Business of Medicine

Common complaints of abdominal pain, fever, shortness of breath, or rash can signal more serious disease that should be referred to specialty care or might be related to benign conditions.

Combine the vague nature of many patients’ descriptions and the pressure of short visits, and clinicians have a recipe for all manner of diagnostic error.

An estimated 5% of US adults who seek outpatient care each year experience a diagnostic error. Most Americans will eventually have this experience, according to a 2015 report from the National Academy of Medicine.

The most frequently missed diagnoses in primary care involve conditions such as pneumonia, decompensated heart failure, acute renal failure, cancer, urinary tract infection, and pyelonephritis.

“It’s not one or two or three types of diagnosis that are missed: We miss a lot of things, especially in primary care,” said Hardeep Singh, MD, MPH, a patient safety researcher at the Michael E. DeBakey VA Medical Center and the Baylor College of Medicine in Houston, Texas.

One of the most serious errors is to miss cancer, with failing to follow‐up on abnormal tests ranking consistently as one of the leading causes of malpractice claims. But most diagnostic errors do not lead to lawsuits, although they often result in missed and delayed opportunities for patients to get needed care.

In interviews with this news organization, experts who have studied the root causes of diagnostic error suggested primary care clinicians focus on several practices to avoid mistakes: Ask questions with humility and curiosity, use checklists, and brainstorm with patients the potential root cause of symptoms.
 

Humility and Curiosity 

Clinicians should remain aware of the potential for errors and reach out for assistance when needed, keeping an open mind that common symptoms may, in rare cases, signal serious illness, Dr. Singh said.

Dr. Singh recommends continual review with what he calls “byte-sized” learning through digital tools such as the Human Diagnosis app and podcasts and webinars offered by Clinical Problem Solvers.

Continuing education activities such as classes for Maintenance of Certification (MOC) can help keep physicians up to date and alert for cases where seemingly common symptoms may turn out to be something serious, said Richard M. Wardrop, III, MD, PhD, an internal medicine physician at the Cleveland Clinic in Ohio, and chair of the internal medicine board at the American Board of Internal Medicine.

“I’ve been in practice for 20 years. I’m double board certified in peds and medicine, and I regularly teach students and residents and mentor other physicians, but the further I go in my career and in practice, the more humble I become,” Dr. Wardrop told this news organization.

He said he recently spent a few hours on MOC for pediatrics and found the review was helpful in his practice in medicine.

“If I find myself taking care of a patient in a newborn nursery anytime soon, I’m going to understand the new hyperbilirubinemia guidelines,” Dr. Wardrop said. “That takes time and energy, but when I was done with the questions for this quarter, I felt good about myself.”
 

Checking It Twice

Clinicians should incorporate checklists into daily practice. Reviewing these with patients can not only help rule out an illness but also serve as a nonconfrontational method to inquire about issues patients may find uncomfortable, said John Ely, MD, MSPH, professor emeritus of family medicine at the University of Iowa Carver College of Medicine in Iowa City.

Clinicians could benefit from the approach used in aviation, where checklists are a required and routine part of a pilot’s job, Dr. Ely said.

Although clinicians may assume patients expect them to work from memory and knowledge without this aide, many will see using a checklist as a sign of providing thorough care, he said.

Checklists can also open a pathway for discussions about potentially difficult or touchy issues in short visits. For example, a patient might feel defensive if a clinician asks about depression during a visit for abdominal pain. But incorporating a question in a checklist allows for a different framing of the question.

“A clinician could say ‘I didn’t say you were depressed because of your abdominal pain, I brought it up because it’s on the list,’” Dr. Ely said. The checklist is “a very easy way to bring up those things.”

Dr. Ely said he has cared for a few patients who sought help for abdominal pain that turned out to be linked to sexual abuse in their past. Dr. Ely used a checklist with these patients to review possible causes for their illness. He recalled one of these patients who had suffered sexual abuse and had depression, neither of which was readily apparent.

“There was nothing about her affect that appeared to be depressed, and she had seen multiple physicians unable to make a diagnosis,” Dr. Ely said. “She had worked up for multiple other diseases and this had never come up before.”
 

Cooperation 

“Coproduction” is how Kathryn McDonald, PhD, describes an ideal path to getting an accurate diagnosis. The intent is for clinicians to enlist patients in helping them in finding the root cause of symptoms.

“It’s bringing the patient into knowing that they are in a partnership to coproduce, knowing that there is a process going on,” said Dr. McDonald, who is codirector of the Armstrong Institute Center for Diagnostic Excellence at Johns Hopkins University in Baltimore, Maryland.

In many cases, patients seek reassurance for ruling out a suspected condition, which the physician can sometimes provide. In others, clinicians may not be able to offer a concrete diagnosis.

“There are times when uncertainty is more pervasive and I will ask patients, ‘Let’s brainstorm this together,’” Dr. Wardrop said.

A version of this article appeared on Medscape.com.

Common complaints of abdominal pain, fever, shortness of breath, or rash can signal more serious disease that should be referred to specialty care or might be related to benign conditions.

Combine the vague nature of many patients’ descriptions and the pressure of short visits, and clinicians have a recipe for all manner of diagnostic error.

An estimated 5% of US adults who seek outpatient care each year experience a diagnostic error. Most Americans will eventually have this experience, according to a 2015 report from the National Academy of Medicine.

The most frequently missed diagnoses in primary care involve conditions such as pneumonia, decompensated heart failure, acute renal failure, cancer, urinary tract infection, and pyelonephritis.

“It’s not one or two or three types of diagnosis that are missed: We miss a lot of things, especially in primary care,” said Hardeep Singh, MD, MPH, a patient safety researcher at the Michael E. DeBakey VA Medical Center and the Baylor College of Medicine in Houston, Texas.

One of the most serious errors is to miss cancer, with failing to follow‐up on abnormal tests ranking consistently as one of the leading causes of malpractice claims. But most diagnostic errors do not lead to lawsuits, although they often result in missed and delayed opportunities for patients to get needed care.

In interviews with this news organization, experts who have studied the root causes of diagnostic error suggested primary care clinicians focus on several practices to avoid mistakes: Ask questions with humility and curiosity, use checklists, and brainstorm with patients the potential root cause of symptoms.
 

Humility and Curiosity 

Clinicians should remain aware of the potential for errors and reach out for assistance when needed, keeping an open mind that common symptoms may, in rare cases, signal serious illness, Dr. Singh said.

Dr. Singh recommends continual review with what he calls “byte-sized” learning through digital tools such as the Human Diagnosis app and podcasts and webinars offered by Clinical Problem Solvers.

Continuing education activities such as classes for Maintenance of Certification (MOC) can help keep physicians up to date and alert for cases where seemingly common symptoms may turn out to be something serious, said Richard M. Wardrop, III, MD, PhD, an internal medicine physician at the Cleveland Clinic in Ohio, and chair of the internal medicine board at the American Board of Internal Medicine.

“I’ve been in practice for 20 years. I’m double board certified in peds and medicine, and I regularly teach students and residents and mentor other physicians, but the further I go in my career and in practice, the more humble I become,” Dr. Wardrop told this news organization.

He said he recently spent a few hours on MOC for pediatrics and found the review was helpful in his practice in medicine.

“If I find myself taking care of a patient in a newborn nursery anytime soon, I’m going to understand the new hyperbilirubinemia guidelines,” Dr. Wardrop said. “That takes time and energy, but when I was done with the questions for this quarter, I felt good about myself.”
 

Checking It Twice

Clinicians should incorporate checklists into daily practice. Reviewing these with patients can not only help rule out an illness but also serve as a nonconfrontational method to inquire about issues patients may find uncomfortable, said John Ely, MD, MSPH, professor emeritus of family medicine at the University of Iowa Carver College of Medicine in Iowa City.

Clinicians could benefit from the approach used in aviation, where checklists are a required and routine part of a pilot’s job, Dr. Ely said.

Although clinicians may assume patients expect them to work from memory and knowledge without this aide, many will see using a checklist as a sign of providing thorough care, he said.

Checklists can also open a pathway for discussions about potentially difficult or touchy issues in short visits. For example, a patient might feel defensive if a clinician asks about depression during a visit for abdominal pain. But incorporating a question in a checklist allows for a different framing of the question.

“A clinician could say ‘I didn’t say you were depressed because of your abdominal pain, I brought it up because it’s on the list,’” Dr. Ely said. The checklist is “a very easy way to bring up those things.”

Dr. Ely said he has cared for a few patients who sought help for abdominal pain that turned out to be linked to sexual abuse in their past. Dr. Ely used a checklist with these patients to review possible causes for their illness. He recalled one of these patients who had suffered sexual abuse and had depression, neither of which was readily apparent.

“There was nothing about her affect that appeared to be depressed, and she had seen multiple physicians unable to make a diagnosis,” Dr. Ely said. “She had worked up for multiple other diseases and this had never come up before.”
 

Cooperation 

“Coproduction” is how Kathryn McDonald, PhD, describes an ideal path to getting an accurate diagnosis. The intent is for clinicians to enlist patients in helping them in finding the root cause of symptoms.

“It’s bringing the patient into knowing that they are in a partnership to coproduce, knowing that there is a process going on,” said Dr. McDonald, who is codirector of the Armstrong Institute Center for Diagnostic Excellence at Johns Hopkins University in Baltimore, Maryland.

In many cases, patients seek reassurance for ruling out a suspected condition, which the physician can sometimes provide. In others, clinicians may not be able to offer a concrete diagnosis.

“There are times when uncertainty is more pervasive and I will ask patients, ‘Let’s brainstorm this together,’” Dr. Wardrop said.

A version of this article appeared on Medscape.com.

Common complaints of abdominal pain, fever, shortness of breath, or rash can signal more serious disease that should be referred to specialty care or might be related to benign conditions.

Combine the vague nature of many patients’ descriptions and the pressure of short visits, and clinicians have a recipe for all manner of diagnostic error.

An estimated 5% of US adults who seek outpatient care each year experience a diagnostic error. Most Americans will eventually have this experience, according to a 2015 report from the National Academy of Medicine.

The most frequently missed diagnoses in primary care involve conditions such as pneumonia, decompensated heart failure, acute renal failure, cancer, urinary tract infection, and pyelonephritis.

“It’s not one or two or three types of diagnosis that are missed: We miss a lot of things, especially in primary care,” said Hardeep Singh, MD, MPH, a patient safety researcher at the Michael E. DeBakey VA Medical Center and the Baylor College of Medicine in Houston, Texas.

One of the most serious errors is to miss cancer, with failing to follow‐up on abnormal tests ranking consistently as one of the leading causes of malpractice claims. But most diagnostic errors do not lead to lawsuits, although they often result in missed and delayed opportunities for patients to get needed care.

In interviews with this news organization, experts who have studied the root causes of diagnostic error suggested primary care clinicians focus on several practices to avoid mistakes: Ask questions with humility and curiosity, use checklists, and brainstorm with patients the potential root cause of symptoms.
 

Humility and Curiosity 

Clinicians should remain aware of the potential for errors and reach out for assistance when needed, keeping an open mind that common symptoms may, in rare cases, signal serious illness, Dr. Singh said.

Dr. Singh recommends continual review with what he calls “byte-sized” learning through digital tools such as the Human Diagnosis app and podcasts and webinars offered by Clinical Problem Solvers.

Continuing education activities such as classes for Maintenance of Certification (MOC) can help keep physicians up to date and alert for cases where seemingly common symptoms may turn out to be something serious, said Richard M. Wardrop, III, MD, PhD, an internal medicine physician at the Cleveland Clinic in Ohio, and chair of the internal medicine board at the American Board of Internal Medicine.

“I’ve been in practice for 20 years. I’m double board certified in peds and medicine, and I regularly teach students and residents and mentor other physicians, but the further I go in my career and in practice, the more humble I become,” Dr. Wardrop told this news organization.

He said he recently spent a few hours on MOC for pediatrics and found the review was helpful in his practice in medicine.

“If I find myself taking care of a patient in a newborn nursery anytime soon, I’m going to understand the new hyperbilirubinemia guidelines,” Dr. Wardrop said. “That takes time and energy, but when I was done with the questions for this quarter, I felt good about myself.”
 

Checking It Twice

Clinicians should incorporate checklists into daily practice. Reviewing these with patients can not only help rule out an illness but also serve as a nonconfrontational method to inquire about issues patients may find uncomfortable, said John Ely, MD, MSPH, professor emeritus of family medicine at the University of Iowa Carver College of Medicine in Iowa City.

Clinicians could benefit from the approach used in aviation, where checklists are a required and routine part of a pilot’s job, Dr. Ely said.

Although clinicians may assume patients expect them to work from memory and knowledge without this aide, many will see using a checklist as a sign of providing thorough care, he said.

Checklists can also open a pathway for discussions about potentially difficult or touchy issues in short visits. For example, a patient might feel defensive if a clinician asks about depression during a visit for abdominal pain. But incorporating a question in a checklist allows for a different framing of the question.

“A clinician could say ‘I didn’t say you were depressed because of your abdominal pain, I brought it up because it’s on the list,’” Dr. Ely said. The checklist is “a very easy way to bring up those things.”

Dr. Ely said he has cared for a few patients who sought help for abdominal pain that turned out to be linked to sexual abuse in their past. Dr. Ely used a checklist with these patients to review possible causes for their illness. He recalled one of these patients who had suffered sexual abuse and had depression, neither of which was readily apparent.

“There was nothing about her affect that appeared to be depressed, and she had seen multiple physicians unable to make a diagnosis,” Dr. Ely said. “She had worked up for multiple other diseases and this had never come up before.”
 

Cooperation 

“Coproduction” is how Kathryn McDonald, PhD, describes an ideal path to getting an accurate diagnosis. The intent is for clinicians to enlist patients in helping them in finding the root cause of symptoms.

“It’s bringing the patient into knowing that they are in a partnership to coproduce, knowing that there is a process going on,” said Dr. McDonald, who is codirector of the Armstrong Institute Center for Diagnostic Excellence at Johns Hopkins University in Baltimore, Maryland.

In many cases, patients seek reassurance for ruling out a suspected condition, which the physician can sometimes provide. In others, clinicians may not be able to offer a concrete diagnosis.

“There are times when uncertainty is more pervasive and I will ask patients, ‘Let’s brainstorm this together,’” Dr. Wardrop said.

A version of this article appeared on Medscape.com.

Eliezer Masliah, MD, director of the neuroscience division at the National Institute on Aging (NIA), has been “relieved of his position” following an investigation by the National Institutes of Health (NIH) that turned up research misconduct, the NIH said in a statement.

The misconduct involved “falsification and/or fabrication involving reuse and relabel of figure panels representing different experimental results in two publications,” the NIH said.

The agency said it will notify the two journals of its findings so that appropriate action can be taken.

The NIH reportedly launched its probe into potential research misconduct in May 2023 after it received allegations from the Health and Human Service (HHS) Office of Research Integrity (ORI) that month.

The investigation phase began in December 2023 and concluded on September 15, 2024. The institute subsequently notified HHS ORI of its findings.

Dr. Masliah joined the NIH in the summer of 2016 as director of the Division of Neuroscience at the NIA and an NIH intramural researcher investigating synaptic damage in neurodegenerative disorders, publishing “numerous” papers, the NIH said.

Given the findings of their investigation, the NIH said, Dr. Masliah is no longer serving as director of NIA’s Division of Neuroscience.

NIA deputy director Amy Kelley, MD, is now acting director of NIA’s neuroscience division.

Consistent with NIH policies and procedures, any allegations involving Dr. Masliah’s NIH-supported extramural research prior to joining NIH would be referred to HHS ORI, the NIH said.

The NIH announcement came on the same day that Science magazine published an investigative piece suggesting that Dr. Masliah may have fabricated or falsified images or other information in far more than the two studies NIH cited.

According to the article, “scores” of Dr. Masliah’s lab studies conducted at the NIA and the University of California San Diego are “riddled with apparently falsified Western blots — images used to show the presence of proteins — and micrographs of brain tissue. Numerous images seem to have been inappropriately reused within and across papers, sometimes published years apart in different journals, describing divergent experimental conditions.”

The article noted that a neuroscientist and forensic analysts who had previously worked with Science magazine produced a “300-page dossier revealing a steady stream of suspect images between 1997 and 2023 in 132 of his published research papers.”

They concluded that this “pattern of anomalous data raises a credible concern for research misconduct and calls into question a remarkably large body of scientific work,” the Science article stated.
 

A version of this article appeared on Medscape.com.

Eliezer Masliah, MD, director of the neuroscience division at the National Institute on Aging (NIA), has been “relieved of his position” following an investigation by the National Institutes of Health (NIH) that turned up research misconduct, the NIH said in a statement.

The misconduct involved “falsification and/or fabrication involving reuse and relabel of figure panels representing different experimental results in two publications,” the NIH said.

The agency said it will notify the two journals of its findings so that appropriate action can be taken.

The NIH reportedly launched its probe into potential research misconduct in May 2023 after it received allegations from the Health and Human Service (HHS) Office of Research Integrity (ORI) that month.

The investigation phase began in December 2023 and concluded on September 15, 2024. The institute subsequently notified HHS ORI of its findings.

Dr. Masliah joined the NIH in the summer of 2016 as director of the Division of Neuroscience at the NIA and an NIH intramural researcher investigating synaptic damage in neurodegenerative disorders, publishing “numerous” papers, the NIH said.

Given the findings of their investigation, the NIH said, Dr. Masliah is no longer serving as director of NIA’s Division of Neuroscience.

NIA deputy director Amy Kelley, MD, is now acting director of NIA’s neuroscience division.

Consistent with NIH policies and procedures, any allegations involving Dr. Masliah’s NIH-supported extramural research prior to joining NIH would be referred to HHS ORI, the NIH said.

The NIH announcement came on the same day that Science magazine published an investigative piece suggesting that Dr. Masliah may have fabricated or falsified images or other information in far more than the two studies NIH cited.

According to the article, “scores” of Dr. Masliah’s lab studies conducted at the NIA and the University of California San Diego are “riddled with apparently falsified Western blots — images used to show the presence of proteins — and micrographs of brain tissue. Numerous images seem to have been inappropriately reused within and across papers, sometimes published years apart in different journals, describing divergent experimental conditions.”

The article noted that a neuroscientist and forensic analysts who had previously worked with Science magazine produced a “300-page dossier revealing a steady stream of suspect images between 1997 and 2023 in 132 of his published research papers.”

They concluded that this “pattern of anomalous data raises a credible concern for research misconduct and calls into question a remarkably large body of scientific work,” the Science article stated.
 

A version of this article appeared on Medscape.com.

Eliezer Masliah, MD, director of the neuroscience division at the National Institute on Aging (NIA), has been “relieved of his position” following an investigation by the National Institutes of Health (NIH) that turned up research misconduct, the NIH said in a statement.

The misconduct involved “falsification and/or fabrication involving reuse and relabel of figure panels representing different experimental results in two publications,” the NIH said.

The agency said it will notify the two journals of its findings so that appropriate action can be taken.

The NIH reportedly launched its probe into potential research misconduct in May 2023 after it received allegations from the Health and Human Service (HHS) Office of Research Integrity (ORI) that month.

The investigation phase began in December 2023 and concluded on September 15, 2024. The institute subsequently notified HHS ORI of its findings.

Dr. Masliah joined the NIH in the summer of 2016 as director of the Division of Neuroscience at the NIA and an NIH intramural researcher investigating synaptic damage in neurodegenerative disorders, publishing “numerous” papers, the NIH said.

Given the findings of their investigation, the NIH said, Dr. Masliah is no longer serving as director of NIA’s Division of Neuroscience.

NIA deputy director Amy Kelley, MD, is now acting director of NIA’s neuroscience division.

Consistent with NIH policies and procedures, any allegations involving Dr. Masliah’s NIH-supported extramural research prior to joining NIH would be referred to HHS ORI, the NIH said.

The NIH announcement came on the same day that Science magazine published an investigative piece suggesting that Dr. Masliah may have fabricated or falsified images or other information in far more than the two studies NIH cited.

According to the article, “scores” of Dr. Masliah’s lab studies conducted at the NIA and the University of California San Diego are “riddled with apparently falsified Western blots — images used to show the presence of proteins — and micrographs of brain tissue. Numerous images seem to have been inappropriately reused within and across papers, sometimes published years apart in different journals, describing divergent experimental conditions.”

The article noted that a neuroscientist and forensic analysts who had previously worked with Science magazine produced a “300-page dossier revealing a steady stream of suspect images between 1997 and 2023 in 132 of his published research papers.”

They concluded that this “pattern of anomalous data raises a credible concern for research misconduct and calls into question a remarkably large body of scientific work,” the Science article stated.
 

A version of this article appeared on Medscape.com.

“Here’s my records.”

I hear that a lot, usually in the context of a patient handing me a flash drive or (less commonly) trying to plug it into my computer. (I have the USB ports turned toward me to keep that from happening.)

Uh, no.

I love flash drives. They definitely make data transfer easy, compared with the CDs, ZIPs, JAZZ, floppies, paper, and punch cards of past years (I should also, as a childhood TRS-80 user, include cassette tapes).

At this point an encrypted flash drive is pretty much the entire briefcase I carry back and forth to work each day.

But there is no patient I trust enough to plug in one they handed me.

I’m sure most, if not all, are well meaning. But look at how many large corporations have been damaged by someone slipping in a flash drive with a malicious program somewhere in their network. Once in, it’s almost impossible to get out, and can spread quickly.

Even if the patient is benign, I have no idea who formatted the gadget, or put the records on. It could be a relative, or friend, with other motives. It could even be a random flash drive and they don’t even know what else is on it.

My desktop is my chart system. I have to protect the data of all my patients, so I exercise caution about what emails I open and what I plug into it. Even the person offering me the flash drive wants the info guarded.

So I don’t, as a rule, plug in anything a patient hands me. All it takes is one malicious file to compromise it all. Yeah, I pay for software to watch for that sort of thing, but you still can’t be too careful.

This is where paper still shines. It’s readable and it’s transportable (at least for small things like an MRI report and lab results). I can scan it into a PDF without risking any damage to my computer. And it definitely shouldn’t be plugged into a USB drive unless you’re trying to start a fire.

Of course, paper isn’t secure, either. If you have it piled up everywhere it’s pretty easy for an unsupervised person to walk off with it. That actually happened to a doctor I shared space with 20 years ago, albeit unintentionally. A patient had brought in a bunch of his records in a folder and set them down on the counter. When he left he grabbed another patient’s chart by mistake and didn’t realize it until the next day. Fortunately he returned them promptly, and there were no issues. But it had the potential to be worse.

Today my charts on roughly 20,000 patients can all fit on a gadget the size of my thumb instead of a multi-room shelving system and storage closet. That’s pretty cool, actually. But it also opens other vulnerabilities.

It ticks some patients off that I won’t plug in their flash drives, but I don’t care. Most of them understand when I explain it, because it’s to protect them, too.

The odds are that they don’t mean any harm, but I can’t take that chance.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

“Here’s my records.”

I hear that a lot, usually in the context of a patient handing me a flash drive or (less commonly) trying to plug it into my computer. (I have the USB ports turned toward me to keep that from happening.)

Uh, no.

I love flash drives. They definitely make data transfer easy, compared with the CDs, ZIPs, JAZZ, floppies, paper, and punch cards of past years (I should also, as a childhood TRS-80 user, include cassette tapes).

At this point an encrypted flash drive is pretty much the entire briefcase I carry back and forth to work each day.

But there is no patient I trust enough to plug in one they handed me.

I’m sure most, if not all, are well meaning. But look at how many large corporations have been damaged by someone slipping in a flash drive with a malicious program somewhere in their network. Once in, it’s almost impossible to get out, and can spread quickly.

Even if the patient is benign, I have no idea who formatted the gadget, or put the records on. It could be a relative, or friend, with other motives. It could even be a random flash drive and they don’t even know what else is on it.

My desktop is my chart system. I have to protect the data of all my patients, so I exercise caution about what emails I open and what I plug into it. Even the person offering me the flash drive wants the info guarded.

So I don’t, as a rule, plug in anything a patient hands me. All it takes is one malicious file to compromise it all. Yeah, I pay for software to watch for that sort of thing, but you still can’t be too careful.

This is where paper still shines. It’s readable and it’s transportable (at least for small things like an MRI report and lab results). I can scan it into a PDF without risking any damage to my computer. And it definitely shouldn’t be plugged into a USB drive unless you’re trying to start a fire.

Of course, paper isn’t secure, either. If you have it piled up everywhere it’s pretty easy for an unsupervised person to walk off with it. That actually happened to a doctor I shared space with 20 years ago, albeit unintentionally. A patient had brought in a bunch of his records in a folder and set them down on the counter. When he left he grabbed another patient’s chart by mistake and didn’t realize it until the next day. Fortunately he returned them promptly, and there were no issues. But it had the potential to be worse.

Today my charts on roughly 20,000 patients can all fit on a gadget the size of my thumb instead of a multi-room shelving system and storage closet. That’s pretty cool, actually. But it also opens other vulnerabilities.

It ticks some patients off that I won’t plug in their flash drives, but I don’t care. Most of them understand when I explain it, because it’s to protect them, too.

The odds are that they don’t mean any harm, but I can’t take that chance.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

“Here’s my records.”

I hear that a lot, usually in the context of a patient handing me a flash drive or (less commonly) trying to plug it into my computer. (I have the USB ports turned toward me to keep that from happening.)

Uh, no.

I love flash drives. They definitely make data transfer easy, compared with the CDs, ZIPs, JAZZ, floppies, paper, and punch cards of past years (I should also, as a childhood TRS-80 user, include cassette tapes).

At this point an encrypted flash drive is pretty much the entire briefcase I carry back and forth to work each day.

But there is no patient I trust enough to plug in one they handed me.

I’m sure most, if not all, are well meaning. But look at how many large corporations have been damaged by someone slipping in a flash drive with a malicious program somewhere in their network. Once in, it’s almost impossible to get out, and can spread quickly.

Even if the patient is benign, I have no idea who formatted the gadget, or put the records on. It could be a relative, or friend, with other motives. It could even be a random flash drive and they don’t even know what else is on it.

My desktop is my chart system. I have to protect the data of all my patients, so I exercise caution about what emails I open and what I plug into it. Even the person offering me the flash drive wants the info guarded.

So I don’t, as a rule, plug in anything a patient hands me. All it takes is one malicious file to compromise it all. Yeah, I pay for software to watch for that sort of thing, but you still can’t be too careful.

This is where paper still shines. It’s readable and it’s transportable (at least for small things like an MRI report and lab results). I can scan it into a PDF without risking any damage to my computer. And it definitely shouldn’t be plugged into a USB drive unless you’re trying to start a fire.

Of course, paper isn’t secure, either. If you have it piled up everywhere it’s pretty easy for an unsupervised person to walk off with it. That actually happened to a doctor I shared space with 20 years ago, albeit unintentionally. A patient had brought in a bunch of his records in a folder and set them down on the counter. When he left he grabbed another patient’s chart by mistake and didn’t realize it until the next day. Fortunately he returned them promptly, and there were no issues. But it had the potential to be worse.

Today my charts on roughly 20,000 patients can all fit on a gadget the size of my thumb instead of a multi-room shelving system and storage closet. That’s pretty cool, actually. But it also opens other vulnerabilities.

It ticks some patients off that I won’t plug in their flash drives, but I don’t care. Most of them understand when I explain it, because it’s to protect them, too.

The odds are that they don’t mean any harm, but I can’t take that chance.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Over the last few decades the patient encounter has changed dramatically. Most recently fueled by the COVID pandemic, face-to-face events between patients and providers have become less frequent. The shift began years before with the slow acceptance of telemedicine by third-party payers.

As more practices have opened portals, the encounters between providers and patients via the internet have become more common, but received mixed reviews, often leaving both providers and patients with more questions than answers. Even more recently, the explosive arrival of generative artificial intelligence (AI) has promised, some might say threatened, to add a whole new complexity and uncertainty to patient encounters regardless of the venue or platform.

Still, among the growing collection of options, I think it is fair to say that a live face-to-face encounter remains the gold standard in the opinions of both patients and providers. Patients may have become increasingly critical and vocal when they feel their provider appears rushed or is over focused on the desktop computer screen. However, given all of the options, I suspect that for the moment patients feel a face-to-face meeting continues to offer them the best chance of being heard and their concerns answered.

Even when the image on the video screen is sharp and the intelligibility of the audio feed is crystal clear, I bet most providers feel they can learn more about the patient during a live face-to-face encounter than a Zoom-style encounter.

Nonetheless, there are hints that face-to-face visits maybe losing their place in the pantheon of patient-provider encounters. A recent study from England found that there were a significant number of patients who were more forthcoming in reporting their preferences for social care-related quality of life when they were surveyed by internet rather than face-to-face. It is unclear what was behind this observation, however it may be that patients were embarrassed and viewed these questions about their social neediness as too sensitive to share face-to-face.

There is ample evidence of situations in which the internet can provide a level of anonymity that emboldens the user to say things that are cruel and hurtful, using words they might be afraid to voice in a live setting. This license to act in an uncivil manner is behind much of the harm generated by chat rooms and other social media sites. While in these cases the ability to hide behind the video screen is a negative, this study from England suggests that we should be looking for more opportunities to use this emboldening feature with certain individuals and populations who may be intimidated during a face-to-face encounter. It is likely a hybrid approach may be the most beneficial strategy tailored to the individual patient.

One advantage of a face-to-face visit is that each participant can read the body language of the other. This, of course, can be a disadvantage for the provider who has failed to master the art of disguising his “I’m running behind” stress level, when he should be replacing it with an “I’m ready to listen” posture.

Portals have opened up a whole other can of worms, particularly when the provider has failed to clearly delineate what sort of questions are appropriate for an online forum, not informed the patient who will be providing the answer, and a rough idea of when this will happen. It may take several trips up the learning curve for patients and providers to develop a style of writing that make optimal use of the portal format and make it fit the needs of the practice and the patients.

Regardless of what kind of visit platform we are talking about, a lot hinges on the providers choice of words. I recently reviewed some of the work of Jeffrey D. Robinson, PhD, a professor of communication at the Portland State University, Portland, Oregon. He offers the example of the difference between “some” and “any.” When the patient was asked “Is there something else you would like to address today” almost 80% of the patient’s unmet questions were addressed. However, when the question was “Is there anything else ...” very few of the patient’s unmet questions were addressed. Dr. Robinson has also found that when the question is posed early in the visit rather than at the end, it improves the chances of having the patient’s unmet concerns addressed.

I suspect that the face-to-face patient encounter will survive, but it will continue to lose its market share as other platforms emerge. We can be sure there will be change. We need look no further than generative AI to look for the next step. A well-crafted question could help the patient and the provider choose the most appropriate patient encounter format given the patient’s demographic, chief complaint, and prior history, and match this with the provider’s background and strengths.
 

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

Over the last few decades the patient encounter has changed dramatically. Most recently fueled by the COVID pandemic, face-to-face events between patients and providers have become less frequent. The shift began years before with the slow acceptance of telemedicine by third-party payers.

As more practices have opened portals, the encounters between providers and patients via the internet have become more common, but received mixed reviews, often leaving both providers and patients with more questions than answers. Even more recently, the explosive arrival of generative artificial intelligence (AI) has promised, some might say threatened, to add a whole new complexity and uncertainty to patient encounters regardless of the venue or platform.

Still, among the growing collection of options, I think it is fair to say that a live face-to-face encounter remains the gold standard in the opinions of both patients and providers. Patients may have become increasingly critical and vocal when they feel their provider appears rushed or is over focused on the desktop computer screen. However, given all of the options, I suspect that for the moment patients feel a face-to-face meeting continues to offer them the best chance of being heard and their concerns answered.

Even when the image on the video screen is sharp and the intelligibility of the audio feed is crystal clear, I bet most providers feel they can learn more about the patient during a live face-to-face encounter than a Zoom-style encounter.

Nonetheless, there are hints that face-to-face visits maybe losing their place in the pantheon of patient-provider encounters. A recent study from England found that there were a significant number of patients who were more forthcoming in reporting their preferences for social care-related quality of life when they were surveyed by internet rather than face-to-face. It is unclear what was behind this observation, however it may be that patients were embarrassed and viewed these questions about their social neediness as too sensitive to share face-to-face.

There is ample evidence of situations in which the internet can provide a level of anonymity that emboldens the user to say things that are cruel and hurtful, using words they might be afraid to voice in a live setting. This license to act in an uncivil manner is behind much of the harm generated by chat rooms and other social media sites. While in these cases the ability to hide behind the video screen is a negative, this study from England suggests that we should be looking for more opportunities to use this emboldening feature with certain individuals and populations who may be intimidated during a face-to-face encounter. It is likely a hybrid approach may be the most beneficial strategy tailored to the individual patient.

One advantage of a face-to-face visit is that each participant can read the body language of the other. This, of course, can be a disadvantage for the provider who has failed to master the art of disguising his “I’m running behind” stress level, when he should be replacing it with an “I’m ready to listen” posture.

Portals have opened up a whole other can of worms, particularly when the provider has failed to clearly delineate what sort of questions are appropriate for an online forum, not informed the patient who will be providing the answer, and a rough idea of when this will happen. It may take several trips up the learning curve for patients and providers to develop a style of writing that make optimal use of the portal format and make it fit the needs of the practice and the patients.

Regardless of what kind of visit platform we are talking about, a lot hinges on the providers choice of words. I recently reviewed some of the work of Jeffrey D. Robinson, PhD, a professor of communication at the Portland State University, Portland, Oregon. He offers the example of the difference between “some” and “any.” When the patient was asked “Is there something else you would like to address today” almost 80% of the patient’s unmet questions were addressed. However, when the question was “Is there anything else ...” very few of the patient’s unmet questions were addressed. Dr. Robinson has also found that when the question is posed early in the visit rather than at the end, it improves the chances of having the patient’s unmet concerns addressed.

I suspect that the face-to-face patient encounter will survive, but it will continue to lose its market share as other platforms emerge. We can be sure there will be change. We need look no further than generative AI to look for the next step. A well-crafted question could help the patient and the provider choose the most appropriate patient encounter format given the patient’s demographic, chief complaint, and prior history, and match this with the provider’s background and strengths.
 

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

Over the last few decades the patient encounter has changed dramatically. Most recently fueled by the COVID pandemic, face-to-face events between patients and providers have become less frequent. The shift began years before with the slow acceptance of telemedicine by third-party payers.

As more practices have opened portals, the encounters between providers and patients via the internet have become more common, but received mixed reviews, often leaving both providers and patients with more questions than answers. Even more recently, the explosive arrival of generative artificial intelligence (AI) has promised, some might say threatened, to add a whole new complexity and uncertainty to patient encounters regardless of the venue or platform.

Still, among the growing collection of options, I think it is fair to say that a live face-to-face encounter remains the gold standard in the opinions of both patients and providers. Patients may have become increasingly critical and vocal when they feel their provider appears rushed or is over focused on the desktop computer screen. However, given all of the options, I suspect that for the moment patients feel a face-to-face meeting continues to offer them the best chance of being heard and their concerns answered.

Even when the image on the video screen is sharp and the intelligibility of the audio feed is crystal clear, I bet most providers feel they can learn more about the patient during a live face-to-face encounter than a Zoom-style encounter.

Nonetheless, there are hints that face-to-face visits maybe losing their place in the pantheon of patient-provider encounters. A recent study from England found that there were a significant number of patients who were more forthcoming in reporting their preferences for social care-related quality of life when they were surveyed by internet rather than face-to-face. It is unclear what was behind this observation, however it may be that patients were embarrassed and viewed these questions about their social neediness as too sensitive to share face-to-face.

There is ample evidence of situations in which the internet can provide a level of anonymity that emboldens the user to say things that are cruel and hurtful, using words they might be afraid to voice in a live setting. This license to act in an uncivil manner is behind much of the harm generated by chat rooms and other social media sites. While in these cases the ability to hide behind the video screen is a negative, this study from England suggests that we should be looking for more opportunities to use this emboldening feature with certain individuals and populations who may be intimidated during a face-to-face encounter. It is likely a hybrid approach may be the most beneficial strategy tailored to the individual patient.

One advantage of a face-to-face visit is that each participant can read the body language of the other. This, of course, can be a disadvantage for the provider who has failed to master the art of disguising his “I’m running behind” stress level, when he should be replacing it with an “I’m ready to listen” posture.

Portals have opened up a whole other can of worms, particularly when the provider has failed to clearly delineate what sort of questions are appropriate for an online forum, not informed the patient who will be providing the answer, and a rough idea of when this will happen. It may take several trips up the learning curve for patients and providers to develop a style of writing that make optimal use of the portal format and make it fit the needs of the practice and the patients.

Regardless of what kind of visit platform we are talking about, a lot hinges on the providers choice of words. I recently reviewed some of the work of Jeffrey D. Robinson, PhD, a professor of communication at the Portland State University, Portland, Oregon. He offers the example of the difference between “some” and “any.” When the patient was asked “Is there something else you would like to address today” almost 80% of the patient’s unmet questions were addressed. However, when the question was “Is there anything else ...” very few of the patient’s unmet questions were addressed. Dr. Robinson has also found that when the question is posed early in the visit rather than at the end, it improves the chances of having the patient’s unmet concerns addressed.

I suspect that the face-to-face patient encounter will survive, but it will continue to lose its market share as other platforms emerge. We can be sure there will be change. We need look no further than generative AI to look for the next step. A well-crafted question could help the patient and the provider choose the most appropriate patient encounter format given the patient’s demographic, chief complaint, and prior history, and match this with the provider’s background and strengths.
 

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

Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.

These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.

“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
 

Study Compared Gestational Carriage With IVF and Unassisted Conception

To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.

Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.

Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.

Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).

The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.

Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.

These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).

Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.

“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
 

Causes of Worse Outcomes Remain Unclear

While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.

The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.

“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”

In the meantime, more care is needed in surrogate selection, according to Dr. Velez.

“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”

But improving surrogate selection may be easier said than done.

The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.

And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
 

Present Study Offers Much-Needed Data in Understudied Field

According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.

“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”

These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.

Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.

In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.

Dr. Swanson and Dr. Velez offered starkly different views on this topic.

“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”

Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.

“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”

Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.

“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”

Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.

She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.

This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
 

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

Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.

These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.

“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
 

Study Compared Gestational Carriage With IVF and Unassisted Conception

To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.

Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.

Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.

Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).

The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.

Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.

These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).

Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.

“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
 

Causes of Worse Outcomes Remain Unclear

While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.

The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.

“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”

In the meantime, more care is needed in surrogate selection, according to Dr. Velez.

“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”

But improving surrogate selection may be easier said than done.

The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.

And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
 

Present Study Offers Much-Needed Data in Understudied Field

According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.

“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”

These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.

Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.

In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.

Dr. Swanson and Dr. Velez offered starkly different views on this topic.

“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”

Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.

“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”

Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.

“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”

Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.

She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.

This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
 

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

Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.

These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.

“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
 

Study Compared Gestational Carriage With IVF and Unassisted Conception

To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.

Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.

Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.

Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).

The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.

Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.

These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).

Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.

“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
 

Causes of Worse Outcomes Remain Unclear

While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.

The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.

“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”

In the meantime, more care is needed in surrogate selection, according to Dr. Velez.

“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”

But improving surrogate selection may be easier said than done.

The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.

And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
 

Present Study Offers Much-Needed Data in Understudied Field

According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.

“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”

These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.

Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.

In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.

Dr. Swanson and Dr. Velez offered starkly different views on this topic.

“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”

Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.

“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”

Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.

“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”

Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.

She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.

This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
 

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

Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Association for Diagnostics & Laboratory Medicine

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Kim

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Putman

Ron Hester Photography

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Association for Diagnostics & Laboratory Medicine

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Kim

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Putman

Ron Hester Photography

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Association for Diagnostics & Laboratory Medicine

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Kim

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Putman

Ron Hester Photography

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.

Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”

But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”

At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”

Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”

This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”

Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”

The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
 

Ending Careers Early. A Catalyst for Change

Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.

Long-term occupational exposure to radiation is linked to cataracts; brain tumors; cancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.

Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.

But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”

James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”

Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.

While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”

“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.

His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”

Dr. Kereiakes’ case was “a catalyst” for his hospital to investigate, and eventually commit to, the purchase of a new radiation protection system which allows the labs using radiation to effectively go “lead-free.”

Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.

His focus as SCAI president is to help get these protection systems in place at more hospitals.

But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.

Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
 

How Do the Lead-Free Systems Work?

Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).

According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”

Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”

If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.

Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”

The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.

Data for the EggNest Protect are available but are as yet unpublished.

Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.

“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
 

Regulation at the State Level

Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.

There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”

James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”

The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.

“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.

Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.

Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.

“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.

SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.

“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.

Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”

Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”

He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
 

Pregnancy Safe in the Cath Lab

Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.

She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.

Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”

Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.

Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”

But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”

At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”

Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”

This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”

Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”

The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
 

Ending Careers Early. A Catalyst for Change

Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.

Long-term occupational exposure to radiation is linked to cataracts; brain tumors; cancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.

Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.

But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”

James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”

Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.

While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”

“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.

His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”

Dr. Kereiakes’ case was “a catalyst” for his hospital to investigate, and eventually commit to, the purchase of a new radiation protection system which allows the labs using radiation to effectively go “lead-free.”

Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.

His focus as SCAI president is to help get these protection systems in place at more hospitals.

But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.

Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
 

How Do the Lead-Free Systems Work?

Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).

According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”

Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”

If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.

Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”

The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.

Data for the EggNest Protect are available but are as yet unpublished.

Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.

“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
 

Regulation at the State Level

Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.

There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”

James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”

The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.

“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.

Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.

Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.

“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.

SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.

“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.

Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”

Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”

He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
 

Pregnancy Safe in the Cath Lab

Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.

She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.

Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”

Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.

Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”

But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”

At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”

Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”

This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”

Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”

The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
 

Ending Careers Early. A Catalyst for Change

Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.

Long-term occupational exposure to radiation is linked to cataracts; brain tumors; cancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.

Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.

But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”

James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”

Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.

While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”

“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.

His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”

Dr. Kereiakes’ case was “a catalyst” for his hospital to investigate, and eventually commit to, the purchase of a new radiation protection system which allows the labs using radiation to effectively go “lead-free.”

Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.

His focus as SCAI president is to help get these protection systems in place at more hospitals.

But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.

Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
 

How Do the Lead-Free Systems Work?

Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).

According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”

Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”

If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.

Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”

The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.

Data for the EggNest Protect are available but are as yet unpublished.

Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.

“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
 

Regulation at the State Level

Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.

There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”

James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”

The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.

“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.

Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.

Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.

“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.

SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.

“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.

Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”

Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”

He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
 

Pregnancy Safe in the Cath Lab

Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.

She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.

Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”

Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent. As one respondent said in a recent Medscape PA Burnout report, there are expectations for PAs to see the same complexity and quantity of patients as physician providers with less support, little oversight, less respect, and less pay.

Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.

“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”

Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.

He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.

“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
 

See How Other PAs Are Managing

Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.

“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”

Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms^® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.

“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
 

Speak Up

Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.

“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”

None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.

“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
 

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

Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent. As one respondent said in a recent Medscape PA Burnout report, there are expectations for PAs to see the same complexity and quantity of patients as physician providers with less support, little oversight, less respect, and less pay.

Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.

“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”

Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.

He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.

“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
 

See How Other PAs Are Managing

Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.

“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”

Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms^® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.

“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
 

Speak Up

Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.

“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”

None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.

“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
 

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

Within the physician assistant (PA) community, many PAs have expressed the heavy weight of their job expectation and their subsequent feelings of discontent. As one respondent said in a recent Medscape PA Burnout report, there are expectations for PAs to see the same complexity and quantity of patients as physician providers with less support, little oversight, less respect, and less pay.

Mirela Bruza-Augatis, PhD, MS, PA-C, a researcher at the National Commission on Certification of Physician Assistants, said the sentiment is similar to what she’s heard from colleagues, as well as seen in her own research examining PA work-life balance.

“Unfortunately, part of this is just the culture of medicine — and other healthcare workers report similar experiences. The patient comes first, and you are secondary,” she said. “You have to make do with the resources you have, and that’s not always enough.”

Yet, despite the challenges of working as a PA in today’s healthcare industry, many are finding ways not just to survive but to thrive. Brian McCambley, DHSc, PA-C, who works as both an emergency medicine PA and a system wellness officer at Nuvance Health, has been looking at ways to improve morale (and, consequently, lower turnover rates), especially among new PA recruits.

He said that the first step is finding the right practice environment. He encourages even experienced PAs to take the time to understand the culture of any practice they consider joining — and ask a lot of questions about what kind of support is available.

“Ask the right questions from the very beginning. What does the job truly entail? What is the culture within the group that you’ll be joining? Talk to the entire team to get a real sense of what’s going on there day to day,” he said. “One benefit of being a PA is that most of us are trained as generalists. We have a lot of mobility between specialties. If the work hours, culture, or fit doesn’t work, it is possible to morph and try something different.”
 

See How Other PAs Are Managing

Dr. Bruza-Augatis added that finding peer support is also beneficial. She said being able to discuss your experiences with other PAs, both within your workplace and outside of it, offers more than just the benefit of knowing you are not alone.

“When you talk to other colleagues who have had similar experiences, they may have found solutions to help,” she said. “The solution that works for one person may not work for everyone. But it can at least offer some ideas and help you focus on the things you may be able to control and change.”

Raquelle Akavan, DMSc, PA-C, founder of the popular PA Moms^® group, agreed on both points. She said that finding both institutional and personal support is remarkably helpful in dealing with the stressors most PAs face both at work and home. With that kind of support in place, you can start to set the appropriate boundaries to help ensure you aren’t feeling overwhelmed by all the expectations placed on you.

“This is crucial to finding good work-life integration,” she said. “You can set boundaries with both your patients and your managers. You can carve out time for your family and let your job know that you won’t be taking calls between 5:00 pm and 9:00 pm. You can go to your manager and let them know what you need to do your job well — whether it’s a scribe, continuing medical education, or help managing the workload.”
 

Speak Up

Advocating for yourself is key, said Hope Cook, PA-C, who works as both a PA in a dermatology practice and as a licensed life coach. She said that taking the time to be self-aware of the work stressors that negatively affect you allows you to “give yourself permission” to do something about them.

“Like any profession, you have to know your limits,” she said. “If you need more collaboration from your team, you need to figure out how to get that. You need to ask for it. If you feel like you have insufficient training to deal with the complexity of the patients who are coming to see you, you need to talk to the practice about how to fix that. It’s important to let people know what support you need. And, if they aren’t going to help provide it, understand that it may be time to go elsewhere.”

None of these things are necessarily easy, said Dr. McCambley. But replacing a PA costs a practice significant time and money. So, finding ways to promote growth and resilience early on in your career will help protect you from later burnout, and save the healthcare organization in the long run, too. He believes Nuvance has had great success in their efforts to support clinician wellness across the board by having PAs contribute to leadership discussions and decisions.

“When you can get with like-minded folks and sit with hospital administration to talk about the best ways to get PAs intermixed with the medical staff and how to support them in their roles, you can make a difference,” he told this news organization. “I’ve been at my healthcare institution for 26 years. We PAs didn’t really have a big voice at the beginning. But, little by little, by having important discussions with our leadership, we’ve been able to show our medical staff that PAs bring something really important to the table — and that it benefits everyone when we support them.”
 

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

The turf war between two types of anesthesia providers is escalating: The American Society of Anesthesiologists (ASA) has filed a trademark complaint against the recently renamed American Association of Nurse Anesthesiology (AANA), alleging its use of the word “anesthesiology” is “deceptively misdescriptive.”

At issue: Who can be called an anesthesiologist?

In its complaint, filed in June 2024 with the US Trademark Trial and Appeal Board, the 54,000-member physician society seeks to deny the nurse group the registration of its trademark. If ASA wins, it could sue AANA in federal court.

AANA denied the physicians’ allegations in its recent response to the complaint.

The dispute between the two associations comes at a time when physicians are facing challenges from providers such as nurse practitioners and physician assistants who seek new titles and more autonomy in medical decision-making.
 

A Controversial Name Change

In 2021, the 61,000-member AANA changed its name from the American Association of Nurse Anesthetists, saying the change “clarifies” the role of its members.

The ASA declared it was “gravely concerned” by the name change, which “confuses patients and creates discord in the care setting, ultimately risking patient safety.

“ ’Anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from nonphysicians, including nurse anesthetists,” the physicians’ group said in a news release.

Chicago Intellectual Property Attorney Laura M. Schaefer, who represents AANA, told this news organization that certified registered nurse anesthetists (CRNAs) — “also known as nurse anesthesiologists or nurse anesthetists — have a 150-year track record of administering safe, effective anesthesia to patients in need of care. Not only are CRNAs highly trained and capable, they also use the exact same techniques to provide anesthesia as other anesthesiology professionals.”

Ms. Schaefer declined to comment further, and ASA declined to comment at all, citing pending litigation.

The scope of practice of nurse anesthetists has long been disputed. In mid-September, California health officials clarified what nurse anesthetists can do on the job after complaints about lack of oversight, The Modesto Bee reported.

According to nursing education site NurseJournal.org, CRNAs and anesthesiologists “perform many of the same duties,” although CRNAs are in more demand. Also, the site says some states require CRNAs to be supervised by anesthesiologists.

“It is possible that scope of practice debates are increasing in prominence due to the increase in demand for healthcare services, coupled with workforce shortages in certain areas,” Alice Chen, PhD, MBA, vice dean for research at the USC Sol Price School of Public Policy in Los Angeles, told this news organization. “For example, during COVID, the federal government temporarily expanded scope of practice to help address healthcare needs.”

She added her group’s research has shown that despite the large stakes perceived by both sides of the debate, changes in practice behavior were actually quite small in states that allowed CRNAs to practice without supervision.

“In fact, we found only modest reduction in anesthesiologist billing for supervision, and we did not find an increase in the supply of anesthesia care,” she noted.

Trademark law specialists told this news organization that they couldn’t predict which way the board will rule. However, they noted potential weaknesses of the ASA’s case.

Rebecca Tushnet, JD, a professor at Harvard Law School, Cambridge, Massachusetts, explained that a trademark “can’t misrepresent those goods or services in a way that deceives consumers.” However, if insurers, doctors, and hospitals are considered the “consumers” — and not patients — “then confusion is probably less likely because they will have relevant expertise to distinguish among groups.”

Christine Farley, JD, LLM, JSD, professor at American University Washington College of Law, said attacking the AANA’s trademark as deceptive may be one of the ASA’s strongest arguments. The suggestion, she said, is that “nurse anesthesiologist” is an oxymoron, like “jumbo shrimp.”

On the other hand, she said it’s not clear that people will miss the word “nurse” in AANA’s name and say, “ ’Well, obviously these people are doctors.’ So that that’s an uphill battle.”

What happens now? The Trademark Trial and Appeal Board will decide whether AANA’s trademark application should be granted or denied, said Kayla Jimenez, JD, a San Diego trademark attorney and adjunct law professor at the University of San Diego. The entire process can take 2-3 years, she said.

The board “cannot award attorneys’ fees or force a party to stop using a trademark,” she said. “You would have to go file a lawsuit in federal court if that is your endgame.” Also, she said, the board’s ultimate decision can be appealed in federal court.

Eric Goldman, JD, MBA, associate dean for research and professor at Santa Clara University School of Law, Santa Clara, California, doesn’t expect the trademark case will spell the end of this dispute.

“ASA is signaling that it will challenge AANA’s use of the term in multiple battlegrounds,” he said. “I see this as a move by ASA to contest AANA in every potentially relevant venue, even if neither side can score a knockout blow in the Trademark Trial and Appeal Board.”

Dr. Chen, Ms. Farley, Ms. Jimenez, and Mr. Goldman had no disclosures. 
 

A version of this article appeared on Medscape.com.

The turf war between two types of anesthesia providers is escalating: The American Society of Anesthesiologists (ASA) has filed a trademark complaint against the recently renamed American Association of Nurse Anesthesiology (AANA), alleging its use of the word “anesthesiology” is “deceptively misdescriptive.”

At issue: Who can be called an anesthesiologist?

In its complaint, filed in June 2024 with the US Trademark Trial and Appeal Board, the 54,000-member physician society seeks to deny the nurse group the registration of its trademark. If ASA wins, it could sue AANA in federal court.

AANA denied the physicians’ allegations in its recent response to the complaint.

The dispute between the two associations comes at a time when physicians are facing challenges from providers such as nurse practitioners and physician assistants who seek new titles and more autonomy in medical decision-making.
 

A Controversial Name Change

In 2021, the 61,000-member AANA changed its name from the American Association of Nurse Anesthetists, saying the change “clarifies” the role of its members.

The ASA declared it was “gravely concerned” by the name change, which “confuses patients and creates discord in the care setting, ultimately risking patient safety.

“ ’Anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from nonphysicians, including nurse anesthetists,” the physicians’ group said in a news release.

Chicago Intellectual Property Attorney Laura M. Schaefer, who represents AANA, told this news organization that certified registered nurse anesthetists (CRNAs) — “also known as nurse anesthesiologists or nurse anesthetists — have a 150-year track record of administering safe, effective anesthesia to patients in need of care. Not only are CRNAs highly trained and capable, they also use the exact same techniques to provide anesthesia as other anesthesiology professionals.”

Ms. Schaefer declined to comment further, and ASA declined to comment at all, citing pending litigation.

The scope of practice of nurse anesthetists has long been disputed. In mid-September, California health officials clarified what nurse anesthetists can do on the job after complaints about lack of oversight, The Modesto Bee reported.

According to nursing education site NurseJournal.org, CRNAs and anesthesiologists “perform many of the same duties,” although CRNAs are in more demand. Also, the site says some states require CRNAs to be supervised by anesthesiologists.

“It is possible that scope of practice debates are increasing in prominence due to the increase in demand for healthcare services, coupled with workforce shortages in certain areas,” Alice Chen, PhD, MBA, vice dean for research at the USC Sol Price School of Public Policy in Los Angeles, told this news organization. “For example, during COVID, the federal government temporarily expanded scope of practice to help address healthcare needs.”

She added her group’s research has shown that despite the large stakes perceived by both sides of the debate, changes in practice behavior were actually quite small in states that allowed CRNAs to practice without supervision.

“In fact, we found only modest reduction in anesthesiologist billing for supervision, and we did not find an increase in the supply of anesthesia care,” she noted.

Trademark law specialists told this news organization that they couldn’t predict which way the board will rule. However, they noted potential weaknesses of the ASA’s case.

Rebecca Tushnet, JD, a professor at Harvard Law School, Cambridge, Massachusetts, explained that a trademark “can’t misrepresent those goods or services in a way that deceives consumers.” However, if insurers, doctors, and hospitals are considered the “consumers” — and not patients — “then confusion is probably less likely because they will have relevant expertise to distinguish among groups.”

Christine Farley, JD, LLM, JSD, professor at American University Washington College of Law, said attacking the AANA’s trademark as deceptive may be one of the ASA’s strongest arguments. The suggestion, she said, is that “nurse anesthesiologist” is an oxymoron, like “jumbo shrimp.”

On the other hand, she said it’s not clear that people will miss the word “nurse” in AANA’s name and say, “ ’Well, obviously these people are doctors.’ So that that’s an uphill battle.”

What happens now? The Trademark Trial and Appeal Board will decide whether AANA’s trademark application should be granted or denied, said Kayla Jimenez, JD, a San Diego trademark attorney and adjunct law professor at the University of San Diego. The entire process can take 2-3 years, she said.

The board “cannot award attorneys’ fees or force a party to stop using a trademark,” she said. “You would have to go file a lawsuit in federal court if that is your endgame.” Also, she said, the board’s ultimate decision can be appealed in federal court.

Eric Goldman, JD, MBA, associate dean for research and professor at Santa Clara University School of Law, Santa Clara, California, doesn’t expect the trademark case will spell the end of this dispute.

“ASA is signaling that it will challenge AANA’s use of the term in multiple battlegrounds,” he said. “I see this as a move by ASA to contest AANA in every potentially relevant venue, even if neither side can score a knockout blow in the Trademark Trial and Appeal Board.”

Dr. Chen, Ms. Farley, Ms. Jimenez, and Mr. Goldman had no disclosures. 
 

A version of this article appeared on Medscape.com.

The turf war between two types of anesthesia providers is escalating: The American Society of Anesthesiologists (ASA) has filed a trademark complaint against the recently renamed American Association of Nurse Anesthesiology (AANA), alleging its use of the word “anesthesiology” is “deceptively misdescriptive.”

At issue: Who can be called an anesthesiologist?

In its complaint, filed in June 2024 with the US Trademark Trial and Appeal Board, the 54,000-member physician society seeks to deny the nurse group the registration of its trademark. If ASA wins, it could sue AANA in federal court.

AANA denied the physicians’ allegations in its recent response to the complaint.

The dispute between the two associations comes at a time when physicians are facing challenges from providers such as nurse practitioners and physician assistants who seek new titles and more autonomy in medical decision-making.
 

A Controversial Name Change

In 2021, the 61,000-member AANA changed its name from the American Association of Nurse Anesthetists, saying the change “clarifies” the role of its members.

The ASA declared it was “gravely concerned” by the name change, which “confuses patients and creates discord in the care setting, ultimately risking patient safety.

“ ’Anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from nonphysicians, including nurse anesthetists,” the physicians’ group said in a news release.

Chicago Intellectual Property Attorney Laura M. Schaefer, who represents AANA, told this news organization that certified registered nurse anesthetists (CRNAs) — “also known as nurse anesthesiologists or nurse anesthetists — have a 150-year track record of administering safe, effective anesthesia to patients in need of care. Not only are CRNAs highly trained and capable, they also use the exact same techniques to provide anesthesia as other anesthesiology professionals.”

Ms. Schaefer declined to comment further, and ASA declined to comment at all, citing pending litigation.

The scope of practice of nurse anesthetists has long been disputed. In mid-September, California health officials clarified what nurse anesthetists can do on the job after complaints about lack of oversight, The Modesto Bee reported.

According to nursing education site NurseJournal.org, CRNAs and anesthesiologists “perform many of the same duties,” although CRNAs are in more demand. Also, the site says some states require CRNAs to be supervised by anesthesiologists.

“It is possible that scope of practice debates are increasing in prominence due to the increase in demand for healthcare services, coupled with workforce shortages in certain areas,” Alice Chen, PhD, MBA, vice dean for research at the USC Sol Price School of Public Policy in Los Angeles, told this news organization. “For example, during COVID, the federal government temporarily expanded scope of practice to help address healthcare needs.”

She added her group’s research has shown that despite the large stakes perceived by both sides of the debate, changes in practice behavior were actually quite small in states that allowed CRNAs to practice without supervision.

“In fact, we found only modest reduction in anesthesiologist billing for supervision, and we did not find an increase in the supply of anesthesia care,” she noted.

Trademark law specialists told this news organization that they couldn’t predict which way the board will rule. However, they noted potential weaknesses of the ASA’s case.

Rebecca Tushnet, JD, a professor at Harvard Law School, Cambridge, Massachusetts, explained that a trademark “can’t misrepresent those goods or services in a way that deceives consumers.” However, if insurers, doctors, and hospitals are considered the “consumers” — and not patients — “then confusion is probably less likely because they will have relevant expertise to distinguish among groups.”

Christine Farley, JD, LLM, JSD, professor at American University Washington College of Law, said attacking the AANA’s trademark as deceptive may be one of the ASA’s strongest arguments. The suggestion, she said, is that “nurse anesthesiologist” is an oxymoron, like “jumbo shrimp.”

On the other hand, she said it’s not clear that people will miss the word “nurse” in AANA’s name and say, “ ’Well, obviously these people are doctors.’ So that that’s an uphill battle.”

What happens now? The Trademark Trial and Appeal Board will decide whether AANA’s trademark application should be granted or denied, said Kayla Jimenez, JD, a San Diego trademark attorney and adjunct law professor at the University of San Diego. The entire process can take 2-3 years, she said.

The board “cannot award attorneys’ fees or force a party to stop using a trademark,” she said. “You would have to go file a lawsuit in federal court if that is your endgame.” Also, she said, the board’s ultimate decision can be appealed in federal court.

Eric Goldman, JD, MBA, associate dean for research and professor at Santa Clara University School of Law, Santa Clara, California, doesn’t expect the trademark case will spell the end of this dispute.

“ASA is signaling that it will challenge AANA’s use of the term in multiple battlegrounds,” he said. “I see this as a move by ASA to contest AANA in every potentially relevant venue, even if neither side can score a knockout blow in the Trademark Trial and Appeal Board.”

Dr. Chen, Ms. Farley, Ms. Jimenez, and Mr. Goldman had no disclosures. 
 

A version of this article appeared on Medscape.com.