty to begin. The rationale for pubertal suppression for adolescent gender dysphoria is somewhat similar – these medications allow for the temporary pausing of puberty, which can be particularly helpful for adolescents who are having severe negative psychological reactions to the ways in which their bodies are developing. The major advantage here is that pubertal suppression can be reversed (if the medication is stopped, endogenous puberty will proceed), whereas puberty itself cannot be easily reversed (resulting in adult transgender people needing surgery and other interventions later in life, if these changes can be fully undone at all). As with all medications, puberty blockers do carry known side effects, including falling behind on bone density (sex hormones are needed to mineralize bones). Because of this, it is generally recommended that adolescents have their bone density monitored during treatment, pursue avenues to improve bone health (for example, exercise), and either stop the puberty blocker to undergo endogenous puberty or start gender-affirming hormones (estrogen or testosterone) by around age 16. 

It is also important to note that, under current guidelines, an adolescent must first undergo a comprehensive biopsychosocial mental health evaluation prior to starting pubertal suppression to ensure the clinical team has a comprehensive understanding of the adolescent’s mental health, that all potential gender supports that are needed are put into place, and that the adolescent and their guardians have a strong understanding of the medical intervention, its risks, side effects, and potential benefits. In addition, consent must be provided by parents or legal guardians, whereas adolescents themselves provide assent. Several studies have linked access to pubertal suppression, when indicated for gender dysphoria, to improved mental health outcomes (for example, van der Miesen and colleagues, Turban and colleagues, de Vries and colleagues, and Costa and colleagues).^6-9

 

Later adolescence and gender-affirming hormones

Later in adolescence, transgender youth may be candidates for gender-affirming hormone treatment (for example, estrogen or testosterone) to induce pubertal changes that align with their gender identities. Once again, under current guidelines, a comprehensive mental health biopsychosocial evaluation must be conducted prior to initiation of these treatments. Part of this evaluation includes fertility counseling and consideration of fertility preservation (for example, oocyte or semen cryopreservation), given the potential for these medications to impact fertility. It also involves discussion of several of the physiologic changes from these medications that can be irreversible (for example, voice changes from testosterone are particularly difficult to reverse in the future). Tables of the physical changes from these medications, when they begin after starting, and when they generally reach their maximum are available in the Endocrine Society guidelines.² The past endocrine society guidelines recommended not initiating gender-affirming hormones until age 16. The most recent guidelines note that there may be instances in which providers may consider starting them as early as age 13 (for example, to reduce risk of falling behind on bone density, or if a patient is having psychological distress related to their peers going through puberty while they are still in a prepubertal state). The latest World Professional Association for Transgender Health Standards of Care removed specific age cutoffs, highlighting the importance of a multidisciplinary team of mental health and hormone prescribing providers working together to understand the best course of action for a particular patient. As with pubertal suppression, several studies have linked access to gender-affirming hormones to improve mental health for adolescents with gender dysphoria (for example, Turban and colleagues, Chen and colleagues, de Vries and colleagues, Allen and colleagues, and Tordoff and colleagues).^10-14

Gender-affirming surgeries

The vast majority of gender-affirming surgeries are not considered until adulthood. The most notable exception to this is masculinizing top surgery for trans masculine and nonbinary adolescents. As with all surgeries, this is a major decision, and requires agreement from a mental health provider, a medical provider, and the surgeon. Early research suggests such surgeries result in improved chest dysphoria and that regret rates appear to be low.^15,16 While the latest World Professional Association for Transgender Health similarly removed strict age cutoffs for gender-affirming surgery, again noting the importance of individualized care, I suspect most will read this change in the context of the Endocrine Society guidelines and past WPATH guidelines that noted gender-affirming genital surgeries are not offered until adulthood (a rare exception perhaps being someone pursuing a gender-affirming vaginoplasty at say age 17 in the summer prior to college to avoid needing to take off from school for surgical recovery). Gender-affirming genital surgeries are generally much more involved surgeries with prolonged recovery times. 

Given the substantial proportion of young people who openly identify as transgender,¹⁷ and the proliferation of misinformation, political rhetoric, and legislation that can impact gender-affirming care for adolescents with gender dysphoria,¹⁸ it is essential that providers have accurate, up-to-date information on what this care entails and how it is provided.

Dr. Turban is director of the gender psychiatry program at the University of California, San Francisco, where he is an assistant professor of child & adolescent psychiatry and affiliate faculty at the Philip R. Lee Institute for Health Policy Studies. He is on Twitter @jack_turban.
 

References

1. Malta M et al. Lancet Public Health. 2020 Apr;5(4):e178-9.

2. Hembree WC et al. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.

3. Coleman E et al. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-259.

4. Durwood L et al. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):116-23.e2.

5. Rae JR et al. Psychol Sci. 2019 May;30(5):669-81.

6. van der Miesen AIR et al. J Adolesc Health. 2020 Jun;66(6):699-704.

7. Turban JL et al. Pediatrics. 2020 Feb;145(2):e20191725.

8. de Vries ALC et al. J Sex Med. 2011 Aug;8(8):2276-83.

9. Costa R et al. J Sex Med. 2015 Nov;12(11):2206-14.

10. Turban JL et al. PLoS One. 2022 Jan 12;17(1):e0261039.

11. Chen D et al. N Engl J Med. 2023;388:240-50.

12. de Vries ALC et al. Pediatrics. 2014 Oct;134(4):696-70.

13. Allen LR et al. Clin Pract Pediatr Psychol. 2019. doi: 10.1037/cpp0000288.

14. Tordoff DM et al. JAMA Netw Open. 2022 Feb 1;5(2):e220978.

15. Olson-Kennedy J et al. JAMA Pediatr. 2018;172(5):431-6.

16. Tang A et al. Ann Plast Surg. 2022 May;88(4 Suppl):S325-31

17. Johns MM et al. Morb Mortal Wkly Rep. 2019 Jan 25;68(3):67-71.

18. Turban JL et al. JAMA. 2021;325(22):2251-2.

Over the past few years, there has been rampant misinformation regarding gender-affirming care for transgender youth. In particular, there has been confusion regarding how care is administered, and what types of care are considered at various stages of development. This primer will help you understand the developmental approach to supporting transgender youth.

Gender-affirming care is a broad term that can encapsulate many different domains: social, legal, medical, and surgical affirmation. While people generally think of medical and surgical aspects of gender-affirming care, other domains can be just as important. For example, a 2020 publication in The Lancet Public Health found that access to gender-congruent government identification documents was associated with lower odds of severe psychological distress and suicidality.¹ 

Stanford Lucille Packard Children's Hospital.

Considerations for prepubertal children

The youngest developmental stage at which a young person may seek care regarding gender diversity is the prepubertal childhood stage. Guidelines set forth by The Endocrine Society and The World Professional Association for Transgender Health make it clear that no medical or surgical interventions are considered at this developmental stage.^2,3 However, some young people may choose to pursue a “social transition.” Though this may sound like one thing, social transition can mean very different things for different people. It may include any combination of adopting a new name, pronouns, hairstyle, clothing, etc. Young people may also choose to pursue these various aspects of social transition in all settings, or sometimes only in some settings (for example, only at home if they don’t yet feel comfortable doing so at school). Research so far shows that prepubertal children who are allowed to socially transition have levels of anxiety and depression nearly indistinguishable from their cisgender peers.⁴ While some in the past have raised the question of whether a social transition increases a child’s degree of gender incongruence and thus their likelihood to “persist” in a transgender identity, research has suggested this is not the case, and that gender identity does not meaningfully differ before and after a social transition.⁵ It’s worth noting, that “desistance” of a young person’s transgender identity is generally not considered an ethical goal and that gender identity conversion efforts (that is, attempts to force transgender people to be cisgender) have been labeled unethical by the American Academy of Child & Adolescent Psychiatry.

Sadly, transgender children are victims of bullying at high rates in their schools and communities. Creating safe and affirming school and community environments can be some of the highest yield ways in which providers can support the mental health of gender-diverse youth at this stage. Gender Spectrum is an excellent nonprofit that provides resources to help families and communities with some of these nonmedical supports.

 

Early adolescence and pubertal suppression

The earliest gender-affirming medical intervention that may be considered is pubertal suppression. Pubertal suppression is achieved with gonadotropin-releasing hormone agonists. This class of medications is Food and Drug Administration approved in pediatrics for precocious puberty – a condition in which young people enter puberty much earlier than expected (sometimes as early as age 3). For that condition, the rationale is to delay puberty until the patient reaches a more developmentally normative age for puberty to begin. The rationale for pubertal suppression for adolescent gender dysphoria is somewhat similar – these medications allow for the temporary pausing of puberty, which can be particularly helpful for adolescents who are having severe negative psychological reactions to the ways in which their bodies are developing. The major advantage here is that pubertal suppression can be reversed (if the medication is stopped, endogenous puberty will proceed), whereas puberty itself cannot be easily reversed (resulting in adult transgender people needing surgery and other interventions later in life, if these changes can be fully undone at all). As with all medications, puberty blockers do carry known side effects, including falling behind on bone density (sex hormones are needed to mineralize bones). Because of this, it is generally recommended that adolescents have their bone density monitored during treatment, pursue avenues to improve bone health (for example, exercise), and either stop the puberty blocker to undergo endogenous puberty or start gender-affirming hormones (estrogen or testosterone) by around age 16. 

It is also important to note that, under current guidelines, an adolescent must first undergo a comprehensive biopsychosocial mental health evaluation prior to starting pubertal suppression to ensure the clinical team has a comprehensive understanding of the adolescent’s mental health, that all potential gender supports that are needed are put into place, and that the adolescent and their guardians have a strong understanding of the medical intervention, its risks, side effects, and potential benefits. In addition, consent must be provided by parents or legal guardians, whereas adolescents themselves provide assent. Several studies have linked access to pubertal suppression, when indicated for gender dysphoria, to improved mental health outcomes (for example, van der Miesen and colleagues, Turban and colleagues, de Vries and colleagues, and Costa and colleagues).^6-9

 

Later adolescence and gender-affirming hormones

Later in adolescence, transgender youth may be candidates for gender-affirming hormone treatment (for example, estrogen or testosterone) to induce pubertal changes that align with their gender identities. Once again, under current guidelines, a comprehensive mental health biopsychosocial evaluation must be conducted prior to initiation of these treatments. Part of this evaluation includes fertility counseling and consideration of fertility preservation (for example, oocyte or semen cryopreservation), given the potential for these medications to impact fertility. It also involves discussion of several of the physiologic changes from these medications that can be irreversible (for example, voice changes from testosterone are particularly difficult to reverse in the future). Tables of the physical changes from these medications, when they begin after starting, and when they generally reach their maximum are available in the Endocrine Society guidelines.² The past endocrine society guidelines recommended not initiating gender-affirming hormones until age 16. The most recent guidelines note that there may be instances in which providers may consider starting them as early as age 13 (for example, to reduce risk of falling behind on bone density, or if a patient is having psychological distress related to their peers going through puberty while they are still in a prepubertal state). The latest World Professional Association for Transgender Health Standards of Care removed specific age cutoffs, highlighting the importance of a multidisciplinary team of mental health and hormone prescribing providers working together to understand the best course of action for a particular patient. As with pubertal suppression, several studies have linked access to gender-affirming hormones to improve mental health for adolescents with gender dysphoria (for example, Turban and colleagues, Chen and colleagues, de Vries and colleagues, Allen and colleagues, and Tordoff and colleagues).^10-14

Gender-affirming surgeries

The vast majority of gender-affirming surgeries are not considered until adulthood. The most notable exception to this is masculinizing top surgery for trans masculine and nonbinary adolescents. As with all surgeries, this is a major decision, and requires agreement from a mental health provider, a medical provider, and the surgeon. Early research suggests such surgeries result in improved chest dysphoria and that regret rates appear to be low.^15,16 While the latest World Professional Association for Transgender Health similarly removed strict age cutoffs for gender-affirming surgery, again noting the importance of individualized care, I suspect most will read this change in the context of the Endocrine Society guidelines and past WPATH guidelines that noted gender-affirming genital surgeries are not offered until adulthood (a rare exception perhaps being someone pursuing a gender-affirming vaginoplasty at say age 17 in the summer prior to college to avoid needing to take off from school for surgical recovery). Gender-affirming genital surgeries are generally much more involved surgeries with prolonged recovery times. 

Given the substantial proportion of young people who openly identify as transgender,¹⁷ and the proliferation of misinformation, political rhetoric, and legislation that can impact gender-affirming care for adolescents with gender dysphoria,¹⁸ it is essential that providers have accurate, up-to-date information on what this care entails and how it is provided.

Dr. Turban is director of the gender psychiatry program at the University of California, San Francisco, where he is an assistant professor of child & adolescent psychiatry and affiliate faculty at the Philip R. Lee Institute for Health Policy Studies. He is on Twitter @jack_turban.
 

References

1. Malta M et al. Lancet Public Health. 2020 Apr;5(4):e178-9.

2. Hembree WC et al. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.

3. Coleman E et al. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-259.

4. Durwood L et al. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):116-23.e2.

5. Rae JR et al. Psychol Sci. 2019 May;30(5):669-81.

6. van der Miesen AIR et al. J Adolesc Health. 2020 Jun;66(6):699-704.

7. Turban JL et al. Pediatrics. 2020 Feb;145(2):e20191725.

8. de Vries ALC et al. J Sex Med. 2011 Aug;8(8):2276-83.

9. Costa R et al. J Sex Med. 2015 Nov;12(11):2206-14.

10. Turban JL et al. PLoS One. 2022 Jan 12;17(1):e0261039.

11. Chen D et al. N Engl J Med. 2023;388:240-50.

12. de Vries ALC et al. Pediatrics. 2014 Oct;134(4):696-70.

13. Allen LR et al. Clin Pract Pediatr Psychol. 2019. doi: 10.1037/cpp0000288.

14. Tordoff DM et al. JAMA Netw Open. 2022 Feb 1;5(2):e220978.

15. Olson-Kennedy J et al. JAMA Pediatr. 2018;172(5):431-6.

16. Tang A et al. Ann Plast Surg. 2022 May;88(4 Suppl):S325-31

17. Johns MM et al. Morb Mortal Wkly Rep. 2019 Jan 25;68(3):67-71.

18. Turban JL et al. JAMA. 2021;325(22):2251-2.

Over the past few years, there has been rampant misinformation regarding gender-affirming care for transgender youth. In particular, there has been confusion regarding how care is administered, and what types of care are considered at various stages of development. This primer will help you understand the developmental approach to supporting transgender youth.

Gender-affirming care is a broad term that can encapsulate many different domains: social, legal, medical, and surgical affirmation. While people generally think of medical and surgical aspects of gender-affirming care, other domains can be just as important. For example, a 2020 publication in The Lancet Public Health found that access to gender-congruent government identification documents was associated with lower odds of severe psychological distress and suicidality.¹ 

Stanford Lucille Packard Children's Hospital.

Considerations for prepubertal children

The youngest developmental stage at which a young person may seek care regarding gender diversity is the prepubertal childhood stage. Guidelines set forth by The Endocrine Society and The World Professional Association for Transgender Health make it clear that no medical or surgical interventions are considered at this developmental stage.^2,3 However, some young people may choose to pursue a “social transition.” Though this may sound like one thing, social transition can mean very different things for different people. It may include any combination of adopting a new name, pronouns, hairstyle, clothing, etc. Young people may also choose to pursue these various aspects of social transition in all settings, or sometimes only in some settings (for example, only at home if they don’t yet feel comfortable doing so at school). Research so far shows that prepubertal children who are allowed to socially transition have levels of anxiety and depression nearly indistinguishable from their cisgender peers.⁴ While some in the past have raised the question of whether a social transition increases a child’s degree of gender incongruence and thus their likelihood to “persist” in a transgender identity, research has suggested this is not the case, and that gender identity does not meaningfully differ before and after a social transition.⁵ It’s worth noting, that “desistance” of a young person’s transgender identity is generally not considered an ethical goal and that gender identity conversion efforts (that is, attempts to force transgender people to be cisgender) have been labeled unethical by the American Academy of Child & Adolescent Psychiatry.

Sadly, transgender children are victims of bullying at high rates in their schools and communities. Creating safe and affirming school and community environments can be some of the highest yield ways in which providers can support the mental health of gender-diverse youth at this stage. Gender Spectrum is an excellent nonprofit that provides resources to help families and communities with some of these nonmedical supports.

 

Early adolescence and pubertal suppression

The earliest gender-affirming medical intervention that may be considered is pubertal suppression. Pubertal suppression is achieved with gonadotropin-releasing hormone agonists. This class of medications is Food and Drug Administration approved in pediatrics for precocious puberty – a condition in which young people enter puberty much earlier than expected (sometimes as early as age 3). For that condition, the rationale is to delay puberty until the patient reaches a more developmentally normative age for puberty to begin. The rationale for pubertal suppression for adolescent gender dysphoria is somewhat similar – these medications allow for the temporary pausing of puberty, which can be particularly helpful for adolescents who are having severe negative psychological reactions to the ways in which their bodies are developing. The major advantage here is that pubertal suppression can be reversed (if the medication is stopped, endogenous puberty will proceed), whereas puberty itself cannot be easily reversed (resulting in adult transgender people needing surgery and other interventions later in life, if these changes can be fully undone at all). As with all medications, puberty blockers do carry known side effects, including falling behind on bone density (sex hormones are needed to mineralize bones). Because of this, it is generally recommended that adolescents have their bone density monitored during treatment, pursue avenues to improve bone health (for example, exercise), and either stop the puberty blocker to undergo endogenous puberty or start gender-affirming hormones (estrogen or testosterone) by around age 16. 

It is also important to note that, under current guidelines, an adolescent must first undergo a comprehensive biopsychosocial mental health evaluation prior to starting pubertal suppression to ensure the clinical team has a comprehensive understanding of the adolescent’s mental health, that all potential gender supports that are needed are put into place, and that the adolescent and their guardians have a strong understanding of the medical intervention, its risks, side effects, and potential benefits. In addition, consent must be provided by parents or legal guardians, whereas adolescents themselves provide assent. Several studies have linked access to pubertal suppression, when indicated for gender dysphoria, to improved mental health outcomes (for example, van der Miesen and colleagues, Turban and colleagues, de Vries and colleagues, and Costa and colleagues).^6-9

 

Later adolescence and gender-affirming hormones

Later in adolescence, transgender youth may be candidates for gender-affirming hormone treatment (for example, estrogen or testosterone) to induce pubertal changes that align with their gender identities. Once again, under current guidelines, a comprehensive mental health biopsychosocial evaluation must be conducted prior to initiation of these treatments. Part of this evaluation includes fertility counseling and consideration of fertility preservation (for example, oocyte or semen cryopreservation), given the potential for these medications to impact fertility. It also involves discussion of several of the physiologic changes from these medications that can be irreversible (for example, voice changes from testosterone are particularly difficult to reverse in the future). Tables of the physical changes from these medications, when they begin after starting, and when they generally reach their maximum are available in the Endocrine Society guidelines.² The past endocrine society guidelines recommended not initiating gender-affirming hormones until age 16. The most recent guidelines note that there may be instances in which providers may consider starting them as early as age 13 (for example, to reduce risk of falling behind on bone density, or if a patient is having psychological distress related to their peers going through puberty while they are still in a prepubertal state). The latest World Professional Association for Transgender Health Standards of Care removed specific age cutoffs, highlighting the importance of a multidisciplinary team of mental health and hormone prescribing providers working together to understand the best course of action for a particular patient. As with pubertal suppression, several studies have linked access to gender-affirming hormones to improve mental health for adolescents with gender dysphoria (for example, Turban and colleagues, Chen and colleagues, de Vries and colleagues, Allen and colleagues, and Tordoff and colleagues).^10-14

Gender-affirming surgeries

The vast majority of gender-affirming surgeries are not considered until adulthood. The most notable exception to this is masculinizing top surgery for trans masculine and nonbinary adolescents. As with all surgeries, this is a major decision, and requires agreement from a mental health provider, a medical provider, and the surgeon. Early research suggests such surgeries result in improved chest dysphoria and that regret rates appear to be low.^15,16 While the latest World Professional Association for Transgender Health similarly removed strict age cutoffs for gender-affirming surgery, again noting the importance of individualized care, I suspect most will read this change in the context of the Endocrine Society guidelines and past WPATH guidelines that noted gender-affirming genital surgeries are not offered until adulthood (a rare exception perhaps being someone pursuing a gender-affirming vaginoplasty at say age 17 in the summer prior to college to avoid needing to take off from school for surgical recovery). Gender-affirming genital surgeries are generally much more involved surgeries with prolonged recovery times. 

Given the substantial proportion of young people who openly identify as transgender,¹⁷ and the proliferation of misinformation, political rhetoric, and legislation that can impact gender-affirming care for adolescents with gender dysphoria,¹⁸ it is essential that providers have accurate, up-to-date information on what this care entails and how it is provided.

Dr. Turban is director of the gender psychiatry program at the University of California, San Francisco, where he is an assistant professor of child & adolescent psychiatry and affiliate faculty at the Philip R. Lee Institute for Health Policy Studies. He is on Twitter @jack_turban.
 

References

1. Malta M et al. Lancet Public Health. 2020 Apr;5(4):e178-9.

2. Hembree WC et al. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.

3. Coleman E et al. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-259.

4. Durwood L et al. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):116-23.e2.

5. Rae JR et al. Psychol Sci. 2019 May;30(5):669-81.

6. van der Miesen AIR et al. J Adolesc Health. 2020 Jun;66(6):699-704.

7. Turban JL et al. Pediatrics. 2020 Feb;145(2):e20191725.

8. de Vries ALC et al. J Sex Med. 2011 Aug;8(8):2276-83.

9. Costa R et al. J Sex Med. 2015 Nov;12(11):2206-14.

10. Turban JL et al. PLoS One. 2022 Jan 12;17(1):e0261039.

11. Chen D et al. N Engl J Med. 2023;388:240-50.

12. de Vries ALC et al. Pediatrics. 2014 Oct;134(4):696-70.

13. Allen LR et al. Clin Pract Pediatr Psychol. 2019. doi: 10.1037/cpp0000288.

14. Tordoff DM et al. JAMA Netw Open. 2022 Feb 1;5(2):e220978.

15. Olson-Kennedy J et al. JAMA Pediatr. 2018;172(5):431-6.

16. Tang A et al. Ann Plast Surg. 2022 May;88(4 Suppl):S325-31

17. Johns MM et al. Morb Mortal Wkly Rep. 2019 Jan 25;68(3):67-71.

18. Turban JL et al. JAMA. 2021;325(22):2251-2.