In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.

Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.

“Are you kidding me that this is happening?” she thought.

But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.

“The last 2 years have kind of been this dance with Lady Death,” she said.

They have also been a dance with Lady Justice.

In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.

Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.

Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.

This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.

The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.

It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.

“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
 

Reverberations of Right to Try

The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.

After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.

She died in 2001 at age 21.

Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.

Still, the case sparked a Right to Try movement.

“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.

Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.

The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.

“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”

He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.

Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.

The response, she said, was predictable.

“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “

The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
 

Suing the DEA

Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.

They decided to sue.

Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.

The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.

In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.

In late June, the DEA provided its final answer: No access.

In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”

In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”

The government’s response is due in January 2023.

Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.

The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”

Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.

Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.

In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.

And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
 

The fight north of the border

In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.

After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.

Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.

In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.

“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”

TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.

But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.

Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”

As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.

“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”

Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.

In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
 

An uncertain future

Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.

When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.

Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.

That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.

In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.

“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”

A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”

But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.

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

In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.

Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.

“Are you kidding me that this is happening?” she thought.

But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.

“The last 2 years have kind of been this dance with Lady Death,” she said.

They have also been a dance with Lady Justice.

In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.

Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.

Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.

This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.

The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.

It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.

“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
 

Reverberations of Right to Try

The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.

After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.

She died in 2001 at age 21.

Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.

Still, the case sparked a Right to Try movement.

“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.

Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.

The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.

“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”

He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.

Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.

The response, she said, was predictable.

“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “

The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
 

Suing the DEA

Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.

They decided to sue.

Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.

The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.

In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.

In late June, the DEA provided its final answer: No access.

In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”

In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”

The government’s response is due in January 2023.

Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.

The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”

Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.

Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.

In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.

And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
 

The fight north of the border

In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.

After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.

Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.

In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.

“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”

TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.

But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.

Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”

As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.

“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”

Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.

In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
 

An uncertain future

Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.

When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.

Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.

That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.

In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.

“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”

A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”

But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.

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

In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.

Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.

“Are you kidding me that this is happening?” she thought.

But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.

“The last 2 years have kind of been this dance with Lady Death,” she said.

They have also been a dance with Lady Justice.

In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.

Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.

Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.

This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.

The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.

It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.

“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
 

Reverberations of Right to Try

The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.

After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.

She died in 2001 at age 21.

Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.

Still, the case sparked a Right to Try movement.

“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.

Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.

The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.

“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”

He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.

Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.

The response, she said, was predictable.

“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “

The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
 

Suing the DEA

Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.

They decided to sue.

Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.

The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.

In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.

In late June, the DEA provided its final answer: No access.

In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”

In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”

The government’s response is due in January 2023.

Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.

The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”

Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.

Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.

In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.

And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
 

The fight north of the border

In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.

After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.

Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.

In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.

“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”

TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.

But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.

Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”

As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.

“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”

Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.

In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
 

An uncertain future

Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.

When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.

Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.

That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.

In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.

“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”

A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”

But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.

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

“Everyone said private practice is dying,” said Omar Maniya, MD, an emergency physician who left his hospital job for family practice in New Jersey. “But I think it could be one of the best models we have to advance our health care system and prevent burnout – and bring joy back to the practice of medicine.”

In 2021, the American Medical Association found that, for the first time, less than half of all physicians work in private practice. But employment doesn’t necessarily mean happiness. In the Medscape “Employed Physicians: Loving the Focus, Hating the Bureaucracy” ” report, more than 1,350 U.S. physicians employed by a health care organization, hospital, large group practice, or other medical group were surveyedabout their work. As the subtitle suggests, many are torn.

In the survey, employed doctors cited three main downsides to the lifestyle: They have less autonomy, more corporate rules than they’d like, and lower earning potential. Nearly one-third say they’re unhappy about their work-life balance, too, which raises the risk for burnout.

Some physicians find that employment has more cons than pros and turn to private practice instead.
 

A system skewed toward employment

In the mid-1990s, when James Milford, MD, completed his residency, going straight into private practice was the norm. The family physician bucked that trend by joining a large regional medical center in Wisconsin. He spent the next 20+ years working to establish a network of medical clinics.

“It was very satisfying,” Dr. Milford said. “When I started, I had a lot of input, a lot of control.”

Since then, the pendulum has been swinging toward employment. Brieanna Seefeldt, DO, a family physician outside Denver, completed her residency in 2012.

“I told the recruiter I wanted my own practice,” Dr. Seefeldt said, “They said if you’re not independently wealthy, there’s no way.”

Sonal G. Patel, MD, a pediatric neurologist in Bethesda, finished her residency the same year as Dr. Seefeldt. Dr. Patel never even considered private practice.

“I always thought I would have a certain amount of clinic time where I have my regular patients,” she said, “but I’d also be doing hospital rounds and reading EEG studies at the hospital.”

For Dr. Maniya, who completed his residency in 2021, the choice was simple. Growing up, he watched his immigrant parents, both doctors in private practice, struggle to keep up.

“I opted for a big, sophisticated health system,” he said. “I thought we’d be pushing the envelope of what was possible in medicine.”
 

Becoming disillusioned with employment

All four of these physicians are now in private practice and are much happier.

Within a few years of starting her job, Dr. Seefeldt was one of the top producers in her area but felt tremendous pressure to see more and more patients. The last straw came after an unpaid maternity leave.

“They told me I owed them for my maternity leave, for lack of productivity,” she said. “I was in practice for only 4 years, but already feeling the effects of burnout.”

Dr. Patel only lasted 2 years before realizing employment didn’t suit her.

“There was an excessive amount of hospital calls,” she said. “And there were bureaucratic issues that made it very difficult to practice the way I thought my practice would be.”

It took just 18 months for Dr. Maniya’s light-bulb moment. He was working at a hospital when COVID-19 hit.

“At my big health care system, it took 9 months to come up with a way to get COVID swabs for free,” he said. “At the same time, I was helping out the family business, a private practice. It took me two calls and 48 hours to get free swabs for not just the practice, not just our patients, but the entire city of Hamilton, New Jersey.”

Milford lasted the longest as an employee – nearly 25 years. The end came after a healthcare company with hospitals in 30 states bought out the medical center.

“My control gradually eroded,” he said. “It got to the point where I had no input regarding things like employees or processes we wanted to improve.”
 

Making the leap to private practice

Private practice can take different forms.

Dr. Seefeldt opted for direct primary care, a model in which her patients pay a set monthly fee for care whenever needed. Her practice doesn’t take any insurance besides Medicaid.

“Direct primary care is about working directly with the patient and cost-conscious, transparent care,” she said. “And I don’t have to deal with insurance.”

For Dr. Patel, working with an accountable care organization made the transition easier. She owns her practice solo but works with a company called Privia for administrative needs. Privia sent a consultant to set up her office in the company’s electronic medical record. Things were up and running within the first week.

Dr. Maniya joined his mother’s practice, easing his way in over 18 months.

And then there’s what Milford did, building a private practice from the ground up.

“We did a lot of Googling, a lot of meeting with accountants, meeting with small business development from the state of Wisconsin,” he said. “We asked people that were in business, ‘What are the things businesses fail on? Not medical practices, but businesses.’” All that research helped him launch successfully.
 

Making the dollars and cents add up

Moving from employment into private practice takes time, effort, and of course, money. How much of each varies depending on where you live, your specialty, whether you choose to rent or buy office space, staffing needs, and other factors.

Dr. Seefeldt, Dr. Patel, Dr. Milford, and Dr. Maniya illustrate the range.

• Dr. Seefeldt got a home equity loan of $50,000 to cover startup costs – and paid it back within 6 months.
• Purchasing EEG equipment added to Dr. Patel’s budget; she spent $130,000 of her own money to launch her practice in a temporary office and took out a $150,000 loan to finance the buildout of her final space. It took her 3 years to pay it back.
• When Dr. Milford left employment, he borrowed the buildout and startup costs for his practice from his father, a retired surgeon, to the tune of $500,000.
• Dr. Maniya assumed the largest risk. When he took over the family practice, he borrowed $1.5 million to modernize and build a new office. The practice has now quintupled in size. “It’s going great,” he said. “One of our questions is, should we pay back the loan at a faster pace rather than make the minimum payments?”

Several years in, Dr. Patel reports she’s easily making three to four times as much as she would have at a hospital. However, Dr. Maniya’s guaranteed compensation is 10% less than his old job.

“But as a partner in a private practice, if it succeeds, it could be 100%-150% more in a good year,” he said. On the flip side, if the practice runs into financial trouble, so does he. “Does the risk keep me up at night, give me heartburn? You betcha.”

Dr. Milford and Dr. Seefeldt have both chosen to take less compensation than they could, opting to reinvest in and nurture their practices.

“I love it,” said Dr. Milford. “I joke that I have half as much in my pocketbook, twice as much in my heart. But it’s not really half as much, 5 years in. If I weren’t growing the business, I’d be making more than before.”
 

Private practice is not without challenges

Being the big cheese does have drawbacks. In the current climate, staffing is a persistent issue for doctors in private practice – both maintaining a full staff and managing their employees.

And without the backing of a large corporation, doctors are sometimes called on to do less than pleasant tasks.

“If the toilet gets clogged and the plumber can’t come for a few hours, the patients still need a bathroom,” Dr. Maniya said. “I’ll go in with my $400 shoes and snake the toilet.”

Dr. Milford pointed out that when the buck stops with you, small mistakes can have enormous ramifications. “But with the bad comes the great potential for good. You have the ability to positively affect patients and healthcare, and to make a difference for people. It creates great personal satisfaction.”
 

Is running your own practice all it’s cracked up to be?

If it’s not yet apparent, all four doctors highly recommend moving from employment to private practice when possible. The autonomy and the improved work-life balance have helped them find the satisfaction they’d been missing while making burnout less likely.

“When you don’t have to spend 30% of your day apologizing to patients for how bad the health care system is, it reignites your passion for why you went into medicine in the first place,” said Dr. Maniya. In his practice, he’s made a conscious decision to pursue a mix of demographics. “Thirty percent of our patients are Medicaid. The vast majority are middle to low income.”

For physicians who are also parents, the ability to set their own schedules is life-changing.

“My son got an award ... and the teacher invited me to the assembly. In a corporate-based world, I’d struggle to be able to go,” said Dr. Seefeldt. As her own boss, she didn’t have to forgo this special event. Instead, she coordinated directly with her scheduled patient to make time for it.

In Medscape’s report, 61% of employed physicians indicated that they don’t have a say on key management decisions. However, doctors who launch private practices embrace the chance to set their own standards.

“We make sure from the minute someone calls they know they’re in good hands, we’re responsive, we address concerns right away. That’s the difference with private practice – the one-on-one connection is huge,” said Dr. Patel.

“This is exactly what I always wanted. It brings me joy knowing we’ve made a difference in these children’s lives, in their parents’ lives,” she concluded.

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

“Everyone said private practice is dying,” said Omar Maniya, MD, an emergency physician who left his hospital job for family practice in New Jersey. “But I think it could be one of the best models we have to advance our health care system and prevent burnout – and bring joy back to the practice of medicine.”

In 2021, the American Medical Association found that, for the first time, less than half of all physicians work in private practice. But employment doesn’t necessarily mean happiness. In the Medscape “Employed Physicians: Loving the Focus, Hating the Bureaucracy” ” report, more than 1,350 U.S. physicians employed by a health care organization, hospital, large group practice, or other medical group were surveyedabout their work. As the subtitle suggests, many are torn.

In the survey, employed doctors cited three main downsides to the lifestyle: They have less autonomy, more corporate rules than they’d like, and lower earning potential. Nearly one-third say they’re unhappy about their work-life balance, too, which raises the risk for burnout.

Some physicians find that employment has more cons than pros and turn to private practice instead.
 

A system skewed toward employment

In the mid-1990s, when James Milford, MD, completed his residency, going straight into private practice was the norm. The family physician bucked that trend by joining a large regional medical center in Wisconsin. He spent the next 20+ years working to establish a network of medical clinics.

“It was very satisfying,” Dr. Milford said. “When I started, I had a lot of input, a lot of control.”

Since then, the pendulum has been swinging toward employment. Brieanna Seefeldt, DO, a family physician outside Denver, completed her residency in 2012.

“I told the recruiter I wanted my own practice,” Dr. Seefeldt said, “They said if you’re not independently wealthy, there’s no way.”

Sonal G. Patel, MD, a pediatric neurologist in Bethesda, finished her residency the same year as Dr. Seefeldt. Dr. Patel never even considered private practice.

“I always thought I would have a certain amount of clinic time where I have my regular patients,” she said, “but I’d also be doing hospital rounds and reading EEG studies at the hospital.”

For Dr. Maniya, who completed his residency in 2021, the choice was simple. Growing up, he watched his immigrant parents, both doctors in private practice, struggle to keep up.

“I opted for a big, sophisticated health system,” he said. “I thought we’d be pushing the envelope of what was possible in medicine.”
 

Becoming disillusioned with employment

All four of these physicians are now in private practice and are much happier.

Within a few years of starting her job, Dr. Seefeldt was one of the top producers in her area but felt tremendous pressure to see more and more patients. The last straw came after an unpaid maternity leave.

“They told me I owed them for my maternity leave, for lack of productivity,” she said. “I was in practice for only 4 years, but already feeling the effects of burnout.”

Dr. Patel only lasted 2 years before realizing employment didn’t suit her.

“There was an excessive amount of hospital calls,” she said. “And there were bureaucratic issues that made it very difficult to practice the way I thought my practice would be.”

It took just 18 months for Dr. Maniya’s light-bulb moment. He was working at a hospital when COVID-19 hit.

“At my big health care system, it took 9 months to come up with a way to get COVID swabs for free,” he said. “At the same time, I was helping out the family business, a private practice. It took me two calls and 48 hours to get free swabs for not just the practice, not just our patients, but the entire city of Hamilton, New Jersey.”

Milford lasted the longest as an employee – nearly 25 years. The end came after a healthcare company with hospitals in 30 states bought out the medical center.

“My control gradually eroded,” he said. “It got to the point where I had no input regarding things like employees or processes we wanted to improve.”
 

Making the leap to private practice

Private practice can take different forms.

Dr. Seefeldt opted for direct primary care, a model in which her patients pay a set monthly fee for care whenever needed. Her practice doesn’t take any insurance besides Medicaid.

“Direct primary care is about working directly with the patient and cost-conscious, transparent care,” she said. “And I don’t have to deal with insurance.”

For Dr. Patel, working with an accountable care organization made the transition easier. She owns her practice solo but works with a company called Privia for administrative needs. Privia sent a consultant to set up her office in the company’s electronic medical record. Things were up and running within the first week.

Dr. Maniya joined his mother’s practice, easing his way in over 18 months.

And then there’s what Milford did, building a private practice from the ground up.

“We did a lot of Googling, a lot of meeting with accountants, meeting with small business development from the state of Wisconsin,” he said. “We asked people that were in business, ‘What are the things businesses fail on? Not medical practices, but businesses.’” All that research helped him launch successfully.
 

Making the dollars and cents add up

Moving from employment into private practice takes time, effort, and of course, money. How much of each varies depending on where you live, your specialty, whether you choose to rent or buy office space, staffing needs, and other factors.

Dr. Seefeldt, Dr. Patel, Dr. Milford, and Dr. Maniya illustrate the range.

• Dr. Seefeldt got a home equity loan of $50,000 to cover startup costs – and paid it back within 6 months.
• Purchasing EEG equipment added to Dr. Patel’s budget; she spent $130,000 of her own money to launch her practice in a temporary office and took out a $150,000 loan to finance the buildout of her final space. It took her 3 years to pay it back.
• When Dr. Milford left employment, he borrowed the buildout and startup costs for his practice from his father, a retired surgeon, to the tune of $500,000.
• Dr. Maniya assumed the largest risk. When he took over the family practice, he borrowed $1.5 million to modernize and build a new office. The practice has now quintupled in size. “It’s going great,” he said. “One of our questions is, should we pay back the loan at a faster pace rather than make the minimum payments?”

Several years in, Dr. Patel reports she’s easily making three to four times as much as she would have at a hospital. However, Dr. Maniya’s guaranteed compensation is 10% less than his old job.

“But as a partner in a private practice, if it succeeds, it could be 100%-150% more in a good year,” he said. On the flip side, if the practice runs into financial trouble, so does he. “Does the risk keep me up at night, give me heartburn? You betcha.”

Dr. Milford and Dr. Seefeldt have both chosen to take less compensation than they could, opting to reinvest in and nurture their practices.

“I love it,” said Dr. Milford. “I joke that I have half as much in my pocketbook, twice as much in my heart. But it’s not really half as much, 5 years in. If I weren’t growing the business, I’d be making more than before.”
 

Private practice is not without challenges

Being the big cheese does have drawbacks. In the current climate, staffing is a persistent issue for doctors in private practice – both maintaining a full staff and managing their employees.

And without the backing of a large corporation, doctors are sometimes called on to do less than pleasant tasks.

“If the toilet gets clogged and the plumber can’t come for a few hours, the patients still need a bathroom,” Dr. Maniya said. “I’ll go in with my $400 shoes and snake the toilet.”

Dr. Milford pointed out that when the buck stops with you, small mistakes can have enormous ramifications. “But with the bad comes the great potential for good. You have the ability to positively affect patients and healthcare, and to make a difference for people. It creates great personal satisfaction.”
 

Is running your own practice all it’s cracked up to be?

If it’s not yet apparent, all four doctors highly recommend moving from employment to private practice when possible. The autonomy and the improved work-life balance have helped them find the satisfaction they’d been missing while making burnout less likely.

“When you don’t have to spend 30% of your day apologizing to patients for how bad the health care system is, it reignites your passion for why you went into medicine in the first place,” said Dr. Maniya. In his practice, he’s made a conscious decision to pursue a mix of demographics. “Thirty percent of our patients are Medicaid. The vast majority are middle to low income.”

For physicians who are also parents, the ability to set their own schedules is life-changing.

“My son got an award ... and the teacher invited me to the assembly. In a corporate-based world, I’d struggle to be able to go,” said Dr. Seefeldt. As her own boss, she didn’t have to forgo this special event. Instead, she coordinated directly with her scheduled patient to make time for it.

In Medscape’s report, 61% of employed physicians indicated that they don’t have a say on key management decisions. However, doctors who launch private practices embrace the chance to set their own standards.

“We make sure from the minute someone calls they know they’re in good hands, we’re responsive, we address concerns right away. That’s the difference with private practice – the one-on-one connection is huge,” said Dr. Patel.

“This is exactly what I always wanted. It brings me joy knowing we’ve made a difference in these children’s lives, in their parents’ lives,” she concluded.

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

“Everyone said private practice is dying,” said Omar Maniya, MD, an emergency physician who left his hospital job for family practice in New Jersey. “But I think it could be one of the best models we have to advance our health care system and prevent burnout – and bring joy back to the practice of medicine.”

In 2021, the American Medical Association found that, for the first time, less than half of all physicians work in private practice. But employment doesn’t necessarily mean happiness. In the Medscape “Employed Physicians: Loving the Focus, Hating the Bureaucracy” ” report, more than 1,350 U.S. physicians employed by a health care organization, hospital, large group practice, or other medical group were surveyedabout their work. As the subtitle suggests, many are torn.

In the survey, employed doctors cited three main downsides to the lifestyle: They have less autonomy, more corporate rules than they’d like, and lower earning potential. Nearly one-third say they’re unhappy about their work-life balance, too, which raises the risk for burnout.

Some physicians find that employment has more cons than pros and turn to private practice instead.
 

A system skewed toward employment

In the mid-1990s, when James Milford, MD, completed his residency, going straight into private practice was the norm. The family physician bucked that trend by joining a large regional medical center in Wisconsin. He spent the next 20+ years working to establish a network of medical clinics.

“It was very satisfying,” Dr. Milford said. “When I started, I had a lot of input, a lot of control.”

Since then, the pendulum has been swinging toward employment. Brieanna Seefeldt, DO, a family physician outside Denver, completed her residency in 2012.

“I told the recruiter I wanted my own practice,” Dr. Seefeldt said, “They said if you’re not independently wealthy, there’s no way.”

Sonal G. Patel, MD, a pediatric neurologist in Bethesda, finished her residency the same year as Dr. Seefeldt. Dr. Patel never even considered private practice.

“I always thought I would have a certain amount of clinic time where I have my regular patients,” she said, “but I’d also be doing hospital rounds and reading EEG studies at the hospital.”

For Dr. Maniya, who completed his residency in 2021, the choice was simple. Growing up, he watched his immigrant parents, both doctors in private practice, struggle to keep up.

“I opted for a big, sophisticated health system,” he said. “I thought we’d be pushing the envelope of what was possible in medicine.”
 

Becoming disillusioned with employment

All four of these physicians are now in private practice and are much happier.

Within a few years of starting her job, Dr. Seefeldt was one of the top producers in her area but felt tremendous pressure to see more and more patients. The last straw came after an unpaid maternity leave.

“They told me I owed them for my maternity leave, for lack of productivity,” she said. “I was in practice for only 4 years, but already feeling the effects of burnout.”

Dr. Patel only lasted 2 years before realizing employment didn’t suit her.

“There was an excessive amount of hospital calls,” she said. “And there were bureaucratic issues that made it very difficult to practice the way I thought my practice would be.”

It took just 18 months for Dr. Maniya’s light-bulb moment. He was working at a hospital when COVID-19 hit.

“At my big health care system, it took 9 months to come up with a way to get COVID swabs for free,” he said. “At the same time, I was helping out the family business, a private practice. It took me two calls and 48 hours to get free swabs for not just the practice, not just our patients, but the entire city of Hamilton, New Jersey.”

Milford lasted the longest as an employee – nearly 25 years. The end came after a healthcare company with hospitals in 30 states bought out the medical center.

“My control gradually eroded,” he said. “It got to the point where I had no input regarding things like employees or processes we wanted to improve.”
 

Making the leap to private practice

Private practice can take different forms.

Dr. Seefeldt opted for direct primary care, a model in which her patients pay a set monthly fee for care whenever needed. Her practice doesn’t take any insurance besides Medicaid.

“Direct primary care is about working directly with the patient and cost-conscious, transparent care,” she said. “And I don’t have to deal with insurance.”

For Dr. Patel, working with an accountable care organization made the transition easier. She owns her practice solo but works with a company called Privia for administrative needs. Privia sent a consultant to set up her office in the company’s electronic medical record. Things were up and running within the first week.

Dr. Maniya joined his mother’s practice, easing his way in over 18 months.

And then there’s what Milford did, building a private practice from the ground up.

“We did a lot of Googling, a lot of meeting with accountants, meeting with small business development from the state of Wisconsin,” he said. “We asked people that were in business, ‘What are the things businesses fail on? Not medical practices, but businesses.’” All that research helped him launch successfully.
 

Making the dollars and cents add up

Moving from employment into private practice takes time, effort, and of course, money. How much of each varies depending on where you live, your specialty, whether you choose to rent or buy office space, staffing needs, and other factors.

Dr. Seefeldt, Dr. Patel, Dr. Milford, and Dr. Maniya illustrate the range.

• Dr. Seefeldt got a home equity loan of $50,000 to cover startup costs – and paid it back within 6 months.
• Purchasing EEG equipment added to Dr. Patel’s budget; she spent $130,000 of her own money to launch her practice in a temporary office and took out a $150,000 loan to finance the buildout of her final space. It took her 3 years to pay it back.
• When Dr. Milford left employment, he borrowed the buildout and startup costs for his practice from his father, a retired surgeon, to the tune of $500,000.
• Dr. Maniya assumed the largest risk. When he took over the family practice, he borrowed $1.5 million to modernize and build a new office. The practice has now quintupled in size. “It’s going great,” he said. “One of our questions is, should we pay back the loan at a faster pace rather than make the minimum payments?”

Several years in, Dr. Patel reports she’s easily making three to four times as much as she would have at a hospital. However, Dr. Maniya’s guaranteed compensation is 10% less than his old job.

“But as a partner in a private practice, if it succeeds, it could be 100%-150% more in a good year,” he said. On the flip side, if the practice runs into financial trouble, so does he. “Does the risk keep me up at night, give me heartburn? You betcha.”

Dr. Milford and Dr. Seefeldt have both chosen to take less compensation than they could, opting to reinvest in and nurture their practices.

“I love it,” said Dr. Milford. “I joke that I have half as much in my pocketbook, twice as much in my heart. But it’s not really half as much, 5 years in. If I weren’t growing the business, I’d be making more than before.”
 

Private practice is not without challenges

Being the big cheese does have drawbacks. In the current climate, staffing is a persistent issue for doctors in private practice – both maintaining a full staff and managing their employees.

And without the backing of a large corporation, doctors are sometimes called on to do less than pleasant tasks.

“If the toilet gets clogged and the plumber can’t come for a few hours, the patients still need a bathroom,” Dr. Maniya said. “I’ll go in with my $400 shoes and snake the toilet.”

Dr. Milford pointed out that when the buck stops with you, small mistakes can have enormous ramifications. “But with the bad comes the great potential for good. You have the ability to positively affect patients and healthcare, and to make a difference for people. It creates great personal satisfaction.”
 

Is running your own practice all it’s cracked up to be?

If it’s not yet apparent, all four doctors highly recommend moving from employment to private practice when possible. The autonomy and the improved work-life balance have helped them find the satisfaction they’d been missing while making burnout less likely.

“When you don’t have to spend 30% of your day apologizing to patients for how bad the health care system is, it reignites your passion for why you went into medicine in the first place,” said Dr. Maniya. In his practice, he’s made a conscious decision to pursue a mix of demographics. “Thirty percent of our patients are Medicaid. The vast majority are middle to low income.”

For physicians who are also parents, the ability to set their own schedules is life-changing.

“My son got an award ... and the teacher invited me to the assembly. In a corporate-based world, I’d struggle to be able to go,” said Dr. Seefeldt. As her own boss, she didn’t have to forgo this special event. Instead, she coordinated directly with her scheduled patient to make time for it.

In Medscape’s report, 61% of employed physicians indicated that they don’t have a say on key management decisions. However, doctors who launch private practices embrace the chance to set their own standards.

“We make sure from the minute someone calls they know they’re in good hands, we’re responsive, we address concerns right away. That’s the difference with private practice – the one-on-one connection is huge,” said Dr. Patel.

“This is exactly what I always wanted. It brings me joy knowing we’ve made a difference in these children’s lives, in their parents’ lives,” she concluded.

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

Long-acting injectable cabotegravir (CAB-LA) has the potential to fill the gaps for people at high risk for sexually transmitted HIV who have trouble taking oral preexposure prophylaxis (PrEP), but several factors stand in the way of a widespread rollout, say authors of a new review article.

CAB-LA “represents the most important breakthrough in HIV prevention in recent years,” write Geoffroy Liegeon, MD, and Jade Ghosn, MD, PhD, with Université Paris Cité, in this month’s HIV Medicine.

It has been found to be safe, and more effective in phase 3 trials than oral PrEP, and is well-accepted in men who have sex with men, and transgender and cisgender women.
 

Reductions in stigma

Surveys show patients at high risk for HIV – especially those who see PrEP as burdensome – are highly interested in long-acting injectable drugs. Reduced stigma with the injections also appears to steer the choice toward a long-acting agent and may attract more people to HIV prevention programs.

The first two injections are given 4 weeks apart, followed by an injection every 8 weeks.

Models designed to increase uptake, adherence, and persistence when on and after discontinuing CAB-LA will be important for wider rollout, as will better patient education and demonstrated efficacy and safety in populations not included in clinical trials, Dr. Liegeon and Dr. Ghosn note.

Still, they point out that its broader integration into clinical routine is held back by factors including breakthrough infections despite timely injections, complexity of follow-up, logistical considerations, and its cost-effectiveness compared with oral PrEP.
 

A hefty price tag

“[T]he cost effectiveness compared with TDF-FTC [tenofovir/emtricitabine] generics may not support its use at the current price in many settings,” the authors write.

For low- and middle-income countries, the TDF/FTC price is about $55, according to the World Health Organization’s Global Price Reporting, while the current price of CAB-LA in the United States is about $22,000, according to Dr. Ghosn. He said in an interview that because the cost of generics can reach $400-$500 per year in the United States, depending on the pharmaceutical companies, the price for CAB-LA is almost 60 times higher than TDF/FTC in the Untied States.

The biggest hope for the price reduction, at least in lower-income countries, he said, is a new licensing agreement.

ViiV Healthcare signed a new voluntary licensing agreement with the Medicines Patent Pool in July to help access in low-income, lower-middle-income, and sub-Saharan African countries, he explained.

The authors summarize: “[E]stablishing the effectiveness of CAB-LA does not guarantee its uptake into clinical routine.”

Because of the combined issues, the WHO recommended CAB-LA as an additional prevention choice for PrEP in its recent guidelines, pending further studies.
 

Barriers frustrate providers

Lauren Fontana, DO, assistant professor at the University of Minnesota, Minneapolis, and infectious disease physician at M Health Fairview, said in an interview that “as a health care provider, cost and insurance barriers can be frustrating, especially when CAB-LA is identified as the best option for a patient.”

Lack of nonphysician-led initiatives, such as nurse- or pharmacy-led services for CAB-LA, may limit availability to marginalized and at-risk populations, she said.

“If a clinic can acquire CAB-LA, clinic protocols need to be developed and considerations of missed visits and doses must be thought about when implementing a program,” Dr. Fontana said.

Clinics need resources to engage with patients to promote retention in the program with case management and pharmacy support, she added.

“Simplification processes need to be developed to make CAB-LA an option for more clinics and patients,” she continued. “We are still learning about the incidence of breakthrough HIV infections, patterns of HIV seroconversion, and how to optimize testing so that HIV infections are detected early.”

Dr. Liegeon, Dr. Ghosn, and Dr. Fontana report no relevant financial relationships.

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

Long-acting injectable cabotegravir (CAB-LA) has the potential to fill the gaps for people at high risk for sexually transmitted HIV who have trouble taking oral preexposure prophylaxis (PrEP), but several factors stand in the way of a widespread rollout, say authors of a new review article.

CAB-LA “represents the most important breakthrough in HIV prevention in recent years,” write Geoffroy Liegeon, MD, and Jade Ghosn, MD, PhD, with Université Paris Cité, in this month’s HIV Medicine.

It has been found to be safe, and more effective in phase 3 trials than oral PrEP, and is well-accepted in men who have sex with men, and transgender and cisgender women.
 

Reductions in stigma

Surveys show patients at high risk for HIV – especially those who see PrEP as burdensome – are highly interested in long-acting injectable drugs. Reduced stigma with the injections also appears to steer the choice toward a long-acting agent and may attract more people to HIV prevention programs.

The first two injections are given 4 weeks apart, followed by an injection every 8 weeks.

Models designed to increase uptake, adherence, and persistence when on and after discontinuing CAB-LA will be important for wider rollout, as will better patient education and demonstrated efficacy and safety in populations not included in clinical trials, Dr. Liegeon and Dr. Ghosn note.

Still, they point out that its broader integration into clinical routine is held back by factors including breakthrough infections despite timely injections, complexity of follow-up, logistical considerations, and its cost-effectiveness compared with oral PrEP.
 

A hefty price tag

“[T]he cost effectiveness compared with TDF-FTC [tenofovir/emtricitabine] generics may not support its use at the current price in many settings,” the authors write.

For low- and middle-income countries, the TDF/FTC price is about $55, according to the World Health Organization’s Global Price Reporting, while the current price of CAB-LA in the United States is about $22,000, according to Dr. Ghosn. He said in an interview that because the cost of generics can reach $400-$500 per year in the United States, depending on the pharmaceutical companies, the price for CAB-LA is almost 60 times higher than TDF/FTC in the Untied States.

The biggest hope for the price reduction, at least in lower-income countries, he said, is a new licensing agreement.

ViiV Healthcare signed a new voluntary licensing agreement with the Medicines Patent Pool in July to help access in low-income, lower-middle-income, and sub-Saharan African countries, he explained.

The authors summarize: “[E]stablishing the effectiveness of CAB-LA does not guarantee its uptake into clinical routine.”

Because of the combined issues, the WHO recommended CAB-LA as an additional prevention choice for PrEP in its recent guidelines, pending further studies.
 

Barriers frustrate providers

Lauren Fontana, DO, assistant professor at the University of Minnesota, Minneapolis, and infectious disease physician at M Health Fairview, said in an interview that “as a health care provider, cost and insurance barriers can be frustrating, especially when CAB-LA is identified as the best option for a patient.”

Lack of nonphysician-led initiatives, such as nurse- or pharmacy-led services for CAB-LA, may limit availability to marginalized and at-risk populations, she said.

“If a clinic can acquire CAB-LA, clinic protocols need to be developed and considerations of missed visits and doses must be thought about when implementing a program,” Dr. Fontana said.

Clinics need resources to engage with patients to promote retention in the program with case management and pharmacy support, she added.

“Simplification processes need to be developed to make CAB-LA an option for more clinics and patients,” she continued. “We are still learning about the incidence of breakthrough HIV infections, patterns of HIV seroconversion, and how to optimize testing so that HIV infections are detected early.”

Dr. Liegeon, Dr. Ghosn, and Dr. Fontana report no relevant financial relationships.

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

Long-acting injectable cabotegravir (CAB-LA) has the potential to fill the gaps for people at high risk for sexually transmitted HIV who have trouble taking oral preexposure prophylaxis (PrEP), but several factors stand in the way of a widespread rollout, say authors of a new review article.

CAB-LA “represents the most important breakthrough in HIV prevention in recent years,” write Geoffroy Liegeon, MD, and Jade Ghosn, MD, PhD, with Université Paris Cité, in this month’s HIV Medicine.

It has been found to be safe, and more effective in phase 3 trials than oral PrEP, and is well-accepted in men who have sex with men, and transgender and cisgender women.
 

Reductions in stigma

Surveys show patients at high risk for HIV – especially those who see PrEP as burdensome – are highly interested in long-acting injectable drugs. Reduced stigma with the injections also appears to steer the choice toward a long-acting agent and may attract more people to HIV prevention programs.

The first two injections are given 4 weeks apart, followed by an injection every 8 weeks.

Models designed to increase uptake, adherence, and persistence when on and after discontinuing CAB-LA will be important for wider rollout, as will better patient education and demonstrated efficacy and safety in populations not included in clinical trials, Dr. Liegeon and Dr. Ghosn note.

Still, they point out that its broader integration into clinical routine is held back by factors including breakthrough infections despite timely injections, complexity of follow-up, logistical considerations, and its cost-effectiveness compared with oral PrEP.
 

A hefty price tag

“[T]he cost effectiveness compared with TDF-FTC [tenofovir/emtricitabine] generics may not support its use at the current price in many settings,” the authors write.

For low- and middle-income countries, the TDF/FTC price is about $55, according to the World Health Organization’s Global Price Reporting, while the current price of CAB-LA in the United States is about $22,000, according to Dr. Ghosn. He said in an interview that because the cost of generics can reach $400-$500 per year in the United States, depending on the pharmaceutical companies, the price for CAB-LA is almost 60 times higher than TDF/FTC in the Untied States.

The biggest hope for the price reduction, at least in lower-income countries, he said, is a new licensing agreement.

ViiV Healthcare signed a new voluntary licensing agreement with the Medicines Patent Pool in July to help access in low-income, lower-middle-income, and sub-Saharan African countries, he explained.

The authors summarize: “[E]stablishing the effectiveness of CAB-LA does not guarantee its uptake into clinical routine.”

Because of the combined issues, the WHO recommended CAB-LA as an additional prevention choice for PrEP in its recent guidelines, pending further studies.
 

Barriers frustrate providers

Lauren Fontana, DO, assistant professor at the University of Minnesota, Minneapolis, and infectious disease physician at M Health Fairview, said in an interview that “as a health care provider, cost and insurance barriers can be frustrating, especially when CAB-LA is identified as the best option for a patient.”

Lack of nonphysician-led initiatives, such as nurse- or pharmacy-led services for CAB-LA, may limit availability to marginalized and at-risk populations, she said.

“If a clinic can acquire CAB-LA, clinic protocols need to be developed and considerations of missed visits and doses must be thought about when implementing a program,” Dr. Fontana said.

Clinics need resources to engage with patients to promote retention in the program with case management and pharmacy support, she added.

“Simplification processes need to be developed to make CAB-LA an option for more clinics and patients,” she continued. “We are still learning about the incidence of breakthrough HIV infections, patterns of HIV seroconversion, and how to optimize testing so that HIV infections are detected early.”

Dr. Liegeon, Dr. Ghosn, and Dr. Fontana report no relevant financial relationships.

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

Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.¹ The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.¹ Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.² During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.³ In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.⁴ These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.

The US health care system often does not adequately address the needs of patients with dementia and their caregivers.⁵ Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.⁶ Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.⁷ PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.^8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.^6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.¹⁰ These community services benefit patients and caregivers and significantly improve the overall quality of care.⁶

Memory clinics have emerged to address these deficiencies when managing dementia.¹³ The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.^1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.^11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.^11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).^{1,6,11,12,20,21}

The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.²² Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.²³ A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.

Program Description

In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.

The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).

Procedures

Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.

Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.

The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.

As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)

Transdisciplinary Conference

Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.²⁴ The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.

During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.

Postconference Continuity

After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.

Discussion

Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.

This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.²⁵ This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.

Conclusions

We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.⁵ To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.

Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.¹ The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.¹ Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.² During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.³ In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.⁴ These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.

The US health care system often does not adequately address the needs of patients with dementia and their caregivers.⁵ Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.⁶ Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.⁷ PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.^8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.^6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.¹⁰ These community services benefit patients and caregivers and significantly improve the overall quality of care.⁶

Memory clinics have emerged to address these deficiencies when managing dementia.¹³ The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.^1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.^11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.^11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).^{1,6,11,12,20,21}

The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.²² Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.²³ A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.

Program Description

In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.

The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).

Procedures

Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.

Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.

The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.

As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)

Transdisciplinary Conference

Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.²⁴ The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.

During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.

Postconference Continuity

After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.

Discussion

Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.

This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.²⁵ This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.

Conclusions

We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.⁵ To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.

Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.¹ The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.¹ Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.² During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.³ In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.⁴ These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.

The US health care system often does not adequately address the needs of patients with dementia and their caregivers.⁵ Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.⁶ Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.⁷ PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.^8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.^6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.¹⁰ These community services benefit patients and caregivers and significantly improve the overall quality of care.⁶

Memory clinics have emerged to address these deficiencies when managing dementia.¹³ The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.^1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.^11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.^11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).^{1,6,11,12,20,21}

The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.²² Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.²³ A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.

Program Description

In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.

The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).

Procedures

Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.

Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.

The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.

As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)

Transdisciplinary Conference

Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.²⁴ The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.

During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.

Postconference Continuity

After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.

Discussion

Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.

This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.²⁵ This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.

Conclusions

We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.⁵ To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.

Colorectal cancer is the third leading cause of cancer-related death in both men and women.¹ Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.² Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.³

Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.^3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.^6-10

In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.¹¹ We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.

Methods

We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.

The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed.

On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.

We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.¹² Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.¹² Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.¹³ Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.^3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).

Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.

Statistical Analysis

We used both Pearson χ² test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages. 

RESULTS

During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.

The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).

Patient Feedback

We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.

Patient satisfaction with the Annie text messaging service was high.

DISCUSSION

To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.

The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.

We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.

Limitations

Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.

Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.¹⁴ This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.^15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.

Conclusions

There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.

Colorectal cancer is the third leading cause of cancer-related death in both men and women.¹ Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.² Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.³

Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.^3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.^6-10

In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.¹¹ We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.

Methods

We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.

The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed.

On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.

We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.¹² Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.¹² Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.¹³ Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.^3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).

Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.

Statistical Analysis

We used both Pearson χ² test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages. 

RESULTS

During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.

The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).

Patient Feedback

We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.

Patient satisfaction with the Annie text messaging service was high.

DISCUSSION

To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.

The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.

We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.

Limitations

Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.

Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.¹⁴ This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.^15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.

Conclusions

There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.

Colorectal cancer is the third leading cause of cancer-related death in both men and women.¹ Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.² Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.³

Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.^3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.^6-10

In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.¹¹ We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.

Methods

We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.

The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed.

On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.

We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.¹² Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.¹² Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.¹³ Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.^3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).

Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.

Statistical Analysis

We used both Pearson χ² test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages. 

RESULTS

During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.

The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).

Patient Feedback

We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.

Patient satisfaction with the Annie text messaging service was high.

DISCUSSION

To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.

The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.

We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.

Limitations

Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.

Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.¹⁴ This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.^15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.

Conclusions

There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.

Radiation therapy can cause long-term dysphagia that seriously affects quality of life for survivors of head and neck (H&N) cancer.^1-3 Numerous studies have linked pharyngeal constrictor dose to long-term dysphagia, but conclusions about the dose distribution that can be safely tolerated have been inconsistent. For example, a group from the Netherlands found that the mean dose to the superior pharyngeal constrictor muscle and the supraglottic larynx were each predictive of dysphagia.⁴ A subsequent Vanderbilt study refuted these findings, reporting that these structures were not predictive but that dose to the inferior pharyngeal constrictor muscle was.⁵ Other studies have connected late dysphagia with dose to the middle pharyngeal constrictor muscle, total larynx, oral cavity, contralateral submandibular gland, contralateral parotid gland, or a combination of these structures.^6-14 NRG Oncology trials commonly evaluate dose to the “uninvolved pharynx,” which is the total pharyngeal constrictor muscle volume minus the planning target volume for the lowest dose target volume. NRG H&N trials 3, 4, 5, 6, 8, and 9 all use uninvolved pharynx mean dose  ≤ 45 Gy as a constraint to judge radiation plan quality.

Differences in methodology or patient population may explain the inconsistency of prior studies on dosimetric predictors of dysphagia, but it is possible that these studies did not evaluate the optimal metric for dysphagia. This study evaluates a novel organ at risk, the contralateral pharyngeal constrictor muscle, to determine whether dose to this structure is predictive of late swallowing function. The study also compares a constraint based on this structure to the NRG uninvolved pharynx constraint mentioned earlier.

Methods

This study is a retrospective review of patients treated at the Richard L. Roudebush Veterans Affairs (VA) Medical Center in Indianapolis, Indiana. Patients were identified by searching the VA Cancer Registry for patients treated for H&N squamous cell carcinoma between September 1, 2016, and August 30, 2019. Eligible sites included cancers of the nasopharynx, oropharynx, hypopharynx, larynx and oral cavity, as well as H&N cancer of an unknown primary site. Only patients treated with primary radiation with concurrent systemic therapy were included. Patients were excluded if they had prior surgery or radiation to the H&N.

The pharyngeal constrictor muscles were contoured per the techniques described by Bhide and colleagues.¹¹ The contralateral constrictor was defined as the half of the constrictor volume contralateral to the primary site. For midline tumors, the side of the neck with a lower volume of lymph node metastases was judged to be the contralateral side.

Results

The VA Cancer Registry identified 113 patients treated for H&N cancer during the study period. Of these, 55 patients met the inclusion criteria. No patients were lost to follow-up. The median follow-up was 29 months. The median age was 67 years (range, 41-83) (Table 1).

All patients were treated with intensity-modulated radiotherapy (IMRT). Patients treated with a sequential boost had an initial dose of 54 Gy and/or 50 Gy, followed by a boost to a total of 70 Gy at 2 Gy per fraction. Patients treated with a simultaneous integrated boost (SIB) technique received 69.96 Gy in 33 fractions, with elective volumes treated to 54.45 Gy in 33 fractions. Both patients with nasopharyngeal cancer were treated with SIB plans and had an intermediate dose volume of 59.4 Gy.

Systemic therapy was weekly cisplatin in 41 patients (75%) and cetuximab in 14 (25%). Twenty percent of patients receiving cisplatin switched to an alternative agent during treatment, most commonly carboplatin.

Forty-nine patients (89%) had a G-tube placed before starting radiation. G-tubes were in place for an interval of 0 to 47 months (mean, 8.6); 12 (22%) had a G-tube > 12 months. After completion of radiation, 18 patients (33%) had an abnormal MBS. These were done 1 to 50 months (mean, 14.8) after completion of radiation. Abnormal MBS occurred ≥ 12 months after radiation in 9 patients, 5 of whom had their G-tube in place for less than a year.

Forty-six patients (84%) survived more than 1 year and could be evaluated for late swallowing function. One-year dysphagia was seen in 17 (37%) of these patients. Recurrence was seen in 20 patients (36%), with locoregional recurrence in 12 (60%) of these cases. Recurrence occurred at a range of 0 to 15 months (mean, 5.6). Neither recurrence (P = .69) nor locoregional recurrence (P = .11) was associated with increased 1-year dysphagia.

In patients who could be evaluated for long-term swallowing function, contralateral constrictor V60 ranged from 0% to 100% (median, 51%). V60 was < 40% in 18 patients (39%). With V60 < 40%, there was a 6% rate of 1-year dysphagia compared with 57% for V60 ≥ 40% (P < .001).

Patients with contralateral constrictor V60 < 40 and V60 ≥ 40 both had a mean age of 65 years. χ² analysis did not show a difference in T stage or systemic treatment but did show that patients with V60 < 40% were more likely to have N1 disease (P = .01), and less likely to have N2 disease (P = .01) compared with patients with V60 ≥ 40%. The difference in 1-year dysphagia between N0 to N1 patients (27%) and N2 to N3 patients (46%) was not statistically significant (P = .19).

In patients who could be evaluated for long-term swallowing function, the uninvolved pharynx volume median of the total constrictor volume was 32% (range, < 1%-62%). The uninvolved pharynx mean dose ranged from 28 to 68 Gy (median, 45). When the uninvolved pharynx mean dose was < 45 Gy, 1-year dysphagia was 22% compared with 52% with a dose ≥ 45 Gy (P = .03).

Discussion

This is the first study to link contralateral constrictor dose to long-term dysphagia in patients treated with radiation for H&N cancer. Editing the boost volume off air cavities was associated with lower contralateral constrictor V60 and with less long-term dysphagia. This may indicate that optimizing plans to meet a contralateral constrictor constraint can reduce rates of long-term dysphagia.

The most useful clinical predictors are those that identify a patient at low risk for toxicity. These constraints are useful because they reassure physicians that treatments will have a favorable risk/benefit ratio while identifying plans that may need modification before starting treatment.

The contralateral constrictor outperformed the uninvolved pharynx in identifying patients at low risk for long-term dysphagia. This difference could not be overcome by decreasing the threshold of the pharynx constraint, as 17% of patients with dysphagia had a mean dose of < 40 Gy to the uninvolved pharynx, which was not statistically significant.

An advantage of contralateral constrictor is that it is independent of planning target volume (PTV) size. The uninvolved pharynx structure depends on the PTV contour, so it may obscure a connection between PTV size and dysphagia.

In the context of a clinical trial, only measuring dose to the uninvolved pharynx may allow more plans to meet constraints, but even in NRG trials, physicians have some control over target volumes. For example, NRG HN009, a national trial for patients with H&N cancer, recommends editing the CTV_7000 (clinical target volume treated to 70 Gy) off air cavities but does not define how much the volume should be cropped or specify protocol violations if the volume is not cropped.¹⁵ Furthermore, constraints used in clinical trials are often adopted for use outside the trial, where physicians have extensive control over target volumes.

The broad range of uninvolved pharynx volume relative to total constrictor volume confounds predictions using this variable. For example, according to the NRG constraint, a patient with an uninvolved pharynx mean dose of 44 Gy will have a low risk of dysphagia even if this structure is only 1% of the total constrictor. The contralateral constrictor is always about 50% of the total constrictor volume, which means that predictions using this structure will not be confounded by the same variation in volume size.

Figure 2 shows a representative patient who met the NRG uninvolved pharynx constraint but developed long-term dysphagia.

Limitations

This study is limited by its single institution, retrospective design, small sample size, and by all patients being male. The high correlation between air cavity editing and the use of SIB makes it impossible to assess the impact of each technique individually. Patients with contralateral constrictor V60 < 40% were less likely to have N2 disease, but N2 to N3 disease did not predict higher 1-year dysphagia, so the difference in N-category cannot fully explain the difference in 1-year dysphagia. It is possible that unreported factors, such as CTV, may contribute significantly to swallowing function. Nevertheless, within the study population, contralateral constrictor dose was able to identify a group with a low rate of long-term dysphagia.

Conclusions

Contralateral constrictor dose is a promising predictor of late dysphagia for patients with H&N cancer treated with radiation with concurrent systemic therapy. Contralateral constrictor V60 < 40% was able to identify a group of patients with a low rate of 1-year dysphagia in this single-center retrospective study. The correlation between air cavity editing and contralateral constrictor V60 suggests that contralateral constrictor dose may depend partly on technique. Further studies are needed to see if the contralateral constrictor dose can be used to predict long-term dysphagia prospectively and in other patient populations.

Radiation therapy can cause long-term dysphagia that seriously affects quality of life for survivors of head and neck (H&N) cancer.^1-3 Numerous studies have linked pharyngeal constrictor dose to long-term dysphagia, but conclusions about the dose distribution that can be safely tolerated have been inconsistent. For example, a group from the Netherlands found that the mean dose to the superior pharyngeal constrictor muscle and the supraglottic larynx were each predictive of dysphagia.⁴ A subsequent Vanderbilt study refuted these findings, reporting that these structures were not predictive but that dose to the inferior pharyngeal constrictor muscle was.⁵ Other studies have connected late dysphagia with dose to the middle pharyngeal constrictor muscle, total larynx, oral cavity, contralateral submandibular gland, contralateral parotid gland, or a combination of these structures.^6-14 NRG Oncology trials commonly evaluate dose to the “uninvolved pharynx,” which is the total pharyngeal constrictor muscle volume minus the planning target volume for the lowest dose target volume. NRG H&N trials 3, 4, 5, 6, 8, and 9 all use uninvolved pharynx mean dose  ≤ 45 Gy as a constraint to judge radiation plan quality.

Differences in methodology or patient population may explain the inconsistency of prior studies on dosimetric predictors of dysphagia, but it is possible that these studies did not evaluate the optimal metric for dysphagia. This study evaluates a novel organ at risk, the contralateral pharyngeal constrictor muscle, to determine whether dose to this structure is predictive of late swallowing function. The study also compares a constraint based on this structure to the NRG uninvolved pharynx constraint mentioned earlier.

Methods

This study is a retrospective review of patients treated at the Richard L. Roudebush Veterans Affairs (VA) Medical Center in Indianapolis, Indiana. Patients were identified by searching the VA Cancer Registry for patients treated for H&N squamous cell carcinoma between September 1, 2016, and August 30, 2019. Eligible sites included cancers of the nasopharynx, oropharynx, hypopharynx, larynx and oral cavity, as well as H&N cancer of an unknown primary site. Only patients treated with primary radiation with concurrent systemic therapy were included. Patients were excluded if they had prior surgery or radiation to the H&N.

The pharyngeal constrictor muscles were contoured per the techniques described by Bhide and colleagues.¹¹ The contralateral constrictor was defined as the half of the constrictor volume contralateral to the primary site. For midline tumors, the side of the neck with a lower volume of lymph node metastases was judged to be the contralateral side.

Results

The VA Cancer Registry identified 113 patients treated for H&N cancer during the study period. Of these, 55 patients met the inclusion criteria. No patients were lost to follow-up. The median follow-up was 29 months. The median age was 67 years (range, 41-83) (Table 1).

All patients were treated with intensity-modulated radiotherapy (IMRT). Patients treated with a sequential boost had an initial dose of 54 Gy and/or 50 Gy, followed by a boost to a total of 70 Gy at 2 Gy per fraction. Patients treated with a simultaneous integrated boost (SIB) technique received 69.96 Gy in 33 fractions, with elective volumes treated to 54.45 Gy in 33 fractions. Both patients with nasopharyngeal cancer were treated with SIB plans and had an intermediate dose volume of 59.4 Gy.

Systemic therapy was weekly cisplatin in 41 patients (75%) and cetuximab in 14 (25%). Twenty percent of patients receiving cisplatin switched to an alternative agent during treatment, most commonly carboplatin.

Forty-nine patients (89%) had a G-tube placed before starting radiation. G-tubes were in place for an interval of 0 to 47 months (mean, 8.6); 12 (22%) had a G-tube > 12 months. After completion of radiation, 18 patients (33%) had an abnormal MBS. These were done 1 to 50 months (mean, 14.8) after completion of radiation. Abnormal MBS occurred ≥ 12 months after radiation in 9 patients, 5 of whom had their G-tube in place for less than a year.

Forty-six patients (84%) survived more than 1 year and could be evaluated for late swallowing function. One-year dysphagia was seen in 17 (37%) of these patients. Recurrence was seen in 20 patients (36%), with locoregional recurrence in 12 (60%) of these cases. Recurrence occurred at a range of 0 to 15 months (mean, 5.6). Neither recurrence (P = .69) nor locoregional recurrence (P = .11) was associated with increased 1-year dysphagia.

In patients who could be evaluated for long-term swallowing function, contralateral constrictor V60 ranged from 0% to 100% (median, 51%). V60 was < 40% in 18 patients (39%). With V60 < 40%, there was a 6% rate of 1-year dysphagia compared with 57% for V60 ≥ 40% (P < .001).

Patients with contralateral constrictor V60 < 40 and V60 ≥ 40 both had a mean age of 65 years. χ² analysis did not show a difference in T stage or systemic treatment but did show that patients with V60 < 40% were more likely to have N1 disease (P = .01), and less likely to have N2 disease (P = .01) compared with patients with V60 ≥ 40%. The difference in 1-year dysphagia between N0 to N1 patients (27%) and N2 to N3 patients (46%) was not statistically significant (P = .19).

In patients who could be evaluated for long-term swallowing function, the uninvolved pharynx volume median of the total constrictor volume was 32% (range, < 1%-62%). The uninvolved pharynx mean dose ranged from 28 to 68 Gy (median, 45). When the uninvolved pharynx mean dose was < 45 Gy, 1-year dysphagia was 22% compared with 52% with a dose ≥ 45 Gy (P = .03).

Discussion

This is the first study to link contralateral constrictor dose to long-term dysphagia in patients treated with radiation for H&N cancer. Editing the boost volume off air cavities was associated with lower contralateral constrictor V60 and with less long-term dysphagia. This may indicate that optimizing plans to meet a contralateral constrictor constraint can reduce rates of long-term dysphagia.

The most useful clinical predictors are those that identify a patient at low risk for toxicity. These constraints are useful because they reassure physicians that treatments will have a favorable risk/benefit ratio while identifying plans that may need modification before starting treatment.

The contralateral constrictor outperformed the uninvolved pharynx in identifying patients at low risk for long-term dysphagia. This difference could not be overcome by decreasing the threshold of the pharynx constraint, as 17% of patients with dysphagia had a mean dose of < 40 Gy to the uninvolved pharynx, which was not statistically significant.

An advantage of contralateral constrictor is that it is independent of planning target volume (PTV) size. The uninvolved pharynx structure depends on the PTV contour, so it may obscure a connection between PTV size and dysphagia.

In the context of a clinical trial, only measuring dose to the uninvolved pharynx may allow more plans to meet constraints, but even in NRG trials, physicians have some control over target volumes. For example, NRG HN009, a national trial for patients with H&N cancer, recommends editing the CTV_7000 (clinical target volume treated to 70 Gy) off air cavities but does not define how much the volume should be cropped or specify protocol violations if the volume is not cropped.¹⁵ Furthermore, constraints used in clinical trials are often adopted for use outside the trial, where physicians have extensive control over target volumes.

The broad range of uninvolved pharynx volume relative to total constrictor volume confounds predictions using this variable. For example, according to the NRG constraint, a patient with an uninvolved pharynx mean dose of 44 Gy will have a low risk of dysphagia even if this structure is only 1% of the total constrictor. The contralateral constrictor is always about 50% of the total constrictor volume, which means that predictions using this structure will not be confounded by the same variation in volume size.

Figure 2 shows a representative patient who met the NRG uninvolved pharynx constraint but developed long-term dysphagia.

Limitations

This study is limited by its single institution, retrospective design, small sample size, and by all patients being male. The high correlation between air cavity editing and the use of SIB makes it impossible to assess the impact of each technique individually. Patients with contralateral constrictor V60 < 40% were less likely to have N2 disease, but N2 to N3 disease did not predict higher 1-year dysphagia, so the difference in N-category cannot fully explain the difference in 1-year dysphagia. It is possible that unreported factors, such as CTV, may contribute significantly to swallowing function. Nevertheless, within the study population, contralateral constrictor dose was able to identify a group with a low rate of long-term dysphagia.

Conclusions

Contralateral constrictor dose is a promising predictor of late dysphagia for patients with H&N cancer treated with radiation with concurrent systemic therapy. Contralateral constrictor V60 < 40% was able to identify a group of patients with a low rate of 1-year dysphagia in this single-center retrospective study. The correlation between air cavity editing and contralateral constrictor V60 suggests that contralateral constrictor dose may depend partly on technique. Further studies are needed to see if the contralateral constrictor dose can be used to predict long-term dysphagia prospectively and in other patient populations.

Radiation therapy can cause long-term dysphagia that seriously affects quality of life for survivors of head and neck (H&N) cancer.^1-3 Numerous studies have linked pharyngeal constrictor dose to long-term dysphagia, but conclusions about the dose distribution that can be safely tolerated have been inconsistent. For example, a group from the Netherlands found that the mean dose to the superior pharyngeal constrictor muscle and the supraglottic larynx were each predictive of dysphagia.⁴ A subsequent Vanderbilt study refuted these findings, reporting that these structures were not predictive but that dose to the inferior pharyngeal constrictor muscle was.⁵ Other studies have connected late dysphagia with dose to the middle pharyngeal constrictor muscle, total larynx, oral cavity, contralateral submandibular gland, contralateral parotid gland, or a combination of these structures.^6-14 NRG Oncology trials commonly evaluate dose to the “uninvolved pharynx,” which is the total pharyngeal constrictor muscle volume minus the planning target volume for the lowest dose target volume. NRG H&N trials 3, 4, 5, 6, 8, and 9 all use uninvolved pharynx mean dose  ≤ 45 Gy as a constraint to judge radiation plan quality.

Differences in methodology or patient population may explain the inconsistency of prior studies on dosimetric predictors of dysphagia, but it is possible that these studies did not evaluate the optimal metric for dysphagia. This study evaluates a novel organ at risk, the contralateral pharyngeal constrictor muscle, to determine whether dose to this structure is predictive of late swallowing function. The study also compares a constraint based on this structure to the NRG uninvolved pharynx constraint mentioned earlier.

Methods

This study is a retrospective review of patients treated at the Richard L. Roudebush Veterans Affairs (VA) Medical Center in Indianapolis, Indiana. Patients were identified by searching the VA Cancer Registry for patients treated for H&N squamous cell carcinoma between September 1, 2016, and August 30, 2019. Eligible sites included cancers of the nasopharynx, oropharynx, hypopharynx, larynx and oral cavity, as well as H&N cancer of an unknown primary site. Only patients treated with primary radiation with concurrent systemic therapy were included. Patients were excluded if they had prior surgery or radiation to the H&N.

The pharyngeal constrictor muscles were contoured per the techniques described by Bhide and colleagues.¹¹ The contralateral constrictor was defined as the half of the constrictor volume contralateral to the primary site. For midline tumors, the side of the neck with a lower volume of lymph node metastases was judged to be the contralateral side.

Results

The VA Cancer Registry identified 113 patients treated for H&N cancer during the study period. Of these, 55 patients met the inclusion criteria. No patients were lost to follow-up. The median follow-up was 29 months. The median age was 67 years (range, 41-83) (Table 1).

All patients were treated with intensity-modulated radiotherapy (IMRT). Patients treated with a sequential boost had an initial dose of 54 Gy and/or 50 Gy, followed by a boost to a total of 70 Gy at 2 Gy per fraction. Patients treated with a simultaneous integrated boost (SIB) technique received 69.96 Gy in 33 fractions, with elective volumes treated to 54.45 Gy in 33 fractions. Both patients with nasopharyngeal cancer were treated with SIB plans and had an intermediate dose volume of 59.4 Gy.

Systemic therapy was weekly cisplatin in 41 patients (75%) and cetuximab in 14 (25%). Twenty percent of patients receiving cisplatin switched to an alternative agent during treatment, most commonly carboplatin.

Forty-nine patients (89%) had a G-tube placed before starting radiation. G-tubes were in place for an interval of 0 to 47 months (mean, 8.6); 12 (22%) had a G-tube > 12 months. After completion of radiation, 18 patients (33%) had an abnormal MBS. These were done 1 to 50 months (mean, 14.8) after completion of radiation. Abnormal MBS occurred ≥ 12 months after radiation in 9 patients, 5 of whom had their G-tube in place for less than a year.

Forty-six patients (84%) survived more than 1 year and could be evaluated for late swallowing function. One-year dysphagia was seen in 17 (37%) of these patients. Recurrence was seen in 20 patients (36%), with locoregional recurrence in 12 (60%) of these cases. Recurrence occurred at a range of 0 to 15 months (mean, 5.6). Neither recurrence (P = .69) nor locoregional recurrence (P = .11) was associated with increased 1-year dysphagia.

In patients who could be evaluated for long-term swallowing function, contralateral constrictor V60 ranged from 0% to 100% (median, 51%). V60 was < 40% in 18 patients (39%). With V60 < 40%, there was a 6% rate of 1-year dysphagia compared with 57% for V60 ≥ 40% (P < .001).

Patients with contralateral constrictor V60 < 40 and V60 ≥ 40 both had a mean age of 65 years. χ² analysis did not show a difference in T stage or systemic treatment but did show that patients with V60 < 40% were more likely to have N1 disease (P = .01), and less likely to have N2 disease (P = .01) compared with patients with V60 ≥ 40%. The difference in 1-year dysphagia between N0 to N1 patients (27%) and N2 to N3 patients (46%) was not statistically significant (P = .19).

In patients who could be evaluated for long-term swallowing function, the uninvolved pharynx volume median of the total constrictor volume was 32% (range, < 1%-62%). The uninvolved pharynx mean dose ranged from 28 to 68 Gy (median, 45). When the uninvolved pharynx mean dose was < 45 Gy, 1-year dysphagia was 22% compared with 52% with a dose ≥ 45 Gy (P = .03).

Discussion

This is the first study to link contralateral constrictor dose to long-term dysphagia in patients treated with radiation for H&N cancer. Editing the boost volume off air cavities was associated with lower contralateral constrictor V60 and with less long-term dysphagia. This may indicate that optimizing plans to meet a contralateral constrictor constraint can reduce rates of long-term dysphagia.

The most useful clinical predictors are those that identify a patient at low risk for toxicity. These constraints are useful because they reassure physicians that treatments will have a favorable risk/benefit ratio while identifying plans that may need modification before starting treatment.

The contralateral constrictor outperformed the uninvolved pharynx in identifying patients at low risk for long-term dysphagia. This difference could not be overcome by decreasing the threshold of the pharynx constraint, as 17% of patients with dysphagia had a mean dose of < 40 Gy to the uninvolved pharynx, which was not statistically significant.

An advantage of contralateral constrictor is that it is independent of planning target volume (PTV) size. The uninvolved pharynx structure depends on the PTV contour, so it may obscure a connection between PTV size and dysphagia.

In the context of a clinical trial, only measuring dose to the uninvolved pharynx may allow more plans to meet constraints, but even in NRG trials, physicians have some control over target volumes. For example, NRG HN009, a national trial for patients with H&N cancer, recommends editing the CTV_7000 (clinical target volume treated to 70 Gy) off air cavities but does not define how much the volume should be cropped or specify protocol violations if the volume is not cropped.¹⁵ Furthermore, constraints used in clinical trials are often adopted for use outside the trial, where physicians have extensive control over target volumes.

The broad range of uninvolved pharynx volume relative to total constrictor volume confounds predictions using this variable. For example, according to the NRG constraint, a patient with an uninvolved pharynx mean dose of 44 Gy will have a low risk of dysphagia even if this structure is only 1% of the total constrictor. The contralateral constrictor is always about 50% of the total constrictor volume, which means that predictions using this structure will not be confounded by the same variation in volume size.

Figure 2 shows a representative patient who met the NRG uninvolved pharynx constraint but developed long-term dysphagia.

Limitations

This study is limited by its single institution, retrospective design, small sample size, and by all patients being male. The high correlation between air cavity editing and the use of SIB makes it impossible to assess the impact of each technique individually. Patients with contralateral constrictor V60 < 40% were less likely to have N2 disease, but N2 to N3 disease did not predict higher 1-year dysphagia, so the difference in N-category cannot fully explain the difference in 1-year dysphagia. It is possible that unreported factors, such as CTV, may contribute significantly to swallowing function. Nevertheless, within the study population, contralateral constrictor dose was able to identify a group with a low rate of long-term dysphagia.

Conclusions

Contralateral constrictor dose is a promising predictor of late dysphagia for patients with H&N cancer treated with radiation with concurrent systemic therapy. Contralateral constrictor V60 < 40% was able to identify a group of patients with a low rate of 1-year dysphagia in this single-center retrospective study. The correlation between air cavity editing and contralateral constrictor V60 suggests that contralateral constrictor dose may depend partly on technique. Further studies are needed to see if the contralateral constrictor dose can be used to predict long-term dysphagia prospectively and in other patient populations.

In a cautiously optimistic report, researchers described pregnancy outcomes in 25 women living with HIV in clinical trials of a new long-acting injectable antiretroviral regimen of cabotegravir and rilpivirine (CAB + RPV).

Among 10 live births, there was one birth defect (congenital ptosis, or droopy eyelid), which was not attributed to the trial drugs. There were no instances of perinatal HIV transmission at delivery or during the 1-year follow-up.

“Long-acting cabotegravir-rilpivirine is the first and only complete injectable regimen potentially available for pregnant women,” first author Parul Patel, PharmD, global medical affairs director for cabotegravir at ViiV Healthcare, said in an interview. The regimen was approved by the U.S. Food and Drug Administration in January 2021 for injections every 4 weeks and in February 2022 for injections every 8 weeks.

“Importantly, it can be dosed monthly or every 2 months,” Patel said. “This could be advantageous for women who are experiencing constant change during pregnancy. This could be a consideration for women who might have problems tolerating oral pills during pregnancy or might have problems with emesis.”

The study was published in HIV Medicine.

“We are really pursuing the development of the long-acting version of cabotegravir in combination with rilpivirine,” Dr. Patel said. “It’s an industry standard during initial development that you start very conservatively and not allow a woman who is pregnant to continue dosing of a drug while still evaluating its overall safety profile. We really want to understand the use of this agent in nonpregnant adults before exposing pregnant women to active treatment.”
 

Pregnancies in trials excluding pregnant women

In the paper, Dr. Patel and her coauthors noted the limited data on pregnant women exposed to CAB + RPV. They analyzed pregnancies in four phase 2b/3/3b clinical trials sponsored by ViiV Healthcare and a compassionate use program. All clinical trial participants first received oral CAB + RPV daily for 4 weeks to assess individual tolerance before the experimental long-acting injection of CAB + RPV every 4 weeks or every 8 weeks.

Women participants were required to use highly effective contraception during the trials and for at least 52 weeks after the last injection. Urine pregnancy tests were given at baseline, before each injection, and when pregnancy was suspected. If a pregnancy was detected, CAB + RPV (oral or long-acting injections) was discontinued and the woman switched to an alternative oral antiretroviral, unless she and her physician decided to continue with injections in the compassionate use program.
 

Pregnancy outcomes

Among 25 reported pregnancies in 22 women during the trial, there were 10 live births. Nine of the mothers who delivered their babies at term had switched to an alternative antiretroviral regimen and maintained virologic suppression throughout pregnancy and post partum, or the last available viral load assessment.

The 10th participant remained on long-acting CAB + RPV during her pregnancy and had a live birth with congenital ptosis that was resolving without treatment at the 4-month ophthalmology consult, the authors wrote. The mother experienced persistent low-level viremia before and throughout her pregnancy.

Two of the pregnancies occurred after the last monthly injection, during the washout period. Other studies have reported that each long-acting drug, CAB and RPV, can be detected more than 1 year after the last injection. In the new report, plasma CAB and RPV washout concentrations during pregnancy were within the range of those in nonpregnant women, the authors wrote.

Among the 14 participants with non–live birth outcomes, 13 switched to an alternative antiretroviral regimen during pregnancy and maintained virologic suppression through pregnancy and post partum, or until their last viral assessment. The remaining participant received long-acting CAB + RPV and continued this treatment for the duration of their pregnancy.

“It’s a very limited data set, so we’re not in a position to be able to make definitive conclusions around long-acting cabotegravir-rilpivirine in pregnancy,” Dr. Patel acknowledged. “But the data that we presented among the 25 women who were exposed to cabotegravir-rilpivirine looks reassuring.”
 

Planned studies during pregnancy

Vani Vannappagari, MBBS, MPH, PhD, global head of epidemiology and real-world evidence at ViiV Healthcare and study coauthor, said in an interview that the initial results are spurring promising new research.

“We are working with an external IMPAACT [International Maternal Pediatric Adolescent AIDS Clinical Trials Network] group on a clinical trial ... to try to determine the appropriate dose of long-acting cabotegravir-rilpivirine during pregnancy,” Dr. Vannappagari said. “The clinical trial will give us the immediate safety, dose information, and viral suppression rates for both the mother and the infant. But long-term safety, especially birth defects and any adverse pregnancy and neonatal outcomes, will come from our antiretroviral pregnancy registry and other noninterventional studies.

“In the very small cohort studied, [in] pregnancies that were continued after exposure to long-acting cabotegravir and rilpivirine in the first trimester, there were no significant adverse fetal outcomes identified,” he said. “That’s reassuring, as is the fact that at the time these patients were switched in early pregnancy, their viral loads were all undetectable at the time that their pregnancies were diagnosed.”

Neil Silverman, MD, professor of clinical obstetrics and gynecology and director of the Infections in Pregnancy Program at the University of California, Los Angeles, Medical Center, who was not associated with the study, provided a comment to this news organization.

“The larger question still remains why pregnant women were so actively excluded from the original study design when this trial was evaluating a newer long-acting preparation of two anti-HIV medications that otherwise would be perfectly fine to use during pregnancy?”

Dr. Silverman continued, “In this case, it’s particularly frustrating since the present study was simply evaluating established medications currently being used to manage HIV infection, but in a newer longer-acting mode of administration by an injection every 2 months. If a patient had already been successfully managed on an oral antiviral regimen containing an integrase inhibitor and a non-nucleoside reverse transcriptase inhibitor, like the two drugs studied here, it would not be considered reasonable to switch that regimen simply because she was found to be pregnant.”

Dr. Patel and Dr. Vannappagari are employees of ViiV Healthcare and stockholders of GlaxoSmithKline.

This analysis was funded by ViiV Healthcare, and all studies were cofunded by ViiV Healthcare and Janssen Research & Development. Dr. Silverman reported no relevant financial relationships.

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

In a cautiously optimistic report, researchers described pregnancy outcomes in 25 women living with HIV in clinical trials of a new long-acting injectable antiretroviral regimen of cabotegravir and rilpivirine (CAB + RPV).

Among 10 live births, there was one birth defect (congenital ptosis, or droopy eyelid), which was not attributed to the trial drugs. There were no instances of perinatal HIV transmission at delivery or during the 1-year follow-up.

“Long-acting cabotegravir-rilpivirine is the first and only complete injectable regimen potentially available for pregnant women,” first author Parul Patel, PharmD, global medical affairs director for cabotegravir at ViiV Healthcare, said in an interview. The regimen was approved by the U.S. Food and Drug Administration in January 2021 for injections every 4 weeks and in February 2022 for injections every 8 weeks.

“Importantly, it can be dosed monthly or every 2 months,” Patel said. “This could be advantageous for women who are experiencing constant change during pregnancy. This could be a consideration for women who might have problems tolerating oral pills during pregnancy or might have problems with emesis.”

The study was published in HIV Medicine.

“We are really pursuing the development of the long-acting version of cabotegravir in combination with rilpivirine,” Dr. Patel said. “It’s an industry standard during initial development that you start very conservatively and not allow a woman who is pregnant to continue dosing of a drug while still evaluating its overall safety profile. We really want to understand the use of this agent in nonpregnant adults before exposing pregnant women to active treatment.”
 

Pregnancies in trials excluding pregnant women

In the paper, Dr. Patel and her coauthors noted the limited data on pregnant women exposed to CAB + RPV. They analyzed pregnancies in four phase 2b/3/3b clinical trials sponsored by ViiV Healthcare and a compassionate use program. All clinical trial participants first received oral CAB + RPV daily for 4 weeks to assess individual tolerance before the experimental long-acting injection of CAB + RPV every 4 weeks or every 8 weeks.

Women participants were required to use highly effective contraception during the trials and for at least 52 weeks after the last injection. Urine pregnancy tests were given at baseline, before each injection, and when pregnancy was suspected. If a pregnancy was detected, CAB + RPV (oral or long-acting injections) was discontinued and the woman switched to an alternative oral antiretroviral, unless she and her physician decided to continue with injections in the compassionate use program.
 

Pregnancy outcomes

Among 25 reported pregnancies in 22 women during the trial, there were 10 live births. Nine of the mothers who delivered their babies at term had switched to an alternative antiretroviral regimen and maintained virologic suppression throughout pregnancy and post partum, or the last available viral load assessment.

The 10th participant remained on long-acting CAB + RPV during her pregnancy and had a live birth with congenital ptosis that was resolving without treatment at the 4-month ophthalmology consult, the authors wrote. The mother experienced persistent low-level viremia before and throughout her pregnancy.

Two of the pregnancies occurred after the last monthly injection, during the washout period. Other studies have reported that each long-acting drug, CAB and RPV, can be detected more than 1 year after the last injection. In the new report, plasma CAB and RPV washout concentrations during pregnancy were within the range of those in nonpregnant women, the authors wrote.

Among the 14 participants with non–live birth outcomes, 13 switched to an alternative antiretroviral regimen during pregnancy and maintained virologic suppression through pregnancy and post partum, or until their last viral assessment. The remaining participant received long-acting CAB + RPV and continued this treatment for the duration of their pregnancy.

“It’s a very limited data set, so we’re not in a position to be able to make definitive conclusions around long-acting cabotegravir-rilpivirine in pregnancy,” Dr. Patel acknowledged. “But the data that we presented among the 25 women who were exposed to cabotegravir-rilpivirine looks reassuring.”
 

Planned studies during pregnancy

Vani Vannappagari, MBBS, MPH, PhD, global head of epidemiology and real-world evidence at ViiV Healthcare and study coauthor, said in an interview that the initial results are spurring promising new research.

“We are working with an external IMPAACT [International Maternal Pediatric Adolescent AIDS Clinical Trials Network] group on a clinical trial ... to try to determine the appropriate dose of long-acting cabotegravir-rilpivirine during pregnancy,” Dr. Vannappagari said. “The clinical trial will give us the immediate safety, dose information, and viral suppression rates for both the mother and the infant. But long-term safety, especially birth defects and any adverse pregnancy and neonatal outcomes, will come from our antiretroviral pregnancy registry and other noninterventional studies.

“In the very small cohort studied, [in] pregnancies that were continued after exposure to long-acting cabotegravir and rilpivirine in the first trimester, there were no significant adverse fetal outcomes identified,” he said. “That’s reassuring, as is the fact that at the time these patients were switched in early pregnancy, their viral loads were all undetectable at the time that their pregnancies were diagnosed.”

Neil Silverman, MD, professor of clinical obstetrics and gynecology and director of the Infections in Pregnancy Program at the University of California, Los Angeles, Medical Center, who was not associated with the study, provided a comment to this news organization.

“The larger question still remains why pregnant women were so actively excluded from the original study design when this trial was evaluating a newer long-acting preparation of two anti-HIV medications that otherwise would be perfectly fine to use during pregnancy?”

Dr. Silverman continued, “In this case, it’s particularly frustrating since the present study was simply evaluating established medications currently being used to manage HIV infection, but in a newer longer-acting mode of administration by an injection every 2 months. If a patient had already been successfully managed on an oral antiviral regimen containing an integrase inhibitor and a non-nucleoside reverse transcriptase inhibitor, like the two drugs studied here, it would not be considered reasonable to switch that regimen simply because she was found to be pregnant.”

Dr. Patel and Dr. Vannappagari are employees of ViiV Healthcare and stockholders of GlaxoSmithKline.

This analysis was funded by ViiV Healthcare, and all studies were cofunded by ViiV Healthcare and Janssen Research & Development. Dr. Silverman reported no relevant financial relationships.

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

In a cautiously optimistic report, researchers described pregnancy outcomes in 25 women living with HIV in clinical trials of a new long-acting injectable antiretroviral regimen of cabotegravir and rilpivirine (CAB + RPV).

Among 10 live births, there was one birth defect (congenital ptosis, or droopy eyelid), which was not attributed to the trial drugs. There were no instances of perinatal HIV transmission at delivery or during the 1-year follow-up.

“Long-acting cabotegravir-rilpivirine is the first and only complete injectable regimen potentially available for pregnant women,” first author Parul Patel, PharmD, global medical affairs director for cabotegravir at ViiV Healthcare, said in an interview. The regimen was approved by the U.S. Food and Drug Administration in January 2021 for injections every 4 weeks and in February 2022 for injections every 8 weeks.

“Importantly, it can be dosed monthly or every 2 months,” Patel said. “This could be advantageous for women who are experiencing constant change during pregnancy. This could be a consideration for women who might have problems tolerating oral pills during pregnancy or might have problems with emesis.”

The study was published in HIV Medicine.

“We are really pursuing the development of the long-acting version of cabotegravir in combination with rilpivirine,” Dr. Patel said. “It’s an industry standard during initial development that you start very conservatively and not allow a woman who is pregnant to continue dosing of a drug while still evaluating its overall safety profile. We really want to understand the use of this agent in nonpregnant adults before exposing pregnant women to active treatment.”
 

Pregnancies in trials excluding pregnant women

In the paper, Dr. Patel and her coauthors noted the limited data on pregnant women exposed to CAB + RPV. They analyzed pregnancies in four phase 2b/3/3b clinical trials sponsored by ViiV Healthcare and a compassionate use program. All clinical trial participants first received oral CAB + RPV daily for 4 weeks to assess individual tolerance before the experimental long-acting injection of CAB + RPV every 4 weeks or every 8 weeks.

Women participants were required to use highly effective contraception during the trials and for at least 52 weeks after the last injection. Urine pregnancy tests were given at baseline, before each injection, and when pregnancy was suspected. If a pregnancy was detected, CAB + RPV (oral or long-acting injections) was discontinued and the woman switched to an alternative oral antiretroviral, unless she and her physician decided to continue with injections in the compassionate use program.
 

Pregnancy outcomes

Among 25 reported pregnancies in 22 women during the trial, there were 10 live births. Nine of the mothers who delivered their babies at term had switched to an alternative antiretroviral regimen and maintained virologic suppression throughout pregnancy and post partum, or the last available viral load assessment.

The 10th participant remained on long-acting CAB + RPV during her pregnancy and had a live birth with congenital ptosis that was resolving without treatment at the 4-month ophthalmology consult, the authors wrote. The mother experienced persistent low-level viremia before and throughout her pregnancy.

Two of the pregnancies occurred after the last monthly injection, during the washout period. Other studies have reported that each long-acting drug, CAB and RPV, can be detected more than 1 year after the last injection. In the new report, plasma CAB and RPV washout concentrations during pregnancy were within the range of those in nonpregnant women, the authors wrote.

Among the 14 participants with non–live birth outcomes, 13 switched to an alternative antiretroviral regimen during pregnancy and maintained virologic suppression through pregnancy and post partum, or until their last viral assessment. The remaining participant received long-acting CAB + RPV and continued this treatment for the duration of their pregnancy.

“It’s a very limited data set, so we’re not in a position to be able to make definitive conclusions around long-acting cabotegravir-rilpivirine in pregnancy,” Dr. Patel acknowledged. “But the data that we presented among the 25 women who were exposed to cabotegravir-rilpivirine looks reassuring.”
 

Planned studies during pregnancy

Vani Vannappagari, MBBS, MPH, PhD, global head of epidemiology and real-world evidence at ViiV Healthcare and study coauthor, said in an interview that the initial results are spurring promising new research.

“We are working with an external IMPAACT [International Maternal Pediatric Adolescent AIDS Clinical Trials Network] group on a clinical trial ... to try to determine the appropriate dose of long-acting cabotegravir-rilpivirine during pregnancy,” Dr. Vannappagari said. “The clinical trial will give us the immediate safety, dose information, and viral suppression rates for both the mother and the infant. But long-term safety, especially birth defects and any adverse pregnancy and neonatal outcomes, will come from our antiretroviral pregnancy registry and other noninterventional studies.

“In the very small cohort studied, [in] pregnancies that were continued after exposure to long-acting cabotegravir and rilpivirine in the first trimester, there were no significant adverse fetal outcomes identified,” he said. “That’s reassuring, as is the fact that at the time these patients were switched in early pregnancy, their viral loads were all undetectable at the time that their pregnancies were diagnosed.”

Neil Silverman, MD, professor of clinical obstetrics and gynecology and director of the Infections in Pregnancy Program at the University of California, Los Angeles, Medical Center, who was not associated with the study, provided a comment to this news organization.

“The larger question still remains why pregnant women were so actively excluded from the original study design when this trial was evaluating a newer long-acting preparation of two anti-HIV medications that otherwise would be perfectly fine to use during pregnancy?”

Dr. Silverman continued, “In this case, it’s particularly frustrating since the present study was simply evaluating established medications currently being used to manage HIV infection, but in a newer longer-acting mode of administration by an injection every 2 months. If a patient had already been successfully managed on an oral antiviral regimen containing an integrase inhibitor and a non-nucleoside reverse transcriptase inhibitor, like the two drugs studied here, it would not be considered reasonable to switch that regimen simply because she was found to be pregnant.”

Dr. Patel and Dr. Vannappagari are employees of ViiV Healthcare and stockholders of GlaxoSmithKline.

This analysis was funded by ViiV Healthcare, and all studies were cofunded by ViiV Healthcare and Janssen Research & Development. Dr. Silverman reported no relevant financial relationships.

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

Regular readers of Federal Practitioner may recall that I have had a tradition of dedicating the last column of the year to an ethics rendition of the popular trope of the annual best and worst. This year we will examine the stories of 2 military physicians through the lens of virtue ethics. Aristotle (384-322 bce), arguably the most famous Western philosopher, is the acknowledged founder of virtue ethics.

Virtue ethics is among the oldest of ethical theories, and Aristotle articulates this school of thought in his work Nicomachean Ethics.² It is a good fit for Federal Practitioner as it has been constructively applied to the moral development of both military³ and medical professionals.⁴

Here is a Reader’s Digest version of virtue theory with apologizes to all the real philosophers out there. There are different ways to categorize ethical theories. One approach is to distinguish them based on the aspects of primary interest. Consequentialist ethics theories are concerned with the outcomes of actions. Deontologic theories emphasize the intention of the moral agent. In contrast, virtue ethics theories focus on the character of a person. The virtuous individual is one who has practiced the habits of moral excellence and embodies the good life. They are honored as heroes and revered as saints; they are the exemplars we imitate in our aspirations.³

The epigraph sums up one of Aristotle’s central philosophical doctrines: the close relationship of ethics and politics.¹ Personal virtue is intelligible only in the context of community and aim, and the goal of virtue is to contribute to human happiness.⁵ War, whether in ancient Greece or modern Europe, is among the forces most inimical to human flourishing. The current war in Ukraine that has united much of the Western world in opposition to tyranny has divided the 2 physicians in our story along the normative lines of virtue ethics.

The doctor of virtue: Michael Siclari, MD. A 71-year-old US Department of Veterans Affairs physician, Siclari had previously served in the military as a National Guard physician during Operation Enduring Freedom (2001-2014) in Afghanistan. He decided to serve again in Ukraine. Siclari expressed his reasons for going to Ukraine in the language of what Aristotle thought was among the highest virtues: justice. “In retrospect, as I think about why I wanted to go to Ukraine, I think it’s more of a sense that I thought an injustice was happening.”⁷

Echoing the great Rabbi Hillel, Siclari saw the Russian invasion of Ukraine as a personal call to use his experience and training as a trauma and emergency medicine physician to help the Ukrainian people. “If not me, then who?” Siclari demonstrated another virtue: generosity in taking 10 days of personal leave in August 2022 to make the trip to Ukraine, hoping to work in a combat zone tending to wounded soldiers as he had in Afghanistan. When due to logistics he instead was assigned to care for refugees and assist with evacuations from the battlefield, he humbly and compassionately cared for those in his charge. Even now, back home, he speaks to audiences of health care professionals encouraging them to consider similar acts of altruism.⁵

Virtue for Aristotle is technically defined as the mean between 2 extremes of disposition or temperament. The virtue of courage is found in the moral middle ground between the deficiency of bravery that is cowardice and the vice of excess of reckless abandon. The former person fears too much and the latter too little and both thus exhibit vicious behavior.

The doctor of vice: James Lee Henry. Henry is a major and internal medicine physician in the United States Army stationed at Fort Bragg, headquarters of the US Army Special Operations Command. Along with his wife Anna Gabrielian, a civilian anesthesiologist, he was charged in September with conspiring to divulge the protected health information of American military and government employees to the Russian government.⁸ According to the Grand Jury indictment, Henry delivered into the hands of an undercover Federal Bureau of Investigation (FBI) agent, the medical records of a US Army officer, Department of Defense employee, and the spouses of 3 Army veterans, 2 of whom were deceased.⁹ In a gross twisting of virtue language, Gabrielian explained her motivation for the couple’s espionage in terms of sacrifice and loyalty. In an antipode of Siclari’s service, Henry purportedly wanted to join the Russian army but did not have the requisite combat experience. For his part, Henry’s abysmal defense of his betrayal of his country and his oath speaks for itself, if the United States were to declare war on Russia, Henry told the FBI agent, “at that point, I’ll have some ethical issues I have to work through.”⁸

We become virtuous people through imitating the example of those who have perfected the habits of moral excellence. During 2022, 2 federal practitioners responded to the challenge of war: one displayed the zenith of virtue, the other exhibited the nadir of vice. Seldom does a single year present us with such clear choices of who and how we want to be in 2023. American culture has so trivialized New Year’s resolutions that they are no longer substantive enough for the weight of the profound question of what constitutes the good life. Rather let us make a commitment in keeping with such morally serious matters. All of us live as mixed creatures, drawn to virtue and prone to vice. May we all strive this coming year to help each other meet the high bar another great man of virtue Abraham Lincoln set in his first inaugural address, to be the “better angels of our natures.”¹⁰

Regular readers of Federal Practitioner may recall that I have had a tradition of dedicating the last column of the year to an ethics rendition of the popular trope of the annual best and worst. This year we will examine the stories of 2 military physicians through the lens of virtue ethics. Aristotle (384-322 bce), arguably the most famous Western philosopher, is the acknowledged founder of virtue ethics.

Virtue ethics is among the oldest of ethical theories, and Aristotle articulates this school of thought in his work Nicomachean Ethics.² It is a good fit for Federal Practitioner as it has been constructively applied to the moral development of both military³ and medical professionals.⁴

Here is a Reader’s Digest version of virtue theory with apologizes to all the real philosophers out there. There are different ways to categorize ethical theories. One approach is to distinguish them based on the aspects of primary interest. Consequentialist ethics theories are concerned with the outcomes of actions. Deontologic theories emphasize the intention of the moral agent. In contrast, virtue ethics theories focus on the character of a person. The virtuous individual is one who has practiced the habits of moral excellence and embodies the good life. They are honored as heroes and revered as saints; they are the exemplars we imitate in our aspirations.³

The epigraph sums up one of Aristotle’s central philosophical doctrines: the close relationship of ethics and politics.¹ Personal virtue is intelligible only in the context of community and aim, and the goal of virtue is to contribute to human happiness.⁵ War, whether in ancient Greece or modern Europe, is among the forces most inimical to human flourishing. The current war in Ukraine that has united much of the Western world in opposition to tyranny has divided the 2 physicians in our story along the normative lines of virtue ethics.

The doctor of virtue: Michael Siclari, MD. A 71-year-old US Department of Veterans Affairs physician, Siclari had previously served in the military as a National Guard physician during Operation Enduring Freedom (2001-2014) in Afghanistan. He decided to serve again in Ukraine. Siclari expressed his reasons for going to Ukraine in the language of what Aristotle thought was among the highest virtues: justice. “In retrospect, as I think about why I wanted to go to Ukraine, I think it’s more of a sense that I thought an injustice was happening.”⁷

Echoing the great Rabbi Hillel, Siclari saw the Russian invasion of Ukraine as a personal call to use his experience and training as a trauma and emergency medicine physician to help the Ukrainian people. “If not me, then who?” Siclari demonstrated another virtue: generosity in taking 10 days of personal leave in August 2022 to make the trip to Ukraine, hoping to work in a combat zone tending to wounded soldiers as he had in Afghanistan. When due to logistics he instead was assigned to care for refugees and assist with evacuations from the battlefield, he humbly and compassionately cared for those in his charge. Even now, back home, he speaks to audiences of health care professionals encouraging them to consider similar acts of altruism.⁵

Virtue for Aristotle is technically defined as the mean between 2 extremes of disposition or temperament. The virtue of courage is found in the moral middle ground between the deficiency of bravery that is cowardice and the vice of excess of reckless abandon. The former person fears too much and the latter too little and both thus exhibit vicious behavior.

The doctor of vice: James Lee Henry. Henry is a major and internal medicine physician in the United States Army stationed at Fort Bragg, headquarters of the US Army Special Operations Command. Along with his wife Anna Gabrielian, a civilian anesthesiologist, he was charged in September with conspiring to divulge the protected health information of American military and government employees to the Russian government.⁸ According to the Grand Jury indictment, Henry delivered into the hands of an undercover Federal Bureau of Investigation (FBI) agent, the medical records of a US Army officer, Department of Defense employee, and the spouses of 3 Army veterans, 2 of whom were deceased.⁹ In a gross twisting of virtue language, Gabrielian explained her motivation for the couple’s espionage in terms of sacrifice and loyalty. In an antipode of Siclari’s service, Henry purportedly wanted to join the Russian army but did not have the requisite combat experience. For his part, Henry’s abysmal defense of his betrayal of his country and his oath speaks for itself, if the United States were to declare war on Russia, Henry told the FBI agent, “at that point, I’ll have some ethical issues I have to work through.”⁸

We become virtuous people through imitating the example of those who have perfected the habits of moral excellence. During 2022, 2 federal practitioners responded to the challenge of war: one displayed the zenith of virtue, the other exhibited the nadir of vice. Seldom does a single year present us with such clear choices of who and how we want to be in 2023. American culture has so trivialized New Year’s resolutions that they are no longer substantive enough for the weight of the profound question of what constitutes the good life. Rather let us make a commitment in keeping with such morally serious matters. All of us live as mixed creatures, drawn to virtue and prone to vice. May we all strive this coming year to help each other meet the high bar another great man of virtue Abraham Lincoln set in his first inaugural address, to be the “better angels of our natures.”¹⁰

Regular readers of Federal Practitioner may recall that I have had a tradition of dedicating the last column of the year to an ethics rendition of the popular trope of the annual best and worst. This year we will examine the stories of 2 military physicians through the lens of virtue ethics. Aristotle (384-322 bce), arguably the most famous Western philosopher, is the acknowledged founder of virtue ethics.

Virtue ethics is among the oldest of ethical theories, and Aristotle articulates this school of thought in his work Nicomachean Ethics.² It is a good fit for Federal Practitioner as it has been constructively applied to the moral development of both military³ and medical professionals.⁴

Here is a Reader’s Digest version of virtue theory with apologizes to all the real philosophers out there. There are different ways to categorize ethical theories. One approach is to distinguish them based on the aspects of primary interest. Consequentialist ethics theories are concerned with the outcomes of actions. Deontologic theories emphasize the intention of the moral agent. In contrast, virtue ethics theories focus on the character of a person. The virtuous individual is one who has practiced the habits of moral excellence and embodies the good life. They are honored as heroes and revered as saints; they are the exemplars we imitate in our aspirations.³

The epigraph sums up one of Aristotle’s central philosophical doctrines: the close relationship of ethics and politics.¹ Personal virtue is intelligible only in the context of community and aim, and the goal of virtue is to contribute to human happiness.⁵ War, whether in ancient Greece or modern Europe, is among the forces most inimical to human flourishing. The current war in Ukraine that has united much of the Western world in opposition to tyranny has divided the 2 physicians in our story along the normative lines of virtue ethics.

The doctor of virtue: Michael Siclari, MD. A 71-year-old US Department of Veterans Affairs physician, Siclari had previously served in the military as a National Guard physician during Operation Enduring Freedom (2001-2014) in Afghanistan. He decided to serve again in Ukraine. Siclari expressed his reasons for going to Ukraine in the language of what Aristotle thought was among the highest virtues: justice. “In retrospect, as I think about why I wanted to go to Ukraine, I think it’s more of a sense that I thought an injustice was happening.”⁷

Echoing the great Rabbi Hillel, Siclari saw the Russian invasion of Ukraine as a personal call to use his experience and training as a trauma and emergency medicine physician to help the Ukrainian people. “If not me, then who?” Siclari demonstrated another virtue: generosity in taking 10 days of personal leave in August 2022 to make the trip to Ukraine, hoping to work in a combat zone tending to wounded soldiers as he had in Afghanistan. When due to logistics he instead was assigned to care for refugees and assist with evacuations from the battlefield, he humbly and compassionately cared for those in his charge. Even now, back home, he speaks to audiences of health care professionals encouraging them to consider similar acts of altruism.⁵

Virtue for Aristotle is technically defined as the mean between 2 extremes of disposition or temperament. The virtue of courage is found in the moral middle ground between the deficiency of bravery that is cowardice and the vice of excess of reckless abandon. The former person fears too much and the latter too little and both thus exhibit vicious behavior.

The doctor of vice: James Lee Henry. Henry is a major and internal medicine physician in the United States Army stationed at Fort Bragg, headquarters of the US Army Special Operations Command. Along with his wife Anna Gabrielian, a civilian anesthesiologist, he was charged in September with conspiring to divulge the protected health information of American military and government employees to the Russian government.⁸ According to the Grand Jury indictment, Henry delivered into the hands of an undercover Federal Bureau of Investigation (FBI) agent, the medical records of a US Army officer, Department of Defense employee, and the spouses of 3 Army veterans, 2 of whom were deceased.⁹ In a gross twisting of virtue language, Gabrielian explained her motivation for the couple’s espionage in terms of sacrifice and loyalty. In an antipode of Siclari’s service, Henry purportedly wanted to join the Russian army but did not have the requisite combat experience. For his part, Henry’s abysmal defense of his betrayal of his country and his oath speaks for itself, if the United States were to declare war on Russia, Henry told the FBI agent, “at that point, I’ll have some ethical issues I have to work through.”⁸

We become virtuous people through imitating the example of those who have perfected the habits of moral excellence. During 2022, 2 federal practitioners responded to the challenge of war: one displayed the zenith of virtue, the other exhibited the nadir of vice. Seldom does a single year present us with such clear choices of who and how we want to be in 2023. American culture has so trivialized New Year’s resolutions that they are no longer substantive enough for the weight of the profound question of what constitutes the good life. Rather let us make a commitment in keeping with such morally serious matters. All of us live as mixed creatures, drawn to virtue and prone to vice. May we all strive this coming year to help each other meet the high bar another great man of virtue Abraham Lincoln set in his first inaugural address, to be the “better angels of our natures.”¹⁰

We are all seeing more children on the autism spectrum than we ever expected. With a Centers for Disease Control–estimated prevalence of 1 in 44, the average pediatrician will be caring for 45 children with autism. It may feel like even more as parents bring in their children with related concerns or fears. Early entry into services has been shown to improve functioning, making early identification important. However, screening at the youngest ages has important limitations.

Sharing a concern about possible autism with parents is a painful aspect of primary care practice. We want to get it right, not frighten parents unnecessarily, nor miss children and delay intervention.

Autism screening is recommended by the American Academy of Pediatrics at 18- and 24-month pediatric well-child visits. There are several reasons for screening repeatedly: Autism symptoms emerge gradually in the toddler period; about 32% of children later found to have autism were developing in a typical pattern and appeared normal at 18 months only to regress by age 24 months; children may miss the 18 month screen; and all screens have false negatives as well as false positives. But even screening at these two ages is not enough.

One criticism of current screening tests pointed out by the U.S. Preventive Services Task Force has been a problem with the sample used to develop or validate the tool. Many test development studies included only children at risk by being in early intervention, siblings of children with diagnosed autism, or children only failing the screening tests rather than a community sample that the screen in actually used for.

Another obstacle to prediction of autism diagnoses made years later is that some children may not have had any clinical manifestations at the younger age even as judged by the best gold standard testing and, thus, negative screens were ambiguous. Additionally, data from prospective studies of high-risk infant siblings reveal that only 18% of children diagnosed with autism at 36 months were given that diagnosis at 18 months of age despite use of comprehensive diagnostic assessments.

Prevalence is also reported as 30% higher at age 8-12 years as at 3-7 years on gold-standard tests. Children identified later with autism tend to have milder symptoms and higher cognitive functioning. Therefore, we need some humility in thinking we can identify children as early as 18 months; rather, we need to use the best available methods at all ages and remain vigilant to symptoms as they evolve as well as to new screening and testing measures.

The most commonly used parent report screen is the 20-item Modified Checklist for Autism in Toddlers–Revised (M-CHAT-R), a modification of the original CHAT screen. To have reasonable positive predictive value, the M-CHAT-R authors recommend a clinician or trained staff member conduct a structured follow-up interview with the parent when the M-CHAT-R has a score of 3-7. Scores of 8 or more reflect enough symptoms to more strongly predict an autism diagnosis and thus the interview may be skipped in those cases. The recommended two-step process is called M-CHAT-R/F. At 18 months without the R/F, a positive M-CHAT-R only is associated with an autism diagnosis 27% of the time (PPV, 0.27); which is unacceptable for primary care use.

Unfortunately, the M-CHAT-R/F appears to be less accurate for 18-month-olds than 24-month-olds, in part because its yes/no response options are harder for a caregiver to answer, especially for behaviors just developing, or because of lack of experience with toddlers.

An alternative modification of the original CHAT called the Quantitative CHAT or Q-CHAT-10 has a range of response options for the caregiver; for example, always/usually/sometimes/rarely/never or many times a day/a few times a day/a few times a week/less than once a week/never. The authors of the Q-CHAT-10, however, recommend a summary pass/fail result for ease of use rather than using the range of response option values in the score. We recently published a study testing accuracy using add-up scoring that utilized the entire range of response option values, called Q-CHAT-10-O (O for ordinal), for children 16-20 months old as well as cartoon depictions of the behaviors. Our study also included diagnostic testing of screen-negative as well as screen-positive children to accurately calculate sensitivity and specificity for this method. In our study, Q-CHAT-10-O with a cutoff score greater than 11 showed higher sensitivity (0.63) than either M-CHAT-R/F (0.34) or Q-CHAT-10 (0.31) for this age range although the PPV (0.35) and negative predictive value (0.92) were comparable with M-CHAT R/F. Although Q-CHAT-10-O sensitivity (0.63) is less than M-CHAT-R (without follow-up; 0.73) and specificity (0.79) is less than the two-stage R/F procedure (0.90), on balance, it is more accurate and more practical for a primary care population. After 20 months of age, the M-CHAT-R/F has adequate accuracy to rescreen, if indicated, and for the subsequent 24 month screening. Language items are often of highest value in predicting outcomes in several tools including in the screen we are now validating for 18 month olds.

The Q-CHAT-10-O with ordinal scoring and pictures can also be recommended because it shows advantages over M-CHAT-R/F with half the number of items (10 vs. 20), no requirement for a follow-up interview, and improved sensitivity. Unlike M-CHAT-R, it also contributes to equity in screening because results did not differ depending on race or socioeconomic background.

Is there an even better way to detect autism in primary care? In 2022 an article was published regarding an exciting method of early autism detection called the Social Attention and Communication Surveillance–Revised (SACS-R), an eight-item observation checklist completed at public health nurse check-ups in Australia. The observers had 4 years of nursing degree education and a 3.5-hour training session.

The SACS-R and the preschool version (for older children) had significant associations with diagnostic testing at 12, 18, 24, and 42 months. The SACS-R had excellent PPV (82.6%), NPV (98.7%), and specificity (99.6%) and moderate sensitivity (61.5%) when used between 12 and 24 months of age. Pointing, eye contact, waving “bye, bye,” social communication by showing, and pretend play were the key indicators for observations at 18 months, with absence of three or more indicating risk for autism. Different key indicators were used at the other ages, reflecting the evolution of autism symptoms. This hybrid (observation and scoring) surveillance method by professionals shows hopeful data for the critical ability to identify children at risk for autism in primary care very early but requires more than parent report, that is, new levels of autism-specific clinician training and direct observations at multiple visits over time.

The takeaway is to remember that we should all watch closely for early signs of autism, informed by research on the key findings that a professional might observe, as well as by using the best screens available. We should remember that both false positives and false negatives are inherent in screening, especially at the youngest ages. We need to combine our concern with the parent’s concern as well as screen results and be sure to follow-up closely as symptoms can change in even a few months. Many factors may prevent a family from returning to see us or following our advice to go for testing or intervention, so tracking the child and their service use is an important part of the good care we strive to provide children with autism.

Other screening tools

You may have heard of other parent-report screens for autism. It is important to compare their accuracy specifically for 18-month-olds in a community setting.

• The Infant Toddler Checklist (https://psychology-tools.com/test/infant-toddler-checklist) has moderate overall psychometrics with sensitivity ranging from 0.55 to 0.77; specificity from 0.42 to 0.85; PPV from 0.20 to 0.55; and NPV from 0.83 to 0.94. However, the data were based on a sample including both community-dwelling toddlers and those with a family history of autism.
• The Brief Infant-Toddler Social and Emotional Assessment (https://eprovide.mapi-trust.org/instruments/brief-infant-toddler-social-emotional-assessment/) – the screen’s four autism-specific scales had high specificity (84%-90%) but low sensitivity (40%-52%).
• Canvas Dx (https://canvasdx.com/) from the Cognoa company is not a parent-report measure but rather a three-part evaluation including an app-based parent questionnaire, parent uploads of home videos analyzed by a specialist, and a 13- to 15-item primary care physician observational checklist. There were 56 diagnosed of the 426 children in the 18- to 24-month-old range from a sample of children presenting with parent or clinician concerns rather than from a community sample.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

Sturner R et al. Autism screening at 18 months of age: A comparison of the Q-CHAT-10 and M-CHAT screeners. Molecular Autism. Jan 3;13(1):2.

Barbaro J et al. Diagnostic accuracy of the Social Attention and Communication Surveillance–Revised with preschool tool for early autism detection in very young children. JAMA Netw Open. 2022;5(3):e2146415.

We are all seeing more children on the autism spectrum than we ever expected. With a Centers for Disease Control–estimated prevalence of 1 in 44, the average pediatrician will be caring for 45 children with autism. It may feel like even more as parents bring in their children with related concerns or fears. Early entry into services has been shown to improve functioning, making early identification important. However, screening at the youngest ages has important limitations.

Sharing a concern about possible autism with parents is a painful aspect of primary care practice. We want to get it right, not frighten parents unnecessarily, nor miss children and delay intervention.

Autism screening is recommended by the American Academy of Pediatrics at 18- and 24-month pediatric well-child visits. There are several reasons for screening repeatedly: Autism symptoms emerge gradually in the toddler period; about 32% of children later found to have autism were developing in a typical pattern and appeared normal at 18 months only to regress by age 24 months; children may miss the 18 month screen; and all screens have false negatives as well as false positives. But even screening at these two ages is not enough.

One criticism of current screening tests pointed out by the U.S. Preventive Services Task Force has been a problem with the sample used to develop or validate the tool. Many test development studies included only children at risk by being in early intervention, siblings of children with diagnosed autism, or children only failing the screening tests rather than a community sample that the screen in actually used for.

Another obstacle to prediction of autism diagnoses made years later is that some children may not have had any clinical manifestations at the younger age even as judged by the best gold standard testing and, thus, negative screens were ambiguous. Additionally, data from prospective studies of high-risk infant siblings reveal that only 18% of children diagnosed with autism at 36 months were given that diagnosis at 18 months of age despite use of comprehensive diagnostic assessments.

Prevalence is also reported as 30% higher at age 8-12 years as at 3-7 years on gold-standard tests. Children identified later with autism tend to have milder symptoms and higher cognitive functioning. Therefore, we need some humility in thinking we can identify children as early as 18 months; rather, we need to use the best available methods at all ages and remain vigilant to symptoms as they evolve as well as to new screening and testing measures.

The most commonly used parent report screen is the 20-item Modified Checklist for Autism in Toddlers–Revised (M-CHAT-R), a modification of the original CHAT screen. To have reasonable positive predictive value, the M-CHAT-R authors recommend a clinician or trained staff member conduct a structured follow-up interview with the parent when the M-CHAT-R has a score of 3-7. Scores of 8 or more reflect enough symptoms to more strongly predict an autism diagnosis and thus the interview may be skipped in those cases. The recommended two-step process is called M-CHAT-R/F. At 18 months without the R/F, a positive M-CHAT-R only is associated with an autism diagnosis 27% of the time (PPV, 0.27); which is unacceptable for primary care use.

Unfortunately, the M-CHAT-R/F appears to be less accurate for 18-month-olds than 24-month-olds, in part because its yes/no response options are harder for a caregiver to answer, especially for behaviors just developing, or because of lack of experience with toddlers.

An alternative modification of the original CHAT called the Quantitative CHAT or Q-CHAT-10 has a range of response options for the caregiver; for example, always/usually/sometimes/rarely/never or many times a day/a few times a day/a few times a week/less than once a week/never. The authors of the Q-CHAT-10, however, recommend a summary pass/fail result for ease of use rather than using the range of response option values in the score. We recently published a study testing accuracy using add-up scoring that utilized the entire range of response option values, called Q-CHAT-10-O (O for ordinal), for children 16-20 months old as well as cartoon depictions of the behaviors. Our study also included diagnostic testing of screen-negative as well as screen-positive children to accurately calculate sensitivity and specificity for this method. In our study, Q-CHAT-10-O with a cutoff score greater than 11 showed higher sensitivity (0.63) than either M-CHAT-R/F (0.34) or Q-CHAT-10 (0.31) for this age range although the PPV (0.35) and negative predictive value (0.92) were comparable with M-CHAT R/F. Although Q-CHAT-10-O sensitivity (0.63) is less than M-CHAT-R (without follow-up; 0.73) and specificity (0.79) is less than the two-stage R/F procedure (0.90), on balance, it is more accurate and more practical for a primary care population. After 20 months of age, the M-CHAT-R/F has adequate accuracy to rescreen, if indicated, and for the subsequent 24 month screening. Language items are often of highest value in predicting outcomes in several tools including in the screen we are now validating for 18 month olds.

The Q-CHAT-10-O with ordinal scoring and pictures can also be recommended because it shows advantages over M-CHAT-R/F with half the number of items (10 vs. 20), no requirement for a follow-up interview, and improved sensitivity. Unlike M-CHAT-R, it also contributes to equity in screening because results did not differ depending on race or socioeconomic background.

Is there an even better way to detect autism in primary care? In 2022 an article was published regarding an exciting method of early autism detection called the Social Attention and Communication Surveillance–Revised (SACS-R), an eight-item observation checklist completed at public health nurse check-ups in Australia. The observers had 4 years of nursing degree education and a 3.5-hour training session.

The SACS-R and the preschool version (for older children) had significant associations with diagnostic testing at 12, 18, 24, and 42 months. The SACS-R had excellent PPV (82.6%), NPV (98.7%), and specificity (99.6%) and moderate sensitivity (61.5%) when used between 12 and 24 months of age. Pointing, eye contact, waving “bye, bye,” social communication by showing, and pretend play were the key indicators for observations at 18 months, with absence of three or more indicating risk for autism. Different key indicators were used at the other ages, reflecting the evolution of autism symptoms. This hybrid (observation and scoring) surveillance method by professionals shows hopeful data for the critical ability to identify children at risk for autism in primary care very early but requires more than parent report, that is, new levels of autism-specific clinician training and direct observations at multiple visits over time.

The takeaway is to remember that we should all watch closely for early signs of autism, informed by research on the key findings that a professional might observe, as well as by using the best screens available. We should remember that both false positives and false negatives are inherent in screening, especially at the youngest ages. We need to combine our concern with the parent’s concern as well as screen results and be sure to follow-up closely as symptoms can change in even a few months. Many factors may prevent a family from returning to see us or following our advice to go for testing or intervention, so tracking the child and their service use is an important part of the good care we strive to provide children with autism.

Other screening tools

You may have heard of other parent-report screens for autism. It is important to compare their accuracy specifically for 18-month-olds in a community setting.

• The Infant Toddler Checklist (https://psychology-tools.com/test/infant-toddler-checklist) has moderate overall psychometrics with sensitivity ranging from 0.55 to 0.77; specificity from 0.42 to 0.85; PPV from 0.20 to 0.55; and NPV from 0.83 to 0.94. However, the data were based on a sample including both community-dwelling toddlers and those with a family history of autism.
• The Brief Infant-Toddler Social and Emotional Assessment (https://eprovide.mapi-trust.org/instruments/brief-infant-toddler-social-emotional-assessment/) – the screen’s four autism-specific scales had high specificity (84%-90%) but low sensitivity (40%-52%).
• Canvas Dx (https://canvasdx.com/) from the Cognoa company is not a parent-report measure but rather a three-part evaluation including an app-based parent questionnaire, parent uploads of home videos analyzed by a specialist, and a 13- to 15-item primary care physician observational checklist. There were 56 diagnosed of the 426 children in the 18- to 24-month-old range from a sample of children presenting with parent or clinician concerns rather than from a community sample.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

Sturner R et al. Autism screening at 18 months of age: A comparison of the Q-CHAT-10 and M-CHAT screeners. Molecular Autism. Jan 3;13(1):2.

Barbaro J et al. Diagnostic accuracy of the Social Attention and Communication Surveillance–Revised with preschool tool for early autism detection in very young children. JAMA Netw Open. 2022;5(3):e2146415.

We are all seeing more children on the autism spectrum than we ever expected. With a Centers for Disease Control–estimated prevalence of 1 in 44, the average pediatrician will be caring for 45 children with autism. It may feel like even more as parents bring in their children with related concerns or fears. Early entry into services has been shown to improve functioning, making early identification important. However, screening at the youngest ages has important limitations.

Sharing a concern about possible autism with parents is a painful aspect of primary care practice. We want to get it right, not frighten parents unnecessarily, nor miss children and delay intervention.

Autism screening is recommended by the American Academy of Pediatrics at 18- and 24-month pediatric well-child visits. There are several reasons for screening repeatedly: Autism symptoms emerge gradually in the toddler period; about 32% of children later found to have autism were developing in a typical pattern and appeared normal at 18 months only to regress by age 24 months; children may miss the 18 month screen; and all screens have false negatives as well as false positives. But even screening at these two ages is not enough.

One criticism of current screening tests pointed out by the U.S. Preventive Services Task Force has been a problem with the sample used to develop or validate the tool. Many test development studies included only children at risk by being in early intervention, siblings of children with diagnosed autism, or children only failing the screening tests rather than a community sample that the screen in actually used for.

Another obstacle to prediction of autism diagnoses made years later is that some children may not have had any clinical manifestations at the younger age even as judged by the best gold standard testing and, thus, negative screens were ambiguous. Additionally, data from prospective studies of high-risk infant siblings reveal that only 18% of children diagnosed with autism at 36 months were given that diagnosis at 18 months of age despite use of comprehensive diagnostic assessments.

Prevalence is also reported as 30% higher at age 8-12 years as at 3-7 years on gold-standard tests. Children identified later with autism tend to have milder symptoms and higher cognitive functioning. Therefore, we need some humility in thinking we can identify children as early as 18 months; rather, we need to use the best available methods at all ages and remain vigilant to symptoms as they evolve as well as to new screening and testing measures.

The most commonly used parent report screen is the 20-item Modified Checklist for Autism in Toddlers–Revised (M-CHAT-R), a modification of the original CHAT screen. To have reasonable positive predictive value, the M-CHAT-R authors recommend a clinician or trained staff member conduct a structured follow-up interview with the parent when the M-CHAT-R has a score of 3-7. Scores of 8 or more reflect enough symptoms to more strongly predict an autism diagnosis and thus the interview may be skipped in those cases. The recommended two-step process is called M-CHAT-R/F. At 18 months without the R/F, a positive M-CHAT-R only is associated with an autism diagnosis 27% of the time (PPV, 0.27); which is unacceptable for primary care use.

Unfortunately, the M-CHAT-R/F appears to be less accurate for 18-month-olds than 24-month-olds, in part because its yes/no response options are harder for a caregiver to answer, especially for behaviors just developing, or because of lack of experience with toddlers.

An alternative modification of the original CHAT called the Quantitative CHAT or Q-CHAT-10 has a range of response options for the caregiver; for example, always/usually/sometimes/rarely/never or many times a day/a few times a day/a few times a week/less than once a week/never. The authors of the Q-CHAT-10, however, recommend a summary pass/fail result for ease of use rather than using the range of response option values in the score. We recently published a study testing accuracy using add-up scoring that utilized the entire range of response option values, called Q-CHAT-10-O (O for ordinal), for children 16-20 months old as well as cartoon depictions of the behaviors. Our study also included diagnostic testing of screen-negative as well as screen-positive children to accurately calculate sensitivity and specificity for this method. In our study, Q-CHAT-10-O with a cutoff score greater than 11 showed higher sensitivity (0.63) than either M-CHAT-R/F (0.34) or Q-CHAT-10 (0.31) for this age range although the PPV (0.35) and negative predictive value (0.92) were comparable with M-CHAT R/F. Although Q-CHAT-10-O sensitivity (0.63) is less than M-CHAT-R (without follow-up; 0.73) and specificity (0.79) is less than the two-stage R/F procedure (0.90), on balance, it is more accurate and more practical for a primary care population. After 20 months of age, the M-CHAT-R/F has adequate accuracy to rescreen, if indicated, and for the subsequent 24 month screening. Language items are often of highest value in predicting outcomes in several tools including in the screen we are now validating for 18 month olds.

The Q-CHAT-10-O with ordinal scoring and pictures can also be recommended because it shows advantages over M-CHAT-R/F with half the number of items (10 vs. 20), no requirement for a follow-up interview, and improved sensitivity. Unlike M-CHAT-R, it also contributes to equity in screening because results did not differ depending on race or socioeconomic background.

Is there an even better way to detect autism in primary care? In 2022 an article was published regarding an exciting method of early autism detection called the Social Attention and Communication Surveillance–Revised (SACS-R), an eight-item observation checklist completed at public health nurse check-ups in Australia. The observers had 4 years of nursing degree education and a 3.5-hour training session.

The SACS-R and the preschool version (for older children) had significant associations with diagnostic testing at 12, 18, 24, and 42 months. The SACS-R had excellent PPV (82.6%), NPV (98.7%), and specificity (99.6%) and moderate sensitivity (61.5%) when used between 12 and 24 months of age. Pointing, eye contact, waving “bye, bye,” social communication by showing, and pretend play were the key indicators for observations at 18 months, with absence of three or more indicating risk for autism. Different key indicators were used at the other ages, reflecting the evolution of autism symptoms. This hybrid (observation and scoring) surveillance method by professionals shows hopeful data for the critical ability to identify children at risk for autism in primary care very early but requires more than parent report, that is, new levels of autism-specific clinician training and direct observations at multiple visits over time.

The takeaway is to remember that we should all watch closely for early signs of autism, informed by research on the key findings that a professional might observe, as well as by using the best screens available. We should remember that both false positives and false negatives are inherent in screening, especially at the youngest ages. We need to combine our concern with the parent’s concern as well as screen results and be sure to follow-up closely as symptoms can change in even a few months. Many factors may prevent a family from returning to see us or following our advice to go for testing or intervention, so tracking the child and their service use is an important part of the good care we strive to provide children with autism.

Other screening tools

You may have heard of other parent-report screens for autism. It is important to compare their accuracy specifically for 18-month-olds in a community setting.

• The Infant Toddler Checklist (https://psychology-tools.com/test/infant-toddler-checklist) has moderate overall psychometrics with sensitivity ranging from 0.55 to 0.77; specificity from 0.42 to 0.85; PPV from 0.20 to 0.55; and NPV from 0.83 to 0.94. However, the data were based on a sample including both community-dwelling toddlers and those with a family history of autism.
• The Brief Infant-Toddler Social and Emotional Assessment (https://eprovide.mapi-trust.org/instruments/brief-infant-toddler-social-emotional-assessment/) – the screen’s four autism-specific scales had high specificity (84%-90%) but low sensitivity (40%-52%).
• Canvas Dx (https://canvasdx.com/) from the Cognoa company is not a parent-report measure but rather a three-part evaluation including an app-based parent questionnaire, parent uploads of home videos analyzed by a specialist, and a 13- to 15-item primary care physician observational checklist. There were 56 diagnosed of the 426 children in the 18- to 24-month-old range from a sample of children presenting with parent or clinician concerns rather than from a community sample.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

Sturner R et al. Autism screening at 18 months of age: A comparison of the Q-CHAT-10 and M-CHAT screeners. Molecular Autism. Jan 3;13(1):2.

Barbaro J et al. Diagnostic accuracy of the Social Attention and Communication Surveillance–Revised with preschool tool for early autism detection in very young children. JAMA Netw Open. 2022;5(3):e2146415.

When I was growing up, I can remember experiencing “duck and cover” drills at school. If a flash appeared in our peripheral vision, we were told we should not look at it but crawl under our desks. My classmates and I were being taught how to protect ourselves in case of a nuclear attack.

Clearly, had there been such an attack, ducking under our desks would not have saved us. Thankfully, such a conflict never occurred – and hopefully never will. Still, the warning did penetrate our psyches. In those days, families and children in schools were worried, and some were scared.

The situation is quite different today. Our children and grandchildren are being taught to protect themselves not from actions overseas – that never happened – but from what someone living in their community might do that has been occurring in real time. According to my daughter-in-law, her young children are taught during “lockdowns” to hide in their classrooms’ closets. During these drills, some children are directed to line up against a wall that would be out of sight of a shooter, and to stay as still as possible.

Since 2017, the number of intentional shootings in U.S. kindergarten through grade 12 schools increased precipitously (Prev Med. 2022 Dec. doi: 10.1016/j.ypmed.2022.107280). Imagine the psychological impact that the vigilance required to deal with such impending threats must be having on our children, as they learn to fear injury and possible death every day they go to school. I’ve talked with numerous parents about this, including my own adult children, and this is clearly a new dimension of life that is on everyone’s minds. Schools, once bastions of safety, are no longer that safe.

For many years, I’ve written about the need to destigmatize mental illness so that it is treated on a par with physical illness. As we look at the challenges faced by young people, reframing mental illness is more important now than ever. This means finding ways to increase the funding of studies that help us understand young people with mental health issues. It also means encouraging patients to pursue treatment from psychiatrists, psychologists, or mental health counselors who specialize in short-term therapy.

The emphasis here on short-term therapy is not to discourage longer-term care when needed, but clearly short-term care strategies, such as cognitive-behavioral therapies, not only work for problem resolution, they also help in the destigmatization of mental health care – as the circumscribed treatment with a clear beginning, middle, and end is consistent with CBT and consistent with much of medical care for physical disorders.

Furthermore, as we aim to destigmatize mental health care, it’s important to equate it with physical care. For example, taking a day or two from school or work for a sprained ankle, seeing a dentist, or an eye exam, plus a myriad of physical issues is quite acceptable. Why is it not also acceptable for a mental health issue and evaluation, such as for anxiety or PTSD, plus being able to talk about it without stigma? Seeing the “shrink” needs to be removed as a negative but viewed as a very positive move toward care for oneself.

In addition, children and adolescents are battling countless other health challenges that could have implications for mental health professionals, for example:

• During the height of the coronavirus pandemic, pediatric endocrinologists reportedly saw a surge of referrals for girls experiencing early puberty. Puberty should never be medicalized, but early maturation has been linked to numerous psychiatric disorders such as depression, anxiety, and eating disorders (J Pediatr Adolec Gynecol. 2022 Oct. doi: 10.1016/j.jpag.2022.05.005).
• A global epidemiologic study of children estimates that nearly 8 million youth lost a parent or caregiver because of a pandemic-related cause between Jan. 1, 2020, and May 1, 2022. An additional 2.5 million children were affected by the loss of secondary caregivers such as grandparents (JAMA Pediatr. 2022 Sept. doi: 10.1001/jamapediatrics.2022.3157).
• The inpatient and outpatient volume of adolescents and young adults receiving care for eating disorders skyrocketed before and after the pandemic, according to the results of case study series (JAMA Pediatrics. 2022 Nov 7. doi: 10.1001/jamapediatrics.2022.4346).
• Children and adolescents who developed COVID-19 suffered tremendously during the height of the pandemic. A nationwide analysis shows that COVID-19 nearly tripled children’s risks of developing new mental health illnesses, such as attention-deficit/hyperactivity disorder, anxiety, trauma, or stress disorder (Psychiatric Services. 2022 Jun 2. doi: 10.1176/appi.ps.202100646).

In addition to those challenges, young children are facing an increase in respiratory syncytial virus (RSV) infection. We were told the “flu” would be quite bad this year and to beware of monkeypox. However, very little mention is made of the equally distressing “epidemic” of mental health issues, PTSD, anxiety, and depression as we are still in the midst of the COVID pandemic in the United States with almost 400 deaths a day – a very unacceptable number.

Interestingly, we seem to have abandoned the use of masks as protection against COVID and other respiratory diseases, despite their effectiveness. A study in Boston that looked at children in two school districts that did not lift mask mandates demonstrated that mask wearing does indeed lead to significant reductions in the number of pediatric COVID cases. In addition to societal violence and school shootings – which certainly exacerbate anxiety – the fear of dying or the death of a loved one, tied to COVID, may lead to epidemic proportions of PTSD in children. As an article in WebMD noted, “pediatricians are imploring the federal government to declare a national emergency as cases of pediatric respiratory illnesses continue to soar.”

In light of the acknowledged mental health crisis in children, which appears epidemic, I would hope the psychiatric and psychological associations would publicly sound an alarm so that resources could be brought to bear to address this critical issue. I believe doing so would also aid in destigmatizing mental disorders, and increase education and treatment.

Layered on top of those issues are natural disasters, such as the fallout from Tropical Storm Nicole when it recently caused devastation across western Florida. The mental health trauma caused by recent tropical storms seems all but forgotten – except for those who are still suffering. All of this adds up to a society-wide mental health crisis, which seems far more expansive than monkeypox, for example. Yet monkeypox, which did lead to thousands of cases and approximately 29 deaths in the United States, was declared a national public health emergency.

Additionally, RSV killed 100-500 U.S. children under age 5 each year before the pandemic, according to the Centers for Disease Control and Prevention, and currently it appears even worse. Yet despite the seriousness of RSV, it nowhere matches the emotional toll COVID has taken on children globally.

Let’s make it standard practice for children – and of course, adults – to be taught that anxiety is a normal response at times. We should teach that, in some cases, feeling “down” or in despair and even experiencing symptoms of PTSD based on what’s going on personally and within our environment (i.e., COVID, school shootings, etc.) are triggers and responses that can be addressed and often quickly treated by talking with a mental health professional.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

When I was growing up, I can remember experiencing “duck and cover” drills at school. If a flash appeared in our peripheral vision, we were told we should not look at it but crawl under our desks. My classmates and I were being taught how to protect ourselves in case of a nuclear attack.

Clearly, had there been such an attack, ducking under our desks would not have saved us. Thankfully, such a conflict never occurred – and hopefully never will. Still, the warning did penetrate our psyches. In those days, families and children in schools were worried, and some were scared.

The situation is quite different today. Our children and grandchildren are being taught to protect themselves not from actions overseas – that never happened – but from what someone living in their community might do that has been occurring in real time. According to my daughter-in-law, her young children are taught during “lockdowns” to hide in their classrooms’ closets. During these drills, some children are directed to line up against a wall that would be out of sight of a shooter, and to stay as still as possible.

Since 2017, the number of intentional shootings in U.S. kindergarten through grade 12 schools increased precipitously (Prev Med. 2022 Dec. doi: 10.1016/j.ypmed.2022.107280). Imagine the psychological impact that the vigilance required to deal with such impending threats must be having on our children, as they learn to fear injury and possible death every day they go to school. I’ve talked with numerous parents about this, including my own adult children, and this is clearly a new dimension of life that is on everyone’s minds. Schools, once bastions of safety, are no longer that safe.

For many years, I’ve written about the need to destigmatize mental illness so that it is treated on a par with physical illness. As we look at the challenges faced by young people, reframing mental illness is more important now than ever. This means finding ways to increase the funding of studies that help us understand young people with mental health issues. It also means encouraging patients to pursue treatment from psychiatrists, psychologists, or mental health counselors who specialize in short-term therapy.

The emphasis here on short-term therapy is not to discourage longer-term care when needed, but clearly short-term care strategies, such as cognitive-behavioral therapies, not only work for problem resolution, they also help in the destigmatization of mental health care – as the circumscribed treatment with a clear beginning, middle, and end is consistent with CBT and consistent with much of medical care for physical disorders.

Furthermore, as we aim to destigmatize mental health care, it’s important to equate it with physical care. For example, taking a day or two from school or work for a sprained ankle, seeing a dentist, or an eye exam, plus a myriad of physical issues is quite acceptable. Why is it not also acceptable for a mental health issue and evaluation, such as for anxiety or PTSD, plus being able to talk about it without stigma? Seeing the “shrink” needs to be removed as a negative but viewed as a very positive move toward care for oneself.

In addition, children and adolescents are battling countless other health challenges that could have implications for mental health professionals, for example:

• During the height of the coronavirus pandemic, pediatric endocrinologists reportedly saw a surge of referrals for girls experiencing early puberty. Puberty should never be medicalized, but early maturation has been linked to numerous psychiatric disorders such as depression, anxiety, and eating disorders (J Pediatr Adolec Gynecol. 2022 Oct. doi: 10.1016/j.jpag.2022.05.005).
• A global epidemiologic study of children estimates that nearly 8 million youth lost a parent or caregiver because of a pandemic-related cause between Jan. 1, 2020, and May 1, 2022. An additional 2.5 million children were affected by the loss of secondary caregivers such as grandparents (JAMA Pediatr. 2022 Sept. doi: 10.1001/jamapediatrics.2022.3157).
• The inpatient and outpatient volume of adolescents and young adults receiving care for eating disorders skyrocketed before and after the pandemic, according to the results of case study series (JAMA Pediatrics. 2022 Nov 7. doi: 10.1001/jamapediatrics.2022.4346).
• Children and adolescents who developed COVID-19 suffered tremendously during the height of the pandemic. A nationwide analysis shows that COVID-19 nearly tripled children’s risks of developing new mental health illnesses, such as attention-deficit/hyperactivity disorder, anxiety, trauma, or stress disorder (Psychiatric Services. 2022 Jun 2. doi: 10.1176/appi.ps.202100646).

In addition to those challenges, young children are facing an increase in respiratory syncytial virus (RSV) infection. We were told the “flu” would be quite bad this year and to beware of monkeypox. However, very little mention is made of the equally distressing “epidemic” of mental health issues, PTSD, anxiety, and depression as we are still in the midst of the COVID pandemic in the United States with almost 400 deaths a day – a very unacceptable number.

Interestingly, we seem to have abandoned the use of masks as protection against COVID and other respiratory diseases, despite their effectiveness. A study in Boston that looked at children in two school districts that did not lift mask mandates demonstrated that mask wearing does indeed lead to significant reductions in the number of pediatric COVID cases. In addition to societal violence and school shootings – which certainly exacerbate anxiety – the fear of dying or the death of a loved one, tied to COVID, may lead to epidemic proportions of PTSD in children. As an article in WebMD noted, “pediatricians are imploring the federal government to declare a national emergency as cases of pediatric respiratory illnesses continue to soar.”

In light of the acknowledged mental health crisis in children, which appears epidemic, I would hope the psychiatric and psychological associations would publicly sound an alarm so that resources could be brought to bear to address this critical issue. I believe doing so would also aid in destigmatizing mental disorders, and increase education and treatment.

Layered on top of those issues are natural disasters, such as the fallout from Tropical Storm Nicole when it recently caused devastation across western Florida. The mental health trauma caused by recent tropical storms seems all but forgotten – except for those who are still suffering. All of this adds up to a society-wide mental health crisis, which seems far more expansive than monkeypox, for example. Yet monkeypox, which did lead to thousands of cases and approximately 29 deaths in the United States, was declared a national public health emergency.

Additionally, RSV killed 100-500 U.S. children under age 5 each year before the pandemic, according to the Centers for Disease Control and Prevention, and currently it appears even worse. Yet despite the seriousness of RSV, it nowhere matches the emotional toll COVID has taken on children globally.

Let’s make it standard practice for children – and of course, adults – to be taught that anxiety is a normal response at times. We should teach that, in some cases, feeling “down” or in despair and even experiencing symptoms of PTSD based on what’s going on personally and within our environment (i.e., COVID, school shootings, etc.) are triggers and responses that can be addressed and often quickly treated by talking with a mental health professional.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

When I was growing up, I can remember experiencing “duck and cover” drills at school. If a flash appeared in our peripheral vision, we were told we should not look at it but crawl under our desks. My classmates and I were being taught how to protect ourselves in case of a nuclear attack.

Clearly, had there been such an attack, ducking under our desks would not have saved us. Thankfully, such a conflict never occurred – and hopefully never will. Still, the warning did penetrate our psyches. In those days, families and children in schools were worried, and some were scared.

The situation is quite different today. Our children and grandchildren are being taught to protect themselves not from actions overseas – that never happened – but from what someone living in their community might do that has been occurring in real time. According to my daughter-in-law, her young children are taught during “lockdowns” to hide in their classrooms’ closets. During these drills, some children are directed to line up against a wall that would be out of sight of a shooter, and to stay as still as possible.

Since 2017, the number of intentional shootings in U.S. kindergarten through grade 12 schools increased precipitously (Prev Med. 2022 Dec. doi: 10.1016/j.ypmed.2022.107280). Imagine the psychological impact that the vigilance required to deal with such impending threats must be having on our children, as they learn to fear injury and possible death every day they go to school. I’ve talked with numerous parents about this, including my own adult children, and this is clearly a new dimension of life that is on everyone’s minds. Schools, once bastions of safety, are no longer that safe.

For many years, I’ve written about the need to destigmatize mental illness so that it is treated on a par with physical illness. As we look at the challenges faced by young people, reframing mental illness is more important now than ever. This means finding ways to increase the funding of studies that help us understand young people with mental health issues. It also means encouraging patients to pursue treatment from psychiatrists, psychologists, or mental health counselors who specialize in short-term therapy.

The emphasis here on short-term therapy is not to discourage longer-term care when needed, but clearly short-term care strategies, such as cognitive-behavioral therapies, not only work for problem resolution, they also help in the destigmatization of mental health care – as the circumscribed treatment with a clear beginning, middle, and end is consistent with CBT and consistent with much of medical care for physical disorders.

Furthermore, as we aim to destigmatize mental health care, it’s important to equate it with physical care. For example, taking a day or two from school or work for a sprained ankle, seeing a dentist, or an eye exam, plus a myriad of physical issues is quite acceptable. Why is it not also acceptable for a mental health issue and evaluation, such as for anxiety or PTSD, plus being able to talk about it without stigma? Seeing the “shrink” needs to be removed as a negative but viewed as a very positive move toward care for oneself.

In addition, children and adolescents are battling countless other health challenges that could have implications for mental health professionals, for example:

• During the height of the coronavirus pandemic, pediatric endocrinologists reportedly saw a surge of referrals for girls experiencing early puberty. Puberty should never be medicalized, but early maturation has been linked to numerous psychiatric disorders such as depression, anxiety, and eating disorders (J Pediatr Adolec Gynecol. 2022 Oct. doi: 10.1016/j.jpag.2022.05.005).
• A global epidemiologic study of children estimates that nearly 8 million youth lost a parent or caregiver because of a pandemic-related cause between Jan. 1, 2020, and May 1, 2022. An additional 2.5 million children were affected by the loss of secondary caregivers such as grandparents (JAMA Pediatr. 2022 Sept. doi: 10.1001/jamapediatrics.2022.3157).
• The inpatient and outpatient volume of adolescents and young adults receiving care for eating disorders skyrocketed before and after the pandemic, according to the results of case study series (JAMA Pediatrics. 2022 Nov 7. doi: 10.1001/jamapediatrics.2022.4346).
• Children and adolescents who developed COVID-19 suffered tremendously during the height of the pandemic. A nationwide analysis shows that COVID-19 nearly tripled children’s risks of developing new mental health illnesses, such as attention-deficit/hyperactivity disorder, anxiety, trauma, or stress disorder (Psychiatric Services. 2022 Jun 2. doi: 10.1176/appi.ps.202100646).

In addition to those challenges, young children are facing an increase in respiratory syncytial virus (RSV) infection. We were told the “flu” would be quite bad this year and to beware of monkeypox. However, very little mention is made of the equally distressing “epidemic” of mental health issues, PTSD, anxiety, and depression as we are still in the midst of the COVID pandemic in the United States with almost 400 deaths a day – a very unacceptable number.

Interestingly, we seem to have abandoned the use of masks as protection against COVID and other respiratory diseases, despite their effectiveness. A study in Boston that looked at children in two school districts that did not lift mask mandates demonstrated that mask wearing does indeed lead to significant reductions in the number of pediatric COVID cases. In addition to societal violence and school shootings – which certainly exacerbate anxiety – the fear of dying or the death of a loved one, tied to COVID, may lead to epidemic proportions of PTSD in children. As an article in WebMD noted, “pediatricians are imploring the federal government to declare a national emergency as cases of pediatric respiratory illnesses continue to soar.”

In light of the acknowledged mental health crisis in children, which appears epidemic, I would hope the psychiatric and psychological associations would publicly sound an alarm so that resources could be brought to bear to address this critical issue. I believe doing so would also aid in destigmatizing mental disorders, and increase education and treatment.

Layered on top of those issues are natural disasters, such as the fallout from Tropical Storm Nicole when it recently caused devastation across western Florida. The mental health trauma caused by recent tropical storms seems all but forgotten – except for those who are still suffering. All of this adds up to a society-wide mental health crisis, which seems far more expansive than monkeypox, for example. Yet monkeypox, which did lead to thousands of cases and approximately 29 deaths in the United States, was declared a national public health emergency.

Additionally, RSV killed 100-500 U.S. children under age 5 each year before the pandemic, according to the Centers for Disease Control and Prevention, and currently it appears even worse. Yet despite the seriousness of RSV, it nowhere matches the emotional toll COVID has taken on children globally.

Let’s make it standard practice for children – and of course, adults – to be taught that anxiety is a normal response at times. We should teach that, in some cases, feeling “down” or in despair and even experiencing symptoms of PTSD based on what’s going on personally and within our environment (i.e., COVID, school shootings, etc.) are triggers and responses that can be addressed and often quickly treated by talking with a mental health professional.

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.