Bill seeks to streamline prior authorization in Medicare Advantage plans

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A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.

Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.

These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.

There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.

There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.

“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
 

Strong support among health care groups

There’s strong support for streamlining prior authorization both in the medical community and in Congress.

The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.

Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.

“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.

Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.

Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.

“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.

In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”

“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”

The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
 

 

 

“Rationing care by hassling”

Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.

Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.

“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”

The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.

In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.

“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”

During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.

Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.

In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.

“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”

Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.

“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.

Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.

“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”

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

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A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.

Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.

These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.

There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.

There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.

“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
 

Strong support among health care groups

There’s strong support for streamlining prior authorization both in the medical community and in Congress.

The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.

Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.

“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.

Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.

Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.

“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.

In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”

“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”

The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
 

 

 

“Rationing care by hassling”

Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.

Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.

“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”

The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.

In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.

“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”

During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.

Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.

In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.

“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”

Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.

“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.

Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.

“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”

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

A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.

Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.

These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.

There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.

There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.

“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
 

Strong support among health care groups

There’s strong support for streamlining prior authorization both in the medical community and in Congress.

The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.

Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.

“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.

Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.

Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.

“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.

In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”

“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”

The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
 

 

 

“Rationing care by hassling”

Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.

Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.

“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”

The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.

In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.

“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”

During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.

Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.

In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.

“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”

Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.

“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.

Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.

“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”

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

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What brought me back from the brink of suicide: A physician’s story

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William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.

Dr. William Lynes

In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”

By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.

“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
 

A way to heal

For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.

Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.

Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.

Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.

He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.

A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.

The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”

For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
 

 

 

Why physicians die by suicide

Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”

Dr. Michael Myers

Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.

Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.

2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.

The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.

The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.

Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
 

Every story is different

It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.

Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started. “What I can tell you is that this is a serious subject,” Dr. Myers said. “And it’s not going away.”

Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.

After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.

The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.

Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.

Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.

His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.

Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
 

 

 

A real gift

Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.

“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”

Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.

Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.

A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.

Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.

In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”

Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.

“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
 

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

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William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.

Dr. William Lynes

In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”

By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.

“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
 

A way to heal

For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.

Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.

Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.

Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.

He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.

A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.

The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”

For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
 

 

 

Why physicians die by suicide

Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”

Dr. Michael Myers

Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.

Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.

2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.

The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.

The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.

Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
 

Every story is different

It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.

Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started. “What I can tell you is that this is a serious subject,” Dr. Myers said. “And it’s not going away.”

Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.

After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.

The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.

Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.

Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.

His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.

Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
 

 

 

A real gift

Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.

“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”

Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.

Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.

A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.

Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.

In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”

Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.

“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
 

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

William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.

Dr. William Lynes

In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”

By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.

“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
 

A way to heal

For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.

Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.

Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.

Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.

He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.

A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.

The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”

For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
 

 

 

Why physicians die by suicide

Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”

Dr. Michael Myers

Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.

Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.

2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.

The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.

The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.

Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
 

Every story is different

It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.

Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started. “What I can tell you is that this is a serious subject,” Dr. Myers said. “And it’s not going away.”

Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.

After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.

The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.

Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.

Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.

His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.

Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
 

 

 

A real gift

Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.

“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”

Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.

Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.

A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.

Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.

In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”

Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.

“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
 

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

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Heart benefits of DASH low-sodium diet ‘swift and direct’

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New data show for the first time that combining the DASH (Dietary Approaches to Stop Hypertension) diet with sodium restriction decreases myocardial injury and cardiac strain, which are associated with subclinical cardiac damage and long-term cardiovascular risk.

Dr. Stephen Juraschek

“The benefits of healthy eating are swift and direct. High sodium is not just about taste, it causes heart strain,” Stephen Juraschek, MD, PhD, from Beth Israel Deaconess Medical Center, Boston, said in an interview.

“We should consciously follow a diet enriched with fruit and vegetables and low in sodium. Collectively, we should think about how foods are promoted in society and what is an acceptable amount of sodium for food supplies,” said Dr. Juraschek.

The findings, from a secondary analysis of the DASH-Sodium trial, were published the Journal of the American College of Cardiology.
 

Renewed focus on diet

“These data should spur a renewed focus on the critical need for widespread adoption of the DASH–low-sodium diet in the United States,” wrote the coauthors of a linked editorial.

“The challenge remains moving the DASH–low-sodium diet from the research world into the real world, where its significant health benefits can be fully realized,” they added.

The researchers evaluated the impact of the DASH diet and sodium restriction, individually and combined, on biomarkers of cardiac injury (high-sensitivity cardiac troponin I [hs-cTnI]), cardiac strain (N-terminal of the prohormone brain natriuretic peptide [NT-proBNP]), and inflammation (high-sensitivity C-reactive protein [hs-CRP]).

The DASH-Sodium trial was a controlled feeding study that enrolled 412 adults (mean age, 48 years; 56% women, 56% Black) with untreated systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure between 80 and 95 mm Hg. Mean baseline BP was 135/86 mm Hg.

Participants were randomly allocated to a typical American diet (control) or the heart-healthy DASH diet. Further, participants in both groups were assigned to each of three sodium intake levels: low (0.5 mg/kcal), medium (1.1 mg/kcal) or high (1.6 mg/kcal) for 30 days using a crossover design with washout periods in between.

Compared with the control diet, the DASH diet reduced hs-cTnI by 18% and hs-CRP by 13% with no impact on NT-proBNP.

In contrast, lowering sodium from high to low levels reduced NT-proBNP independent of diet by 19%, but did not alter hs-cTnI and mildly increased hs-CRP (9%).

Combining the DASH diet with sodium reduction lowered hs-cTnI by 20% and NT-proBNP by 23%, with no significant change in hs-CRP, compared with the high-sodium-control diet.

“Together, these findings imply that two distinct dietary strategies might improve two key pathways of subclinical cardiac damage: injury and strain,” Dr. Juraschek and colleagues wrote.

“These findings should strengthen public resolve for public policies that promote the DASH dietary pattern and lower sodium intake in the United States and globally,” they concluded.

“We need to talk about DASH more. Most adults in the U.S. have never heard of it,” Dr. Juraschek said in an interview.

“We need to promote nutrition literacy with regard to nutrition facts. Labeling is not very transparent and hard to understand. Many people don’t know where salt is hiding in their diet,” he added.

It will also be important to address disparities in access to healthy foods and food insecurity, Dr. Juraschek said.

“If we don’t address food costs and access, disparities in healthy eating will persist. Greater equity is key. We should also be mindful about populations dependent on others for meal preparation [children in schools or older adults on meal plans]. This might be regulated in ways that promote healthier eating population wide, but for these patients, they may not have autonomy to choose what they eat,” Dr. Juraschek said.

In their editorial, Neha J. Pagidipati, MD, and Laura P. Svetkey, MD, from Duke University and Duke Clinical Research Institute, Durham, N.C., said an important caveat is that the beneficial effects of diet and sodium restriction on cardiac injury and strain occurred in people without any clinical evidence of coronary artery disease or heart failure at baseline, “suggesting that this dietary combination can improve subclinical metrics of cardiac health.”

“Further, the impact on these markers was seen within weeks, indicating a relatively rapid impact on cardiac damage,” they added.

The measurement of cardiac biomarkers was supported by the National Institutes of Health/National Heart, Lung, and Blood Institute. The original DASH trial was supported by the NHLBI, the Office of Research on Minority Health, and the National Center for Research Resources. Dr. Juraschek and coauthors disclosed no relevant conflicts of interest. Dr. Pagidipati has received research support to the institution from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Regeneron, Sanofi, and Verily Life Sciences; and has received consultation fees from Boehringer Ingelheim, Eli Lilly, AstraZeneca, and Novo Nordisk. Dr. Svetkey has no relevant disclosures.

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

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New data show for the first time that combining the DASH (Dietary Approaches to Stop Hypertension) diet with sodium restriction decreases myocardial injury and cardiac strain, which are associated with subclinical cardiac damage and long-term cardiovascular risk.

Dr. Stephen Juraschek

“The benefits of healthy eating are swift and direct. High sodium is not just about taste, it causes heart strain,” Stephen Juraschek, MD, PhD, from Beth Israel Deaconess Medical Center, Boston, said in an interview.

“We should consciously follow a diet enriched with fruit and vegetables and low in sodium. Collectively, we should think about how foods are promoted in society and what is an acceptable amount of sodium for food supplies,” said Dr. Juraschek.

The findings, from a secondary analysis of the DASH-Sodium trial, were published the Journal of the American College of Cardiology.
 

Renewed focus on diet

“These data should spur a renewed focus on the critical need for widespread adoption of the DASH–low-sodium diet in the United States,” wrote the coauthors of a linked editorial.

“The challenge remains moving the DASH–low-sodium diet from the research world into the real world, where its significant health benefits can be fully realized,” they added.

The researchers evaluated the impact of the DASH diet and sodium restriction, individually and combined, on biomarkers of cardiac injury (high-sensitivity cardiac troponin I [hs-cTnI]), cardiac strain (N-terminal of the prohormone brain natriuretic peptide [NT-proBNP]), and inflammation (high-sensitivity C-reactive protein [hs-CRP]).

The DASH-Sodium trial was a controlled feeding study that enrolled 412 adults (mean age, 48 years; 56% women, 56% Black) with untreated systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure between 80 and 95 mm Hg. Mean baseline BP was 135/86 mm Hg.

Participants were randomly allocated to a typical American diet (control) or the heart-healthy DASH diet. Further, participants in both groups were assigned to each of three sodium intake levels: low (0.5 mg/kcal), medium (1.1 mg/kcal) or high (1.6 mg/kcal) for 30 days using a crossover design with washout periods in between.

Compared with the control diet, the DASH diet reduced hs-cTnI by 18% and hs-CRP by 13% with no impact on NT-proBNP.

In contrast, lowering sodium from high to low levels reduced NT-proBNP independent of diet by 19%, but did not alter hs-cTnI and mildly increased hs-CRP (9%).

Combining the DASH diet with sodium reduction lowered hs-cTnI by 20% and NT-proBNP by 23%, with no significant change in hs-CRP, compared with the high-sodium-control diet.

“Together, these findings imply that two distinct dietary strategies might improve two key pathways of subclinical cardiac damage: injury and strain,” Dr. Juraschek and colleagues wrote.

“These findings should strengthen public resolve for public policies that promote the DASH dietary pattern and lower sodium intake in the United States and globally,” they concluded.

“We need to talk about DASH more. Most adults in the U.S. have never heard of it,” Dr. Juraschek said in an interview.

“We need to promote nutrition literacy with regard to nutrition facts. Labeling is not very transparent and hard to understand. Many people don’t know where salt is hiding in their diet,” he added.

It will also be important to address disparities in access to healthy foods and food insecurity, Dr. Juraschek said.

“If we don’t address food costs and access, disparities in healthy eating will persist. Greater equity is key. We should also be mindful about populations dependent on others for meal preparation [children in schools or older adults on meal plans]. This might be regulated in ways that promote healthier eating population wide, but for these patients, they may not have autonomy to choose what they eat,” Dr. Juraschek said.

In their editorial, Neha J. Pagidipati, MD, and Laura P. Svetkey, MD, from Duke University and Duke Clinical Research Institute, Durham, N.C., said an important caveat is that the beneficial effects of diet and sodium restriction on cardiac injury and strain occurred in people without any clinical evidence of coronary artery disease or heart failure at baseline, “suggesting that this dietary combination can improve subclinical metrics of cardiac health.”

“Further, the impact on these markers was seen within weeks, indicating a relatively rapid impact on cardiac damage,” they added.

The measurement of cardiac biomarkers was supported by the National Institutes of Health/National Heart, Lung, and Blood Institute. The original DASH trial was supported by the NHLBI, the Office of Research on Minority Health, and the National Center for Research Resources. Dr. Juraschek and coauthors disclosed no relevant conflicts of interest. Dr. Pagidipati has received research support to the institution from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Regeneron, Sanofi, and Verily Life Sciences; and has received consultation fees from Boehringer Ingelheim, Eli Lilly, AstraZeneca, and Novo Nordisk. Dr. Svetkey has no relevant disclosures.

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

New data show for the first time that combining the DASH (Dietary Approaches to Stop Hypertension) diet with sodium restriction decreases myocardial injury and cardiac strain, which are associated with subclinical cardiac damage and long-term cardiovascular risk.

Dr. Stephen Juraschek

“The benefits of healthy eating are swift and direct. High sodium is not just about taste, it causes heart strain,” Stephen Juraschek, MD, PhD, from Beth Israel Deaconess Medical Center, Boston, said in an interview.

“We should consciously follow a diet enriched with fruit and vegetables and low in sodium. Collectively, we should think about how foods are promoted in society and what is an acceptable amount of sodium for food supplies,” said Dr. Juraschek.

The findings, from a secondary analysis of the DASH-Sodium trial, were published the Journal of the American College of Cardiology.
 

Renewed focus on diet

“These data should spur a renewed focus on the critical need for widespread adoption of the DASH–low-sodium diet in the United States,” wrote the coauthors of a linked editorial.

“The challenge remains moving the DASH–low-sodium diet from the research world into the real world, where its significant health benefits can be fully realized,” they added.

The researchers evaluated the impact of the DASH diet and sodium restriction, individually and combined, on biomarkers of cardiac injury (high-sensitivity cardiac troponin I [hs-cTnI]), cardiac strain (N-terminal of the prohormone brain natriuretic peptide [NT-proBNP]), and inflammation (high-sensitivity C-reactive protein [hs-CRP]).

The DASH-Sodium trial was a controlled feeding study that enrolled 412 adults (mean age, 48 years; 56% women, 56% Black) with untreated systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure between 80 and 95 mm Hg. Mean baseline BP was 135/86 mm Hg.

Participants were randomly allocated to a typical American diet (control) or the heart-healthy DASH diet. Further, participants in both groups were assigned to each of three sodium intake levels: low (0.5 mg/kcal), medium (1.1 mg/kcal) or high (1.6 mg/kcal) for 30 days using a crossover design with washout periods in between.

Compared with the control diet, the DASH diet reduced hs-cTnI by 18% and hs-CRP by 13% with no impact on NT-proBNP.

In contrast, lowering sodium from high to low levels reduced NT-proBNP independent of diet by 19%, but did not alter hs-cTnI and mildly increased hs-CRP (9%).

Combining the DASH diet with sodium reduction lowered hs-cTnI by 20% and NT-proBNP by 23%, with no significant change in hs-CRP, compared with the high-sodium-control diet.

“Together, these findings imply that two distinct dietary strategies might improve two key pathways of subclinical cardiac damage: injury and strain,” Dr. Juraschek and colleagues wrote.

“These findings should strengthen public resolve for public policies that promote the DASH dietary pattern and lower sodium intake in the United States and globally,” they concluded.

“We need to talk about DASH more. Most adults in the U.S. have never heard of it,” Dr. Juraschek said in an interview.

“We need to promote nutrition literacy with regard to nutrition facts. Labeling is not very transparent and hard to understand. Many people don’t know where salt is hiding in their diet,” he added.

It will also be important to address disparities in access to healthy foods and food insecurity, Dr. Juraschek said.

“If we don’t address food costs and access, disparities in healthy eating will persist. Greater equity is key. We should also be mindful about populations dependent on others for meal preparation [children in schools or older adults on meal plans]. This might be regulated in ways that promote healthier eating population wide, but for these patients, they may not have autonomy to choose what they eat,” Dr. Juraschek said.

In their editorial, Neha J. Pagidipati, MD, and Laura P. Svetkey, MD, from Duke University and Duke Clinical Research Institute, Durham, N.C., said an important caveat is that the beneficial effects of diet and sodium restriction on cardiac injury and strain occurred in people without any clinical evidence of coronary artery disease or heart failure at baseline, “suggesting that this dietary combination can improve subclinical metrics of cardiac health.”

“Further, the impact on these markers was seen within weeks, indicating a relatively rapid impact on cardiac damage,” they added.

The measurement of cardiac biomarkers was supported by the National Institutes of Health/National Heart, Lung, and Blood Institute. The original DASH trial was supported by the NHLBI, the Office of Research on Minority Health, and the National Center for Research Resources. Dr. Juraschek and coauthors disclosed no relevant conflicts of interest. Dr. Pagidipati has received research support to the institution from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Regeneron, Sanofi, and Verily Life Sciences; and has received consultation fees from Boehringer Ingelheim, Eli Lilly, AstraZeneca, and Novo Nordisk. Dr. Svetkey has no relevant disclosures.

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

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Vaginoplasty basics – what every gynecologist needs to know

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Thu, 05/27/2021 - 10:00

Feminizing gender affirmation surgery is a complex genital surgery that most commonly involves removal of natal male genitalia (testes, penile urethra, a majority of the glans penis, penile shaft) and construction of the vulva and/or neovagina utilizing scrotal and penile shaft tissue. Other surgical procedures can also involve using a peritoneal flap or a portion of the small bowel or sigmoid colon to create the neovaginal canal. As with any major surgical procedure, complications do occur, and these can range from minor to major; intraoperative to postoperative. For the purposes of this article, the focus shall be on postoperative complications. Most postoperative complications occur within the first 4 months of the surgery and include vaginal stenosis, genitourinary fistula formation, urinary stream abnormalities, and sexual dysfunction.1 Minor complications that can be managed in the office include granulation tissue treatment, vaginitis, and hair growth in the neovagina. It is important to note that, if any complication occurs, it is essential to refer to the patient’s original surgeon or to a surgeon with expertise in vaginoplasty techniques and postoperative management.2

Dr. K. Ashley Brandt

For patients who undergo vaginoplasty, or a creation of a neovaginal canal, postoperative dilation is necessary to maintain patency. The frequency and duration of dilation are often determined by each individual surgeon or surgical practice as there is no universal, evidence-based standard to guide recommendations on dilation. Failure to maintain a dilation schedule can result in neovaginal stenosis and inability to engage in penetrative vaginal intercourse (if patients desire). Dilation can be difficult.

Challenges with dilation can occur for a variety of reasons: pain, history of trauma, pelvic floor dysfunction, lack of privacy or a supportive environment, or change in personal goals.3 If the underlying cause is related to pelvic floor dysfunction, postoperative pelvic floor therapy has demonstrated improvement in dilation.4 Additionally, routine douching is required for vaginal hygiene. Unlike natal vaginas, neovaginas do not usually contain mucosa, with the exception of a colonic interposition vaginoplasty, and routine douching with soapy water can help prevent a buildup of lubricant and debris.

If a patient reports abnormal discharge, an exam of the vulva and neovagina is warranted. Many patients are able to tolerate a speculum examination. If a patient has undergone a penile inversion vaginoplasty, the microbiome of the neovagina is quite different than that of a natal vagina and most common causes of abnormal discharge often include retained lubricant, keratin debris, sebum, or semen.5 During a speculum exam, the provider may notice granulation tissue, which is often another cause of persistent vaginal discharge, vaginal bleeding, or pain during dilation. Depending on the patient’s symptoms and quantity of granulation tissue present, it can often resolve spontaneously. Persistent granulation tissue can be treated with silver nitrate. An alternative to silver nitrate is using medical grade honey or a course of a mild-strength topical steroid cream or ointment.5 In some cases, abnormal discharge may be the result of a fistula. If a fistula is noted the patient should be immediately referred back to the original surgeon or to a urogynecologist and/or colorectal surgeon for evaluation and management.

While this surgery often falls outside of the scope of practice of the general obstetrician-gynecologist, most patients will seek the care of a general obstetrician-gynecologist in the postoperative period. It is therefore imperative that obstetrician-gynecologists have a basic understanding of the surgical procedure and the aftercare involved.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. Email her at [email protected].

References

1. Gaither TW et al. J Urol. 2018;199(3):760-5.

2. Ferrando CA and Bowers ML. In: Ferrando CA, ed. “Comprehensive care of the transgender patient” Philadelphia: Elsevier, 2020, p. 82-92.

3. Chi AC et al. Complications of vaginoplasty. In: Niklavsky D and Blakely SA, eds. “Urological care for the transgender patient: A comprehensive guide” Switzerland: Springer Nature, 2021 p. 83-97.

4. Jiang D et al. Obstet Gynecol. 2019;133(5):1003-11.

5. Obedin-Maliver J and Haan GD. Gynecologic care for transgender patients. In: Ferrando CA, ed. “Comprehensive care of the transgender patient” Philadelphia: Elsevier, 2020, p. 131-51.

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Feminizing gender affirmation surgery is a complex genital surgery that most commonly involves removal of natal male genitalia (testes, penile urethra, a majority of the glans penis, penile shaft) and construction of the vulva and/or neovagina utilizing scrotal and penile shaft tissue. Other surgical procedures can also involve using a peritoneal flap or a portion of the small bowel or sigmoid colon to create the neovaginal canal. As with any major surgical procedure, complications do occur, and these can range from minor to major; intraoperative to postoperative. For the purposes of this article, the focus shall be on postoperative complications. Most postoperative complications occur within the first 4 months of the surgery and include vaginal stenosis, genitourinary fistula formation, urinary stream abnormalities, and sexual dysfunction.1 Minor complications that can be managed in the office include granulation tissue treatment, vaginitis, and hair growth in the neovagina. It is important to note that, if any complication occurs, it is essential to refer to the patient’s original surgeon or to a surgeon with expertise in vaginoplasty techniques and postoperative management.2

Dr. K. Ashley Brandt

For patients who undergo vaginoplasty, or a creation of a neovaginal canal, postoperative dilation is necessary to maintain patency. The frequency and duration of dilation are often determined by each individual surgeon or surgical practice as there is no universal, evidence-based standard to guide recommendations on dilation. Failure to maintain a dilation schedule can result in neovaginal stenosis and inability to engage in penetrative vaginal intercourse (if patients desire). Dilation can be difficult.

Challenges with dilation can occur for a variety of reasons: pain, history of trauma, pelvic floor dysfunction, lack of privacy or a supportive environment, or change in personal goals.3 If the underlying cause is related to pelvic floor dysfunction, postoperative pelvic floor therapy has demonstrated improvement in dilation.4 Additionally, routine douching is required for vaginal hygiene. Unlike natal vaginas, neovaginas do not usually contain mucosa, with the exception of a colonic interposition vaginoplasty, and routine douching with soapy water can help prevent a buildup of lubricant and debris.

If a patient reports abnormal discharge, an exam of the vulva and neovagina is warranted. Many patients are able to tolerate a speculum examination. If a patient has undergone a penile inversion vaginoplasty, the microbiome of the neovagina is quite different than that of a natal vagina and most common causes of abnormal discharge often include retained lubricant, keratin debris, sebum, or semen.5 During a speculum exam, the provider may notice granulation tissue, which is often another cause of persistent vaginal discharge, vaginal bleeding, or pain during dilation. Depending on the patient’s symptoms and quantity of granulation tissue present, it can often resolve spontaneously. Persistent granulation tissue can be treated with silver nitrate. An alternative to silver nitrate is using medical grade honey or a course of a mild-strength topical steroid cream or ointment.5 In some cases, abnormal discharge may be the result of a fistula. If a fistula is noted the patient should be immediately referred back to the original surgeon or to a urogynecologist and/or colorectal surgeon for evaluation and management.

While this surgery often falls outside of the scope of practice of the general obstetrician-gynecologist, most patients will seek the care of a general obstetrician-gynecologist in the postoperative period. It is therefore imperative that obstetrician-gynecologists have a basic understanding of the surgical procedure and the aftercare involved.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. Email her at [email protected].

References

1. Gaither TW et al. J Urol. 2018;199(3):760-5.

2. Ferrando CA and Bowers ML. In: Ferrando CA, ed. “Comprehensive care of the transgender patient” Philadelphia: Elsevier, 2020, p. 82-92.

3. Chi AC et al. Complications of vaginoplasty. In: Niklavsky D and Blakely SA, eds. “Urological care for the transgender patient: A comprehensive guide” Switzerland: Springer Nature, 2021 p. 83-97.

4. Jiang D et al. Obstet Gynecol. 2019;133(5):1003-11.

5. Obedin-Maliver J and Haan GD. Gynecologic care for transgender patients. In: Ferrando CA, ed. “Comprehensive care of the transgender patient” Philadelphia: Elsevier, 2020, p. 131-51.

Feminizing gender affirmation surgery is a complex genital surgery that most commonly involves removal of natal male genitalia (testes, penile urethra, a majority of the glans penis, penile shaft) and construction of the vulva and/or neovagina utilizing scrotal and penile shaft tissue. Other surgical procedures can also involve using a peritoneal flap or a portion of the small bowel or sigmoid colon to create the neovaginal canal. As with any major surgical procedure, complications do occur, and these can range from minor to major; intraoperative to postoperative. For the purposes of this article, the focus shall be on postoperative complications. Most postoperative complications occur within the first 4 months of the surgery and include vaginal stenosis, genitourinary fistula formation, urinary stream abnormalities, and sexual dysfunction.1 Minor complications that can be managed in the office include granulation tissue treatment, vaginitis, and hair growth in the neovagina. It is important to note that, if any complication occurs, it is essential to refer to the patient’s original surgeon or to a surgeon with expertise in vaginoplasty techniques and postoperative management.2

Dr. K. Ashley Brandt

For patients who undergo vaginoplasty, or a creation of a neovaginal canal, postoperative dilation is necessary to maintain patency. The frequency and duration of dilation are often determined by each individual surgeon or surgical practice as there is no universal, evidence-based standard to guide recommendations on dilation. Failure to maintain a dilation schedule can result in neovaginal stenosis and inability to engage in penetrative vaginal intercourse (if patients desire). Dilation can be difficult.

Challenges with dilation can occur for a variety of reasons: pain, history of trauma, pelvic floor dysfunction, lack of privacy or a supportive environment, or change in personal goals.3 If the underlying cause is related to pelvic floor dysfunction, postoperative pelvic floor therapy has demonstrated improvement in dilation.4 Additionally, routine douching is required for vaginal hygiene. Unlike natal vaginas, neovaginas do not usually contain mucosa, with the exception of a colonic interposition vaginoplasty, and routine douching with soapy water can help prevent a buildup of lubricant and debris.

If a patient reports abnormal discharge, an exam of the vulva and neovagina is warranted. Many patients are able to tolerate a speculum examination. If a patient has undergone a penile inversion vaginoplasty, the microbiome of the neovagina is quite different than that of a natal vagina and most common causes of abnormal discharge often include retained lubricant, keratin debris, sebum, or semen.5 During a speculum exam, the provider may notice granulation tissue, which is often another cause of persistent vaginal discharge, vaginal bleeding, or pain during dilation. Depending on the patient’s symptoms and quantity of granulation tissue present, it can often resolve spontaneously. Persistent granulation tissue can be treated with silver nitrate. An alternative to silver nitrate is using medical grade honey or a course of a mild-strength topical steroid cream or ointment.5 In some cases, abnormal discharge may be the result of a fistula. If a fistula is noted the patient should be immediately referred back to the original surgeon or to a urogynecologist and/or colorectal surgeon for evaluation and management.

While this surgery often falls outside of the scope of practice of the general obstetrician-gynecologist, most patients will seek the care of a general obstetrician-gynecologist in the postoperative period. It is therefore imperative that obstetrician-gynecologists have a basic understanding of the surgical procedure and the aftercare involved.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. Email her at [email protected].

References

1. Gaither TW et al. J Urol. 2018;199(3):760-5.

2. Ferrando CA and Bowers ML. In: Ferrando CA, ed. “Comprehensive care of the transgender patient” Philadelphia: Elsevier, 2020, p. 82-92.

3. Chi AC et al. Complications of vaginoplasty. In: Niklavsky D and Blakely SA, eds. “Urological care for the transgender patient: A comprehensive guide” Switzerland: Springer Nature, 2021 p. 83-97.

4. Jiang D et al. Obstet Gynecol. 2019;133(5):1003-11.

5. Obedin-Maliver J and Haan GD. Gynecologic care for transgender patients. In: Ferrando CA, ed. “Comprehensive care of the transgender patient” Philadelphia: Elsevier, 2020, p. 131-51.

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Racial and ethnic minorities underrepresented in pancreatic cancer clinical trials

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Thu, 05/27/2021 - 14:09

 

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

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Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

 

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

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New AHA/ASA guideline on secondary stroke prevention

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Fri, 06/25/2021 - 17:15

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

Dr. Dawn O. Kleindorfer

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

  • Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
  • Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
  • Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
  • Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
  • Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
  • In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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

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When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

Dr. Dawn O. Kleindorfer

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

  • Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
  • Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
  • Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
  • Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
  • Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
  • In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

Dr. Dawn O. Kleindorfer

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

  • Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
  • Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
  • Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
  • Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
  • Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
  • In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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

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APA, AMA, others move to stop insurer from overturning mental health claims ruling

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The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.

Dr. Reena Kapoor

Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.

Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”

In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”

The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.

The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.

California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.

“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
 

‘Discrimination must end’

Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.

The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.

In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.

The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.

Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm. 

The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.

However, the APA and other clinician groups said there is no question of harm.

Dr. Saul Levin

“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement

APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.

No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.

“If upheld, the litigation will likely have significant impacts beyond the parties involved,” Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”

This article first appeared on Medscape.com.

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The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.

Dr. Reena Kapoor

Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.

Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”

In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”

The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.

The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.

California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.

“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
 

‘Discrimination must end’

Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.

The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.

In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.

The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.

Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm. 

The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.

However, the APA and other clinician groups said there is no question of harm.

Dr. Saul Levin

“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement

APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.

No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.

“If upheld, the litigation will likely have significant impacts beyond the parties involved,” Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”

This article first appeared on Medscape.com.

The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.

Dr. Reena Kapoor

Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.

Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”

In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”

The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.

The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.

California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.

“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
 

‘Discrimination must end’

Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.

The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.

In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.

The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.

Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm. 

The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.

However, the APA and other clinician groups said there is no question of harm.

Dr. Saul Levin

“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement

APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.

No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.

“If upheld, the litigation will likely have significant impacts beyond the parties involved,” Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”

This article first appeared on Medscape.com.

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Pandemic experience taught lessons about clinician wellness

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As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.

Dr. Mark A. Rudolph

“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”

Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”

Dr. Sarah Richards


Sonia George, MD, recalled first hearing about COVID-19 as she was preparing to attend the 2020 SHM annual conference in San Diego, which was planned for April but was canceled amid the escalating health concerns. “That was difficult for me, because I wanted to travel more in 2020,” said Dr. George, a hospitalist at Long Island Jewish Medical Center in New Hyde Park, N.Y. “Traveling is something that I’ve been wanting to do ever since I finished residency, after all that training. I wanted to reward myself. What I have learned about myself is that I’ve learned to be more patient, to take every day as it is, to find some small moments of joy within each day and try to take that forward with me, and try to remember what I do have, and celebrate that a bit more every day.”

Over the past 14 months or so, Dr. Rudolph said that he grew to appreciate the importance of connecting with colleagues, “however short [the time] may be, where we can talk with one another, commiserate, discuss situations and experiences – whether virtually or in person. Those have been critical. If you add those all up, that’s what’s keeping us all going. At least it’s keeping me going.”

Dr. Richards echoed that sentiment. “The lesson I learned is that people really do want to share and to talk,” she said. “I can’t tell you how many times I told people about my [sense of] guilt and they would say things like, ‘Me, too!’ Knowing ‘it’s not just me’ made me feel so much better.”

During the course of the pandemic, the SHM Wellbeing Task Force created a one-page resource for clinicians known as the “Hospital Medicine COVID-19 Check-in Guide for Self & Peers,” which can be accessed here:. The three main recommended steps are to identify (“self-assess” to see if you are experiencing physical, emotional, cognitive, or behavioral stress); initiate (“reach out to your colleagues one-one-one or in small informal groups”); and intervene (“take action to make change or get help.”)

“Wellness and thriving are a team sport,” observed task force member Patrick Kneeland, MD, vice president of medical affairs at DispatchHealth, which provides hospital to home services. “It’s not an individual task to achieve. The team sport thing is complicated by gowns and masks and the lack of in-person meetings. You can’t even grab a cup of coffee with colleagues. That part has impacted most of us.” However, he said, he learned that clinicians can “double down on those small practices that form human connection” by using virtual communication platforms like Zoom. “For me, it’s been a great reminder [of] why presence with others matters, even if it’s in an unusual format, and how sharing our humanity across [communication] channels or through several layers of PPE is so critical.” Dr. Kneeland said.

None of the presenters reported having financial disclosures.
 

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As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.

Dr. Mark A. Rudolph

“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”

Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”

Dr. Sarah Richards


Sonia George, MD, recalled first hearing about COVID-19 as she was preparing to attend the 2020 SHM annual conference in San Diego, which was planned for April but was canceled amid the escalating health concerns. “That was difficult for me, because I wanted to travel more in 2020,” said Dr. George, a hospitalist at Long Island Jewish Medical Center in New Hyde Park, N.Y. “Traveling is something that I’ve been wanting to do ever since I finished residency, after all that training. I wanted to reward myself. What I have learned about myself is that I’ve learned to be more patient, to take every day as it is, to find some small moments of joy within each day and try to take that forward with me, and try to remember what I do have, and celebrate that a bit more every day.”

Over the past 14 months or so, Dr. Rudolph said that he grew to appreciate the importance of connecting with colleagues, “however short [the time] may be, where we can talk with one another, commiserate, discuss situations and experiences – whether virtually or in person. Those have been critical. If you add those all up, that’s what’s keeping us all going. At least it’s keeping me going.”

Dr. Richards echoed that sentiment. “The lesson I learned is that people really do want to share and to talk,” she said. “I can’t tell you how many times I told people about my [sense of] guilt and they would say things like, ‘Me, too!’ Knowing ‘it’s not just me’ made me feel so much better.”

During the course of the pandemic, the SHM Wellbeing Task Force created a one-page resource for clinicians known as the “Hospital Medicine COVID-19 Check-in Guide for Self & Peers,” which can be accessed here:. The three main recommended steps are to identify (“self-assess” to see if you are experiencing physical, emotional, cognitive, or behavioral stress); initiate (“reach out to your colleagues one-one-one or in small informal groups”); and intervene (“take action to make change or get help.”)

“Wellness and thriving are a team sport,” observed task force member Patrick Kneeland, MD, vice president of medical affairs at DispatchHealth, which provides hospital to home services. “It’s not an individual task to achieve. The team sport thing is complicated by gowns and masks and the lack of in-person meetings. You can’t even grab a cup of coffee with colleagues. That part has impacted most of us.” However, he said, he learned that clinicians can “double down on those small practices that form human connection” by using virtual communication platforms like Zoom. “For me, it’s been a great reminder [of] why presence with others matters, even if it’s in an unusual format, and how sharing our humanity across [communication] channels or through several layers of PPE is so critical.” Dr. Kneeland said.

None of the presenters reported having financial disclosures.
 

As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.

Dr. Mark A. Rudolph

“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”

Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”

Dr. Sarah Richards


Sonia George, MD, recalled first hearing about COVID-19 as she was preparing to attend the 2020 SHM annual conference in San Diego, which was planned for April but was canceled amid the escalating health concerns. “That was difficult for me, because I wanted to travel more in 2020,” said Dr. George, a hospitalist at Long Island Jewish Medical Center in New Hyde Park, N.Y. “Traveling is something that I’ve been wanting to do ever since I finished residency, after all that training. I wanted to reward myself. What I have learned about myself is that I’ve learned to be more patient, to take every day as it is, to find some small moments of joy within each day and try to take that forward with me, and try to remember what I do have, and celebrate that a bit more every day.”

Over the past 14 months or so, Dr. Rudolph said that he grew to appreciate the importance of connecting with colleagues, “however short [the time] may be, where we can talk with one another, commiserate, discuss situations and experiences – whether virtually or in person. Those have been critical. If you add those all up, that’s what’s keeping us all going. At least it’s keeping me going.”

Dr. Richards echoed that sentiment. “The lesson I learned is that people really do want to share and to talk,” she said. “I can’t tell you how many times I told people about my [sense of] guilt and they would say things like, ‘Me, too!’ Knowing ‘it’s not just me’ made me feel so much better.”

During the course of the pandemic, the SHM Wellbeing Task Force created a one-page resource for clinicians known as the “Hospital Medicine COVID-19 Check-in Guide for Self & Peers,” which can be accessed here:. The three main recommended steps are to identify (“self-assess” to see if you are experiencing physical, emotional, cognitive, or behavioral stress); initiate (“reach out to your colleagues one-one-one or in small informal groups”); and intervene (“take action to make change or get help.”)

“Wellness and thriving are a team sport,” observed task force member Patrick Kneeland, MD, vice president of medical affairs at DispatchHealth, which provides hospital to home services. “It’s not an individual task to achieve. The team sport thing is complicated by gowns and masks and the lack of in-person meetings. You can’t even grab a cup of coffee with colleagues. That part has impacted most of us.” However, he said, he learned that clinicians can “double down on those small practices that form human connection” by using virtual communication platforms like Zoom. “For me, it’s been a great reminder [of] why presence with others matters, even if it’s in an unusual format, and how sharing our humanity across [communication] channels or through several layers of PPE is so critical.” Dr. Kneeland said.

None of the presenters reported having financial disclosures.
 

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