When Steven Horowitz, MD, began experiencing neck and arm pain, numbness, and tingling following a bike ride several years ago, he immediately sought care at an elite medical center in California. As he recalls, an incompetent clinical exam and no access to highly abnormal test results done in the ED almost cost him his health. Had he listened to the doctors at that facility, he believes he would have become quadriplegic.

His training as a neurologist likely saved his life: “I was able to recover because, after arriving home, I reviewed my blood work and MRI online and recognized multiple problems.” He was able to get excellent care at his own local health care facility in Maine. The staff and leadership at the hospital in California wouldn’t admit wrongdoing, and efforts to seek recourse have proved fruitless, he said.

A lingering question nags at him: What if he had been an ordinary patient without medical expertise? What do his experiences say about the health care system’s management of medical omissions and errors?

Dr. Horowitz, 78 years old and retired, continues to teach medical students as an adjunct clinical professor of neurology at the Tufts University School of Medicine in Boston. He is also on the teaching faculty of the Maine Medical Center. He was professor and chief of neurology at a major university in the Midwest for many years.

In 2018, he visited his daughter on the West Coast, enjoying a day of biking. The neck pain began 5 or 6 hours after the ride and spread to his arms. “There was also numbness and tingling,” he said.
 

“I told them I was a neurologist”

The next day the pain got worse. Dr. Horowitz went to the ED of a nearby medical center with his daughter and immediately disclosed that he was a neurologist. “I did this for several reasons,” he explained. He wanted to alert staff that he had a cervical spine problem because “I wanted them to do a cervical MRI scan, and I wanted to read it because I’m capable of doing that.” He also related a past history of infection and antibiotic use and asked for C-reactive protein and erythrocyte sedimentation rate tests in addition to regular blood work. “Those inflammatory markers, if abnormal, would indicate an infection,” said Dr. Horowitz.

No reflex hammer or Babinski test

During the reflex exam with a spine consultant, Dr. Horowitz noticed that the consultant wasn’t using a reflex hammer, the clinical equivalent of evaluating the heart or lungs without a stethoscope. “I asked where the reflex hammer was, and he said he didn’t need one or own one. He used the inside of his hand. Apparently, there was some mild weakness in some muscle groups, but he didn’t address that,” said Dr. Horowitz. The consultant also didn’t test for the Babinski sign until reminded of it.

He took out a stethoscope and struck the middle of the soles of Dr. Horowitz’s feet. “I thought to myself, this consultant is the consultant for the spine service? How is it possible that he has a stethoscope and not a reflex hammer and didn’t know how to test for the Babinski sign?” The consultant also didn’t examine for gait, coordination, or hand dexterity. “He took his finger and touched my feet and legs. That was his sensory exam. He didn’t use a pin or a tuning fork” or other methods including touch, temperature, position sense, and vibration to assess sensory abnormalities that might signal spinal cord dysfunction.

An MRI at the hospital revealed a mass at the back of the neck. No contrast material was used during the MRI even though this step would have signaled the presence of infection. “Gadolinium should have been injected during the MRI because that would have strongly suggested that this mass in my neck was not a little blood clot and more likely an infection. They would have realized something more complicated than degenerative arthritis was going on. They told me that I had advanced spondylosis and that the mass was a hematoma. They told me not to worry about the blood results. Then they discharged me.”
 

A life-threatening discovery

Dr. Horowitz didn’t see the results of the blood work-up until returning to Maine a few days later, when he checked the online report. There was a highly elevated CRP level – 30 times above the normal limit – and elevated erythrocyte sedimentation rate and white blood cell counts. “This showed that there was an infective process going on. And it wasn’t just a localized process, it was in my bloodstream,” he said.

Alarmed by the elevated markers, he immediately went to his local hospital. “Not only did I have arthritis, but my spinal cord was compressed.” Urgent surgery was performed, including a C2-7 fusion. The mass in the back of his neck turned out to be an abscess.

His training and experience as a physician/neurologist saved him from further damage, he said. “Because the compression of the spine was at the C2, C3, C4 level, not only would I have become quadriplegic, but my diaphragm would likely have been paralyzed and I would have needed a ventilator.”

Following a month’s care in the hospital and a rehabilitation center, he wrote to the CEO of the California hospital where he received his initial care.

“I wrote about the incompetent exam, the missed infection, a discharge without information. I wrote all that out to the CEO and sent the letter registered so that he would receive it.” The CEO forwarded the letter to a patient risk manager, who interviewed staff and supervisors in the ED, radiology, and the spine program. They responded 3 months later. According to Dr. Horowitz, the spine supervisor said, “The consultant performed the exam to the best of his ability.” No one admitted to any errors in care or the lack of recognition of the infection, although the neuroradiologist did apologize for not allowing Dr. Horowitz to read his own MRI in a timely manner.

“They had promised to wheel a portable computer into my alcove so I could view the MRI.” Several hours later, after persistent complaints, he was given 1 minute to look over at least 300 images at a desktop computer in the crowded ED. They gave him the MRI images on a disk, but he wasn’t able to read it on his iMac computer.

According to Dr. Horowitz, the ED should have called in an infectious disease consultant and a neurologist or neurosurgeon to do a more complete neurologic exam. “Instead of discharging me, they should have admitted me, telling me that I had spinal cord compression, an infection, and a mass in my neck—that they don’t know what this is about, and I shouldn’t go home.”

Eventually, after long-term intravenous antibiotics and extensive physical therapy, Dr. Horowitz recovered. “I definitely had PTSD afterwards. How could a non-eventful bike ride result in an unrecognized threatening illness? I thought a healing opportunity for me and an educational opportunity for the medical staff and students at this medical center would be for me to present my case to them at a conference at their facility the next time I visited my daughter in California. I thought an experienced clinician discussing his own illness in his own specialty would be unique.”

The hospital ignored his offer.

By happenstance, a year and a half later, Dr. Horowitz made contact with a hospital administrator after hearing her speak during a TED Radio Hour in his car. “We had several telephone conversations and email correspondences in October and November 2019 but none since,” he said. In one email, she wrote that “hospitals don’t seem to know what to do with the opportunity you present. I don’t think the challenge is unique to [this institution]. A forum for these kinds of discussions – constructive, insightful patient feedback – does not exist.”

Dr. Horowitz hasn’t considered a malpractice lawsuit. “The only result would be a monetary reward based on damages. Since permanent clinical damage did not occur, the suit would have been time consuming and the reward limited. I was able to recover because I was able to review the blood work and recognize my own problem and get excellent care at my own local health care facility. I was really hoping the doctors at the California hospital would learn from this episode.”

Dr. Horowitz also wrote the Medical Board of California a detailed letter, citing relevant medical literature, guidelines on spinal care, and his test results. Nearly 2 years later, he finally got a response. The board said there was no “clear and convincing evidence that negligence took place.” In Dr. Horowitz’s opinion, “the fact that CRP was 30 times past normal is ‘clear and convincing evidence.’ That the consultant didn’t have a reflex hammer is also ‘clear and convincing evidence.’ That the clinical neurologic exam was incompetent, by any measure, is ‘clear and convincing evidence.’ Even the Medical Board, tasked with patient protection, didn’t recognize negligent medical care. They might have if I had become quadriplegic.”
 

A new normal?

Dr. Horowitz, who wrote of his experience in The Washington Post, said it reflects a persistent, systemic problem in health care: the inability to address medical errors and correct them. In the article, he addressed a phenomenon called the “the normalization of deviance.” Diane Vaughn wrote about this phenomenon in a 1997 book about the Space Shuttle disaster. Multiple flaws were noted in previous shuttle launches but then rationalized and “normalized” when they didn’t cause a disaster – until they ultimately did.

“That’s relevant to my situation,” Dr. Horowitz said. “The spine supervisor at this hospital excused the consultant by saying, ‘he did the exam to the best of his ability.’ Further, the response to my complaints came from hospital representatives rather than physicians, meaning that the ‘normalization’ was institutional, and it was willing to accept his poor performance without sanctions.”

He imagines that he could not be the only case handled poorly by this hospital or that particular consultant. “He could have done the same thing to another patient who didn’t have my medical knowledge,” added Dr. Horowitz.

In her book, Ms. Vaughan noted that whistleblower activity is sometimes the only device that reveals normalization of deviance.

Dr. Horowitz sees himself as a whistleblower for these types of mistakes. “The question is, how do we deal with medical errors even in sophisticated patients who see these errors, and how do you manage this in the average patient? I don’t want to see this type of medical care rendered for any patient, hence my attempt to make this situation public.”
 

A teachable moment lost?

Commenting on this case, Alan Rapoport, MD, said, “[it]illustrates inadequate physician evaluation in the ED, poor communication from the examining doctor about abnormal lab and MRI findings, unwillingness to call in consultants to properly evaluate the situation, and no recognition of the need to admit the patient.”

Dr. Rapoport is the editor in chief of Neurology Reviews and a clinical professor of neurology at UCLA in Los Angeles. He is a past president of the International Headache Society.

He noted that the patient is in his late 70s and needed to fly across the country to arrive at home. “Months later, when this situation was explained to the hospital via the mail, they totally failed to recognize their inadequacies and apologize for their mistakes. They were probably concerned about being sued, but I believe that their actions increased their chances of a lawsuit,” Dr. Rapoport said.

“When a teaching remedy was offered by the patient to the hospital so the doctors involved could learn from the experience, the hospital was not interested. The only party that learned from this unfortunate episode was the patient, not the doctors, or the ER, or the hospital administration,” Dr. Rapoport said.

He continued, “It is scary to think that an excellent hospital would act in this manner and refuse to learn from their mistakes. The California medical board was notified and did not investigate. It is not too late for the hospital to apologize, communicate their shortcomings, and fix the problem at multiple levels in the hospital.”

Dr. Rapoport consulted Morris Levin, MD, a professor of neurology and director of the Headache Program at UCSF, to ask what he thought, theoretically, about how a hospital should respond when they make a mistake and how much they should divulge. Dr. Levin is involved in Medical Ethics and often lectures about it at conferences.

Dr. Levin said, “When medical errors are made, to me, it is ethically sound to identify them and ‘fess up.’ There has always been reluctance to do so because of fears of lawsuits, but it turns out that when institutions do disclose errors, their liability costs actually go down.” Dr. Levin cited the University of Michigan, which tried a full disclosure policy as an experiment. “It led to reduced costs, not to mention a boost in patient satisfaction,” Dr. Levin noted.

He continued, “I think patients want and deserve to know the truth. I also believe they understand that medical errors can and will happen. It is my observation that patients have several key concerns: 1) how the error(s) happened, 2) how the error affected their health and what can be done to restore them to optimal health, and 3) what the institution is going to do to prevent this kind of error from happening to others.”

Dr. Rapoport concurs with Dr. Levin. “I am glad Dr. Horowitz has fully recovered and at least he has learned from the experience. I do not think the hospital and doctors did,” Dr. Rapoport said.

This article was updated 11/12/20.

When Steven Horowitz, MD, began experiencing neck and arm pain, numbness, and tingling following a bike ride several years ago, he immediately sought care at an elite medical center in California. As he recalls, an incompetent clinical exam and no access to highly abnormal test results done in the ED almost cost him his health. Had he listened to the doctors at that facility, he believes he would have become quadriplegic.

His training as a neurologist likely saved his life: “I was able to recover because, after arriving home, I reviewed my blood work and MRI online and recognized multiple problems.” He was able to get excellent care at his own local health care facility in Maine. The staff and leadership at the hospital in California wouldn’t admit wrongdoing, and efforts to seek recourse have proved fruitless, he said.

A lingering question nags at him: What if he had been an ordinary patient without medical expertise? What do his experiences say about the health care system’s management of medical omissions and errors?

Dr. Horowitz, 78 years old and retired, continues to teach medical students as an adjunct clinical professor of neurology at the Tufts University School of Medicine in Boston. He is also on the teaching faculty of the Maine Medical Center. He was professor and chief of neurology at a major university in the Midwest for many years.

In 2018, he visited his daughter on the West Coast, enjoying a day of biking. The neck pain began 5 or 6 hours after the ride and spread to his arms. “There was also numbness and tingling,” he said.
 

“I told them I was a neurologist”

The next day the pain got worse. Dr. Horowitz went to the ED of a nearby medical center with his daughter and immediately disclosed that he was a neurologist. “I did this for several reasons,” he explained. He wanted to alert staff that he had a cervical spine problem because “I wanted them to do a cervical MRI scan, and I wanted to read it because I’m capable of doing that.” He also related a past history of infection and antibiotic use and asked for C-reactive protein and erythrocyte sedimentation rate tests in addition to regular blood work. “Those inflammatory markers, if abnormal, would indicate an infection,” said Dr. Horowitz.

No reflex hammer or Babinski test

During the reflex exam with a spine consultant, Dr. Horowitz noticed that the consultant wasn’t using a reflex hammer, the clinical equivalent of evaluating the heart or lungs without a stethoscope. “I asked where the reflex hammer was, and he said he didn’t need one or own one. He used the inside of his hand. Apparently, there was some mild weakness in some muscle groups, but he didn’t address that,” said Dr. Horowitz. The consultant also didn’t test for the Babinski sign until reminded of it.

He took out a stethoscope and struck the middle of the soles of Dr. Horowitz’s feet. “I thought to myself, this consultant is the consultant for the spine service? How is it possible that he has a stethoscope and not a reflex hammer and didn’t know how to test for the Babinski sign?” The consultant also didn’t examine for gait, coordination, or hand dexterity. “He took his finger and touched my feet and legs. That was his sensory exam. He didn’t use a pin or a tuning fork” or other methods including touch, temperature, position sense, and vibration to assess sensory abnormalities that might signal spinal cord dysfunction.

An MRI at the hospital revealed a mass at the back of the neck. No contrast material was used during the MRI even though this step would have signaled the presence of infection. “Gadolinium should have been injected during the MRI because that would have strongly suggested that this mass in my neck was not a little blood clot and more likely an infection. They would have realized something more complicated than degenerative arthritis was going on. They told me that I had advanced spondylosis and that the mass was a hematoma. They told me not to worry about the blood results. Then they discharged me.”
 

A life-threatening discovery

Dr. Horowitz didn’t see the results of the blood work-up until returning to Maine a few days later, when he checked the online report. There was a highly elevated CRP level – 30 times above the normal limit – and elevated erythrocyte sedimentation rate and white blood cell counts. “This showed that there was an infective process going on. And it wasn’t just a localized process, it was in my bloodstream,” he said.

Alarmed by the elevated markers, he immediately went to his local hospital. “Not only did I have arthritis, but my spinal cord was compressed.” Urgent surgery was performed, including a C2-7 fusion. The mass in the back of his neck turned out to be an abscess.

His training and experience as a physician/neurologist saved him from further damage, he said. “Because the compression of the spine was at the C2, C3, C4 level, not only would I have become quadriplegic, but my diaphragm would likely have been paralyzed and I would have needed a ventilator.”

Following a month’s care in the hospital and a rehabilitation center, he wrote to the CEO of the California hospital where he received his initial care.

“I wrote about the incompetent exam, the missed infection, a discharge without information. I wrote all that out to the CEO and sent the letter registered so that he would receive it.” The CEO forwarded the letter to a patient risk manager, who interviewed staff and supervisors in the ED, radiology, and the spine program. They responded 3 months later. According to Dr. Horowitz, the spine supervisor said, “The consultant performed the exam to the best of his ability.” No one admitted to any errors in care or the lack of recognition of the infection, although the neuroradiologist did apologize for not allowing Dr. Horowitz to read his own MRI in a timely manner.

“They had promised to wheel a portable computer into my alcove so I could view the MRI.” Several hours later, after persistent complaints, he was given 1 minute to look over at least 300 images at a desktop computer in the crowded ED. They gave him the MRI images on a disk, but he wasn’t able to read it on his iMac computer.

According to Dr. Horowitz, the ED should have called in an infectious disease consultant and a neurologist or neurosurgeon to do a more complete neurologic exam. “Instead of discharging me, they should have admitted me, telling me that I had spinal cord compression, an infection, and a mass in my neck—that they don’t know what this is about, and I shouldn’t go home.”

Eventually, after long-term intravenous antibiotics and extensive physical therapy, Dr. Horowitz recovered. “I definitely had PTSD afterwards. How could a non-eventful bike ride result in an unrecognized threatening illness? I thought a healing opportunity for me and an educational opportunity for the medical staff and students at this medical center would be for me to present my case to them at a conference at their facility the next time I visited my daughter in California. I thought an experienced clinician discussing his own illness in his own specialty would be unique.”

The hospital ignored his offer.

By happenstance, a year and a half later, Dr. Horowitz made contact with a hospital administrator after hearing her speak during a TED Radio Hour in his car. “We had several telephone conversations and email correspondences in October and November 2019 but none since,” he said. In one email, she wrote that “hospitals don’t seem to know what to do with the opportunity you present. I don’t think the challenge is unique to [this institution]. A forum for these kinds of discussions – constructive, insightful patient feedback – does not exist.”

Dr. Horowitz hasn’t considered a malpractice lawsuit. “The only result would be a monetary reward based on damages. Since permanent clinical damage did not occur, the suit would have been time consuming and the reward limited. I was able to recover because I was able to review the blood work and recognize my own problem and get excellent care at my own local health care facility. I was really hoping the doctors at the California hospital would learn from this episode.”

Dr. Horowitz also wrote the Medical Board of California a detailed letter, citing relevant medical literature, guidelines on spinal care, and his test results. Nearly 2 years later, he finally got a response. The board said there was no “clear and convincing evidence that negligence took place.” In Dr. Horowitz’s opinion, “the fact that CRP was 30 times past normal is ‘clear and convincing evidence.’ That the consultant didn’t have a reflex hammer is also ‘clear and convincing evidence.’ That the clinical neurologic exam was incompetent, by any measure, is ‘clear and convincing evidence.’ Even the Medical Board, tasked with patient protection, didn’t recognize negligent medical care. They might have if I had become quadriplegic.”
 

A new normal?

Dr. Horowitz, who wrote of his experience in The Washington Post, said it reflects a persistent, systemic problem in health care: the inability to address medical errors and correct them. In the article, he addressed a phenomenon called the “the normalization of deviance.” Diane Vaughn wrote about this phenomenon in a 1997 book about the Space Shuttle disaster. Multiple flaws were noted in previous shuttle launches but then rationalized and “normalized” when they didn’t cause a disaster – until they ultimately did.

“That’s relevant to my situation,” Dr. Horowitz said. “The spine supervisor at this hospital excused the consultant by saying, ‘he did the exam to the best of his ability.’ Further, the response to my complaints came from hospital representatives rather than physicians, meaning that the ‘normalization’ was institutional, and it was willing to accept his poor performance without sanctions.”

He imagines that he could not be the only case handled poorly by this hospital or that particular consultant. “He could have done the same thing to another patient who didn’t have my medical knowledge,” added Dr. Horowitz.

In her book, Ms. Vaughan noted that whistleblower activity is sometimes the only device that reveals normalization of deviance.

Dr. Horowitz sees himself as a whistleblower for these types of mistakes. “The question is, how do we deal with medical errors even in sophisticated patients who see these errors, and how do you manage this in the average patient? I don’t want to see this type of medical care rendered for any patient, hence my attempt to make this situation public.”
 

A teachable moment lost?

Commenting on this case, Alan Rapoport, MD, said, “[it]illustrates inadequate physician evaluation in the ED, poor communication from the examining doctor about abnormal lab and MRI findings, unwillingness to call in consultants to properly evaluate the situation, and no recognition of the need to admit the patient.”

Dr. Rapoport is the editor in chief of Neurology Reviews and a clinical professor of neurology at UCLA in Los Angeles. He is a past president of the International Headache Society.

He noted that the patient is in his late 70s and needed to fly across the country to arrive at home. “Months later, when this situation was explained to the hospital via the mail, they totally failed to recognize their inadequacies and apologize for their mistakes. They were probably concerned about being sued, but I believe that their actions increased their chances of a lawsuit,” Dr. Rapoport said.

“When a teaching remedy was offered by the patient to the hospital so the doctors involved could learn from the experience, the hospital was not interested. The only party that learned from this unfortunate episode was the patient, not the doctors, or the ER, or the hospital administration,” Dr. Rapoport said.

He continued, “It is scary to think that an excellent hospital would act in this manner and refuse to learn from their mistakes. The California medical board was notified and did not investigate. It is not too late for the hospital to apologize, communicate their shortcomings, and fix the problem at multiple levels in the hospital.”

Dr. Rapoport consulted Morris Levin, MD, a professor of neurology and director of the Headache Program at UCSF, to ask what he thought, theoretically, about how a hospital should respond when they make a mistake and how much they should divulge. Dr. Levin is involved in Medical Ethics and often lectures about it at conferences.

Dr. Levin said, “When medical errors are made, to me, it is ethically sound to identify them and ‘fess up.’ There has always been reluctance to do so because of fears of lawsuits, but it turns out that when institutions do disclose errors, their liability costs actually go down.” Dr. Levin cited the University of Michigan, which tried a full disclosure policy as an experiment. “It led to reduced costs, not to mention a boost in patient satisfaction,” Dr. Levin noted.

He continued, “I think patients want and deserve to know the truth. I also believe they understand that medical errors can and will happen. It is my observation that patients have several key concerns: 1) how the error(s) happened, 2) how the error affected their health and what can be done to restore them to optimal health, and 3) what the institution is going to do to prevent this kind of error from happening to others.”

Dr. Rapoport concurs with Dr. Levin. “I am glad Dr. Horowitz has fully recovered and at least he has learned from the experience. I do not think the hospital and doctors did,” Dr. Rapoport said.

This article was updated 11/12/20.

When Steven Horowitz, MD, began experiencing neck and arm pain, numbness, and tingling following a bike ride several years ago, he immediately sought care at an elite medical center in California. As he recalls, an incompetent clinical exam and no access to highly abnormal test results done in the ED almost cost him his health. Had he listened to the doctors at that facility, he believes he would have become quadriplegic.

His training as a neurologist likely saved his life: “I was able to recover because, after arriving home, I reviewed my blood work and MRI online and recognized multiple problems.” He was able to get excellent care at his own local health care facility in Maine. The staff and leadership at the hospital in California wouldn’t admit wrongdoing, and efforts to seek recourse have proved fruitless, he said.

A lingering question nags at him: What if he had been an ordinary patient without medical expertise? What do his experiences say about the health care system’s management of medical omissions and errors?

Dr. Horowitz, 78 years old and retired, continues to teach medical students as an adjunct clinical professor of neurology at the Tufts University School of Medicine in Boston. He is also on the teaching faculty of the Maine Medical Center. He was professor and chief of neurology at a major university in the Midwest for many years.

In 2018, he visited his daughter on the West Coast, enjoying a day of biking. The neck pain began 5 or 6 hours after the ride and spread to his arms. “There was also numbness and tingling,” he said.
 

“I told them I was a neurologist”

The next day the pain got worse. Dr. Horowitz went to the ED of a nearby medical center with his daughter and immediately disclosed that he was a neurologist. “I did this for several reasons,” he explained. He wanted to alert staff that he had a cervical spine problem because “I wanted them to do a cervical MRI scan, and I wanted to read it because I’m capable of doing that.” He also related a past history of infection and antibiotic use and asked for C-reactive protein and erythrocyte sedimentation rate tests in addition to regular blood work. “Those inflammatory markers, if abnormal, would indicate an infection,” said Dr. Horowitz.

No reflex hammer or Babinski test

During the reflex exam with a spine consultant, Dr. Horowitz noticed that the consultant wasn’t using a reflex hammer, the clinical equivalent of evaluating the heart or lungs without a stethoscope. “I asked where the reflex hammer was, and he said he didn’t need one or own one. He used the inside of his hand. Apparently, there was some mild weakness in some muscle groups, but he didn’t address that,” said Dr. Horowitz. The consultant also didn’t test for the Babinski sign until reminded of it.

He took out a stethoscope and struck the middle of the soles of Dr. Horowitz’s feet. “I thought to myself, this consultant is the consultant for the spine service? How is it possible that he has a stethoscope and not a reflex hammer and didn’t know how to test for the Babinski sign?” The consultant also didn’t examine for gait, coordination, or hand dexterity. “He took his finger and touched my feet and legs. That was his sensory exam. He didn’t use a pin or a tuning fork” or other methods including touch, temperature, position sense, and vibration to assess sensory abnormalities that might signal spinal cord dysfunction.

An MRI at the hospital revealed a mass at the back of the neck. No contrast material was used during the MRI even though this step would have signaled the presence of infection. “Gadolinium should have been injected during the MRI because that would have strongly suggested that this mass in my neck was not a little blood clot and more likely an infection. They would have realized something more complicated than degenerative arthritis was going on. They told me that I had advanced spondylosis and that the mass was a hematoma. They told me not to worry about the blood results. Then they discharged me.”
 

A life-threatening discovery

Dr. Horowitz didn’t see the results of the blood work-up until returning to Maine a few days later, when he checked the online report. There was a highly elevated CRP level – 30 times above the normal limit – and elevated erythrocyte sedimentation rate and white blood cell counts. “This showed that there was an infective process going on. And it wasn’t just a localized process, it was in my bloodstream,” he said.

Alarmed by the elevated markers, he immediately went to his local hospital. “Not only did I have arthritis, but my spinal cord was compressed.” Urgent surgery was performed, including a C2-7 fusion. The mass in the back of his neck turned out to be an abscess.

His training and experience as a physician/neurologist saved him from further damage, he said. “Because the compression of the spine was at the C2, C3, C4 level, not only would I have become quadriplegic, but my diaphragm would likely have been paralyzed and I would have needed a ventilator.”

Following a month’s care in the hospital and a rehabilitation center, he wrote to the CEO of the California hospital where he received his initial care.

“I wrote about the incompetent exam, the missed infection, a discharge without information. I wrote all that out to the CEO and sent the letter registered so that he would receive it.” The CEO forwarded the letter to a patient risk manager, who interviewed staff and supervisors in the ED, radiology, and the spine program. They responded 3 months later. According to Dr. Horowitz, the spine supervisor said, “The consultant performed the exam to the best of his ability.” No one admitted to any errors in care or the lack of recognition of the infection, although the neuroradiologist did apologize for not allowing Dr. Horowitz to read his own MRI in a timely manner.

“They had promised to wheel a portable computer into my alcove so I could view the MRI.” Several hours later, after persistent complaints, he was given 1 minute to look over at least 300 images at a desktop computer in the crowded ED. They gave him the MRI images on a disk, but he wasn’t able to read it on his iMac computer.

According to Dr. Horowitz, the ED should have called in an infectious disease consultant and a neurologist or neurosurgeon to do a more complete neurologic exam. “Instead of discharging me, they should have admitted me, telling me that I had spinal cord compression, an infection, and a mass in my neck—that they don’t know what this is about, and I shouldn’t go home.”

Eventually, after long-term intravenous antibiotics and extensive physical therapy, Dr. Horowitz recovered. “I definitely had PTSD afterwards. How could a non-eventful bike ride result in an unrecognized threatening illness? I thought a healing opportunity for me and an educational opportunity for the medical staff and students at this medical center would be for me to present my case to them at a conference at their facility the next time I visited my daughter in California. I thought an experienced clinician discussing his own illness in his own specialty would be unique.”

The hospital ignored his offer.

By happenstance, a year and a half later, Dr. Horowitz made contact with a hospital administrator after hearing her speak during a TED Radio Hour in his car. “We had several telephone conversations and email correspondences in October and November 2019 but none since,” he said. In one email, she wrote that “hospitals don’t seem to know what to do with the opportunity you present. I don’t think the challenge is unique to [this institution]. A forum for these kinds of discussions – constructive, insightful patient feedback – does not exist.”

Dr. Horowitz hasn’t considered a malpractice lawsuit. “The only result would be a monetary reward based on damages. Since permanent clinical damage did not occur, the suit would have been time consuming and the reward limited. I was able to recover because I was able to review the blood work and recognize my own problem and get excellent care at my own local health care facility. I was really hoping the doctors at the California hospital would learn from this episode.”

Dr. Horowitz also wrote the Medical Board of California a detailed letter, citing relevant medical literature, guidelines on spinal care, and his test results. Nearly 2 years later, he finally got a response. The board said there was no “clear and convincing evidence that negligence took place.” In Dr. Horowitz’s opinion, “the fact that CRP was 30 times past normal is ‘clear and convincing evidence.’ That the consultant didn’t have a reflex hammer is also ‘clear and convincing evidence.’ That the clinical neurologic exam was incompetent, by any measure, is ‘clear and convincing evidence.’ Even the Medical Board, tasked with patient protection, didn’t recognize negligent medical care. They might have if I had become quadriplegic.”
 

A new normal?

Dr. Horowitz, who wrote of his experience in The Washington Post, said it reflects a persistent, systemic problem in health care: the inability to address medical errors and correct them. In the article, he addressed a phenomenon called the “the normalization of deviance.” Diane Vaughn wrote about this phenomenon in a 1997 book about the Space Shuttle disaster. Multiple flaws were noted in previous shuttle launches but then rationalized and “normalized” when they didn’t cause a disaster – until they ultimately did.

“That’s relevant to my situation,” Dr. Horowitz said. “The spine supervisor at this hospital excused the consultant by saying, ‘he did the exam to the best of his ability.’ Further, the response to my complaints came from hospital representatives rather than physicians, meaning that the ‘normalization’ was institutional, and it was willing to accept his poor performance without sanctions.”

He imagines that he could not be the only case handled poorly by this hospital or that particular consultant. “He could have done the same thing to another patient who didn’t have my medical knowledge,” added Dr. Horowitz.

In her book, Ms. Vaughan noted that whistleblower activity is sometimes the only device that reveals normalization of deviance.

Dr. Horowitz sees himself as a whistleblower for these types of mistakes. “The question is, how do we deal with medical errors even in sophisticated patients who see these errors, and how do you manage this in the average patient? I don’t want to see this type of medical care rendered for any patient, hence my attempt to make this situation public.”
 

A teachable moment lost?

Commenting on this case, Alan Rapoport, MD, said, “[it]illustrates inadequate physician evaluation in the ED, poor communication from the examining doctor about abnormal lab and MRI findings, unwillingness to call in consultants to properly evaluate the situation, and no recognition of the need to admit the patient.”

Dr. Rapoport is the editor in chief of Neurology Reviews and a clinical professor of neurology at UCLA in Los Angeles. He is a past president of the International Headache Society.

He noted that the patient is in his late 70s and needed to fly across the country to arrive at home. “Months later, when this situation was explained to the hospital via the mail, they totally failed to recognize their inadequacies and apologize for their mistakes. They were probably concerned about being sued, but I believe that their actions increased their chances of a lawsuit,” Dr. Rapoport said.

“When a teaching remedy was offered by the patient to the hospital so the doctors involved could learn from the experience, the hospital was not interested. The only party that learned from this unfortunate episode was the patient, not the doctors, or the ER, or the hospital administration,” Dr. Rapoport said.

He continued, “It is scary to think that an excellent hospital would act in this manner and refuse to learn from their mistakes. The California medical board was notified and did not investigate. It is not too late for the hospital to apologize, communicate their shortcomings, and fix the problem at multiple levels in the hospital.”

Dr. Rapoport consulted Morris Levin, MD, a professor of neurology and director of the Headache Program at UCSF, to ask what he thought, theoretically, about how a hospital should respond when they make a mistake and how much they should divulge. Dr. Levin is involved in Medical Ethics and often lectures about it at conferences.

Dr. Levin said, “When medical errors are made, to me, it is ethically sound to identify them and ‘fess up.’ There has always been reluctance to do so because of fears of lawsuits, but it turns out that when institutions do disclose errors, their liability costs actually go down.” Dr. Levin cited the University of Michigan, which tried a full disclosure policy as an experiment. “It led to reduced costs, not to mention a boost in patient satisfaction,” Dr. Levin noted.

He continued, “I think patients want and deserve to know the truth. I also believe they understand that medical errors can and will happen. It is my observation that patients have several key concerns: 1) how the error(s) happened, 2) how the error affected their health and what can be done to restore them to optimal health, and 3) what the institution is going to do to prevent this kind of error from happening to others.”

Dr. Rapoport concurs with Dr. Levin. “I am glad Dr. Horowitz has fully recovered and at least he has learned from the experience. I do not think the hospital and doctors did,” Dr. Rapoport said.

This article was updated 11/12/20.

Patients with Sjögren’s syndrome can be categorized into four distinct symptom clusters – independent of age, sex, and some disease manifestations – that may both improve symptom relief and aid in the development of targeted therapies, investigators reported.

Analysis of data from a survey conducted by the Sjögren’s Foundation identified four symptom clusters based on the grouping of five common characteristics: anxiety, depression, pain, fatigue, and dryness, Sara S. McCoy, MD, of the University of Wisconsin–Madison, and colleagues reported.

“Verification of features unique to each Sjögren’s cluster might provide guidance for future cluster-targeted therapy,” Dr. McCoy said in an oral abstract presentation during the virtual annual meeting of the American College of Rheumatology.

The dearth of Food and Drug Administration–approved disease-modifying therapies for Sjögren’s syndrome can be attributed in part to the small number of patients with extraglandular disease manifestations, the heterogeneity of disease, and the failure of available therapy to improve common symptoms such as fatigue, dryness, quality-of-life decrements, anxiety and depression, she said.
 

Symptom clusters verify smaller study’s findings

Dr. McCoy and colleagues explored whether symptom clusters identified in a 2019 study from the United Kingdom would apply to a larger U.S. population.

In the U.K. study, Jessica R. Tarn, PhD, and colleagues performed a hierarchical cluster analysis to identify subgroups among 608 patients in the U.K. Primary Sjögren’s Syndrome Registry and in 396 patients in two independent validation cohorts from Norway and France.

They identified four subgroups they categorized as low symptom burden, high symptom burden, dryness dominant with fatigue, and pain dominant with fatigue, and reported that the groups showed significant difference in serum and transcriptomic markers.

In the U.S. study, McCoy et al. sought to verify the symptom-based cluster and report on differences in key measures between the groups. They used data from a survey by the Sjögren’s Foundation of 2,961 adults with self-reported Sjögren’s syndrome. The investigators then used an unsupervised hierarchical clustering method to identify the optimal phenotypically similar clusters based on patient-reported severity of anxiety (from never to daily), depression (never to daily), pain on a visual analog scale (0 to 10), fatigue on a VAS, and dryness on a VAS. They collected data on demographics, medications, quality of life, and Sjögren’s-specific symptom frequency and systemic manifestations within each cluster, and identified cluster differences controlled for age, sex, race, and Social Security disability.

They identified four symptom-based clusters from 2,806 participants for whom complete data on the five key symptoms were available:

• Cluster 1 patients (prevalence, 30%) had high symptom burden in all categories.
• Cluster 2 patients (22%) had high anxiety and depression (22%), with some fatigue.
• Cluster 3 patients (34%) had predominant high dryness and fatigue.
• Cluster 4 patients (14%) had low symptom burden.

“We found that clusters differed in Sjögren’s-specific symptoms,” Dr. McCoy said.

For example, patients in the high-symptom-burden cluster had, as the name implies, an overall higher burden of symptoms among all major ocular, oral, and other dryness symptoms, as well as systemic organ system symptoms, whereas patients in the low-symptom-burden group consistently had the lowest levels of symptoms across the spectrum.

“We also noticed significant differences in systemic medication use. High symptom burden and high dryness and fatigue had higher use of systemic therapies targeting dryness, as might be expected,” she said.

The highest corticosteroid use was in the high-symptom-burden group, while hydroxychloroquine use was highest in the high-anxiety/depression group. Antidepressant use was also high in these two groups.

In addition, 35% of patients in the high-symptom-burden group used prescription opioid analgesics, compared with just 7% in the low-symptom-burden group.

The categories from low to high symptom burden also significantly correlated with quality-of-life measures, including Social Security Disability enrollment, emotional burden of disease, effects of disease on independence, and effects of Sjögren’s on relationships with family and friends (P < .001 for all).

Systemic manifestations of disease differed significantly among the groups for inflammatory arthritis, interstitial lung disease, and neuropathy, but there were no significant differences in the incidence of leukopenia or lymphoma.

The investigators plan to perform symptom-based cluster analysis with validated Sjögren’s syndrome populations, and propose studies to define phenotypic features of distinct clusters “to better define subsets of this heterogeneous disease, and ultimately inform targeted therapy,” Dr. McCoy concluded.
 

Opportunity to tailor practice and research

During the question-and-answer period following the presentation, Gabriela Hernandez-Molina, MD, of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City, commented that “fatigue and pain might be also attributed to other comorbidities in these patients such as fibromyalgia,” and asked Dr. McCoy to comment on that.

“That’s exactly what we’re driving at,” Dr. McCoy replied. “Fatigue and pain frequently affect how patients experience their disease, and it would be beneficial to take this into account when we evaluate patients, and also for the studies that we’re performing, as well as future ‘-omic’ studies – transcriptomics and what-not – there’s potential here to take that type of patient we frequently see and try to tailor our clinical practice and our research to clearly what we’re seeing in practice, which is these other comorbidities.”

Dana DiRenzo, MD, from Johns Hopkins University, Baltimore, who moderated the session, asked how the information is changing the management of patients with Sjögren’s syndrome in clinic.

Dr. McCoy said that the study was based on self-reported data that can introduce bias, and that she and colleagues plan to validate the results before applying them to clinical care.

The study was supported by grants from the National Institutes of Health and the University of Wisconsin. Dr. McCoy disclosed consulting fees from Novartis and Bristol-Myers Squibb. Dr. Hernandez-Molina and Dr. DiRenzo reported no relevant disclosures.

SOURCE: McCoy SS et al. Arthritis Rheumatol. 2020;72(suppl 10), Abstract 1504.

Patients with Sjögren’s syndrome can be categorized into four distinct symptom clusters – independent of age, sex, and some disease manifestations – that may both improve symptom relief and aid in the development of targeted therapies, investigators reported.

Analysis of data from a survey conducted by the Sjögren’s Foundation identified four symptom clusters based on the grouping of five common characteristics: anxiety, depression, pain, fatigue, and dryness, Sara S. McCoy, MD, of the University of Wisconsin–Madison, and colleagues reported.

“Verification of features unique to each Sjögren’s cluster might provide guidance for future cluster-targeted therapy,” Dr. McCoy said in an oral abstract presentation during the virtual annual meeting of the American College of Rheumatology.

The dearth of Food and Drug Administration–approved disease-modifying therapies for Sjögren’s syndrome can be attributed in part to the small number of patients with extraglandular disease manifestations, the heterogeneity of disease, and the failure of available therapy to improve common symptoms such as fatigue, dryness, quality-of-life decrements, anxiety and depression, she said.
 

Symptom clusters verify smaller study’s findings

Dr. McCoy and colleagues explored whether symptom clusters identified in a 2019 study from the United Kingdom would apply to a larger U.S. population.

In the U.K. study, Jessica R. Tarn, PhD, and colleagues performed a hierarchical cluster analysis to identify subgroups among 608 patients in the U.K. Primary Sjögren’s Syndrome Registry and in 396 patients in two independent validation cohorts from Norway and France.

They identified four subgroups they categorized as low symptom burden, high symptom burden, dryness dominant with fatigue, and pain dominant with fatigue, and reported that the groups showed significant difference in serum and transcriptomic markers.

In the U.S. study, McCoy et al. sought to verify the symptom-based cluster and report on differences in key measures between the groups. They used data from a survey by the Sjögren’s Foundation of 2,961 adults with self-reported Sjögren’s syndrome. The investigators then used an unsupervised hierarchical clustering method to identify the optimal phenotypically similar clusters based on patient-reported severity of anxiety (from never to daily), depression (never to daily), pain on a visual analog scale (0 to 10), fatigue on a VAS, and dryness on a VAS. They collected data on demographics, medications, quality of life, and Sjögren’s-specific symptom frequency and systemic manifestations within each cluster, and identified cluster differences controlled for age, sex, race, and Social Security disability.

They identified four symptom-based clusters from 2,806 participants for whom complete data on the five key symptoms were available:

• Cluster 1 patients (prevalence, 30%) had high symptom burden in all categories.
• Cluster 2 patients (22%) had high anxiety and depression (22%), with some fatigue.
• Cluster 3 patients (34%) had predominant high dryness and fatigue.
• Cluster 4 patients (14%) had low symptom burden.

“We found that clusters differed in Sjögren’s-specific symptoms,” Dr. McCoy said.

For example, patients in the high-symptom-burden cluster had, as the name implies, an overall higher burden of symptoms among all major ocular, oral, and other dryness symptoms, as well as systemic organ system symptoms, whereas patients in the low-symptom-burden group consistently had the lowest levels of symptoms across the spectrum.

“We also noticed significant differences in systemic medication use. High symptom burden and high dryness and fatigue had higher use of systemic therapies targeting dryness, as might be expected,” she said.

The highest corticosteroid use was in the high-symptom-burden group, while hydroxychloroquine use was highest in the high-anxiety/depression group. Antidepressant use was also high in these two groups.

In addition, 35% of patients in the high-symptom-burden group used prescription opioid analgesics, compared with just 7% in the low-symptom-burden group.

The categories from low to high symptom burden also significantly correlated with quality-of-life measures, including Social Security Disability enrollment, emotional burden of disease, effects of disease on independence, and effects of Sjögren’s on relationships with family and friends (P < .001 for all).

Systemic manifestations of disease differed significantly among the groups for inflammatory arthritis, interstitial lung disease, and neuropathy, but there were no significant differences in the incidence of leukopenia or lymphoma.

The investigators plan to perform symptom-based cluster analysis with validated Sjögren’s syndrome populations, and propose studies to define phenotypic features of distinct clusters “to better define subsets of this heterogeneous disease, and ultimately inform targeted therapy,” Dr. McCoy concluded.
 

Opportunity to tailor practice and research

During the question-and-answer period following the presentation, Gabriela Hernandez-Molina, MD, of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City, commented that “fatigue and pain might be also attributed to other comorbidities in these patients such as fibromyalgia,” and asked Dr. McCoy to comment on that.

“That’s exactly what we’re driving at,” Dr. McCoy replied. “Fatigue and pain frequently affect how patients experience their disease, and it would be beneficial to take this into account when we evaluate patients, and also for the studies that we’re performing, as well as future ‘-omic’ studies – transcriptomics and what-not – there’s potential here to take that type of patient we frequently see and try to tailor our clinical practice and our research to clearly what we’re seeing in practice, which is these other comorbidities.”

Dana DiRenzo, MD, from Johns Hopkins University, Baltimore, who moderated the session, asked how the information is changing the management of patients with Sjögren’s syndrome in clinic.

Dr. McCoy said that the study was based on self-reported data that can introduce bias, and that she and colleagues plan to validate the results before applying them to clinical care.

The study was supported by grants from the National Institutes of Health and the University of Wisconsin. Dr. McCoy disclosed consulting fees from Novartis and Bristol-Myers Squibb. Dr. Hernandez-Molina and Dr. DiRenzo reported no relevant disclosures.

SOURCE: McCoy SS et al. Arthritis Rheumatol. 2020;72(suppl 10), Abstract 1504.

Patients with Sjögren’s syndrome can be categorized into four distinct symptom clusters – independent of age, sex, and some disease manifestations – that may both improve symptom relief and aid in the development of targeted therapies, investigators reported.

Analysis of data from a survey conducted by the Sjögren’s Foundation identified four symptom clusters based on the grouping of five common characteristics: anxiety, depression, pain, fatigue, and dryness, Sara S. McCoy, MD, of the University of Wisconsin–Madison, and colleagues reported.

“Verification of features unique to each Sjögren’s cluster might provide guidance for future cluster-targeted therapy,” Dr. McCoy said in an oral abstract presentation during the virtual annual meeting of the American College of Rheumatology.

The dearth of Food and Drug Administration–approved disease-modifying therapies for Sjögren’s syndrome can be attributed in part to the small number of patients with extraglandular disease manifestations, the heterogeneity of disease, and the failure of available therapy to improve common symptoms such as fatigue, dryness, quality-of-life decrements, anxiety and depression, she said.
 

Symptom clusters verify smaller study’s findings

Dr. McCoy and colleagues explored whether symptom clusters identified in a 2019 study from the United Kingdom would apply to a larger U.S. population.

In the U.K. study, Jessica R. Tarn, PhD, and colleagues performed a hierarchical cluster analysis to identify subgroups among 608 patients in the U.K. Primary Sjögren’s Syndrome Registry and in 396 patients in two independent validation cohorts from Norway and France.

They identified four subgroups they categorized as low symptom burden, high symptom burden, dryness dominant with fatigue, and pain dominant with fatigue, and reported that the groups showed significant difference in serum and transcriptomic markers.

In the U.S. study, McCoy et al. sought to verify the symptom-based cluster and report on differences in key measures between the groups. They used data from a survey by the Sjögren’s Foundation of 2,961 adults with self-reported Sjögren’s syndrome. The investigators then used an unsupervised hierarchical clustering method to identify the optimal phenotypically similar clusters based on patient-reported severity of anxiety (from never to daily), depression (never to daily), pain on a visual analog scale (0 to 10), fatigue on a VAS, and dryness on a VAS. They collected data on demographics, medications, quality of life, and Sjögren’s-specific symptom frequency and systemic manifestations within each cluster, and identified cluster differences controlled for age, sex, race, and Social Security disability.

They identified four symptom-based clusters from 2,806 participants for whom complete data on the five key symptoms were available:

• Cluster 1 patients (prevalence, 30%) had high symptom burden in all categories.
• Cluster 2 patients (22%) had high anxiety and depression (22%), with some fatigue.
• Cluster 3 patients (34%) had predominant high dryness and fatigue.
• Cluster 4 patients (14%) had low symptom burden.

“We found that clusters differed in Sjögren’s-specific symptoms,” Dr. McCoy said.

For example, patients in the high-symptom-burden cluster had, as the name implies, an overall higher burden of symptoms among all major ocular, oral, and other dryness symptoms, as well as systemic organ system symptoms, whereas patients in the low-symptom-burden group consistently had the lowest levels of symptoms across the spectrum.

“We also noticed significant differences in systemic medication use. High symptom burden and high dryness and fatigue had higher use of systemic therapies targeting dryness, as might be expected,” she said.

The highest corticosteroid use was in the high-symptom-burden group, while hydroxychloroquine use was highest in the high-anxiety/depression group. Antidepressant use was also high in these two groups.

In addition, 35% of patients in the high-symptom-burden group used prescription opioid analgesics, compared with just 7% in the low-symptom-burden group.

The categories from low to high symptom burden also significantly correlated with quality-of-life measures, including Social Security Disability enrollment, emotional burden of disease, effects of disease on independence, and effects of Sjögren’s on relationships with family and friends (P < .001 for all).

Systemic manifestations of disease differed significantly among the groups for inflammatory arthritis, interstitial lung disease, and neuropathy, but there were no significant differences in the incidence of leukopenia or lymphoma.

The investigators plan to perform symptom-based cluster analysis with validated Sjögren’s syndrome populations, and propose studies to define phenotypic features of distinct clusters “to better define subsets of this heterogeneous disease, and ultimately inform targeted therapy,” Dr. McCoy concluded.
 

Opportunity to tailor practice and research

During the question-and-answer period following the presentation, Gabriela Hernandez-Molina, MD, of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City, commented that “fatigue and pain might be also attributed to other comorbidities in these patients such as fibromyalgia,” and asked Dr. McCoy to comment on that.

“That’s exactly what we’re driving at,” Dr. McCoy replied. “Fatigue and pain frequently affect how patients experience their disease, and it would be beneficial to take this into account when we evaluate patients, and also for the studies that we’re performing, as well as future ‘-omic’ studies – transcriptomics and what-not – there’s potential here to take that type of patient we frequently see and try to tailor our clinical practice and our research to clearly what we’re seeing in practice, which is these other comorbidities.”

Dana DiRenzo, MD, from Johns Hopkins University, Baltimore, who moderated the session, asked how the information is changing the management of patients with Sjögren’s syndrome in clinic.

Dr. McCoy said that the study was based on self-reported data that can introduce bias, and that she and colleagues plan to validate the results before applying them to clinical care.

The study was supported by grants from the National Institutes of Health and the University of Wisconsin. Dr. McCoy disclosed consulting fees from Novartis and Bristol-Myers Squibb. Dr. Hernandez-Molina and Dr. DiRenzo reported no relevant disclosures.

SOURCE: McCoy SS et al. Arthritis Rheumatol. 2020;72(suppl 10), Abstract 1504.

Inflammatory bowel disease (IBD) is rapidly increasing among racial and ethnic minorities, which makes it important to consider for patients with compatible symptoms, experts wrote in Gastroenterology.

Crohn’s disease and ulcerative colitis are “chronic diseases with intermittent periods of flare and remission, so access to specialists, appropriate therapies, and frequent follow-up visits are vital to good outcomes,” wrote Edward L. Barnes, MD, MPH, of University of North Carolina at Chapel Hill, with his associates. However, Blacks with IBD tend to be diagnosed later than Whites, are less likely to receive recommended biologics and immunomodulators, and are more likely to receive care at an emergency department, to experience delays in colectomy, and to miss regular visits to IBD specialists because of financial and transportation barriers, they added.

These disparities are known to worsen outcomes. Compared with Whites, for example, Black patients with Crohn’s disease have higher rates of stricture and penetrating lesions and are at greater risk for postsurgical complications and death, even after potential confounders such age, sex, smoking status, time to operation, and obesity are controlled for. To help close these gaps, Dr. Barnes and his associates recommended enhanced recovery after surgery (ERAS) protocols, which “streamline [the] multidisciplinary management of patients with IBD before surgery, incorporating evidence-based practices focused on nutrition, prevention of postoperative ileus, and use of nonopioid analgesia and goal-directed fluid therapy.”

Similar approaches also might improve nonsurgical outcomes in minorities with IBD, the experts said. In the Sinai-Helmsley Alliance for Research Excellence (SHARE) study, Black patients had more complicated IBD at baseline but similar clinical outcomes and patterns of medication use as Whites when they were treated at academic IBD centers. In other studies, race and ethnicity did not affect patterns of medication use, surgery, or surgical outcomes if patients had similar access to care. Such findings “indicate that when patients of minority races and ethnicities have access to appropriate specialty care and IBD-related therapy, many previously identified disparities are resolved or reduced,” the experts said.

However, race and ethnicity do affect some aspects of IBD disease activity, genetics, and treatment safety and efficacy. Since White patients have made up the vast majority of research participants, studies of racial and ethnic minorities are needed to improve their IBD diagnosis, prevention, and treatment. Such research is particularly vital because IBD incidence is rising three times faster rates in racial and ethnic minorities than Whites, said Aline Charabaty, MD, AGAF, clinical director of the gastroenterology division at Johns Hopkins University in Baltimore, and director of the IBD Center at Sibley Memorial Hospital in Washington.

She explained that, when immigrants from countries where IBD is rare adopt the United States’ sedentary lifestyle and Western diet (low in fruits and vegetables; high in proinflammatory saturated fats, sugars, and processed foods), their gut microbiome shifts and their IBD risk increases markedly. Studies in other countries have produced similar findings, said Dr. Charabaty, who did not help author the review article.

She also noted that patients from communities with a historically low prevalence of IBD may not understand its chronicity or the need for long-term treatment. However, treatment adherence is a common issue for patients of all backgrounds with IBD, she said. “What is unique is barriers to continuity of care – not being able to get to the treatment center, not being able to afford treatment or take time off work if you live paycheck to paycheck, not being able to pay someone to care for your kids while you see the doctor.”

Other potential barriers to seeking IBD treatment include cultural taboos against discussing lower GI symptoms or concerns that chronic disease will harm marriage prospects, Dr. Charabaty said. Such challenges only heighten the need to ascertain IBD symptoms: “Studies show that minorities have less follow-up care and their symptoms tend to be minimized. There is a lot of unconscious bias among providers that factors into this. The barriers are multiple, and it is important to define them and find strategies to overcome them at the level of the patient, the clinician, and the health system.”

The Crohn’s and Colitis Foundation supported the work. Dr. Barnes disclosed ties to AbbVie, Gilead, Takeda, and Target Pharmasolutions. Two coauthors also disclosed relevant ties to pharmaceutical companies. Dr. Charabaty disclosed relationships with AbbVie, Takeda, Pfizer, Janssen, and UCB.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

SOURCE: Barnes EL et al. Gastroenterology. 2020 Oct 20. doi: 10.1053/j.gastro.2020.08.064.
 

Inflammatory bowel disease (IBD) is rapidly increasing among racial and ethnic minorities, which makes it important to consider for patients with compatible symptoms, experts wrote in Gastroenterology.

Crohn’s disease and ulcerative colitis are “chronic diseases with intermittent periods of flare and remission, so access to specialists, appropriate therapies, and frequent follow-up visits are vital to good outcomes,” wrote Edward L. Barnes, MD, MPH, of University of North Carolina at Chapel Hill, with his associates. However, Blacks with IBD tend to be diagnosed later than Whites, are less likely to receive recommended biologics and immunomodulators, and are more likely to receive care at an emergency department, to experience delays in colectomy, and to miss regular visits to IBD specialists because of financial and transportation barriers, they added.

These disparities are known to worsen outcomes. Compared with Whites, for example, Black patients with Crohn’s disease have higher rates of stricture and penetrating lesions and are at greater risk for postsurgical complications and death, even after potential confounders such age, sex, smoking status, time to operation, and obesity are controlled for. To help close these gaps, Dr. Barnes and his associates recommended enhanced recovery after surgery (ERAS) protocols, which “streamline [the] multidisciplinary management of patients with IBD before surgery, incorporating evidence-based practices focused on nutrition, prevention of postoperative ileus, and use of nonopioid analgesia and goal-directed fluid therapy.”

Similar approaches also might improve nonsurgical outcomes in minorities with IBD, the experts said. In the Sinai-Helmsley Alliance for Research Excellence (SHARE) study, Black patients had more complicated IBD at baseline but similar clinical outcomes and patterns of medication use as Whites when they were treated at academic IBD centers. In other studies, race and ethnicity did not affect patterns of medication use, surgery, or surgical outcomes if patients had similar access to care. Such findings “indicate that when patients of minority races and ethnicities have access to appropriate specialty care and IBD-related therapy, many previously identified disparities are resolved or reduced,” the experts said.

However, race and ethnicity do affect some aspects of IBD disease activity, genetics, and treatment safety and efficacy. Since White patients have made up the vast majority of research participants, studies of racial and ethnic minorities are needed to improve their IBD diagnosis, prevention, and treatment. Such research is particularly vital because IBD incidence is rising three times faster rates in racial and ethnic minorities than Whites, said Aline Charabaty, MD, AGAF, clinical director of the gastroenterology division at Johns Hopkins University in Baltimore, and director of the IBD Center at Sibley Memorial Hospital in Washington.

She explained that, when immigrants from countries where IBD is rare adopt the United States’ sedentary lifestyle and Western diet (low in fruits and vegetables; high in proinflammatory saturated fats, sugars, and processed foods), their gut microbiome shifts and their IBD risk increases markedly. Studies in other countries have produced similar findings, said Dr. Charabaty, who did not help author the review article.

She also noted that patients from communities with a historically low prevalence of IBD may not understand its chronicity or the need for long-term treatment. However, treatment adherence is a common issue for patients of all backgrounds with IBD, she said. “What is unique is barriers to continuity of care – not being able to get to the treatment center, not being able to afford treatment or take time off work if you live paycheck to paycheck, not being able to pay someone to care for your kids while you see the doctor.”

Other potential barriers to seeking IBD treatment include cultural taboos against discussing lower GI symptoms or concerns that chronic disease will harm marriage prospects, Dr. Charabaty said. Such challenges only heighten the need to ascertain IBD symptoms: “Studies show that minorities have less follow-up care and their symptoms tend to be minimized. There is a lot of unconscious bias among providers that factors into this. The barriers are multiple, and it is important to define them and find strategies to overcome them at the level of the patient, the clinician, and the health system.”

The Crohn’s and Colitis Foundation supported the work. Dr. Barnes disclosed ties to AbbVie, Gilead, Takeda, and Target Pharmasolutions. Two coauthors also disclosed relevant ties to pharmaceutical companies. Dr. Charabaty disclosed relationships with AbbVie, Takeda, Pfizer, Janssen, and UCB.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

SOURCE: Barnes EL et al. Gastroenterology. 2020 Oct 20. doi: 10.1053/j.gastro.2020.08.064.
 

Inflammatory bowel disease (IBD) is rapidly increasing among racial and ethnic minorities, which makes it important to consider for patients with compatible symptoms, experts wrote in Gastroenterology.

Crohn’s disease and ulcerative colitis are “chronic diseases with intermittent periods of flare and remission, so access to specialists, appropriate therapies, and frequent follow-up visits are vital to good outcomes,” wrote Edward L. Barnes, MD, MPH, of University of North Carolina at Chapel Hill, with his associates. However, Blacks with IBD tend to be diagnosed later than Whites, are less likely to receive recommended biologics and immunomodulators, and are more likely to receive care at an emergency department, to experience delays in colectomy, and to miss regular visits to IBD specialists because of financial and transportation barriers, they added.

These disparities are known to worsen outcomes. Compared with Whites, for example, Black patients with Crohn’s disease have higher rates of stricture and penetrating lesions and are at greater risk for postsurgical complications and death, even after potential confounders such age, sex, smoking status, time to operation, and obesity are controlled for. To help close these gaps, Dr. Barnes and his associates recommended enhanced recovery after surgery (ERAS) protocols, which “streamline [the] multidisciplinary management of patients with IBD before surgery, incorporating evidence-based practices focused on nutrition, prevention of postoperative ileus, and use of nonopioid analgesia and goal-directed fluid therapy.”

Similar approaches also might improve nonsurgical outcomes in minorities with IBD, the experts said. In the Sinai-Helmsley Alliance for Research Excellence (SHARE) study, Black patients had more complicated IBD at baseline but similar clinical outcomes and patterns of medication use as Whites when they were treated at academic IBD centers. In other studies, race and ethnicity did not affect patterns of medication use, surgery, or surgical outcomes if patients had similar access to care. Such findings “indicate that when patients of minority races and ethnicities have access to appropriate specialty care and IBD-related therapy, many previously identified disparities are resolved or reduced,” the experts said.

However, race and ethnicity do affect some aspects of IBD disease activity, genetics, and treatment safety and efficacy. Since White patients have made up the vast majority of research participants, studies of racial and ethnic minorities are needed to improve their IBD diagnosis, prevention, and treatment. Such research is particularly vital because IBD incidence is rising three times faster rates in racial and ethnic minorities than Whites, said Aline Charabaty, MD, AGAF, clinical director of the gastroenterology division at Johns Hopkins University in Baltimore, and director of the IBD Center at Sibley Memorial Hospital in Washington.

She explained that, when immigrants from countries where IBD is rare adopt the United States’ sedentary lifestyle and Western diet (low in fruits and vegetables; high in proinflammatory saturated fats, sugars, and processed foods), their gut microbiome shifts and their IBD risk increases markedly. Studies in other countries have produced similar findings, said Dr. Charabaty, who did not help author the review article.

She also noted that patients from communities with a historically low prevalence of IBD may not understand its chronicity or the need for long-term treatment. However, treatment adherence is a common issue for patients of all backgrounds with IBD, she said. “What is unique is barriers to continuity of care – not being able to get to the treatment center, not being able to afford treatment or take time off work if you live paycheck to paycheck, not being able to pay someone to care for your kids while you see the doctor.”

Other potential barriers to seeking IBD treatment include cultural taboos against discussing lower GI symptoms or concerns that chronic disease will harm marriage prospects, Dr. Charabaty said. Such challenges only heighten the need to ascertain IBD symptoms: “Studies show that minorities have less follow-up care and their symptoms tend to be minimized. There is a lot of unconscious bias among providers that factors into this. The barriers are multiple, and it is important to define them and find strategies to overcome them at the level of the patient, the clinician, and the health system.”

The Crohn’s and Colitis Foundation supported the work. Dr. Barnes disclosed ties to AbbVie, Gilead, Takeda, and Target Pharmasolutions. Two coauthors also disclosed relevant ties to pharmaceutical companies. Dr. Charabaty disclosed relationships with AbbVie, Takeda, Pfizer, Janssen, and UCB.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

SOURCE: Barnes EL et al. Gastroenterology. 2020 Oct 20. doi: 10.1053/j.gastro.2020.08.064.
 

No significant differences in major adverse cardiovascular events (MACE) emerged between methotrexate and hydroxychloroquine (HCQ) treatment in a comparison of adults 65 years or older with rheumatoid arthritis. However, researchers reported some elevation in risk for stroke in the methotrexate group and for myocardial infarction and heart failure in the HCQ group.

The primary outcome, a composite of MI, stroke, or cardiovascular death, had an incidence of 23.39 per 1,000 person-years in the methotrexate group versus 24.33 in the HCQ group in this observational study of nearly 60,000 people.

“These results suggest an importance of looking at different individual events of cardiovascular disease rather than the whole ‘CV’ disease only,” Seoyoung Kim, MD, said in an interview. “The other important thing is that the mortality was not significantly different between the two groups.”

For example, the researchers reported 256 cardiovascular-related deaths in the methotrexate group and 263 such deaths in the HCQ cohort.
 

Addressing a recognized risk

“It is well known that patients with rheumatoid arthritis have excessive morbidity and mortality,” Dr. Kim, of the division of rheumatology at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School in Boston, said at the virtual annual meeting of the American College of Rheumatology.

Among prior studies in this area, the Cardiovascular Inflammation Reduction Trial (CIRT) found no significant reduction in cardiovascular events among people taking methotrexate versus placebo. However, the study of 4,786 people was not specific to RA, Dr. Kim said. The lack of efficacy on this endpoint prompted researchers to stop CIRT early.

“So what does the conclusion of the CIRT trial mean for rheumatoid arthritis patients?” Dr. Kim asked.

To find out, she and colleagues compared risk of MACE among participants newly starting either methotrexate or HCQ. The study included 59,329 people aged 65 and older who were identified through Medicare claims data from 2008 to 2016. Mean age was 74 years, and 80% were women.

The investigators used propensity score matching to control for multiple covariates for demographics, other medications, and comorbidities. Use of other medications was similar between groups, including glucocorticoids, NSAIDs, and statins. Baseline cardiovascular morbidities likewise were well balanced, Dr. Kim said.

The hazard ratio for the primary MACE outcome was 0.96 (95% confidence interval, 0.86-1.08).

Secondary outcomes

MI was less common in the methotrexate group, for example, with an incidence of 8.49 per 1,000 person-years versus 10.68 per 1,000 person-years in the HCQ cohort. This finding was statically significant, Dr. Kim said, with a hazard ratio of 0.80 favoring methotrexate.

Heart failure also occurred less often in the methotrexate cohort, with an incidence rate of 8.57 per 1,000 person-years versus a rate of 14.24 in the HCQ group. The hazard ratio again favored methotrexate at 0.60.

In contrast, strokes were more common with methotrexate than with (incidence of 7.94 vs. 6.01 per 1,000 person-years).

Another secondary outcome, all-cause mortality, was not significantly different between groups. There were 821 deaths in the methotrexate group (28.65 per 1,000 person-years) and 796 deaths in the HCQ group (31.33 per 1,000 person-years).
 

Studying causality next?

Session moderator Maya Buch, MD, PhD, professor of rheumatology at the University of Manchester (England), asked Dr. Kim why she found significant differences in some secondary outcomes but not the primary composite endpoint.

“When we think of cardiovascular diseases, we tend to think of them all developing through the same mechanism. But perhaps the exact mechanism might not be identical,” Dr. Kim replied. The findings do not suggest causality because the study was observational, she added, “but maybe this will lead to a randomized, controlled trial.”

When asked for comment, Dr. Buch said that the study was “interesting” and “suggestive of differences in type of MACE between the two drugs evaluated,” but that there should be caution in interpreting the findings because of the lack of detailed information on RA disease and activity in claims databases, in addition to other factors, even though the investigators made adjustments for known differences through propensity score matching.

The division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital supported the study. Dr. Kim has received support for Brigham and Women’s Hospital for unrelated research from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb. Several other coauthors reported having financial relationships with pharmaceutical companies that make drugs for RA. Dr. Buch had no relevant disclosures.

SOURCE: He M et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 1993.

No significant differences in major adverse cardiovascular events (MACE) emerged between methotrexate and hydroxychloroquine (HCQ) treatment in a comparison of adults 65 years or older with rheumatoid arthritis. However, researchers reported some elevation in risk for stroke in the methotrexate group and for myocardial infarction and heart failure in the HCQ group.

The primary outcome, a composite of MI, stroke, or cardiovascular death, had an incidence of 23.39 per 1,000 person-years in the methotrexate group versus 24.33 in the HCQ group in this observational study of nearly 60,000 people.

“These results suggest an importance of looking at different individual events of cardiovascular disease rather than the whole ‘CV’ disease only,” Seoyoung Kim, MD, said in an interview. “The other important thing is that the mortality was not significantly different between the two groups.”

For example, the researchers reported 256 cardiovascular-related deaths in the methotrexate group and 263 such deaths in the HCQ cohort.
 

Addressing a recognized risk

“It is well known that patients with rheumatoid arthritis have excessive morbidity and mortality,” Dr. Kim, of the division of rheumatology at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School in Boston, said at the virtual annual meeting of the American College of Rheumatology.

Among prior studies in this area, the Cardiovascular Inflammation Reduction Trial (CIRT) found no significant reduction in cardiovascular events among people taking methotrexate versus placebo. However, the study of 4,786 people was not specific to RA, Dr. Kim said. The lack of efficacy on this endpoint prompted researchers to stop CIRT early.

“So what does the conclusion of the CIRT trial mean for rheumatoid arthritis patients?” Dr. Kim asked.

To find out, she and colleagues compared risk of MACE among participants newly starting either methotrexate or HCQ. The study included 59,329 people aged 65 and older who were identified through Medicare claims data from 2008 to 2016. Mean age was 74 years, and 80% were women.

The investigators used propensity score matching to control for multiple covariates for demographics, other medications, and comorbidities. Use of other medications was similar between groups, including glucocorticoids, NSAIDs, and statins. Baseline cardiovascular morbidities likewise were well balanced, Dr. Kim said.

The hazard ratio for the primary MACE outcome was 0.96 (95% confidence interval, 0.86-1.08).

Secondary outcomes

MI was less common in the methotrexate group, for example, with an incidence of 8.49 per 1,000 person-years versus 10.68 per 1,000 person-years in the HCQ cohort. This finding was statically significant, Dr. Kim said, with a hazard ratio of 0.80 favoring methotrexate.

Heart failure also occurred less often in the methotrexate cohort, with an incidence rate of 8.57 per 1,000 person-years versus a rate of 14.24 in the HCQ group. The hazard ratio again favored methotrexate at 0.60.

In contrast, strokes were more common with methotrexate than with (incidence of 7.94 vs. 6.01 per 1,000 person-years).

Another secondary outcome, all-cause mortality, was not significantly different between groups. There were 821 deaths in the methotrexate group (28.65 per 1,000 person-years) and 796 deaths in the HCQ group (31.33 per 1,000 person-years).
 

Studying causality next?

Session moderator Maya Buch, MD, PhD, professor of rheumatology at the University of Manchester (England), asked Dr. Kim why she found significant differences in some secondary outcomes but not the primary composite endpoint.

“When we think of cardiovascular diseases, we tend to think of them all developing through the same mechanism. But perhaps the exact mechanism might not be identical,” Dr. Kim replied. The findings do not suggest causality because the study was observational, she added, “but maybe this will lead to a randomized, controlled trial.”

When asked for comment, Dr. Buch said that the study was “interesting” and “suggestive of differences in type of MACE between the two drugs evaluated,” but that there should be caution in interpreting the findings because of the lack of detailed information on RA disease and activity in claims databases, in addition to other factors, even though the investigators made adjustments for known differences through propensity score matching.

The division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital supported the study. Dr. Kim has received support for Brigham and Women’s Hospital for unrelated research from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb. Several other coauthors reported having financial relationships with pharmaceutical companies that make drugs for RA. Dr. Buch had no relevant disclosures.

SOURCE: He M et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 1993.

No significant differences in major adverse cardiovascular events (MACE) emerged between methotrexate and hydroxychloroquine (HCQ) treatment in a comparison of adults 65 years or older with rheumatoid arthritis. However, researchers reported some elevation in risk for stroke in the methotrexate group and for myocardial infarction and heart failure in the HCQ group.

The primary outcome, a composite of MI, stroke, or cardiovascular death, had an incidence of 23.39 per 1,000 person-years in the methotrexate group versus 24.33 in the HCQ group in this observational study of nearly 60,000 people.

“These results suggest an importance of looking at different individual events of cardiovascular disease rather than the whole ‘CV’ disease only,” Seoyoung Kim, MD, said in an interview. “The other important thing is that the mortality was not significantly different between the two groups.”

For example, the researchers reported 256 cardiovascular-related deaths in the methotrexate group and 263 such deaths in the HCQ cohort.
 

Addressing a recognized risk

“It is well known that patients with rheumatoid arthritis have excessive morbidity and mortality,” Dr. Kim, of the division of rheumatology at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School in Boston, said at the virtual annual meeting of the American College of Rheumatology.

Among prior studies in this area, the Cardiovascular Inflammation Reduction Trial (CIRT) found no significant reduction in cardiovascular events among people taking methotrexate versus placebo. However, the study of 4,786 people was not specific to RA, Dr. Kim said. The lack of efficacy on this endpoint prompted researchers to stop CIRT early.

“So what does the conclusion of the CIRT trial mean for rheumatoid arthritis patients?” Dr. Kim asked.

To find out, she and colleagues compared risk of MACE among participants newly starting either methotrexate or HCQ. The study included 59,329 people aged 65 and older who were identified through Medicare claims data from 2008 to 2016. Mean age was 74 years, and 80% were women.

The investigators used propensity score matching to control for multiple covariates for demographics, other medications, and comorbidities. Use of other medications was similar between groups, including glucocorticoids, NSAIDs, and statins. Baseline cardiovascular morbidities likewise were well balanced, Dr. Kim said.

The hazard ratio for the primary MACE outcome was 0.96 (95% confidence interval, 0.86-1.08).

Secondary outcomes

MI was less common in the methotrexate group, for example, with an incidence of 8.49 per 1,000 person-years versus 10.68 per 1,000 person-years in the HCQ cohort. This finding was statically significant, Dr. Kim said, with a hazard ratio of 0.80 favoring methotrexate.

Heart failure also occurred less often in the methotrexate cohort, with an incidence rate of 8.57 per 1,000 person-years versus a rate of 14.24 in the HCQ group. The hazard ratio again favored methotrexate at 0.60.

In contrast, strokes were more common with methotrexate than with (incidence of 7.94 vs. 6.01 per 1,000 person-years).

Another secondary outcome, all-cause mortality, was not significantly different between groups. There were 821 deaths in the methotrexate group (28.65 per 1,000 person-years) and 796 deaths in the HCQ group (31.33 per 1,000 person-years).
 

Studying causality next?

Session moderator Maya Buch, MD, PhD, professor of rheumatology at the University of Manchester (England), asked Dr. Kim why she found significant differences in some secondary outcomes but not the primary composite endpoint.

“When we think of cardiovascular diseases, we tend to think of them all developing through the same mechanism. But perhaps the exact mechanism might not be identical,” Dr. Kim replied. The findings do not suggest causality because the study was observational, she added, “but maybe this will lead to a randomized, controlled trial.”

When asked for comment, Dr. Buch said that the study was “interesting” and “suggestive of differences in type of MACE between the two drugs evaluated,” but that there should be caution in interpreting the findings because of the lack of detailed information on RA disease and activity in claims databases, in addition to other factors, even though the investigators made adjustments for known differences through propensity score matching.

The division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital supported the study. Dr. Kim has received support for Brigham and Women’s Hospital for unrelated research from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb. Several other coauthors reported having financial relationships with pharmaceutical companies that make drugs for RA. Dr. Buch had no relevant disclosures.

SOURCE: He M et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 1993.

Cancer drug approvals between 2000 and 2016 were associated with a significant reduction in deaths from the most common cancers in the United States, according to a new study.

Reductions in mortality were most notable for tumor types with relatively more approvals, including lung and breast cancer, melanoma, lymphoma, and leukemia.

A report from the American Cancer Society (ACS) estimated that, from 1991 to 2017, there were 2,902,200 total cancer deaths avoided from improvements in mortality from all potential sources.

The new findings, reported in the Journal of Medical Economics, suggest that drugs approved between 2000 and 2016 to treat the 15 most common cancer types helped to reduce mortality by 24% per 100,000 people.

“This study provides evidence that a significant share of that reduction from 2000 to 2016 was associated with the introduction of new therapies. The ACS report and other studies demonstrate that the improvements in lung cancer specifically are likely due to new treatments,” said lead study author Joanna P. MacEwan, MD, of PRECISIONheor in Los Angeles.

The findings contribute to a better understanding of whether increased spending on cancer drugs are worth the investment, according to the study authors.

“We provide evidence that the gains in survival measured in clinical trials are translating into health benefits for patients in the real world and confirm previous research that has also shown that new pharmaceutical treatments are associated with improved real-world survival outcomes for patients,” Dr. MacEwan said.
 

Full effect not yet observed

The researchers used a series of national data sets from sources including the Centers for Disease Control and Prevention; the U.S. Mortality Files by the National Center of Health Statistics; Survival, Epidemiology and End Results program; and United States Cancer Statistics.

The team calculated age-adjusted cancer mortality rates per year for the 15 most common tumor types and also looked at incident cases of cancer by tumor type, represented as per 100,000 people, for all ages, races, and genders.

The researchers then translated the change in cancer mortality in the U.S. from 2000 to 2016 associated with treatment stocks in each year into deaths averted per year.

Across the 16 years, mortality was down by 1,291,769 deaths. The following cancers had significant reductions in mortality: breast (n = 127,874), colorectal (n = 46,705), lung (n = 375,256), prostate (n = 476,210), gastric (n = 758), and renal (n = 739) cancers, as well as non-Hodgkin lymphoma (n = 48,836) and leukemia (n = 4,011).

Estimated mortality increased by 825 deaths in patients with thyroid cancer and 7,768 deaths for those with bladder cancer. These rises are likely due to the result of sparse drug approvals during this period – five for thyroid cancer and three for bladder cancer – Dr. MacEwan said. There were no approvals in liver or uterine cancer and few approvals in pancreatic and oral cancer.

The full effect of new drug introductions may not have been observed yet, Dr. MacEwan noted.

“There are fewer patients using the treatments for drugs approved in the later years of our study and less follow-up time to measure outcomes,” she said. “Over time, utilization of the newer therapies will likely increase and the full effect on mortality will be observed.”
 

Other factors at play

Multiple factors have led to the declines in mortality, said William G. Cance, MD, chief medical and scientific officer for the ACS, who was not involved in this study. “We are slowly sorting out the explanations in greater granularity.”  

Dr. MacEwan said improved cancer screening may partially explain the decline in mortality in some tumor types.

“If screening in a particular tumor type improved during the study period and tumors were diagnosed earlier, then mortality for that tumor type may decline,” she said. “However, we did not find strong evidence to suggest that there were significant changes in screening during our study period. Breast cancer screening rates, for example, were stable over our study period.”  

Cancer screening is not as strong an influence as it should be, Dr. Cance said.

“The lung cancer screening rate is low. In breast and colorectal cancers, we need to double down on earlier screening,” he said, noting that less than one-quarter of adults between ages 45 and 50 years are currently screened for colorectal cancer. The ACS recommends that people at average risk of colorectal cancer start regular screening at age 45.

More research is necessary to evaluate the relationship between drug approvals and cancer mortality, Dr. MacEwan said.

“Research directly linking utilization of new therapies to improved survival or reduced mortality in the real-world setting would more definitively demonstrate the impact of new treatments,” she said. “New therapies have improved outcomes for many patients and should continue to be considered as key elements of cancer treatment.”

“We need to continue to reduce tobacco smoking and improve on modifiable behaviors at the same time as we work on getting new drugs to cancer patients,” Dr. Cance said. “We are coming into an era of multiple new therapeutics, including targeted therapies, immunotherapies, and cellular therapies. Clinicians need to look closely at the trial data of new drugs and pay close attention to those that have the most mortality impact.”

“We also need equitable distribution of newer drugs,” Dr. Cance added. “They should be distributed to everybody who deserves them. Mortality is often impacted by social determinants of health.”

Funding for this research was provided by Pfizer. Study authors disclosed relationships, including employment, with Pfizer. Dr. Cance had no disclosures.

SOURCE: MacEwan JP et al. J Med Econ. 2020 Nov 9;1-12.

Cancer drug approvals between 2000 and 2016 were associated with a significant reduction in deaths from the most common cancers in the United States, according to a new study.

Reductions in mortality were most notable for tumor types with relatively more approvals, including lung and breast cancer, melanoma, lymphoma, and leukemia.

A report from the American Cancer Society (ACS) estimated that, from 1991 to 2017, there were 2,902,200 total cancer deaths avoided from improvements in mortality from all potential sources.

The new findings, reported in the Journal of Medical Economics, suggest that drugs approved between 2000 and 2016 to treat the 15 most common cancer types helped to reduce mortality by 24% per 100,000 people.

“This study provides evidence that a significant share of that reduction from 2000 to 2016 was associated with the introduction of new therapies. The ACS report and other studies demonstrate that the improvements in lung cancer specifically are likely due to new treatments,” said lead study author Joanna P. MacEwan, MD, of PRECISIONheor in Los Angeles.

The findings contribute to a better understanding of whether increased spending on cancer drugs are worth the investment, according to the study authors.

“We provide evidence that the gains in survival measured in clinical trials are translating into health benefits for patients in the real world and confirm previous research that has also shown that new pharmaceutical treatments are associated with improved real-world survival outcomes for patients,” Dr. MacEwan said.
 

Full effect not yet observed

The researchers used a series of national data sets from sources including the Centers for Disease Control and Prevention; the U.S. Mortality Files by the National Center of Health Statistics; Survival, Epidemiology and End Results program; and United States Cancer Statistics.

The team calculated age-adjusted cancer mortality rates per year for the 15 most common tumor types and also looked at incident cases of cancer by tumor type, represented as per 100,000 people, for all ages, races, and genders.

The researchers then translated the change in cancer mortality in the U.S. from 2000 to 2016 associated with treatment stocks in each year into deaths averted per year.

Across the 16 years, mortality was down by 1,291,769 deaths. The following cancers had significant reductions in mortality: breast (n = 127,874), colorectal (n = 46,705), lung (n = 375,256), prostate (n = 476,210), gastric (n = 758), and renal (n = 739) cancers, as well as non-Hodgkin lymphoma (n = 48,836) and leukemia (n = 4,011).

Estimated mortality increased by 825 deaths in patients with thyroid cancer and 7,768 deaths for those with bladder cancer. These rises are likely due to the result of sparse drug approvals during this period – five for thyroid cancer and three for bladder cancer – Dr. MacEwan said. There were no approvals in liver or uterine cancer and few approvals in pancreatic and oral cancer.

The full effect of new drug introductions may not have been observed yet, Dr. MacEwan noted.

“There are fewer patients using the treatments for drugs approved in the later years of our study and less follow-up time to measure outcomes,” she said. “Over time, utilization of the newer therapies will likely increase and the full effect on mortality will be observed.”
 

Other factors at play

Multiple factors have led to the declines in mortality, said William G. Cance, MD, chief medical and scientific officer for the ACS, who was not involved in this study. “We are slowly sorting out the explanations in greater granularity.”  

Dr. MacEwan said improved cancer screening may partially explain the decline in mortality in some tumor types.

“If screening in a particular tumor type improved during the study period and tumors were diagnosed earlier, then mortality for that tumor type may decline,” she said. “However, we did not find strong evidence to suggest that there were significant changes in screening during our study period. Breast cancer screening rates, for example, were stable over our study period.”  

Cancer screening is not as strong an influence as it should be, Dr. Cance said.

“The lung cancer screening rate is low. In breast and colorectal cancers, we need to double down on earlier screening,” he said, noting that less than one-quarter of adults between ages 45 and 50 years are currently screened for colorectal cancer. The ACS recommends that people at average risk of colorectal cancer start regular screening at age 45.

More research is necessary to evaluate the relationship between drug approvals and cancer mortality, Dr. MacEwan said.

“Research directly linking utilization of new therapies to improved survival or reduced mortality in the real-world setting would more definitively demonstrate the impact of new treatments,” she said. “New therapies have improved outcomes for many patients and should continue to be considered as key elements of cancer treatment.”

“We need to continue to reduce tobacco smoking and improve on modifiable behaviors at the same time as we work on getting new drugs to cancer patients,” Dr. Cance said. “We are coming into an era of multiple new therapeutics, including targeted therapies, immunotherapies, and cellular therapies. Clinicians need to look closely at the trial data of new drugs and pay close attention to those that have the most mortality impact.”

“We also need equitable distribution of newer drugs,” Dr. Cance added. “They should be distributed to everybody who deserves them. Mortality is often impacted by social determinants of health.”

Funding for this research was provided by Pfizer. Study authors disclosed relationships, including employment, with Pfizer. Dr. Cance had no disclosures.

SOURCE: MacEwan JP et al. J Med Econ. 2020 Nov 9;1-12.

Cancer drug approvals between 2000 and 2016 were associated with a significant reduction in deaths from the most common cancers in the United States, according to a new study.

Reductions in mortality were most notable for tumor types with relatively more approvals, including lung and breast cancer, melanoma, lymphoma, and leukemia.

A report from the American Cancer Society (ACS) estimated that, from 1991 to 2017, there were 2,902,200 total cancer deaths avoided from improvements in mortality from all potential sources.

The new findings, reported in the Journal of Medical Economics, suggest that drugs approved between 2000 and 2016 to treat the 15 most common cancer types helped to reduce mortality by 24% per 100,000 people.

“This study provides evidence that a significant share of that reduction from 2000 to 2016 was associated with the introduction of new therapies. The ACS report and other studies demonstrate that the improvements in lung cancer specifically are likely due to new treatments,” said lead study author Joanna P. MacEwan, MD, of PRECISIONheor in Los Angeles.

The findings contribute to a better understanding of whether increased spending on cancer drugs are worth the investment, according to the study authors.

“We provide evidence that the gains in survival measured in clinical trials are translating into health benefits for patients in the real world and confirm previous research that has also shown that new pharmaceutical treatments are associated with improved real-world survival outcomes for patients,” Dr. MacEwan said.
 

Full effect not yet observed

The researchers used a series of national data sets from sources including the Centers for Disease Control and Prevention; the U.S. Mortality Files by the National Center of Health Statistics; Survival, Epidemiology and End Results program; and United States Cancer Statistics.

The team calculated age-adjusted cancer mortality rates per year for the 15 most common tumor types and also looked at incident cases of cancer by tumor type, represented as per 100,000 people, for all ages, races, and genders.

The researchers then translated the change in cancer mortality in the U.S. from 2000 to 2016 associated with treatment stocks in each year into deaths averted per year.

Across the 16 years, mortality was down by 1,291,769 deaths. The following cancers had significant reductions in mortality: breast (n = 127,874), colorectal (n = 46,705), lung (n = 375,256), prostate (n = 476,210), gastric (n = 758), and renal (n = 739) cancers, as well as non-Hodgkin lymphoma (n = 48,836) and leukemia (n = 4,011).

Estimated mortality increased by 825 deaths in patients with thyroid cancer and 7,768 deaths for those with bladder cancer. These rises are likely due to the result of sparse drug approvals during this period – five for thyroid cancer and three for bladder cancer – Dr. MacEwan said. There were no approvals in liver or uterine cancer and few approvals in pancreatic and oral cancer.

The full effect of new drug introductions may not have been observed yet, Dr. MacEwan noted.

“There are fewer patients using the treatments for drugs approved in the later years of our study and less follow-up time to measure outcomes,” she said. “Over time, utilization of the newer therapies will likely increase and the full effect on mortality will be observed.”
 

Other factors at play

Multiple factors have led to the declines in mortality, said William G. Cance, MD, chief medical and scientific officer for the ACS, who was not involved in this study. “We are slowly sorting out the explanations in greater granularity.”  

Dr. MacEwan said improved cancer screening may partially explain the decline in mortality in some tumor types.

“If screening in a particular tumor type improved during the study period and tumors were diagnosed earlier, then mortality for that tumor type may decline,” she said. “However, we did not find strong evidence to suggest that there were significant changes in screening during our study period. Breast cancer screening rates, for example, were stable over our study period.”  

Cancer screening is not as strong an influence as it should be, Dr. Cance said.

“The lung cancer screening rate is low. In breast and colorectal cancers, we need to double down on earlier screening,” he said, noting that less than one-quarter of adults between ages 45 and 50 years are currently screened for colorectal cancer. The ACS recommends that people at average risk of colorectal cancer start regular screening at age 45.

More research is necessary to evaluate the relationship between drug approvals and cancer mortality, Dr. MacEwan said.

“Research directly linking utilization of new therapies to improved survival or reduced mortality in the real-world setting would more definitively demonstrate the impact of new treatments,” she said. “New therapies have improved outcomes for many patients and should continue to be considered as key elements of cancer treatment.”

“We need to continue to reduce tobacco smoking and improve on modifiable behaviors at the same time as we work on getting new drugs to cancer patients,” Dr. Cance said. “We are coming into an era of multiple new therapeutics, including targeted therapies, immunotherapies, and cellular therapies. Clinicians need to look closely at the trial data of new drugs and pay close attention to those that have the most mortality impact.”

“We also need equitable distribution of newer drugs,” Dr. Cance added. “They should be distributed to everybody who deserves them. Mortality is often impacted by social determinants of health.”

Funding for this research was provided by Pfizer. Study authors disclosed relationships, including employment, with Pfizer. Dr. Cance had no disclosures.

SOURCE: MacEwan JP et al. J Med Econ. 2020 Nov 9;1-12.

About one in eight patients with cancer have inherited genetic mutations that may have contributed to the development of their cancers, but nearly half of these mutations would have been missed using current clinical guidelines.

These findings come from the largest study of its kind so far, conducted in nearly 3,000 patients with a wide range of cancer stages and types, including breast, colorectal, lung, ovarian, pancreatic, bladder, prostate, and endometrial cancers.

“This study tells us that the clinical practice guidelines are not very sensitive for identifying who does or doesn’t have a genetic mutation that is predisposing them to cancer,” commented first author Niloy Jewell Samadder, MD, director of the high-risk cancer clinic at the Mayo Clinic in Phoenix.

Finding a genetic mutation can alter clinical management of the cancer.

“This really does open up treatment and management options that might not have been accessible to these patients,” Dr. Samadder emphasized.

The results were published online on Oct. 30 in JAMA Oncology and were presented simultaneously at the American Society of Human Genetics. Dr. Samadder discussed details of the study in a video posted on YouTube.

A clinician not involved in the study said the new results should lead to changes in practice.

“For cancer patients, I think the debate is over. We should test everybody,” Peter Beitsch, MD, surgical oncologist at the Dallas Surgical Group, said in an interview.

The Mayo Clinic is changing its daily practice at all four of its cancer centers. The changes will begin in the first quarter of 2021 at its Arizona campus.

“Every cancer patient who comes to Mayo Clinic will be offered genomic evaluation that includes genetic testing to identify if they have an underlying genetic mutation that predisposes to their cancer and [helps physicians decide] how to incorporate that knowledge into designing the best surgical and treatment options for that patient and their family,” Dr. Samadder said.
 

Study details

The study included 2,984 patients with cancer who were receiving care for a variety of solid tumor cancers at Mayo Clinic cancer centers in Arizona, Florida, Minnesota, and a community cancer center in Wisconsin.

Patients were tested for about 84 genes using next-generation sequencing provided by Invitae.

Among participants, 13.3% (n = 397) tested positive for pathogenic mutations. Of these, about 70% (282 of 397 patients) carried moderate- and high-penetrance genes that increased their risk for cancer. For almost 28.2% (n = 42) of patients with high-penetrance mutations, changes were made in treatment as a result of genetic testing. These included changes in surgical management, immunotherapy, chemotherapy, or enrollment in a clinical trial for which they may otherwise have not been eligible.

Researchers also compared their universal testing approach with targeted testing recommended in guidelines from the National Comprehensive Cancer Network, the National Society of Genetic Counselors, and the American College of Medical Genetics.

They identified pathogenic mutations in 192 patients whose mutations would have been missed using guideline-recommended criteria, such as tumor pathology or family history. This represents 6.4% of all participants in the study (192 of 2,984 patients) and 48.4% of patients who tested positive for pathogenic mutations (397 of 2,984 patients).

“Genetic testing is underutilized in cancer care, both for patients and for their families, often due to outdated guidelines that restrict testing to a narrow group of high-risk patients. All cancer patients should have access to complete genetic information that can guide their care and inform their families’ health,” coauthor Robert Nussbaum, MD, chief medical officer of Invitae, said in a statement.

Some clinicians have been pushing for genetic testing of all patients with cancer, including Dr. Beitsch, who was lead author of a similar study in breast cancer patients published last year in the Journal of Oncology. That article made waves when the authors concluded that all breast cancer patients should have expanded panel genetic testing.

This new Mayo Clinic study extends the findings in breast cancer to “all cancer patients, not just breast cancer patients,” Dr. Beitsch said in an interview.
 

Long-running debate

The new findings and opinions add to a long-running debate in oncology over the role of genetic testing and screening for pathogenic mutations.

Part of the debate about genetic testing has hinged on the question of costs, said Dr. Beitsch. When genetic testing first became available, it was conducted by hand, and costs were often prohibitive. Since then, genetic testing has been automated using next-generation sequencing, and the cost has decreased considerably.

“The Invitae cash price for an 80-plus gene panel is $250. That’s [the cost of] a mani-pedi in Dallas. I don’t discount that it’s a lot of money for a lot of people. Yes, it’s expensive, but it’s a lot less expensive than it used to be,” Dr. Beitsch said.

Another issue is that doctors are not entirely sure how to manage variants of uncertain significance (VUSs) when they are found. In the Mayo Clinic study, about half (47.4%; n = 1415) of participants had VUSs. The authors noted that these results are consistent with past studies.

Dr. Beitsch said that VUSs are a matter of education. To date, only about 2% of VUSs have been associated with cancer. The remainder, about 98%, do not affect treatment for patients who have already been diagnosed with cancer.

“We all have VUSs. They’re just minor variations in a gene. The vast majority of them have no consequence and don’t alter the function of the gene,” he said. “I tell everybody to ignore the VUSs [when found in patients with cancer]. Do not act on them at all. We just need to educate everybody to make sure they don’t get stressed about it.”

These comments echo guidance from the American Society of Breast Surgeons, which says that VUSs are DNA sequences that are not clinically actionable. This type of result needs to be considered as inconclusive, and patient management should not be influenced by such results.

However, VUSs are more significant if they are found in individuals who do not have cancer but who have a strong family history of cancer. In such cases, clinicians should be more aware, Dr. Beitsch emphasized.

“Patients who have a VUS and don’t have a cancer should absolutely pay more attention to their health. They got tested for a reason, and that reason is usually strong family history,” Dr. Beitsch said.

He added that a major advantage of genetic testing is that it can enable cascade genetic testing of family members. Identifying pathogenic mutations in family members can lead them to undergo screening to detect early cancers, and preventive measures can be taken that may be lifesaving.

In the Mayo Clinic study, researchers offered genetic testing to family members of patients who tested positive for a pathogenic mutation. Testing was available free of charge for up to 90 days after a participant tested positive. In addition, family members were shown an educational video.

Nevertheless, only 17.6% (n = 70) of patients with pathogenic mutations had family members who underwent testing. Among these, 45% (79 of 176) of family members who were tested were found to carry pathogenic mutations.

“This really told us that financial barriers are not the only barrier to families understanding and undergoing preventive testing,” Dr. Samadder said. “There are probably a number of other barriers – socioeconomic or emotional – that we have to deal with.”

Genetic testing was provided by Invitae. The study was supported by several grants, including a Mayo Transform the Practice Grant, and by Mayo Clinic’s Center for Individualized Medicine. Two coauthors are employees of Invitae. Dr. Beitsch reported participating in a study 2 years ago that was funded by Invitae. He currently receives no financial support from Invitae. Several authors report receiving fees from one or more of the following companies: Pfizer, Maze Therapeutics, Genome Medical, Astellas, and Merck.

This article first appeared on Medscape.com.

About one in eight patients with cancer have inherited genetic mutations that may have contributed to the development of their cancers, but nearly half of these mutations would have been missed using current clinical guidelines.

These findings come from the largest study of its kind so far, conducted in nearly 3,000 patients with a wide range of cancer stages and types, including breast, colorectal, lung, ovarian, pancreatic, bladder, prostate, and endometrial cancers.

“This study tells us that the clinical practice guidelines are not very sensitive for identifying who does or doesn’t have a genetic mutation that is predisposing them to cancer,” commented first author Niloy Jewell Samadder, MD, director of the high-risk cancer clinic at the Mayo Clinic in Phoenix.

Finding a genetic mutation can alter clinical management of the cancer.

“This really does open up treatment and management options that might not have been accessible to these patients,” Dr. Samadder emphasized.

The results were published online on Oct. 30 in JAMA Oncology and were presented simultaneously at the American Society of Human Genetics. Dr. Samadder discussed details of the study in a video posted on YouTube.

A clinician not involved in the study said the new results should lead to changes in practice.

“For cancer patients, I think the debate is over. We should test everybody,” Peter Beitsch, MD, surgical oncologist at the Dallas Surgical Group, said in an interview.

The Mayo Clinic is changing its daily practice at all four of its cancer centers. The changes will begin in the first quarter of 2021 at its Arizona campus.

“Every cancer patient who comes to Mayo Clinic will be offered genomic evaluation that includes genetic testing to identify if they have an underlying genetic mutation that predisposes to their cancer and [helps physicians decide] how to incorporate that knowledge into designing the best surgical and treatment options for that patient and their family,” Dr. Samadder said.
 

Study details

The study included 2,984 patients with cancer who were receiving care for a variety of solid tumor cancers at Mayo Clinic cancer centers in Arizona, Florida, Minnesota, and a community cancer center in Wisconsin.

Patients were tested for about 84 genes using next-generation sequencing provided by Invitae.

Among participants, 13.3% (n = 397) tested positive for pathogenic mutations. Of these, about 70% (282 of 397 patients) carried moderate- and high-penetrance genes that increased their risk for cancer. For almost 28.2% (n = 42) of patients with high-penetrance mutations, changes were made in treatment as a result of genetic testing. These included changes in surgical management, immunotherapy, chemotherapy, or enrollment in a clinical trial for which they may otherwise have not been eligible.

Researchers also compared their universal testing approach with targeted testing recommended in guidelines from the National Comprehensive Cancer Network, the National Society of Genetic Counselors, and the American College of Medical Genetics.

They identified pathogenic mutations in 192 patients whose mutations would have been missed using guideline-recommended criteria, such as tumor pathology or family history. This represents 6.4% of all participants in the study (192 of 2,984 patients) and 48.4% of patients who tested positive for pathogenic mutations (397 of 2,984 patients).

“Genetic testing is underutilized in cancer care, both for patients and for their families, often due to outdated guidelines that restrict testing to a narrow group of high-risk patients. All cancer patients should have access to complete genetic information that can guide their care and inform their families’ health,” coauthor Robert Nussbaum, MD, chief medical officer of Invitae, said in a statement.

Some clinicians have been pushing for genetic testing of all patients with cancer, including Dr. Beitsch, who was lead author of a similar study in breast cancer patients published last year in the Journal of Oncology. That article made waves when the authors concluded that all breast cancer patients should have expanded panel genetic testing.

This new Mayo Clinic study extends the findings in breast cancer to “all cancer patients, not just breast cancer patients,” Dr. Beitsch said in an interview.
 

Long-running debate

The new findings and opinions add to a long-running debate in oncology over the role of genetic testing and screening for pathogenic mutations.

Part of the debate about genetic testing has hinged on the question of costs, said Dr. Beitsch. When genetic testing first became available, it was conducted by hand, and costs were often prohibitive. Since then, genetic testing has been automated using next-generation sequencing, and the cost has decreased considerably.

“The Invitae cash price for an 80-plus gene panel is $250. That’s [the cost of] a mani-pedi in Dallas. I don’t discount that it’s a lot of money for a lot of people. Yes, it’s expensive, but it’s a lot less expensive than it used to be,” Dr. Beitsch said.

Another issue is that doctors are not entirely sure how to manage variants of uncertain significance (VUSs) when they are found. In the Mayo Clinic study, about half (47.4%; n = 1415) of participants had VUSs. The authors noted that these results are consistent with past studies.

Dr. Beitsch said that VUSs are a matter of education. To date, only about 2% of VUSs have been associated with cancer. The remainder, about 98%, do not affect treatment for patients who have already been diagnosed with cancer.

“We all have VUSs. They’re just minor variations in a gene. The vast majority of them have no consequence and don’t alter the function of the gene,” he said. “I tell everybody to ignore the VUSs [when found in patients with cancer]. Do not act on them at all. We just need to educate everybody to make sure they don’t get stressed about it.”

These comments echo guidance from the American Society of Breast Surgeons, which says that VUSs are DNA sequences that are not clinically actionable. This type of result needs to be considered as inconclusive, and patient management should not be influenced by such results.

However, VUSs are more significant if they are found in individuals who do not have cancer but who have a strong family history of cancer. In such cases, clinicians should be more aware, Dr. Beitsch emphasized.

“Patients who have a VUS and don’t have a cancer should absolutely pay more attention to their health. They got tested for a reason, and that reason is usually strong family history,” Dr. Beitsch said.

He added that a major advantage of genetic testing is that it can enable cascade genetic testing of family members. Identifying pathogenic mutations in family members can lead them to undergo screening to detect early cancers, and preventive measures can be taken that may be lifesaving.

In the Mayo Clinic study, researchers offered genetic testing to family members of patients who tested positive for a pathogenic mutation. Testing was available free of charge for up to 90 days after a participant tested positive. In addition, family members were shown an educational video.

Nevertheless, only 17.6% (n = 70) of patients with pathogenic mutations had family members who underwent testing. Among these, 45% (79 of 176) of family members who were tested were found to carry pathogenic mutations.

“This really told us that financial barriers are not the only barrier to families understanding and undergoing preventive testing,” Dr. Samadder said. “There are probably a number of other barriers – socioeconomic or emotional – that we have to deal with.”

Genetic testing was provided by Invitae. The study was supported by several grants, including a Mayo Transform the Practice Grant, and by Mayo Clinic’s Center for Individualized Medicine. Two coauthors are employees of Invitae. Dr. Beitsch reported participating in a study 2 years ago that was funded by Invitae. He currently receives no financial support from Invitae. Several authors report receiving fees from one or more of the following companies: Pfizer, Maze Therapeutics, Genome Medical, Astellas, and Merck.

This article first appeared on Medscape.com.

About one in eight patients with cancer have inherited genetic mutations that may have contributed to the development of their cancers, but nearly half of these mutations would have been missed using current clinical guidelines.

These findings come from the largest study of its kind so far, conducted in nearly 3,000 patients with a wide range of cancer stages and types, including breast, colorectal, lung, ovarian, pancreatic, bladder, prostate, and endometrial cancers.

“This study tells us that the clinical practice guidelines are not very sensitive for identifying who does or doesn’t have a genetic mutation that is predisposing them to cancer,” commented first author Niloy Jewell Samadder, MD, director of the high-risk cancer clinic at the Mayo Clinic in Phoenix.

Finding a genetic mutation can alter clinical management of the cancer.

“This really does open up treatment and management options that might not have been accessible to these patients,” Dr. Samadder emphasized.

The results were published online on Oct. 30 in JAMA Oncology and were presented simultaneously at the American Society of Human Genetics. Dr. Samadder discussed details of the study in a video posted on YouTube.

A clinician not involved in the study said the new results should lead to changes in practice.

“For cancer patients, I think the debate is over. We should test everybody,” Peter Beitsch, MD, surgical oncologist at the Dallas Surgical Group, said in an interview.

The Mayo Clinic is changing its daily practice at all four of its cancer centers. The changes will begin in the first quarter of 2021 at its Arizona campus.

“Every cancer patient who comes to Mayo Clinic will be offered genomic evaluation that includes genetic testing to identify if they have an underlying genetic mutation that predisposes to their cancer and [helps physicians decide] how to incorporate that knowledge into designing the best surgical and treatment options for that patient and their family,” Dr. Samadder said.
 

Study details

The study included 2,984 patients with cancer who were receiving care for a variety of solid tumor cancers at Mayo Clinic cancer centers in Arizona, Florida, Minnesota, and a community cancer center in Wisconsin.

Patients were tested for about 84 genes using next-generation sequencing provided by Invitae.

Among participants, 13.3% (n = 397) tested positive for pathogenic mutations. Of these, about 70% (282 of 397 patients) carried moderate- and high-penetrance genes that increased their risk for cancer. For almost 28.2% (n = 42) of patients with high-penetrance mutations, changes were made in treatment as a result of genetic testing. These included changes in surgical management, immunotherapy, chemotherapy, or enrollment in a clinical trial for which they may otherwise have not been eligible.

Researchers also compared their universal testing approach with targeted testing recommended in guidelines from the National Comprehensive Cancer Network, the National Society of Genetic Counselors, and the American College of Medical Genetics.

They identified pathogenic mutations in 192 patients whose mutations would have been missed using guideline-recommended criteria, such as tumor pathology or family history. This represents 6.4% of all participants in the study (192 of 2,984 patients) and 48.4% of patients who tested positive for pathogenic mutations (397 of 2,984 patients).

“Genetic testing is underutilized in cancer care, both for patients and for their families, often due to outdated guidelines that restrict testing to a narrow group of high-risk patients. All cancer patients should have access to complete genetic information that can guide their care and inform their families’ health,” coauthor Robert Nussbaum, MD, chief medical officer of Invitae, said in a statement.

Some clinicians have been pushing for genetic testing of all patients with cancer, including Dr. Beitsch, who was lead author of a similar study in breast cancer patients published last year in the Journal of Oncology. That article made waves when the authors concluded that all breast cancer patients should have expanded panel genetic testing.

This new Mayo Clinic study extends the findings in breast cancer to “all cancer patients, not just breast cancer patients,” Dr. Beitsch said in an interview.
 

Long-running debate

The new findings and opinions add to a long-running debate in oncology over the role of genetic testing and screening for pathogenic mutations.

Part of the debate about genetic testing has hinged on the question of costs, said Dr. Beitsch. When genetic testing first became available, it was conducted by hand, and costs were often prohibitive. Since then, genetic testing has been automated using next-generation sequencing, and the cost has decreased considerably.

“The Invitae cash price for an 80-plus gene panel is $250. That’s [the cost of] a mani-pedi in Dallas. I don’t discount that it’s a lot of money for a lot of people. Yes, it’s expensive, but it’s a lot less expensive than it used to be,” Dr. Beitsch said.

Another issue is that doctors are not entirely sure how to manage variants of uncertain significance (VUSs) when they are found. In the Mayo Clinic study, about half (47.4%; n = 1415) of participants had VUSs. The authors noted that these results are consistent with past studies.

Dr. Beitsch said that VUSs are a matter of education. To date, only about 2% of VUSs have been associated with cancer. The remainder, about 98%, do not affect treatment for patients who have already been diagnosed with cancer.

“We all have VUSs. They’re just minor variations in a gene. The vast majority of them have no consequence and don’t alter the function of the gene,” he said. “I tell everybody to ignore the VUSs [when found in patients with cancer]. Do not act on them at all. We just need to educate everybody to make sure they don’t get stressed about it.”

These comments echo guidance from the American Society of Breast Surgeons, which says that VUSs are DNA sequences that are not clinically actionable. This type of result needs to be considered as inconclusive, and patient management should not be influenced by such results.

However, VUSs are more significant if they are found in individuals who do not have cancer but who have a strong family history of cancer. In such cases, clinicians should be more aware, Dr. Beitsch emphasized.

“Patients who have a VUS and don’t have a cancer should absolutely pay more attention to their health. They got tested for a reason, and that reason is usually strong family history,” Dr. Beitsch said.

He added that a major advantage of genetic testing is that it can enable cascade genetic testing of family members. Identifying pathogenic mutations in family members can lead them to undergo screening to detect early cancers, and preventive measures can be taken that may be lifesaving.

In the Mayo Clinic study, researchers offered genetic testing to family members of patients who tested positive for a pathogenic mutation. Testing was available free of charge for up to 90 days after a participant tested positive. In addition, family members were shown an educational video.

Nevertheless, only 17.6% (n = 70) of patients with pathogenic mutations had family members who underwent testing. Among these, 45% (79 of 176) of family members who were tested were found to carry pathogenic mutations.

“This really told us that financial barriers are not the only barrier to families understanding and undergoing preventive testing,” Dr. Samadder said. “There are probably a number of other barriers – socioeconomic or emotional – that we have to deal with.”

Genetic testing was provided by Invitae. The study was supported by several grants, including a Mayo Transform the Practice Grant, and by Mayo Clinic’s Center for Individualized Medicine. Two coauthors are employees of Invitae. Dr. Beitsch reported participating in a study 2 years ago that was funded by Invitae. He currently receives no financial support from Invitae. Several authors report receiving fees from one or more of the following companies: Pfizer, Maze Therapeutics, Genome Medical, Astellas, and Merck.

This article first appeared on Medscape.com.

All patients with postpartum depression should be screened for thyroid dysfunction, as postpartum thyroiditis is often missed and misdiagnosed, according to Christine Kessler, CNS, ANP.

Postpartum thyroiditis (PPT) is “an inflammatory, autoimmune thyroid condition,” Ms. Kessler said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education. This dysfunction can involve high or low thyroid-stimulating hormone and may occur during the first postpartum year in women who were euthyroid prior to pregnancy. Women with PPT will be thyroid peroxidase (TPO) antibody positive. Postpartum thyroiditis also can occur after a miscarriage.

PPT can occur when the immune system rebounds after pregnancy following immune suppression during pregnancy. “Autoimmune destruction of the thyroid gland leads to initial release of stored thyroid hormone,” Ms. Kessler said. Notably, “patients with a predisposition for Hashimoto’s will have an attack on the thyroid gland. Don’t miss this in your patients.”

PPT is the most common endocrine disease in premenopausal women, with an incidence of 8%-14% in the United States, noted Ms. Kessler, a nurse practitioner in private practice in Virginia. However, the symptoms are often attributed to anxiety, depression, or the stress of new motherhood.

Women with PPT have positive thyroid peroxidase antibodies, said Ms. Kessler, and the higher the antibody, the higher the risk for PPT. Other risk factors include the presence of autoimmune disorders prior to pregnancy, a patient or family history of thyroid dysfunction, and a history of PPT.

Roughly one-third of women with PPT present with hyperthyroidism alone, another third present with hypothyroidism alone, and another third have the classic presentation of PPT, which starts with a transient hyperthyroid phase that usually occurs 1-4 months post partum, followed by a hypothyroid phase and euthyroid phase that is usually achieved within the first 12-18 months post partum, she said.

Patients presenting with PPT in the hyperthyroid phase display symptoms including insomnia, anxiety, irritability, heat intolerance, fatigue, and palpitations, Ms. Kessler said. These women “are often told they have postpartum depression; they aren’t sleeping well, and they feel like they are failing as a mom.”

Patients in the hypothyroid phase may present with fatigue, depression, cold intolerance, dry skin, impaired concentration, and paresthesias, she noted.

Treatment for PPT depends on the stage patients are in when they present. For patients in the hyperthyroid phase, Ms. Kessler recommended beta-blockers for relief of symptoms including tremor and palpitations, but these should be tapered as symptoms decrease. “There is no need for antithyroid drugs for women in the hyperthyroid phase.”

For patients presenting in the hypothyroid phase, Ms. Kessler recommended levothyroxine for 6-12 months if needed, but the drug should be tapered and discontinued after PPT, as about 80% of patients will become euthyroid. However, approximately 50% of women with PPT will develop hypothyroidism in 2-10 years, so ongoing follow-up is essential for these patients.

Ms. Kessler disclosed serving as an adviser/speaker for Novo Nordisk, serving as a speaker for Salix and Acella, and serving as National Study Chair of probiotic use with antibiotics for Clarion Brand. Global Academy and this news organization are owned by the same parent company.

All patients with postpartum depression should be screened for thyroid dysfunction, as postpartum thyroiditis is often missed and misdiagnosed, according to Christine Kessler, CNS, ANP.

Postpartum thyroiditis (PPT) is “an inflammatory, autoimmune thyroid condition,” Ms. Kessler said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education. This dysfunction can involve high or low thyroid-stimulating hormone and may occur during the first postpartum year in women who were euthyroid prior to pregnancy. Women with PPT will be thyroid peroxidase (TPO) antibody positive. Postpartum thyroiditis also can occur after a miscarriage.

PPT can occur when the immune system rebounds after pregnancy following immune suppression during pregnancy. “Autoimmune destruction of the thyroid gland leads to initial release of stored thyroid hormone,” Ms. Kessler said. Notably, “patients with a predisposition for Hashimoto’s will have an attack on the thyroid gland. Don’t miss this in your patients.”

PPT is the most common endocrine disease in premenopausal women, with an incidence of 8%-14% in the United States, noted Ms. Kessler, a nurse practitioner in private practice in Virginia. However, the symptoms are often attributed to anxiety, depression, or the stress of new motherhood.

Women with PPT have positive thyroid peroxidase antibodies, said Ms. Kessler, and the higher the antibody, the higher the risk for PPT. Other risk factors include the presence of autoimmune disorders prior to pregnancy, a patient or family history of thyroid dysfunction, and a history of PPT.

Roughly one-third of women with PPT present with hyperthyroidism alone, another third present with hypothyroidism alone, and another third have the classic presentation of PPT, which starts with a transient hyperthyroid phase that usually occurs 1-4 months post partum, followed by a hypothyroid phase and euthyroid phase that is usually achieved within the first 12-18 months post partum, she said.

Patients presenting with PPT in the hyperthyroid phase display symptoms including insomnia, anxiety, irritability, heat intolerance, fatigue, and palpitations, Ms. Kessler said. These women “are often told they have postpartum depression; they aren’t sleeping well, and they feel like they are failing as a mom.”

Patients in the hypothyroid phase may present with fatigue, depression, cold intolerance, dry skin, impaired concentration, and paresthesias, she noted.

Treatment for PPT depends on the stage patients are in when they present. For patients in the hyperthyroid phase, Ms. Kessler recommended beta-blockers for relief of symptoms including tremor and palpitations, but these should be tapered as symptoms decrease. “There is no need for antithyroid drugs for women in the hyperthyroid phase.”

For patients presenting in the hypothyroid phase, Ms. Kessler recommended levothyroxine for 6-12 months if needed, but the drug should be tapered and discontinued after PPT, as about 80% of patients will become euthyroid. However, approximately 50% of women with PPT will develop hypothyroidism in 2-10 years, so ongoing follow-up is essential for these patients.

Ms. Kessler disclosed serving as an adviser/speaker for Novo Nordisk, serving as a speaker for Salix and Acella, and serving as National Study Chair of probiotic use with antibiotics for Clarion Brand. Global Academy and this news organization are owned by the same parent company.

All patients with postpartum depression should be screened for thyroid dysfunction, as postpartum thyroiditis is often missed and misdiagnosed, according to Christine Kessler, CNS, ANP.

Postpartum thyroiditis (PPT) is “an inflammatory, autoimmune thyroid condition,” Ms. Kessler said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education. This dysfunction can involve high or low thyroid-stimulating hormone and may occur during the first postpartum year in women who were euthyroid prior to pregnancy. Women with PPT will be thyroid peroxidase (TPO) antibody positive. Postpartum thyroiditis also can occur after a miscarriage.

PPT can occur when the immune system rebounds after pregnancy following immune suppression during pregnancy. “Autoimmune destruction of the thyroid gland leads to initial release of stored thyroid hormone,” Ms. Kessler said. Notably, “patients with a predisposition for Hashimoto’s will have an attack on the thyroid gland. Don’t miss this in your patients.”

PPT is the most common endocrine disease in premenopausal women, with an incidence of 8%-14% in the United States, noted Ms. Kessler, a nurse practitioner in private practice in Virginia. However, the symptoms are often attributed to anxiety, depression, or the stress of new motherhood.

Women with PPT have positive thyroid peroxidase antibodies, said Ms. Kessler, and the higher the antibody, the higher the risk for PPT. Other risk factors include the presence of autoimmune disorders prior to pregnancy, a patient or family history of thyroid dysfunction, and a history of PPT.

Roughly one-third of women with PPT present with hyperthyroidism alone, another third present with hypothyroidism alone, and another third have the classic presentation of PPT, which starts with a transient hyperthyroid phase that usually occurs 1-4 months post partum, followed by a hypothyroid phase and euthyroid phase that is usually achieved within the first 12-18 months post partum, she said.

Patients presenting with PPT in the hyperthyroid phase display symptoms including insomnia, anxiety, irritability, heat intolerance, fatigue, and palpitations, Ms. Kessler said. These women “are often told they have postpartum depression; they aren’t sleeping well, and they feel like they are failing as a mom.”

Patients in the hypothyroid phase may present with fatigue, depression, cold intolerance, dry skin, impaired concentration, and paresthesias, she noted.

Treatment for PPT depends on the stage patients are in when they present. For patients in the hyperthyroid phase, Ms. Kessler recommended beta-blockers for relief of symptoms including tremor and palpitations, but these should be tapered as symptoms decrease. “There is no need for antithyroid drugs for women in the hyperthyroid phase.”

For patients presenting in the hypothyroid phase, Ms. Kessler recommended levothyroxine for 6-12 months if needed, but the drug should be tapered and discontinued after PPT, as about 80% of patients will become euthyroid. However, approximately 50% of women with PPT will develop hypothyroidism in 2-10 years, so ongoing follow-up is essential for these patients.

Ms. Kessler disclosed serving as an adviser/speaker for Novo Nordisk, serving as a speaker for Salix and Acella, and serving as National Study Chair of probiotic use with antibiotics for Clarion Brand. Global Academy and this news organization are owned by the same parent company.

About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).

Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.

Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.

To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.

Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.

Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).

After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).

They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.

The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.

Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.

“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”

But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.

One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.

The authors have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).

Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.

Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.

To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.

Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.

Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).

After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).

They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.

The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.

Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.

“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”

But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.

One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.

The authors have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).

Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.

Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.

To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.

Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.

Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).

After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).

They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.

The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.

Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.

“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”

But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.

One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.

The authors have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.

Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.

Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.

In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.

Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.

Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.

Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
 

High-risk population

Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.

For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.

Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.

Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.

In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.

“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.

The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
 

An argument for fairness

Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.

“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.

“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.

“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.

Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.

Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.

Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.

In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.

Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.

Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.

Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
 

High-risk population

Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.

For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.

Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.

Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.

In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.

“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.

The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
 

An argument for fairness

Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.

“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.

“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.

“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.

Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.

Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.

Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.

In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.

Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.

Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.

Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
 

High-risk population

Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.

For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.

Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.

Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.

In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.

“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.

The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
 

An argument for fairness

Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.

“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.

“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.

“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.

Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.

This article first appeared on Medscape.com.