Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.

But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.

In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”

After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.

Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
 

Challenge: Reaching the rest

With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.

And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.

But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?

Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.

So what does work, according to these experts?

• Emphasizing the trends of more people getting vaccinated.
• Focusing on everyone’s freedom of choice.
• Listening to concerns without judgment.
• Offering credible information.
• Correcting myths when necessary.
• Helping them fit vaccination into their “world view.”

Stories over statistics

Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.

Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”

A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”

If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”

“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”

This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.

Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”

The person decided to get the vaccine.
 

‘Live in that space’

“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.

“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”

Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”

Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.

For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.

For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.

One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.

Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
 

From peer to peer

A theme that runs through many of these persuasion techniques is peer pressure.

One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.

“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”

For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.

Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
 

Let them talk, give them time

Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.

The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”

It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”

Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”

With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.

When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”

Those conversations are what convinced her to get vaccinated this summer.
 

Simpson’s transformation

Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.

Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.

Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.

So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.

These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”

So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.

“Facts help once you are already moved,” Ms. Simpson said.

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

Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.

But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.

In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”

After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.

Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
 

Challenge: Reaching the rest

With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.

And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.

But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?

Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.

So what does work, according to these experts?

• Emphasizing the trends of more people getting vaccinated.
• Focusing on everyone’s freedom of choice.
• Listening to concerns without judgment.
• Offering credible information.
• Correcting myths when necessary.
• Helping them fit vaccination into their “world view.”

Stories over statistics

Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.

Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”

A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”

If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”

“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”

This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.

Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”

The person decided to get the vaccine.
 

‘Live in that space’

“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.

“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”

Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”

Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.

For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.

For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.

One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.

Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
 

From peer to peer

A theme that runs through many of these persuasion techniques is peer pressure.

One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.

“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”

For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.

Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
 

Let them talk, give them time

Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.

The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”

It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”

Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”

With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.

When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”

Those conversations are what convinced her to get vaccinated this summer.
 

Simpson’s transformation

Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.

Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.

Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.

So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.

These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”

So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.

“Facts help once you are already moved,” Ms. Simpson said.

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

Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.

But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.

In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”

After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.

Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
 

Challenge: Reaching the rest

With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.

And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.

But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?

Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.

So what does work, according to these experts?

• Emphasizing the trends of more people getting vaccinated.
• Focusing on everyone’s freedom of choice.
• Listening to concerns without judgment.
• Offering credible information.
• Correcting myths when necessary.
• Helping them fit vaccination into their “world view.”

Stories over statistics

Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.

Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”

A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”

If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”

“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”

This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.

Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”

The person decided to get the vaccine.
 

‘Live in that space’

“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.

“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”

Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”

Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.

For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.

For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.

One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.

Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
 

From peer to peer

A theme that runs through many of these persuasion techniques is peer pressure.

One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.

“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”

For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.

Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
 

Let them talk, give them time

Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.

The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”

It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”

Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”

With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.

When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”

Those conversations are what convinced her to get vaccinated this summer.
 

Simpson’s transformation

Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.

Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.

Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.

So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.

These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”

So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.

“Facts help once you are already moved,” Ms. Simpson said.

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

Although well tolerated, metformin does not improve survival when given alongside chemoradiotherapy to patients with locally advanced non–small cell lung cancer (NSCLC), and may even make survival worse, suggest results from two recent phase 2 trials.

Epidemiologic studies have suggested that metformin is associated with a reduced incidence of cancer, while retrospective case studies have indicated that patients taking the drug have improved outcomes.

Moreover, preclinical data indicated that metformin has antineoplastic effects, with the drug showing both cytostatic and cytotoxic effects.

The current results cast doubt, however, over whether these benefits can be replicated in randomized controlled trials and thence brought to the clinic.

Despite this, “I don’t think metformin is dead,” commented Heath D. Skinner, MD, PhD, first author on one of the trials, published in JAMA Oncology.

He said in an interview there are “a few key areas where I think metformin could be of benefit” in lung cancer, such as in combination with tyrosine kinase inhibitors, or with immunotherapy.

Dr. Skinner also highlighted the unexpectedly good performance of standard chemoradiation, showing the “progress” that has been made in recent years in treatment delivery and quality.
 

No survival benefit

In the first trial, which was an open-label phase 2 study, NRG-LU001, patients with unresectable stage 3 NSCLC who did not have diabetes were randomized to carboplatin and paclitaxel-based chemoradiation either alone or with metformin.

Among the 167 patients eligible for analysis, 1-year progression-free survival (PFS) was 60.4% in the control group and 51.3% in the metformin group (P = .24) after a median follow-up of 27.7 months.

The only clinical factor associated with progression-free survival on multivariate analysis was clinical stage, at a hazard ratio of 1.79 (P = .05), reports Dr. Skinner, from the University of Pittsburgh Hillman Cancer Center, and colleagues.

With 1-year overall survival at 80.2% in the control group and 80.8% in the metformin arm, and no significant differences in rates of locoregional recurrence or distant metastasis, the team concluded that adding metformin to chemoradiation may have been “well tolerated but did not improve survival.”
 

Not recommended

The second randomized controlled trial, OCOG-ALMERA, involved patients with locally advanced NSCLC stratified into stages 3A and 3B, again without diabetes.

They were treated with platinum-based chemoradiotherapy, with chest radiotherapy with or without consolidation chemotherapy. They were randomized to metformin or no additional treatment for up to 12 months.

The trial had to be stopped early because of slow accrual, with only 54 patients randomized between 2014 and 2019, wrote the authors who were led by Theodoros Tsakiridis, MD, PhD, Juravinski Cancer Center, McMaster University, Hamilton, Ont.

The results revealed that treatment failure at 1 year was seen in 69.2% of metformin patients and 42.9% of those in the control arm.

The 1-year progression survival was markedly worse with metformin, at 34.8% versus 63.0% in the control arm and an HR for progression of 2.42, while overall survival was 47.4% versus 85.2% and an HR for death of 3.80.

With more than twice as many metformin than control patients reporting at least one grade 3 or higher adverse event, the researchers conclude the drug is “not recommended in patients with locally advanced non–small cell lung cancer who are candidates for chemoradiotherapy.”
 

Future research directions

Do these results sound the death knell for metformin in the treatment of lung cancer, or could lessons be learned from both studies that leave the door open for future research?

Chukwuka Eze, MD, of the University Hospital LMU Munich (Germany), thinks there may well be.

In an editorial accompanying the two studies, he and colleagues wrote: “Despite the negative results of both studies, invaluable information for the subsequent design of future trials could be extracted.”

For example, “there might yet be a role for metformin in selected patients with non–small cell lung cancer patients,” they continued, such as those with KRAS/LKB1-mutated tumors, or with tumors that have elevated fluorodeoxyglucose metabolism.

They also suggested that future studies should include continuous assessment of metabolic parameters and “comprehensive” analysis of responses on imaging, as well as biomarker analysis.

Moreover, in the era of immuno-oncology, “special attention to the immunomodulatory effects of metformin in the host and tumor are pertinent.”
 

Better-than-expected outcomes

Beyond that, both studies were hampered by limitations that make drawing conclusions difficult.

In the OCOG-ALMERA trial, the lack of double-blinding or placebo control, and limited accrual are identified by the authors as “weaknesses.”

The “much slower than anticipated” accrual may have been caused not only by exclusion of patients with diabetes, but also bias against the trial among physicians, who may have looked instead to immunotherapy trials for their patients.

On the other hand, the issue for NRG-LU001 was the “better-than-expected” performance of control arm, the researchers noted.

They make the comparison with the PACIFIC trial, which showed that giving durvalumab (Imfinzi, AstraZeneca) after platinum-based doublet chemotherapy and concurrent radiotherapy was associated with a doubling of progression-free survival over chemoradiation alone.

However, Dr. Skinner and colleagues pointed out that the 1-year progression-free survival achieved in PACIFIC with durvalumab after chemoradiotherapy was, at 55.9%, lower than that seen in the control arm of NRG-LU001.

“The PFS in NRG-LU001 remains striking, particularly as PACIFIC trial patients were randomized only when progression was not detected after concurrent chemoradiation,” the researchers wrote.

Dr. Skinner said in an interview they expected the control arm in their study “to do far worse than it actually did.”

He continued that they did not follow up chemoradiation with adjuvant immunotherapy, as would be the case nowadays, because it was “not the standard when we started the trial,” and did not become so “until the very end of accrual.”

Dr. Skinner warned that there are “many caveats” to comparing two different trials, but looking at the current results alongside those from PACIFIC, he said that, “for me, it seems like we have been making progress in the delivery of concurrent chemoradiation. I think that good quality concurrent chemoradiation and improvement in delivery really is one of the take-homes from this trial.”

NRG-LU001 was supported by grants from NRG Oncology and the National Cancer Institute. OCOG-ALMERA was funded by a grant from the Canadian Institutes of Health Research to Dr Tsakiridis. The Ontario Clinical Oncology Group assumed the role of the sponsor of this trial. Dr. Skinner reported receiving research funding from the National Cancer Institute and National Institute of Dental and Craniofacial Research outside the submitted work and has previously received a grant from the National Cancer Institute for a separate metformin-related clinical trial. Dr. Tsakiridis reported receiving a grant from Sanofi Canada for prostate cancer research outside the submitted work. Dr. Eze declares no relevant relationships.

Although well tolerated, metformin does not improve survival when given alongside chemoradiotherapy to patients with locally advanced non–small cell lung cancer (NSCLC), and may even make survival worse, suggest results from two recent phase 2 trials.

Epidemiologic studies have suggested that metformin is associated with a reduced incidence of cancer, while retrospective case studies have indicated that patients taking the drug have improved outcomes.

Moreover, preclinical data indicated that metformin has antineoplastic effects, with the drug showing both cytostatic and cytotoxic effects.

The current results cast doubt, however, over whether these benefits can be replicated in randomized controlled trials and thence brought to the clinic.

Despite this, “I don’t think metformin is dead,” commented Heath D. Skinner, MD, PhD, first author on one of the trials, published in JAMA Oncology.

He said in an interview there are “a few key areas where I think metformin could be of benefit” in lung cancer, such as in combination with tyrosine kinase inhibitors, or with immunotherapy.

Dr. Skinner also highlighted the unexpectedly good performance of standard chemoradiation, showing the “progress” that has been made in recent years in treatment delivery and quality.
 

No survival benefit

In the first trial, which was an open-label phase 2 study, NRG-LU001, patients with unresectable stage 3 NSCLC who did not have diabetes were randomized to carboplatin and paclitaxel-based chemoradiation either alone or with metformin.

Among the 167 patients eligible for analysis, 1-year progression-free survival (PFS) was 60.4% in the control group and 51.3% in the metformin group (P = .24) after a median follow-up of 27.7 months.

The only clinical factor associated with progression-free survival on multivariate analysis was clinical stage, at a hazard ratio of 1.79 (P = .05), reports Dr. Skinner, from the University of Pittsburgh Hillman Cancer Center, and colleagues.

With 1-year overall survival at 80.2% in the control group and 80.8% in the metformin arm, and no significant differences in rates of locoregional recurrence or distant metastasis, the team concluded that adding metformin to chemoradiation may have been “well tolerated but did not improve survival.”
 

Not recommended

The second randomized controlled trial, OCOG-ALMERA, involved patients with locally advanced NSCLC stratified into stages 3A and 3B, again without diabetes.

They were treated with platinum-based chemoradiotherapy, with chest radiotherapy with or without consolidation chemotherapy. They were randomized to metformin or no additional treatment for up to 12 months.

The trial had to be stopped early because of slow accrual, with only 54 patients randomized between 2014 and 2019, wrote the authors who were led by Theodoros Tsakiridis, MD, PhD, Juravinski Cancer Center, McMaster University, Hamilton, Ont.

The results revealed that treatment failure at 1 year was seen in 69.2% of metformin patients and 42.9% of those in the control arm.

The 1-year progression survival was markedly worse with metformin, at 34.8% versus 63.0% in the control arm and an HR for progression of 2.42, while overall survival was 47.4% versus 85.2% and an HR for death of 3.80.

With more than twice as many metformin than control patients reporting at least one grade 3 or higher adverse event, the researchers conclude the drug is “not recommended in patients with locally advanced non–small cell lung cancer who are candidates for chemoradiotherapy.”
 

Future research directions

Do these results sound the death knell for metformin in the treatment of lung cancer, or could lessons be learned from both studies that leave the door open for future research?

Chukwuka Eze, MD, of the University Hospital LMU Munich (Germany), thinks there may well be.

In an editorial accompanying the two studies, he and colleagues wrote: “Despite the negative results of both studies, invaluable information for the subsequent design of future trials could be extracted.”

For example, “there might yet be a role for metformin in selected patients with non–small cell lung cancer patients,” they continued, such as those with KRAS/LKB1-mutated tumors, or with tumors that have elevated fluorodeoxyglucose metabolism.

They also suggested that future studies should include continuous assessment of metabolic parameters and “comprehensive” analysis of responses on imaging, as well as biomarker analysis.

Moreover, in the era of immuno-oncology, “special attention to the immunomodulatory effects of metformin in the host and tumor are pertinent.”
 

Better-than-expected outcomes

Beyond that, both studies were hampered by limitations that make drawing conclusions difficult.

In the OCOG-ALMERA trial, the lack of double-blinding or placebo control, and limited accrual are identified by the authors as “weaknesses.”

The “much slower than anticipated” accrual may have been caused not only by exclusion of patients with diabetes, but also bias against the trial among physicians, who may have looked instead to immunotherapy trials for their patients.

On the other hand, the issue for NRG-LU001 was the “better-than-expected” performance of control arm, the researchers noted.

They make the comparison with the PACIFIC trial, which showed that giving durvalumab (Imfinzi, AstraZeneca) after platinum-based doublet chemotherapy and concurrent radiotherapy was associated with a doubling of progression-free survival over chemoradiation alone.

However, Dr. Skinner and colleagues pointed out that the 1-year progression-free survival achieved in PACIFIC with durvalumab after chemoradiotherapy was, at 55.9%, lower than that seen in the control arm of NRG-LU001.

“The PFS in NRG-LU001 remains striking, particularly as PACIFIC trial patients were randomized only when progression was not detected after concurrent chemoradiation,” the researchers wrote.

Dr. Skinner said in an interview they expected the control arm in their study “to do far worse than it actually did.”

He continued that they did not follow up chemoradiation with adjuvant immunotherapy, as would be the case nowadays, because it was “not the standard when we started the trial,” and did not become so “until the very end of accrual.”

Dr. Skinner warned that there are “many caveats” to comparing two different trials, but looking at the current results alongside those from PACIFIC, he said that, “for me, it seems like we have been making progress in the delivery of concurrent chemoradiation. I think that good quality concurrent chemoradiation and improvement in delivery really is one of the take-homes from this trial.”

NRG-LU001 was supported by grants from NRG Oncology and the National Cancer Institute. OCOG-ALMERA was funded by a grant from the Canadian Institutes of Health Research to Dr Tsakiridis. The Ontario Clinical Oncology Group assumed the role of the sponsor of this trial. Dr. Skinner reported receiving research funding from the National Cancer Institute and National Institute of Dental and Craniofacial Research outside the submitted work and has previously received a grant from the National Cancer Institute for a separate metformin-related clinical trial. Dr. Tsakiridis reported receiving a grant from Sanofi Canada for prostate cancer research outside the submitted work. Dr. Eze declares no relevant relationships.

Although well tolerated, metformin does not improve survival when given alongside chemoradiotherapy to patients with locally advanced non–small cell lung cancer (NSCLC), and may even make survival worse, suggest results from two recent phase 2 trials.

Epidemiologic studies have suggested that metformin is associated with a reduced incidence of cancer, while retrospective case studies have indicated that patients taking the drug have improved outcomes.

Moreover, preclinical data indicated that metformin has antineoplastic effects, with the drug showing both cytostatic and cytotoxic effects.

The current results cast doubt, however, over whether these benefits can be replicated in randomized controlled trials and thence brought to the clinic.

Despite this, “I don’t think metformin is dead,” commented Heath D. Skinner, MD, PhD, first author on one of the trials, published in JAMA Oncology.

He said in an interview there are “a few key areas where I think metformin could be of benefit” in lung cancer, such as in combination with tyrosine kinase inhibitors, or with immunotherapy.

Dr. Skinner also highlighted the unexpectedly good performance of standard chemoradiation, showing the “progress” that has been made in recent years in treatment delivery and quality.
 

No survival benefit

In the first trial, which was an open-label phase 2 study, NRG-LU001, patients with unresectable stage 3 NSCLC who did not have diabetes were randomized to carboplatin and paclitaxel-based chemoradiation either alone or with metformin.

Among the 167 patients eligible for analysis, 1-year progression-free survival (PFS) was 60.4% in the control group and 51.3% in the metformin group (P = .24) after a median follow-up of 27.7 months.

The only clinical factor associated with progression-free survival on multivariate analysis was clinical stage, at a hazard ratio of 1.79 (P = .05), reports Dr. Skinner, from the University of Pittsburgh Hillman Cancer Center, and colleagues.

With 1-year overall survival at 80.2% in the control group and 80.8% in the metformin arm, and no significant differences in rates of locoregional recurrence or distant metastasis, the team concluded that adding metformin to chemoradiation may have been “well tolerated but did not improve survival.”
 

Not recommended

The second randomized controlled trial, OCOG-ALMERA, involved patients with locally advanced NSCLC stratified into stages 3A and 3B, again without diabetes.

They were treated with platinum-based chemoradiotherapy, with chest radiotherapy with or without consolidation chemotherapy. They were randomized to metformin or no additional treatment for up to 12 months.

The trial had to be stopped early because of slow accrual, with only 54 patients randomized between 2014 and 2019, wrote the authors who were led by Theodoros Tsakiridis, MD, PhD, Juravinski Cancer Center, McMaster University, Hamilton, Ont.

The results revealed that treatment failure at 1 year was seen in 69.2% of metformin patients and 42.9% of those in the control arm.

The 1-year progression survival was markedly worse with metformin, at 34.8% versus 63.0% in the control arm and an HR for progression of 2.42, while overall survival was 47.4% versus 85.2% and an HR for death of 3.80.

With more than twice as many metformin than control patients reporting at least one grade 3 or higher adverse event, the researchers conclude the drug is “not recommended in patients with locally advanced non–small cell lung cancer who are candidates for chemoradiotherapy.”
 

Future research directions

Do these results sound the death knell for metformin in the treatment of lung cancer, or could lessons be learned from both studies that leave the door open for future research?

Chukwuka Eze, MD, of the University Hospital LMU Munich (Germany), thinks there may well be.

In an editorial accompanying the two studies, he and colleagues wrote: “Despite the negative results of both studies, invaluable information for the subsequent design of future trials could be extracted.”

For example, “there might yet be a role for metformin in selected patients with non–small cell lung cancer patients,” they continued, such as those with KRAS/LKB1-mutated tumors, or with tumors that have elevated fluorodeoxyglucose metabolism.

They also suggested that future studies should include continuous assessment of metabolic parameters and “comprehensive” analysis of responses on imaging, as well as biomarker analysis.

Moreover, in the era of immuno-oncology, “special attention to the immunomodulatory effects of metformin in the host and tumor are pertinent.”
 

Better-than-expected outcomes

Beyond that, both studies were hampered by limitations that make drawing conclusions difficult.

In the OCOG-ALMERA trial, the lack of double-blinding or placebo control, and limited accrual are identified by the authors as “weaknesses.”

The “much slower than anticipated” accrual may have been caused not only by exclusion of patients with diabetes, but also bias against the trial among physicians, who may have looked instead to immunotherapy trials for their patients.

On the other hand, the issue for NRG-LU001 was the “better-than-expected” performance of control arm, the researchers noted.

They make the comparison with the PACIFIC trial, which showed that giving durvalumab (Imfinzi, AstraZeneca) after platinum-based doublet chemotherapy and concurrent radiotherapy was associated with a doubling of progression-free survival over chemoradiation alone.

However, Dr. Skinner and colleagues pointed out that the 1-year progression-free survival achieved in PACIFIC with durvalumab after chemoradiotherapy was, at 55.9%, lower than that seen in the control arm of NRG-LU001.

“The PFS in NRG-LU001 remains striking, particularly as PACIFIC trial patients were randomized only when progression was not detected after concurrent chemoradiation,” the researchers wrote.

Dr. Skinner said in an interview they expected the control arm in their study “to do far worse than it actually did.”

He continued that they did not follow up chemoradiation with adjuvant immunotherapy, as would be the case nowadays, because it was “not the standard when we started the trial,” and did not become so “until the very end of accrual.”

Dr. Skinner warned that there are “many caveats” to comparing two different trials, but looking at the current results alongside those from PACIFIC, he said that, “for me, it seems like we have been making progress in the delivery of concurrent chemoradiation. I think that good quality concurrent chemoradiation and improvement in delivery really is one of the take-homes from this trial.”

NRG-LU001 was supported by grants from NRG Oncology and the National Cancer Institute. OCOG-ALMERA was funded by a grant from the Canadian Institutes of Health Research to Dr Tsakiridis. The Ontario Clinical Oncology Group assumed the role of the sponsor of this trial. Dr. Skinner reported receiving research funding from the National Cancer Institute and National Institute of Dental and Craniofacial Research outside the submitted work and has previously received a grant from the National Cancer Institute for a separate metformin-related clinical trial. Dr. Tsakiridis reported receiving a grant from Sanofi Canada for prostate cancer research outside the submitted work. Dr. Eze declares no relevant relationships.

Equine therapy, which involves interactions with horses in a controlled environment, reduces fear and other symptoms of posttraumatic stress disorder, new research suggests.

Man O'War Project

Results from a study of about 60 military veterans who underwent weekly sessions of horse-assisted therapy showed “marked reductions” in clinician-rated and self-reported symptoms of PTSD and depression up to 3 months post treatment.

“What we’re doing here with horses is helping people overcome something very specific to PTSD,” coinvestigator Yuval Neria, PhD, professor of clinical medical psychology and director of the PTSD treatment and research program, Columbia University Medical Center, New York, said in an interview.

“It offers the opportunity to overcome fear, to facilitate self-efficacy, to facilitate trust in yourself, to understand your feelings, and perhaps to change them over time, he said.

In addition, veterans loved the experience, Dr. Neria reported. He noted that many patients with PTSD have trouble with traditional treatments and are eager to try something “creative and new.”

The findings were published online Aug. 31, 2021, in the Journal of Clinical Psychiatry.
 

Building bonds

PTSD affects an estimated 10%-30% of U.S. military personnel. These rates are higher than in the general population because veterans may experience increased trauma through combat, injury, and sexual assault, the investigators noted.

Previous research has suggested that horse-human interactions can build bonds that foster behavioral changes. These powerful animals provide instantaneous feedback, allowing patients to develop emotional awareness.

“Horses are very sensitive to whatever we communicate with them, whether it’s fear or anger or stress,” said Dr. Neria.

Equine-assisted therapy is increasingly being used for various mental and physical conditions. Launching an open-label study to examine this type of treatment for PTSD “was an opportunity to look at something very, very different,” Dr. Neria said.

“This is not psychotherapy, it’s not medication, and it’s not neural stimulation,” he added.

The study included 63 veterans with PTSD (mean age, 50 years; 37% women). Of these, 47 were receiving psychotherapy alone, pharmacotherapy alone, or both. In addition, 48 had at least one comorbid disorder. All were divided into 16 groups of three to five participants each.

The program consisted of eight 90-minute weekly sessions conducted at a large equestrian center. Sessions were coled by a mental health professional and an equine specialist who guided participants in horse communication and behavior.

Early sessions focused on acquainting patients with the horses, grooming exercises, and learning “leading,” which involved directing a horse with a rope or wand. During subsequent sessions, patients became more comfortable with managing the horses in individual and teamwork exercises.

The horses were specifically chosen for their temperament and had no history of aggression. A horse wrangler attended sessions to further ensure safety.
 

Few dropouts

The study included four assessment points: pretreatment, midpoint, post treatment, and 3-month follow-up.

All 63 participants completed baseline assessments. Only five patients (7.9%) discontinued the program.

“We didn’t see dropouts at the rate we usually see in evidence-based therapies for PTSD, which is remarkable and suggests that people really loved it,” said Dr. Neria.

Man O'War Project

The primary outcome was the Clinician-Administered PTSD Scale–5 (CAPS-5), a structured interview that evaluates intrusive memories, social avoidance, and other symptoms based on DSM-5 criteria.

In the intent-to-treat analysis, mean CAPS-5 scores decreased from 38.6 at baseline to 26.9 post treatment. In addition, 29 (46.0%) and 23 (36.5%) participants scored below the PTSD diagnostic threshold of 25 at posttreatment and follow-up, respectively.

Notably, 50.8% of the study population had a clinically significant change, defined as 30% or greater decrease in CAPS-5 score, at post treatment; 54.0% had a significant change at follow-up.

Mean scores on the self-reported 20-item PTSD Checklist for DSM-5 questionnaire decreased from 50.7 at baseline to 34.6 at study termination.

Depression symptoms, measured by the clinician-rated Hamilton Depression Rating Scale and the self-reported Beck Depression Inventory–II, also improved.
 

Structural, functional change

The results did not differ by age, gender, or type of trauma. Dr. Neria noted that many women in the study had suffered sexual abuse or assault, suggesting that the intervention might be appropriate for PTSD outside the military.

“I’m very keen on moving this along into a civilian population,” he said.

The study did not examine potential mechanisms of action. The benefits may come from something inherent in the equine interactions, the human group process, or just being in the beautiful setting where the treatment took place, the investigators noted.

However, Dr. Neria thinks there is another potential explanation – real changes in the brain.

Neuroimaging of a subsample of 20 participants before and after the intervention showed a significant increase in caudate functional connectivity and a reduction in gray matter density of the thalamus and the caudate.

“We see a big change both structurally and functionally,” with the results pointing to an impact on the reward network of the brain, said Dr. Neria.

“This suggests that pleasure was perhaps the main mechanism of action,” which corresponds with patient reports of really enjoying the experience, he added.

Dr. Neria noted that equine therapy is different from bonding with a loyal dog. Interacting with a large and powerful animal may give veterans a sense of accomplishment and self-worth, which can be tremendously therapeutic.
 

Next step in therapy?

Commenting on the research, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, called equine therapy “innovative” in PTSD.

“I see this as the next step in finding acceptable therapies that people like to do,” she said.

Some patients have an aversion to talk therapy because it makes them relive their trauma; and many dislike the side effects of medications, which can include erectile dysfunction, said Dr. Ritchie, who was not involved with the research.

“So something like this that they can enjoy, have a sense of mastery, can bond with an animal, I think is wonderful,” she said.

Dr. Ritchie noted that working with animals offers “a kind of biofeedback” that may calm anxieties, help maintain control, and “is very nonjudgmental.”

However, she pointed out that equine therapy is not new. For example, horses have been used previously to treat patients with a variety of disabilities, including autism.

Dr. Ritchie thought it was “very wise” that study participants just learned to control the horses and didn’t actually ride them, because that could be a frightening experience.

Nonetheless, she noted equine therapy “is not going to be accessible for everybody.”

In addition, Dr. Ritchie was surprised that the investigators didn’t mention more of the quite extensive research that has been conducted on dog therapy in patients with PTSD.

Dr. Neria and Ritchie disclosed no relevant financial relationships.

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

Equine therapy, which involves interactions with horses in a controlled environment, reduces fear and other symptoms of posttraumatic stress disorder, new research suggests.

Man O'War Project

Results from a study of about 60 military veterans who underwent weekly sessions of horse-assisted therapy showed “marked reductions” in clinician-rated and self-reported symptoms of PTSD and depression up to 3 months post treatment.

“What we’re doing here with horses is helping people overcome something very specific to PTSD,” coinvestigator Yuval Neria, PhD, professor of clinical medical psychology and director of the PTSD treatment and research program, Columbia University Medical Center, New York, said in an interview.

“It offers the opportunity to overcome fear, to facilitate self-efficacy, to facilitate trust in yourself, to understand your feelings, and perhaps to change them over time, he said.

In addition, veterans loved the experience, Dr. Neria reported. He noted that many patients with PTSD have trouble with traditional treatments and are eager to try something “creative and new.”

The findings were published online Aug. 31, 2021, in the Journal of Clinical Psychiatry.
 

Building bonds

PTSD affects an estimated 10%-30% of U.S. military personnel. These rates are higher than in the general population because veterans may experience increased trauma through combat, injury, and sexual assault, the investigators noted.

Previous research has suggested that horse-human interactions can build bonds that foster behavioral changes. These powerful animals provide instantaneous feedback, allowing patients to develop emotional awareness.

“Horses are very sensitive to whatever we communicate with them, whether it’s fear or anger or stress,” said Dr. Neria.

Equine-assisted therapy is increasingly being used for various mental and physical conditions. Launching an open-label study to examine this type of treatment for PTSD “was an opportunity to look at something very, very different,” Dr. Neria said.

“This is not psychotherapy, it’s not medication, and it’s not neural stimulation,” he added.

The study included 63 veterans with PTSD (mean age, 50 years; 37% women). Of these, 47 were receiving psychotherapy alone, pharmacotherapy alone, or both. In addition, 48 had at least one comorbid disorder. All were divided into 16 groups of three to five participants each.

The program consisted of eight 90-minute weekly sessions conducted at a large equestrian center. Sessions were coled by a mental health professional and an equine specialist who guided participants in horse communication and behavior.

Early sessions focused on acquainting patients with the horses, grooming exercises, and learning “leading,” which involved directing a horse with a rope or wand. During subsequent sessions, patients became more comfortable with managing the horses in individual and teamwork exercises.

The horses were specifically chosen for their temperament and had no history of aggression. A horse wrangler attended sessions to further ensure safety.
 

Few dropouts

The study included four assessment points: pretreatment, midpoint, post treatment, and 3-month follow-up.

All 63 participants completed baseline assessments. Only five patients (7.9%) discontinued the program.

“We didn’t see dropouts at the rate we usually see in evidence-based therapies for PTSD, which is remarkable and suggests that people really loved it,” said Dr. Neria.

Man O'War Project

The primary outcome was the Clinician-Administered PTSD Scale–5 (CAPS-5), a structured interview that evaluates intrusive memories, social avoidance, and other symptoms based on DSM-5 criteria.

In the intent-to-treat analysis, mean CAPS-5 scores decreased from 38.6 at baseline to 26.9 post treatment. In addition, 29 (46.0%) and 23 (36.5%) participants scored below the PTSD diagnostic threshold of 25 at posttreatment and follow-up, respectively.

Notably, 50.8% of the study population had a clinically significant change, defined as 30% or greater decrease in CAPS-5 score, at post treatment; 54.0% had a significant change at follow-up.

Mean scores on the self-reported 20-item PTSD Checklist for DSM-5 questionnaire decreased from 50.7 at baseline to 34.6 at study termination.

Depression symptoms, measured by the clinician-rated Hamilton Depression Rating Scale and the self-reported Beck Depression Inventory–II, also improved.
 

Structural, functional change

The results did not differ by age, gender, or type of trauma. Dr. Neria noted that many women in the study had suffered sexual abuse or assault, suggesting that the intervention might be appropriate for PTSD outside the military.

“I’m very keen on moving this along into a civilian population,” he said.

The study did not examine potential mechanisms of action. The benefits may come from something inherent in the equine interactions, the human group process, or just being in the beautiful setting where the treatment took place, the investigators noted.

However, Dr. Neria thinks there is another potential explanation – real changes in the brain.

Neuroimaging of a subsample of 20 participants before and after the intervention showed a significant increase in caudate functional connectivity and a reduction in gray matter density of the thalamus and the caudate.

“We see a big change both structurally and functionally,” with the results pointing to an impact on the reward network of the brain, said Dr. Neria.

“This suggests that pleasure was perhaps the main mechanism of action,” which corresponds with patient reports of really enjoying the experience, he added.

Dr. Neria noted that equine therapy is different from bonding with a loyal dog. Interacting with a large and powerful animal may give veterans a sense of accomplishment and self-worth, which can be tremendously therapeutic.
 

Next step in therapy?

Commenting on the research, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, called equine therapy “innovative” in PTSD.

“I see this as the next step in finding acceptable therapies that people like to do,” she said.

Some patients have an aversion to talk therapy because it makes them relive their trauma; and many dislike the side effects of medications, which can include erectile dysfunction, said Dr. Ritchie, who was not involved with the research.

“So something like this that they can enjoy, have a sense of mastery, can bond with an animal, I think is wonderful,” she said.

Dr. Ritchie noted that working with animals offers “a kind of biofeedback” that may calm anxieties, help maintain control, and “is very nonjudgmental.”

However, she pointed out that equine therapy is not new. For example, horses have been used previously to treat patients with a variety of disabilities, including autism.

Dr. Ritchie thought it was “very wise” that study participants just learned to control the horses and didn’t actually ride them, because that could be a frightening experience.

Nonetheless, she noted equine therapy “is not going to be accessible for everybody.”

In addition, Dr. Ritchie was surprised that the investigators didn’t mention more of the quite extensive research that has been conducted on dog therapy in patients with PTSD.

Dr. Neria and Ritchie disclosed no relevant financial relationships.

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

Equine therapy, which involves interactions with horses in a controlled environment, reduces fear and other symptoms of posttraumatic stress disorder, new research suggests.

Man O'War Project

Results from a study of about 60 military veterans who underwent weekly sessions of horse-assisted therapy showed “marked reductions” in clinician-rated and self-reported symptoms of PTSD and depression up to 3 months post treatment.

“What we’re doing here with horses is helping people overcome something very specific to PTSD,” coinvestigator Yuval Neria, PhD, professor of clinical medical psychology and director of the PTSD treatment and research program, Columbia University Medical Center, New York, said in an interview.

“It offers the opportunity to overcome fear, to facilitate self-efficacy, to facilitate trust in yourself, to understand your feelings, and perhaps to change them over time, he said.

In addition, veterans loved the experience, Dr. Neria reported. He noted that many patients with PTSD have trouble with traditional treatments and are eager to try something “creative and new.”

The findings were published online Aug. 31, 2021, in the Journal of Clinical Psychiatry.
 

Building bonds

PTSD affects an estimated 10%-30% of U.S. military personnel. These rates are higher than in the general population because veterans may experience increased trauma through combat, injury, and sexual assault, the investigators noted.

Previous research has suggested that horse-human interactions can build bonds that foster behavioral changes. These powerful animals provide instantaneous feedback, allowing patients to develop emotional awareness.

“Horses are very sensitive to whatever we communicate with them, whether it’s fear or anger or stress,” said Dr. Neria.

Equine-assisted therapy is increasingly being used for various mental and physical conditions. Launching an open-label study to examine this type of treatment for PTSD “was an opportunity to look at something very, very different,” Dr. Neria said.

“This is not psychotherapy, it’s not medication, and it’s not neural stimulation,” he added.

The study included 63 veterans with PTSD (mean age, 50 years; 37% women). Of these, 47 were receiving psychotherapy alone, pharmacotherapy alone, or both. In addition, 48 had at least one comorbid disorder. All were divided into 16 groups of three to five participants each.

The program consisted of eight 90-minute weekly sessions conducted at a large equestrian center. Sessions were coled by a mental health professional and an equine specialist who guided participants in horse communication and behavior.

Early sessions focused on acquainting patients with the horses, grooming exercises, and learning “leading,” which involved directing a horse with a rope or wand. During subsequent sessions, patients became more comfortable with managing the horses in individual and teamwork exercises.

The horses were specifically chosen for their temperament and had no history of aggression. A horse wrangler attended sessions to further ensure safety.
 

Few dropouts

The study included four assessment points: pretreatment, midpoint, post treatment, and 3-month follow-up.

All 63 participants completed baseline assessments. Only five patients (7.9%) discontinued the program.

“We didn’t see dropouts at the rate we usually see in evidence-based therapies for PTSD, which is remarkable and suggests that people really loved it,” said Dr. Neria.

Man O'War Project

The primary outcome was the Clinician-Administered PTSD Scale–5 (CAPS-5), a structured interview that evaluates intrusive memories, social avoidance, and other symptoms based on DSM-5 criteria.

In the intent-to-treat analysis, mean CAPS-5 scores decreased from 38.6 at baseline to 26.9 post treatment. In addition, 29 (46.0%) and 23 (36.5%) participants scored below the PTSD diagnostic threshold of 25 at posttreatment and follow-up, respectively.

Notably, 50.8% of the study population had a clinically significant change, defined as 30% or greater decrease in CAPS-5 score, at post treatment; 54.0% had a significant change at follow-up.

Mean scores on the self-reported 20-item PTSD Checklist for DSM-5 questionnaire decreased from 50.7 at baseline to 34.6 at study termination.

Depression symptoms, measured by the clinician-rated Hamilton Depression Rating Scale and the self-reported Beck Depression Inventory–II, also improved.
 

Structural, functional change

The results did not differ by age, gender, or type of trauma. Dr. Neria noted that many women in the study had suffered sexual abuse or assault, suggesting that the intervention might be appropriate for PTSD outside the military.

“I’m very keen on moving this along into a civilian population,” he said.

The study did not examine potential mechanisms of action. The benefits may come from something inherent in the equine interactions, the human group process, or just being in the beautiful setting where the treatment took place, the investigators noted.

However, Dr. Neria thinks there is another potential explanation – real changes in the brain.

Neuroimaging of a subsample of 20 participants before and after the intervention showed a significant increase in caudate functional connectivity and a reduction in gray matter density of the thalamus and the caudate.

“We see a big change both structurally and functionally,” with the results pointing to an impact on the reward network of the brain, said Dr. Neria.

“This suggests that pleasure was perhaps the main mechanism of action,” which corresponds with patient reports of really enjoying the experience, he added.

Dr. Neria noted that equine therapy is different from bonding with a loyal dog. Interacting with a large and powerful animal may give veterans a sense of accomplishment and self-worth, which can be tremendously therapeutic.
 

Next step in therapy?

Commenting on the research, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, called equine therapy “innovative” in PTSD.

“I see this as the next step in finding acceptable therapies that people like to do,” she said.

Some patients have an aversion to talk therapy because it makes them relive their trauma; and many dislike the side effects of medications, which can include erectile dysfunction, said Dr. Ritchie, who was not involved with the research.

“So something like this that they can enjoy, have a sense of mastery, can bond with an animal, I think is wonderful,” she said.

Dr. Ritchie noted that working with animals offers “a kind of biofeedback” that may calm anxieties, help maintain control, and “is very nonjudgmental.”

However, she pointed out that equine therapy is not new. For example, horses have been used previously to treat patients with a variety of disabilities, including autism.

Dr. Ritchie thought it was “very wise” that study participants just learned to control the horses and didn’t actually ride them, because that could be a frightening experience.

Nonetheless, she noted equine therapy “is not going to be accessible for everybody.”

In addition, Dr. Ritchie was surprised that the investigators didn’t mention more of the quite extensive research that has been conducted on dog therapy in patients with PTSD.

Dr. Neria and Ritchie disclosed no relevant financial relationships.

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

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major driver of disease-related morbidity. Their prevention and treatment are a focus of COPD management. Antibiotics, corticosteroids, and nebulized bronchodilators are all given to patients with AECOPD, and while the supporting data aren’t perfect, there’s little debate surrounding their use. These medications are well known to most physicians; we’re comfortable with their efficacy and aware of their side effects. They are nothing if not familiar.

What about magnesium (Mg), though? Apparently, in the emergency room (ER) it is part of the standard AECOPD cocktail. I would argue that Mg is familiar to most too; every internal medicine trainee in the United States is taught to infuse 2 g of Mg intravenously for any inpatient (ICU or otherwise) with a serum level <2.0 mg/dL. In fact, “electrolyte protocols” are part of the order sets at most hospitals where I’ve worked. Mg is infused reflexively when it drops below certain levels.

I’m less familiar with using Mg in the setting of an AECOPD, though. A recent online post by an academic ER physician (Richard Pescatore, DO) urged caution in this setting. He argues that too many in the ER are embracing the “Dutch Hypothesis” and treating asthma and COPD as the same disease. Dr. Pescatore believes that Mg works for asthma exacerbations because asthma is a disease of smooth muscle and large airways, while COPD is not. COPD, he says, is a disease of the small airways, largely resulting from parenchymal distortions due to emphysema. Therefore, Mg, which is thought to act on the smooth muscle surrounding the large airways, won’t be beneficial for AECOPD and may even cause harm.

Data are lacking

What data exist for using Mg for AECOPD? The best randomized controlled trial (RCT) I could find was published in 1995 and is cited in the reader’s rebuttal. The trial found a significant improvement in peak expiratory flow rate (PEFR) with Mg and a nonsignificant reduction in hospitalizations.

A poorly done systematic review of RCTs using Mg for AECOPD was published in 2014, and in 2020 the Agency for Healthcare Research and Quality (AHRQ) included Mg in its well-executed meta-analysis of pharmacologic treatments for AECOPD. Data across the four to five Mg RCTs included in each of the reviews (study inclusion criteria were slightly different) could not be combined. All RCTs were small, and only soft outcomes like PEFR and forced expiratory volume in 1 second (FEV1) seemed to improve with Mg. No adverse events were noted, but this should be interpreted with caution given that many studies did not report on adverse events at all.

A small RCT published this year (after both systematic reviews were completed) showed that using intravenous magnesium sulfate had no significant effect on FEV1, vital signs, or symptoms.

In summary, the data aren’t great. Mg doesn’t show up at all as a treatment option in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report on COPD, and the authors of the AHRQ review concluded that large, high-quality RCTs are needed to assess the impact of Mg in AECOPD. Although I didn’t do an extensive review of Mg for asthma exacerbations, it’s not clear that the data here are much better. Mg gets an honorable mention (add for severe exacerbations when there’s inadequate response to standard treatments) in both the 2007 National Heart, Lung, and Blood Institute (NHLBI) guideline and the 2019 Global Initiative for Asthma (GINA) guide. The 2020 update to the 2007 NHLBI guideline is more targeted in its review and does not cover Mg as a treatment option. On the basis of my anecdotal clinical experience and on networking with airway experts, I do think Mg is used more often for asthma than for AECOPD.

Final thoughts on using Mg for AECOPD

All that being said, is it reasonable to use Mg for AECOPD? I think so. I’d stick to using it for severe cases where conventional treatments have failed, just like the NHLBI and GINA advise for asthma. I’d also limit it to 2-3 g, which is the dosing range employed by several of the existing AECOPD RCTs. The assertion that Mg may be harmful in AECOPD because COPD affects the small airways, and asthma does not, is misguided. Both affect the small airways. Furthermore, none of our inhaled therapies reach the small airways, so one can’t argue against using Mg because it only targets larger airways without abandoning albuterol and ipratropium as well. I don’t think anyone would advise that. Given what we now know about asthma and COPD phenotypes and asthma-COPD overlap, I’d caution against pedantic theories about response to therapies.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He has received research grants from Fisher-Paykel and has received payments from the American College of Chest Physicians.

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

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major driver of disease-related morbidity. Their prevention and treatment are a focus of COPD management. Antibiotics, corticosteroids, and nebulized bronchodilators are all given to patients with AECOPD, and while the supporting data aren’t perfect, there’s little debate surrounding their use. These medications are well known to most physicians; we’re comfortable with their efficacy and aware of their side effects. They are nothing if not familiar.

What about magnesium (Mg), though? Apparently, in the emergency room (ER) it is part of the standard AECOPD cocktail. I would argue that Mg is familiar to most too; every internal medicine trainee in the United States is taught to infuse 2 g of Mg intravenously for any inpatient (ICU or otherwise) with a serum level <2.0 mg/dL. In fact, “electrolyte protocols” are part of the order sets at most hospitals where I’ve worked. Mg is infused reflexively when it drops below certain levels.

I’m less familiar with using Mg in the setting of an AECOPD, though. A recent online post by an academic ER physician (Richard Pescatore, DO) urged caution in this setting. He argues that too many in the ER are embracing the “Dutch Hypothesis” and treating asthma and COPD as the same disease. Dr. Pescatore believes that Mg works for asthma exacerbations because asthma is a disease of smooth muscle and large airways, while COPD is not. COPD, he says, is a disease of the small airways, largely resulting from parenchymal distortions due to emphysema. Therefore, Mg, which is thought to act on the smooth muscle surrounding the large airways, won’t be beneficial for AECOPD and may even cause harm.

Data are lacking

What data exist for using Mg for AECOPD? The best randomized controlled trial (RCT) I could find was published in 1995 and is cited in the reader’s rebuttal. The trial found a significant improvement in peak expiratory flow rate (PEFR) with Mg and a nonsignificant reduction in hospitalizations.

A poorly done systematic review of RCTs using Mg for AECOPD was published in 2014, and in 2020 the Agency for Healthcare Research and Quality (AHRQ) included Mg in its well-executed meta-analysis of pharmacologic treatments for AECOPD. Data across the four to five Mg RCTs included in each of the reviews (study inclusion criteria were slightly different) could not be combined. All RCTs were small, and only soft outcomes like PEFR and forced expiratory volume in 1 second (FEV1) seemed to improve with Mg. No adverse events were noted, but this should be interpreted with caution given that many studies did not report on adverse events at all.

A small RCT published this year (after both systematic reviews were completed) showed that using intravenous magnesium sulfate had no significant effect on FEV1, vital signs, or symptoms.

In summary, the data aren’t great. Mg doesn’t show up at all as a treatment option in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report on COPD, and the authors of the AHRQ review concluded that large, high-quality RCTs are needed to assess the impact of Mg in AECOPD. Although I didn’t do an extensive review of Mg for asthma exacerbations, it’s not clear that the data here are much better. Mg gets an honorable mention (add for severe exacerbations when there’s inadequate response to standard treatments) in both the 2007 National Heart, Lung, and Blood Institute (NHLBI) guideline and the 2019 Global Initiative for Asthma (GINA) guide. The 2020 update to the 2007 NHLBI guideline is more targeted in its review and does not cover Mg as a treatment option. On the basis of my anecdotal clinical experience and on networking with airway experts, I do think Mg is used more often for asthma than for AECOPD.

Final thoughts on using Mg for AECOPD

All that being said, is it reasonable to use Mg for AECOPD? I think so. I’d stick to using it for severe cases where conventional treatments have failed, just like the NHLBI and GINA advise for asthma. I’d also limit it to 2-3 g, which is the dosing range employed by several of the existing AECOPD RCTs. The assertion that Mg may be harmful in AECOPD because COPD affects the small airways, and asthma does not, is misguided. Both affect the small airways. Furthermore, none of our inhaled therapies reach the small airways, so one can’t argue against using Mg because it only targets larger airways without abandoning albuterol and ipratropium as well. I don’t think anyone would advise that. Given what we now know about asthma and COPD phenotypes and asthma-COPD overlap, I’d caution against pedantic theories about response to therapies.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He has received research grants from Fisher-Paykel and has received payments from the American College of Chest Physicians.

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

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major driver of disease-related morbidity. Their prevention and treatment are a focus of COPD management. Antibiotics, corticosteroids, and nebulized bronchodilators are all given to patients with AECOPD, and while the supporting data aren’t perfect, there’s little debate surrounding their use. These medications are well known to most physicians; we’re comfortable with their efficacy and aware of their side effects. They are nothing if not familiar.

What about magnesium (Mg), though? Apparently, in the emergency room (ER) it is part of the standard AECOPD cocktail. I would argue that Mg is familiar to most too; every internal medicine trainee in the United States is taught to infuse 2 g of Mg intravenously for any inpatient (ICU or otherwise) with a serum level <2.0 mg/dL. In fact, “electrolyte protocols” are part of the order sets at most hospitals where I’ve worked. Mg is infused reflexively when it drops below certain levels.

I’m less familiar with using Mg in the setting of an AECOPD, though. A recent online post by an academic ER physician (Richard Pescatore, DO) urged caution in this setting. He argues that too many in the ER are embracing the “Dutch Hypothesis” and treating asthma and COPD as the same disease. Dr. Pescatore believes that Mg works for asthma exacerbations because asthma is a disease of smooth muscle and large airways, while COPD is not. COPD, he says, is a disease of the small airways, largely resulting from parenchymal distortions due to emphysema. Therefore, Mg, which is thought to act on the smooth muscle surrounding the large airways, won’t be beneficial for AECOPD and may even cause harm.

Data are lacking

What data exist for using Mg for AECOPD? The best randomized controlled trial (RCT) I could find was published in 1995 and is cited in the reader’s rebuttal. The trial found a significant improvement in peak expiratory flow rate (PEFR) with Mg and a nonsignificant reduction in hospitalizations.

A poorly done systematic review of RCTs using Mg for AECOPD was published in 2014, and in 2020 the Agency for Healthcare Research and Quality (AHRQ) included Mg in its well-executed meta-analysis of pharmacologic treatments for AECOPD. Data across the four to five Mg RCTs included in each of the reviews (study inclusion criteria were slightly different) could not be combined. All RCTs were small, and only soft outcomes like PEFR and forced expiratory volume in 1 second (FEV1) seemed to improve with Mg. No adverse events were noted, but this should be interpreted with caution given that many studies did not report on adverse events at all.

A small RCT published this year (after both systematic reviews were completed) showed that using intravenous magnesium sulfate had no significant effect on FEV1, vital signs, or symptoms.

In summary, the data aren’t great. Mg doesn’t show up at all as a treatment option in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report on COPD, and the authors of the AHRQ review concluded that large, high-quality RCTs are needed to assess the impact of Mg in AECOPD. Although I didn’t do an extensive review of Mg for asthma exacerbations, it’s not clear that the data here are much better. Mg gets an honorable mention (add for severe exacerbations when there’s inadequate response to standard treatments) in both the 2007 National Heart, Lung, and Blood Institute (NHLBI) guideline and the 2019 Global Initiative for Asthma (GINA) guide. The 2020 update to the 2007 NHLBI guideline is more targeted in its review and does not cover Mg as a treatment option. On the basis of my anecdotal clinical experience and on networking with airway experts, I do think Mg is used more often for asthma than for AECOPD.

Final thoughts on using Mg for AECOPD

All that being said, is it reasonable to use Mg for AECOPD? I think so. I’d stick to using it for severe cases where conventional treatments have failed, just like the NHLBI and GINA advise for asthma. I’d also limit it to 2-3 g, which is the dosing range employed by several of the existing AECOPD RCTs. The assertion that Mg may be harmful in AECOPD because COPD affects the small airways, and asthma does not, is misguided. Both affect the small airways. Furthermore, none of our inhaled therapies reach the small airways, so one can’t argue against using Mg because it only targets larger airways without abandoning albuterol and ipratropium as well. I don’t think anyone would advise that. Given what we now know about asthma and COPD phenotypes and asthma-COPD overlap, I’d caution against pedantic theories about response to therapies.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He has received research grants from Fisher-Paykel and has received payments from the American College of Chest Physicians.

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

Compared with placebo, tranexamic acid did not reduce hematoma growth in patients with intracerebral hemorrhage (ICH), a new study shows.

In the randomized controlled trial, the rate of hematoma expansion was 40.4% among patients who received tranexamic acid and 41.5% among those who received placebo. The degree of disability at 90 days also did not differ between treatment arms.

“Our work has once again shown that tranexamic acid is safe in spontaneous ICH,” said Jingyi Liu, MD, a physician in the neurocritical care unit at Beijing Tiantan Hospital, Capital Medical University, Beijing. “Larger studies with more specified population are needed to further assess safety and efficacy of tranexamic acid in patients with ICH.”

The findings of the TRAIGE study were presented at the virtual European Stroke Organization Conference (ESOC) 2021. They were also published online June 28 in Stroke and Vascular Neurology.
 

Imaging-based patient selection

ICH is often fatal and entails a high risk for disability, the researchers wrote. Approximately 40% of patients with ICH die within a month of onset, and about two-thirds of patients do not achieve long-term functional independence.

Intracerebral hematoma expansion is predictive of poor clinical outcome in ICH. Data indicate that tranexamic acid, an antifibrinolytic agent, reduces hematoma expansion. But evidence of a clinical benefit of tranexamic acid has been elusive, they noted.

This lack of observed benefit may result from the inappropriate selection of research participants. The emergence of imaging biomarkers may help address this potential problem. In recent years, the blend sign and the black hole sign on noncontrast CT, as well as the spot sign on CT angiography, have been associated with higher risk for hematoma expansion and worse clinical outcome, the researchers wrote.

Between January 2015 and March 2020, the investigators enrolled consecutive patients with acute primary spontaneous ICH into their prospective study. Eligible patients presented at any of 10 stroke centers in China. They had the spot sign, blend sign, or black hole sign at admission and were able to receive treatment within 8 hours of onset.

The investigators randomly assigned patients in equal groups to receive placebo (0.9% NaCl) or tranexamic acid. Patients and study investigators were blinded to treatment assignment. Treatment was administered as an intravenous infusion over 8 hours.

The study’s primary endpoint was intracerebral hematoma expansion by 24 hours after start of treatment. Expansion was defined as an increase of > 6 mL or a growth of > 33% from baseline. Secondary endpoints included poor clinical outcome, defined as a Modified Rankin Scale (mRS) score of 4-6, and all-cause mortality, both at 90 days.
 

No differences in disability

The investigators enrolled 171 patients in their study; 24-hour CT images were available for 169 of them. Follow-up data at 90 days were available for 164 patients. The mean age of the patients was 55.9 years, and 72.5% of participants were men. At baseline, the mean ICH volume was 23.7 mL, and the median hematoma volume was 19.8 mL.

All patients received treatment within 8 hours. Hematoma expansion occurred in 40.9% of patients overall; 34.9% had a poor clinical outcome.

The investigators found no significant difference between treatment arms in the rate of hematoma expansion. This outcome occurred in 40.4% of the tranexamic acid group and 41.5% of the placebo group (odds ratio, 0.96; P = .89).

In addition, the researchers found no significant difference in the distribution of mRS scores at day 90 (P = .70). The rate of all-cause mortality at 90 days was lower in the tranexamic acid group (8.1%) than in the control group (10.0%), but this difference was not statistically significant (P = .71).
 

Potential clotting risk

One reason for the lack of observed benefit with tranexamic acid may be an inappropriate sample size, said Dr. Liu. Patient recruitment was difficult, especially in centers that used the spot sign as an inclusion criterion.

“We think a positive result could be seen in a substantially larger sample size,” said Dr. Liu. “Furthermore, we infer from our subgroup analysis that a more specified patient selection and shorter treatment window may be required for better effect.”

In some of their subgroup analyses, the researchers found a trend toward an increased effect in patients with moderate-size hematoma who received treatment in an earlier window. “That could be the targeted population for future studies,” said Dr. Liu. “We are working on further analysis of the population and possibly international collaboration.”

But tranexamic acid also entails risks, said Louis R. Caplan, MD, professor of neurology at Harvard Medical School, Boston, who provided independent commentary on the findings. “Tranexamic acid works on the thrombolytic system, so it increases clotting, and it does have a risk in people who are older and have risk factors for coronary disease and pulmonary embolism.”

As in ischemic stroke, time to treatment is a crucial consideration. Patients with ICH may receive treatment within 5 or 6 hours of onset, but most hemorrhages have reached their maximum size at that point. “The number of people that you can actually help by reducing the size is small,” said Dr. Caplan. “And then reducing the size in most hemorrhages doesn’t make any clinical difference.”

Stereotactic drainage, in which fluid is physically removed, is more likely to lead to long-term improvement for some patients with hemorrhage than limiting expansion, said Dr. Caplan. “That seems to be a more promising therapy,” he added.

The study was supported by the National Key R&D program of China, the National Natural Science Foundation of China, and the Beijing Science and Technology Commission. Dr. Liu and Dr. Caplan have disclosed no relevant financial relationshps.

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

Compared with placebo, tranexamic acid did not reduce hematoma growth in patients with intracerebral hemorrhage (ICH), a new study shows.

In the randomized controlled trial, the rate of hematoma expansion was 40.4% among patients who received tranexamic acid and 41.5% among those who received placebo. The degree of disability at 90 days also did not differ between treatment arms.

“Our work has once again shown that tranexamic acid is safe in spontaneous ICH,” said Jingyi Liu, MD, a physician in the neurocritical care unit at Beijing Tiantan Hospital, Capital Medical University, Beijing. “Larger studies with more specified population are needed to further assess safety and efficacy of tranexamic acid in patients with ICH.”

The findings of the TRAIGE study were presented at the virtual European Stroke Organization Conference (ESOC) 2021. They were also published online June 28 in Stroke and Vascular Neurology.
 

Imaging-based patient selection

ICH is often fatal and entails a high risk for disability, the researchers wrote. Approximately 40% of patients with ICH die within a month of onset, and about two-thirds of patients do not achieve long-term functional independence.

Intracerebral hematoma expansion is predictive of poor clinical outcome in ICH. Data indicate that tranexamic acid, an antifibrinolytic agent, reduces hematoma expansion. But evidence of a clinical benefit of tranexamic acid has been elusive, they noted.

This lack of observed benefit may result from the inappropriate selection of research participants. The emergence of imaging biomarkers may help address this potential problem. In recent years, the blend sign and the black hole sign on noncontrast CT, as well as the spot sign on CT angiography, have been associated with higher risk for hematoma expansion and worse clinical outcome, the researchers wrote.

Between January 2015 and March 2020, the investigators enrolled consecutive patients with acute primary spontaneous ICH into their prospective study. Eligible patients presented at any of 10 stroke centers in China. They had the spot sign, blend sign, or black hole sign at admission and were able to receive treatment within 8 hours of onset.

The investigators randomly assigned patients in equal groups to receive placebo (0.9% NaCl) or tranexamic acid. Patients and study investigators were blinded to treatment assignment. Treatment was administered as an intravenous infusion over 8 hours.

The study’s primary endpoint was intracerebral hematoma expansion by 24 hours after start of treatment. Expansion was defined as an increase of > 6 mL or a growth of > 33% from baseline. Secondary endpoints included poor clinical outcome, defined as a Modified Rankin Scale (mRS) score of 4-6, and all-cause mortality, both at 90 days.
 

No differences in disability

The investigators enrolled 171 patients in their study; 24-hour CT images were available for 169 of them. Follow-up data at 90 days were available for 164 patients. The mean age of the patients was 55.9 years, and 72.5% of participants were men. At baseline, the mean ICH volume was 23.7 mL, and the median hematoma volume was 19.8 mL.

All patients received treatment within 8 hours. Hematoma expansion occurred in 40.9% of patients overall; 34.9% had a poor clinical outcome.

The investigators found no significant difference between treatment arms in the rate of hematoma expansion. This outcome occurred in 40.4% of the tranexamic acid group and 41.5% of the placebo group (odds ratio, 0.96; P = .89).

In addition, the researchers found no significant difference in the distribution of mRS scores at day 90 (P = .70). The rate of all-cause mortality at 90 days was lower in the tranexamic acid group (8.1%) than in the control group (10.0%), but this difference was not statistically significant (P = .71).
 

Potential clotting risk

One reason for the lack of observed benefit with tranexamic acid may be an inappropriate sample size, said Dr. Liu. Patient recruitment was difficult, especially in centers that used the spot sign as an inclusion criterion.

“We think a positive result could be seen in a substantially larger sample size,” said Dr. Liu. “Furthermore, we infer from our subgroup analysis that a more specified patient selection and shorter treatment window may be required for better effect.”

In some of their subgroup analyses, the researchers found a trend toward an increased effect in patients with moderate-size hematoma who received treatment in an earlier window. “That could be the targeted population for future studies,” said Dr. Liu. “We are working on further analysis of the population and possibly international collaboration.”

But tranexamic acid also entails risks, said Louis R. Caplan, MD, professor of neurology at Harvard Medical School, Boston, who provided independent commentary on the findings. “Tranexamic acid works on the thrombolytic system, so it increases clotting, and it does have a risk in people who are older and have risk factors for coronary disease and pulmonary embolism.”

As in ischemic stroke, time to treatment is a crucial consideration. Patients with ICH may receive treatment within 5 or 6 hours of onset, but most hemorrhages have reached their maximum size at that point. “The number of people that you can actually help by reducing the size is small,” said Dr. Caplan. “And then reducing the size in most hemorrhages doesn’t make any clinical difference.”

Stereotactic drainage, in which fluid is physically removed, is more likely to lead to long-term improvement for some patients with hemorrhage than limiting expansion, said Dr. Caplan. “That seems to be a more promising therapy,” he added.

The study was supported by the National Key R&D program of China, the National Natural Science Foundation of China, and the Beijing Science and Technology Commission. Dr. Liu and Dr. Caplan have disclosed no relevant financial relationshps.

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

Compared with placebo, tranexamic acid did not reduce hematoma growth in patients with intracerebral hemorrhage (ICH), a new study shows.

In the randomized controlled trial, the rate of hematoma expansion was 40.4% among patients who received tranexamic acid and 41.5% among those who received placebo. The degree of disability at 90 days also did not differ between treatment arms.

“Our work has once again shown that tranexamic acid is safe in spontaneous ICH,” said Jingyi Liu, MD, a physician in the neurocritical care unit at Beijing Tiantan Hospital, Capital Medical University, Beijing. “Larger studies with more specified population are needed to further assess safety and efficacy of tranexamic acid in patients with ICH.”

The findings of the TRAIGE study were presented at the virtual European Stroke Organization Conference (ESOC) 2021. They were also published online June 28 in Stroke and Vascular Neurology.
 

Imaging-based patient selection

ICH is often fatal and entails a high risk for disability, the researchers wrote. Approximately 40% of patients with ICH die within a month of onset, and about two-thirds of patients do not achieve long-term functional independence.

Intracerebral hematoma expansion is predictive of poor clinical outcome in ICH. Data indicate that tranexamic acid, an antifibrinolytic agent, reduces hematoma expansion. But evidence of a clinical benefit of tranexamic acid has been elusive, they noted.

This lack of observed benefit may result from the inappropriate selection of research participants. The emergence of imaging biomarkers may help address this potential problem. In recent years, the blend sign and the black hole sign on noncontrast CT, as well as the spot sign on CT angiography, have been associated with higher risk for hematoma expansion and worse clinical outcome, the researchers wrote.

Between January 2015 and March 2020, the investigators enrolled consecutive patients with acute primary spontaneous ICH into their prospective study. Eligible patients presented at any of 10 stroke centers in China. They had the spot sign, blend sign, or black hole sign at admission and were able to receive treatment within 8 hours of onset.

The investigators randomly assigned patients in equal groups to receive placebo (0.9% NaCl) or tranexamic acid. Patients and study investigators were blinded to treatment assignment. Treatment was administered as an intravenous infusion over 8 hours.

The study’s primary endpoint was intracerebral hematoma expansion by 24 hours after start of treatment. Expansion was defined as an increase of > 6 mL or a growth of > 33% from baseline. Secondary endpoints included poor clinical outcome, defined as a Modified Rankin Scale (mRS) score of 4-6, and all-cause mortality, both at 90 days.
 

No differences in disability

The investigators enrolled 171 patients in their study; 24-hour CT images were available for 169 of them. Follow-up data at 90 days were available for 164 patients. The mean age of the patients was 55.9 years, and 72.5% of participants were men. At baseline, the mean ICH volume was 23.7 mL, and the median hematoma volume was 19.8 mL.

All patients received treatment within 8 hours. Hematoma expansion occurred in 40.9% of patients overall; 34.9% had a poor clinical outcome.

The investigators found no significant difference between treatment arms in the rate of hematoma expansion. This outcome occurred in 40.4% of the tranexamic acid group and 41.5% of the placebo group (odds ratio, 0.96; P = .89).

In addition, the researchers found no significant difference in the distribution of mRS scores at day 90 (P = .70). The rate of all-cause mortality at 90 days was lower in the tranexamic acid group (8.1%) than in the control group (10.0%), but this difference was not statistically significant (P = .71).
 

Potential clotting risk

One reason for the lack of observed benefit with tranexamic acid may be an inappropriate sample size, said Dr. Liu. Patient recruitment was difficult, especially in centers that used the spot sign as an inclusion criterion.

“We think a positive result could be seen in a substantially larger sample size,” said Dr. Liu. “Furthermore, we infer from our subgroup analysis that a more specified patient selection and shorter treatment window may be required for better effect.”

In some of their subgroup analyses, the researchers found a trend toward an increased effect in patients with moderate-size hematoma who received treatment in an earlier window. “That could be the targeted population for future studies,” said Dr. Liu. “We are working on further analysis of the population and possibly international collaboration.”

But tranexamic acid also entails risks, said Louis R. Caplan, MD, professor of neurology at Harvard Medical School, Boston, who provided independent commentary on the findings. “Tranexamic acid works on the thrombolytic system, so it increases clotting, and it does have a risk in people who are older and have risk factors for coronary disease and pulmonary embolism.”

As in ischemic stroke, time to treatment is a crucial consideration. Patients with ICH may receive treatment within 5 or 6 hours of onset, but most hemorrhages have reached their maximum size at that point. “The number of people that you can actually help by reducing the size is small,” said Dr. Caplan. “And then reducing the size in most hemorrhages doesn’t make any clinical difference.”

Stereotactic drainage, in which fluid is physically removed, is more likely to lead to long-term improvement for some patients with hemorrhage than limiting expansion, said Dr. Caplan. “That seems to be a more promising therapy,” he added.

The study was supported by the National Key R&D program of China, the National Natural Science Foundation of China, and the Beijing Science and Technology Commission. Dr. Liu and Dr. Caplan have disclosed no relevant financial relationshps.

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

Basing referral of patients with chronic kidney disease (CKD) to nephrologists on 2-year kidney failure risk exceeding 1% would catch those at higher risk without increasing referral volumes generated from current laboratory-based guidelines, new research indicates.

And combining the two methods – predicted kidney failure risk with lab values – will lead to better patient outcomes by pinpointing CKD patients who most need specialty care, said study author Vishal Duggal, MD, who was a postdoctoral fellow in medical informatics at the Veterans Affairs Palo Alto (Calif.) Health Care System while conducting the research.

“We hope this can provide guidance to primary care physicians and nephrologists to give context for their decision-making,” Dr. Duggal told this news organization.

The VA is the largest provider of CKD care in the United States, developing clinical practice guidelines for CKD management that include suggested indications for nephrology referral based on laboratory values. Laboratory values that are typically used to guide referral include estimated glomerular filtration rate (eGFR) and its rate of decline per year, as well as heavy proteinuria in patients with and without diabetes. 

Dr. Duggal and colleagues – who published their findings in the American Journal of Kidney Diseases – conducted a retrospective analysis of nearly 400,000 veterans with CKD over a yearlong period to determine if referral volume would change if it was based on the estimated risk for kidney failure, rather than solely using laboratory values.

They also estimated the potential volume of nephrology referrals based on a combination of both estimated risk for kidney failure and laboratory data.

Kidney failure risk was calculated using an electronic clinical decision support tool, called Kidney Failure Risk Equation incorporating age, eGFR, gender, and urine albumin-to-creatinine ratio.
 

Targeting fewer patients to specialty care

Among all participants with CKD not already receiving nephrology care, more than 150,000 (41.5%) had a urine albumin or protein measurement leading to computable risk for end-stage kidney disease.

More than 66,200 patients met actual laboratory indications for referral but had not previously seen a nephrologist. Among these patients, 11,752 (17.7%) were referred to nephrology in the following year, and all had a median 2-year predicted risk for kidney failure of 1.5%.

Referred patients were more likely to meet several potential referral criteria, especially eGFR less than 30 mL/min per 1.73 m² and heavy proteinuria. Those with heavy proteinuria with diabetes, or the eGFR indication, had the highest predicted risk for kidney failure at 2 years, at 10% and 7.1% respectively.

Boosting referral volume can be problematic if patients aren’t prioritized by need, Dr. Duggal said, noting that many reasons explain why fewer than one in five CKD patients meeting lab indications for referral aren’t actually referred.

This can include patient preference, he noted: “Kidney disease is a disease of aging, and some patients don’t want to see a specialist or escalate their care.”

“Also, not everyone who has CKD is recommended to see a nephrologist, since primary care physicians do manage a lot of CKD as well.”

Basing referral on predicted kidney failure risk alone, a 2-year risk threshold of at least 1%, would identify a comparable number of patients (n = 72,948) as laboratory-based criteria, the team found, although they note that the patients identified using the KFRE tool would be at higher risk than those identified by lab values alone.

But when they combined the two – a minimum kidney failure risk of at least 1% over 2 years being applied to all new patients meeting lab-based referral indications, those pinpointed for nephrology referral dropped by 42.3%, from 66,276 to an estimated 38,229 patients.

“The current guidelines that just incorporate lab values identify a significant number of patients who are at low risk of developing end-stage kidney disease (ESKD), so incorporating kidney failure risk into current guidelines would target fewer patients to get to specialty care,” Dr. Duggal explained.
 

KFRE tool can be found online

Dr. Duggal emphasized that his findings do not change nephrology referral guidelines, but said physicians can find the KFRE tool online and use it to supplement their decision-making about a patient’s care.

“Further incorporating this [kidney failure] risk into referral practices might highlight a patient at extremely high risk who would benefit more from an interdisciplinary care team,” he said.

This could include, for example, a nutritionist to help the patient modify his or her diet. “Getting that kind of teaching process in place for a patient might be highly valuable,” he added.

Dr. Duggal disclosed no relevant financial relationships.

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

Basing referral of patients with chronic kidney disease (CKD) to nephrologists on 2-year kidney failure risk exceeding 1% would catch those at higher risk without increasing referral volumes generated from current laboratory-based guidelines, new research indicates.

And combining the two methods – predicted kidney failure risk with lab values – will lead to better patient outcomes by pinpointing CKD patients who most need specialty care, said study author Vishal Duggal, MD, who was a postdoctoral fellow in medical informatics at the Veterans Affairs Palo Alto (Calif.) Health Care System while conducting the research.

“We hope this can provide guidance to primary care physicians and nephrologists to give context for their decision-making,” Dr. Duggal told this news organization.

The VA is the largest provider of CKD care in the United States, developing clinical practice guidelines for CKD management that include suggested indications for nephrology referral based on laboratory values. Laboratory values that are typically used to guide referral include estimated glomerular filtration rate (eGFR) and its rate of decline per year, as well as heavy proteinuria in patients with and without diabetes. 

Dr. Duggal and colleagues – who published their findings in the American Journal of Kidney Diseases – conducted a retrospective analysis of nearly 400,000 veterans with CKD over a yearlong period to determine if referral volume would change if it was based on the estimated risk for kidney failure, rather than solely using laboratory values.

They also estimated the potential volume of nephrology referrals based on a combination of both estimated risk for kidney failure and laboratory data.

Kidney failure risk was calculated using an electronic clinical decision support tool, called Kidney Failure Risk Equation incorporating age, eGFR, gender, and urine albumin-to-creatinine ratio.
 

Targeting fewer patients to specialty care

Among all participants with CKD not already receiving nephrology care, more than 150,000 (41.5%) had a urine albumin or protein measurement leading to computable risk for end-stage kidney disease.

More than 66,200 patients met actual laboratory indications for referral but had not previously seen a nephrologist. Among these patients, 11,752 (17.7%) were referred to nephrology in the following year, and all had a median 2-year predicted risk for kidney failure of 1.5%.

Referred patients were more likely to meet several potential referral criteria, especially eGFR less than 30 mL/min per 1.73 m² and heavy proteinuria. Those with heavy proteinuria with diabetes, or the eGFR indication, had the highest predicted risk for kidney failure at 2 years, at 10% and 7.1% respectively.

Boosting referral volume can be problematic if patients aren’t prioritized by need, Dr. Duggal said, noting that many reasons explain why fewer than one in five CKD patients meeting lab indications for referral aren’t actually referred.

This can include patient preference, he noted: “Kidney disease is a disease of aging, and some patients don’t want to see a specialist or escalate their care.”

“Also, not everyone who has CKD is recommended to see a nephrologist, since primary care physicians do manage a lot of CKD as well.”

Basing referral on predicted kidney failure risk alone, a 2-year risk threshold of at least 1%, would identify a comparable number of patients (n = 72,948) as laboratory-based criteria, the team found, although they note that the patients identified using the KFRE tool would be at higher risk than those identified by lab values alone.

But when they combined the two – a minimum kidney failure risk of at least 1% over 2 years being applied to all new patients meeting lab-based referral indications, those pinpointed for nephrology referral dropped by 42.3%, from 66,276 to an estimated 38,229 patients.

“The current guidelines that just incorporate lab values identify a significant number of patients who are at low risk of developing end-stage kidney disease (ESKD), so incorporating kidney failure risk into current guidelines would target fewer patients to get to specialty care,” Dr. Duggal explained.
 

KFRE tool can be found online

Dr. Duggal emphasized that his findings do not change nephrology referral guidelines, but said physicians can find the KFRE tool online and use it to supplement their decision-making about a patient’s care.

“Further incorporating this [kidney failure] risk into referral practices might highlight a patient at extremely high risk who would benefit more from an interdisciplinary care team,” he said.

This could include, for example, a nutritionist to help the patient modify his or her diet. “Getting that kind of teaching process in place for a patient might be highly valuable,” he added.

Dr. Duggal disclosed no relevant financial relationships.

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

Basing referral of patients with chronic kidney disease (CKD) to nephrologists on 2-year kidney failure risk exceeding 1% would catch those at higher risk without increasing referral volumes generated from current laboratory-based guidelines, new research indicates.

And combining the two methods – predicted kidney failure risk with lab values – will lead to better patient outcomes by pinpointing CKD patients who most need specialty care, said study author Vishal Duggal, MD, who was a postdoctoral fellow in medical informatics at the Veterans Affairs Palo Alto (Calif.) Health Care System while conducting the research.

“We hope this can provide guidance to primary care physicians and nephrologists to give context for their decision-making,” Dr. Duggal told this news organization.

The VA is the largest provider of CKD care in the United States, developing clinical practice guidelines for CKD management that include suggested indications for nephrology referral based on laboratory values. Laboratory values that are typically used to guide referral include estimated glomerular filtration rate (eGFR) and its rate of decline per year, as well as heavy proteinuria in patients with and without diabetes. 

Dr. Duggal and colleagues – who published their findings in the American Journal of Kidney Diseases – conducted a retrospective analysis of nearly 400,000 veterans with CKD over a yearlong period to determine if referral volume would change if it was based on the estimated risk for kidney failure, rather than solely using laboratory values.

They also estimated the potential volume of nephrology referrals based on a combination of both estimated risk for kidney failure and laboratory data.

Kidney failure risk was calculated using an electronic clinical decision support tool, called Kidney Failure Risk Equation incorporating age, eGFR, gender, and urine albumin-to-creatinine ratio.
 

Targeting fewer patients to specialty care

Among all participants with CKD not already receiving nephrology care, more than 150,000 (41.5%) had a urine albumin or protein measurement leading to computable risk for end-stage kidney disease.

More than 66,200 patients met actual laboratory indications for referral but had not previously seen a nephrologist. Among these patients, 11,752 (17.7%) were referred to nephrology in the following year, and all had a median 2-year predicted risk for kidney failure of 1.5%.

Referred patients were more likely to meet several potential referral criteria, especially eGFR less than 30 mL/min per 1.73 m² and heavy proteinuria. Those with heavy proteinuria with diabetes, or the eGFR indication, had the highest predicted risk for kidney failure at 2 years, at 10% and 7.1% respectively.

Boosting referral volume can be problematic if patients aren’t prioritized by need, Dr. Duggal said, noting that many reasons explain why fewer than one in five CKD patients meeting lab indications for referral aren’t actually referred.

This can include patient preference, he noted: “Kidney disease is a disease of aging, and some patients don’t want to see a specialist or escalate their care.”

“Also, not everyone who has CKD is recommended to see a nephrologist, since primary care physicians do manage a lot of CKD as well.”

Basing referral on predicted kidney failure risk alone, a 2-year risk threshold of at least 1%, would identify a comparable number of patients (n = 72,948) as laboratory-based criteria, the team found, although they note that the patients identified using the KFRE tool would be at higher risk than those identified by lab values alone.

But when they combined the two – a minimum kidney failure risk of at least 1% over 2 years being applied to all new patients meeting lab-based referral indications, those pinpointed for nephrology referral dropped by 42.3%, from 66,276 to an estimated 38,229 patients.

“The current guidelines that just incorporate lab values identify a significant number of patients who are at low risk of developing end-stage kidney disease (ESKD), so incorporating kidney failure risk into current guidelines would target fewer patients to get to specialty care,” Dr. Duggal explained.
 

KFRE tool can be found online

Dr. Duggal emphasized that his findings do not change nephrology referral guidelines, but said physicians can find the KFRE tool online and use it to supplement their decision-making about a patient’s care.

“Further incorporating this [kidney failure] risk into referral practices might highlight a patient at extremely high risk who would benefit more from an interdisciplinary care team,” he said.

This could include, for example, a nutritionist to help the patient modify his or her diet. “Getting that kind of teaching process in place for a patient might be highly valuable,” he added.

Dr. Duggal disclosed no relevant financial relationships.

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

Estimating an individual’s risk of cardiovascular disease (CVD) remains the cornerstone of the 2021 European Society of Cardiology guidelines on CVD prevention in clinical practice. The new guidelines were published online Aug. 30 in the European Heart Journal to coincide with presentation at the European Stroke Congress (ESOC) 2021.   

They were developed by an ESOC task force in collaboration with 12 medical societies and with special contribution of the European Association of Preventive Cardiology.

“A chief goal of the task force was to create a single CVD prevention guideline for everyone – for primary care, for hospital care, for guiding clinical practice – so one guideline for all,” said cochair of the guideline committee Frank Visseren, MD, PhD, University Medical Center Utrecht, Netherlands. “We also wanted to make a more personalized CVD prevention guideline, instead of a one-size-fits-all. In clinical practice, people are very, very different, and we really want to have a more individualized prevention guideline,” said Dr. Visseren, as well as provide “more room for shared decision-making.”
 

Prevention at the individual and population levels

The new guidelines also give more attention to CVD prevention in older persons. “Many of our patients are over 70 years old and we really want to have more detail, more guidance on older persons,” said Dr. Visseren.

The guideline is divided into two sections. One section covers CVD prevention at the individual level in apparently healthy people, in patients with established CVD, and in those with diabetes, familial hypercholesterolemia, or chronic kidney disease.

The other section covers CVD prevention at the population level, including public health policy, interventions, and the environment, including putting in place measures to reduce air pollution, use of fossil fuels, and limiting carbon dioxide emissions.

Targets for blood lipids, blood pressure, and glycemic control in diabetes remain in line with recent ESC guidelines on dyslipidemias, hypertension, or diabetes.

However, the guidelines introduce a new stepwise treatment-intensification approach to achieve these targets, with consideration of CVD risk, treatment benefit of risk factors, risk modifiers, comorbidities, and patient preferences.

The 2021 CVD prevention guidelines also embrace the recently published Systemic Coronary Risk Estimation 2 (SCORE2) and Systemic Coronary Risk Estimation 2-Older Persons (SCORE2-OP) algorithms. “The algorithms we are using are a bit old and we want to have more updated risk prediction, because that’s the starting point of CVD prevention,” Dr. Visseren said.

The guidelines also introduce age-specific risk thresholds for risk factor treatments in apparently healthy people and provide estimation of lifetime CVD risk and treatment benefit. This will allow clinicians to have “an informed discussion with patients on lifetime risk and potential treatment benefits,” Dr. Visseren said.

For the first time, the guidelines recommend smoking cessation regardless of whether it leads to weight gain, as weight gain does not lessen the benefits of cessation.

Regarding exercise, adults of all ages should aim for at least 150-300 minutes a week of moderate, or 75-150 minutes a week of vigorous, aerobic physical activity. The guidelines recommend reducing sedentary time and engaging in at least light activity throughout the day.

Regarding nutrition, the guidelines advise adopting a Mediterranean or similar diet; restricting alcohol intake to a maximum of 100 g per week (a standard drink is 8-14 g); eating fish, preferably fatty fish, at least once a week; and restricting consumption of meat, particularly processed meat.

Also for the first time, the guidelines state that bariatric surgery should be considered for obese individuals at elevated risk of CVD when a healthy diet and exercise fail to lead to weight loss that is maintained.

They note that individuals with mental disorders need additional attention and support to improve adherence to lifestyle changes and drug treatment.

They advise consideration of referring patients with heart disease and significant stress and anxiety to psychotherapeutic stress management to reduce stress symptoms and improve CV outcomes.

Potential cost issues that could be considered when implementing the guidelines are also reviewed.

Dr. Visseren acknowledged and thanked the task force members for continuing their work on the guidelines over the 2 “challenging” years.
 

Setting the bar lower?

Discussant for the guideline presentation, Diederick Grobbee, MD, University Medical Center Utrecht, who was not involved in drafting the guidelines, said he does have one conflict of interest, which is a “passion for prevention.” From that perspective, he said the guideline panel “should be applauded; the once-every-5-year issuing of the prevention guidelines is a major event.”

Dr. Grobbee noted that the working group “really tried to follow their ambitions and goals, in a way making the guidelines simpler, or perhaps setting the bar not initially as high as we used to do, which may, in fact, sometimes scare off physicians and patients alike.”

“We’ve had prevention guidelines for quite some time now, yet looking at what is accomplished in practice is sobering,” said Dr. Grobbee. Introducing a stepwise approach is “really appealing,” he added.

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

Estimating an individual’s risk of cardiovascular disease (CVD) remains the cornerstone of the 2021 European Society of Cardiology guidelines on CVD prevention in clinical practice. The new guidelines were published online Aug. 30 in the European Heart Journal to coincide with presentation at the European Stroke Congress (ESOC) 2021.   

They were developed by an ESOC task force in collaboration with 12 medical societies and with special contribution of the European Association of Preventive Cardiology.

“A chief goal of the task force was to create a single CVD prevention guideline for everyone – for primary care, for hospital care, for guiding clinical practice – so one guideline for all,” said cochair of the guideline committee Frank Visseren, MD, PhD, University Medical Center Utrecht, Netherlands. “We also wanted to make a more personalized CVD prevention guideline, instead of a one-size-fits-all. In clinical practice, people are very, very different, and we really want to have a more individualized prevention guideline,” said Dr. Visseren, as well as provide “more room for shared decision-making.”
 

Prevention at the individual and population levels

The new guidelines also give more attention to CVD prevention in older persons. “Many of our patients are over 70 years old and we really want to have more detail, more guidance on older persons,” said Dr. Visseren.

The guideline is divided into two sections. One section covers CVD prevention at the individual level in apparently healthy people, in patients with established CVD, and in those with diabetes, familial hypercholesterolemia, or chronic kidney disease.

The other section covers CVD prevention at the population level, including public health policy, interventions, and the environment, including putting in place measures to reduce air pollution, use of fossil fuels, and limiting carbon dioxide emissions.

Targets for blood lipids, blood pressure, and glycemic control in diabetes remain in line with recent ESC guidelines on dyslipidemias, hypertension, or diabetes.

However, the guidelines introduce a new stepwise treatment-intensification approach to achieve these targets, with consideration of CVD risk, treatment benefit of risk factors, risk modifiers, comorbidities, and patient preferences.

The 2021 CVD prevention guidelines also embrace the recently published Systemic Coronary Risk Estimation 2 (SCORE2) and Systemic Coronary Risk Estimation 2-Older Persons (SCORE2-OP) algorithms. “The algorithms we are using are a bit old and we want to have more updated risk prediction, because that’s the starting point of CVD prevention,” Dr. Visseren said.

The guidelines also introduce age-specific risk thresholds for risk factor treatments in apparently healthy people and provide estimation of lifetime CVD risk and treatment benefit. This will allow clinicians to have “an informed discussion with patients on lifetime risk and potential treatment benefits,” Dr. Visseren said.

For the first time, the guidelines recommend smoking cessation regardless of whether it leads to weight gain, as weight gain does not lessen the benefits of cessation.

Regarding exercise, adults of all ages should aim for at least 150-300 minutes a week of moderate, or 75-150 minutes a week of vigorous, aerobic physical activity. The guidelines recommend reducing sedentary time and engaging in at least light activity throughout the day.

Regarding nutrition, the guidelines advise adopting a Mediterranean or similar diet; restricting alcohol intake to a maximum of 100 g per week (a standard drink is 8-14 g); eating fish, preferably fatty fish, at least once a week; and restricting consumption of meat, particularly processed meat.

Also for the first time, the guidelines state that bariatric surgery should be considered for obese individuals at elevated risk of CVD when a healthy diet and exercise fail to lead to weight loss that is maintained.

They note that individuals with mental disorders need additional attention and support to improve adherence to lifestyle changes and drug treatment.

They advise consideration of referring patients with heart disease and significant stress and anxiety to psychotherapeutic stress management to reduce stress symptoms and improve CV outcomes.

Potential cost issues that could be considered when implementing the guidelines are also reviewed.

Dr. Visseren acknowledged and thanked the task force members for continuing their work on the guidelines over the 2 “challenging” years.
 

Setting the bar lower?

Discussant for the guideline presentation, Diederick Grobbee, MD, University Medical Center Utrecht, who was not involved in drafting the guidelines, said he does have one conflict of interest, which is a “passion for prevention.” From that perspective, he said the guideline panel “should be applauded; the once-every-5-year issuing of the prevention guidelines is a major event.”

Dr. Grobbee noted that the working group “really tried to follow their ambitions and goals, in a way making the guidelines simpler, or perhaps setting the bar not initially as high as we used to do, which may, in fact, sometimes scare off physicians and patients alike.”

“We’ve had prevention guidelines for quite some time now, yet looking at what is accomplished in practice is sobering,” said Dr. Grobbee. Introducing a stepwise approach is “really appealing,” he added.

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

Estimating an individual’s risk of cardiovascular disease (CVD) remains the cornerstone of the 2021 European Society of Cardiology guidelines on CVD prevention in clinical practice. The new guidelines were published online Aug. 30 in the European Heart Journal to coincide with presentation at the European Stroke Congress (ESOC) 2021.   

They were developed by an ESOC task force in collaboration with 12 medical societies and with special contribution of the European Association of Preventive Cardiology.

“A chief goal of the task force was to create a single CVD prevention guideline for everyone – for primary care, for hospital care, for guiding clinical practice – so one guideline for all,” said cochair of the guideline committee Frank Visseren, MD, PhD, University Medical Center Utrecht, Netherlands. “We also wanted to make a more personalized CVD prevention guideline, instead of a one-size-fits-all. In clinical practice, people are very, very different, and we really want to have a more individualized prevention guideline,” said Dr. Visseren, as well as provide “more room for shared decision-making.”
 

Prevention at the individual and population levels

The new guidelines also give more attention to CVD prevention in older persons. “Many of our patients are over 70 years old and we really want to have more detail, more guidance on older persons,” said Dr. Visseren.

The guideline is divided into two sections. One section covers CVD prevention at the individual level in apparently healthy people, in patients with established CVD, and in those with diabetes, familial hypercholesterolemia, or chronic kidney disease.

The other section covers CVD prevention at the population level, including public health policy, interventions, and the environment, including putting in place measures to reduce air pollution, use of fossil fuels, and limiting carbon dioxide emissions.

Targets for blood lipids, blood pressure, and glycemic control in diabetes remain in line with recent ESC guidelines on dyslipidemias, hypertension, or diabetes.

However, the guidelines introduce a new stepwise treatment-intensification approach to achieve these targets, with consideration of CVD risk, treatment benefit of risk factors, risk modifiers, comorbidities, and patient preferences.

The 2021 CVD prevention guidelines also embrace the recently published Systemic Coronary Risk Estimation 2 (SCORE2) and Systemic Coronary Risk Estimation 2-Older Persons (SCORE2-OP) algorithms. “The algorithms we are using are a bit old and we want to have more updated risk prediction, because that’s the starting point of CVD prevention,” Dr. Visseren said.

The guidelines also introduce age-specific risk thresholds for risk factor treatments in apparently healthy people and provide estimation of lifetime CVD risk and treatment benefit. This will allow clinicians to have “an informed discussion with patients on lifetime risk and potential treatment benefits,” Dr. Visseren said.

For the first time, the guidelines recommend smoking cessation regardless of whether it leads to weight gain, as weight gain does not lessen the benefits of cessation.

Regarding exercise, adults of all ages should aim for at least 150-300 minutes a week of moderate, or 75-150 minutes a week of vigorous, aerobic physical activity. The guidelines recommend reducing sedentary time and engaging in at least light activity throughout the day.

Regarding nutrition, the guidelines advise adopting a Mediterranean or similar diet; restricting alcohol intake to a maximum of 100 g per week (a standard drink is 8-14 g); eating fish, preferably fatty fish, at least once a week; and restricting consumption of meat, particularly processed meat.

Also for the first time, the guidelines state that bariatric surgery should be considered for obese individuals at elevated risk of CVD when a healthy diet and exercise fail to lead to weight loss that is maintained.

They note that individuals with mental disorders need additional attention and support to improve adherence to lifestyle changes and drug treatment.

They advise consideration of referring patients with heart disease and significant stress and anxiety to psychotherapeutic stress management to reduce stress symptoms and improve CV outcomes.

Potential cost issues that could be considered when implementing the guidelines are also reviewed.

Dr. Visseren acknowledged and thanked the task force members for continuing their work on the guidelines over the 2 “challenging” years.
 

Setting the bar lower?

Discussant for the guideline presentation, Diederick Grobbee, MD, University Medical Center Utrecht, who was not involved in drafting the guidelines, said he does have one conflict of interest, which is a “passion for prevention.” From that perspective, he said the guideline panel “should be applauded; the once-every-5-year issuing of the prevention guidelines is a major event.”

Dr. Grobbee noted that the working group “really tried to follow their ambitions and goals, in a way making the guidelines simpler, or perhaps setting the bar not initially as high as we used to do, which may, in fact, sometimes scare off physicians and patients alike.”

“We’ve had prevention guidelines for quite some time now, yet looking at what is accomplished in practice is sobering,” said Dr. Grobbee. Introducing a stepwise approach is “really appealing,” he added.

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

The brain is inarguably the most complex and mysterious organ in the human body.

As the epicenter of intelligence, mastermind of movement, and song for our senses, the brain is more than a 3-lb organ encased in shell and fluid. Rather, it is the crown jewel that defines the self and, broadly, humanity.

©Thinkstock

For decades now, researchers have been exploring the potential for connecting our own astounding biological “computer” with actual physical mainframes. These so-called “brain-computer interfaces” (BCIs) are showing promise in treating an array of conditions, including paralysis, deafness, stroke, and even psychiatric disorders.

Among the big players in this area of research is billionaire entrepreneur Elon Musk, who in 2016 founded Neuralink. The company’s short-term mission is to develop a brain-to-machine interface to help people with neurologic conditions (for example, Parkinson’s disease). The long-term mission is to steer humanity into the era of “superhuman cognition.”

But first, some neuroscience 101.

Neurons are specialized cells that transmit and receive information. The basic structure of a neuron includes the dendrite, soma, and axon. The dendrite is the signal receiver. The soma is the cell body that is connected to the dendrites and serves as a structure to pass signals. The axon, also known as the nerve fiber, transmits the signal away from the soma.

Neurons communicate with each other at the synapse (for example, axon-dendrite connection). Neurons send information to each other through action potentials. An action potential may be defined as an electric impulse that transmits down the axon, causing the release of neurotransmitters, which may consequently either inhibit or excite the next neuron (leading to the initiation of another action potential).

So how will the company and other BCI companies tap into this evolutionarily ancient system to develop an implant that will obtain and decode information output from the brain?

The Neuralink implant is composed of three parts: The Link, neural threads, and the charger.

A robotic system, controlled by a neurosurgeon, will place an implant into the brain. The Link is the central component. It processes and transmits neural signals. The micron-scale neural threads are connected to the Link and other areas of the brain. The threads also contain electrodes, which are responsible for detecting neural signals. The charger ensures the battery is charged via wireless connection.

The invasive nature of this implant allows for precise readouts of electric outputs from the brain – unlike noninvasive devices, which are less sensitive and specific. Additionally, owing to its small size, engineers and neurosurgeons can implant the device in very specific brain regions as well as customize electrode distribution.

The Neuralink implant would be paired with an application via Bluetooth connection. The goal is to enable someone with the implant to control their device or computer by simply thinking. The application offers several exercises to help guide and train individuals on how to use the implant for its intended purpose. This technology would allow people with neurologic difficulties (for example, paralysis) to communicate more easily through text or speech synthesis, as well as partake in creative activities such as photography.

Existing text and speech synthesis technology are already underway. For example, Synchron, a BCI platform company, is investigating the use of Stentrode for people with severe paralysis. This neuroprosthesis was designed to help people associate thought with movement through Bluetooth technology (for example, texting, emailing, shopping, online banking). Preliminary results from a study in which the device was used for patients with amyotrophic lateral sclerosis showed improvements in functional independence via direct thinking.

Software intended to enable high-performance handwriting utilizing BCI technology is being developed by Francis R. Willett, PhD, at Stanford (Calif.) University. The technology has also shown promise.

“We’ve learned that the brain retains its ability to prescribe fine movements a full decade after the body has lost its ability to execute those movements,” says Dr. Willett, who recently reported on results from a BCI study of handwriting conversion in an individual with full-body paralysis. Through a recurrent neural networking decoding approach, the BrainGate study participant was able to type 90 characters per minute – with an impressive 94.1% raw accuracy – using thoughts alone.

Although not a fully implantable brain device, this percutaneous implant has also been studied of its capacity to restore arm function among individuals who suffered from chronic stroke. Preliminary results from the Cortimo trials, led by Mijail D. Serruya, MD, an assistant professor at Thomas Jefferson University, Philadelphia, have been positive. Researchers implanted microelectrode arrays to decode brain signals and power motor function in a participant who had experienced a stroke 2 years earlier. The participant was able to use a powered arm brace on their paralyzed arm.

Neuralink recently released a video demonstrating the use of the interface in a monkey named Pager as it played a game with a joystick. Company researchers inserted a 1024-Electrode neural recording and data transmission device called the N1 Link into the left and right motor cortices. Using the implant, neural activity was sent to a decoder algorithm. Throughout the process, the decoder algorithm was refined and calibrated. After a few minutes, Pager was able to control the cursor on the screen using his mind instead of the joystick.

Mr. Musk hopes to develop Neuralink further to change not only the way we treat neurological disorders but also the way we interact with ourselves and our environment. It’s a lofty goal to be sure, but one that doesn’t seem outside the realm of possibility in the near future.
 

Known unknowns: The ethical dilemmas

One major conundrum facing the future of BCI technology is that researchers don’t fully understand the science regarding how brain signaling, artificial intelligence (AI) software, and prostheses interact. Although offloading computations improves the predictive nature of AI algorithms, there are concerns of identity and personal agency.

How do we know that an action is truly the result of one’s own thinking or, rather, the outcome of AI software? In this context, the autocorrect function while typing can be incredibly useful when we’re in a pinch for time, when we’re using one hand to type, or because of ease. However, it’s also easy to create and send out unintended or inappropriate messages.

These algorithms are designed to learn from our behavior and anticipate our next move. However, a question arises as to whether we are the authors of our own thoughts or whether we are simply the device that delivers messages under the control of external forces.

“People may question whether new personality changes they experience are truly representative of themselves or whether they are now a product of the implant (e.g., ‘Is that really me?’; ‘Have I grown as a person, or is it the technology?’). This then raises questions about agency and who we are as people,” says Kerry Bowman, PhD, a clinical bioethicist and assistant professor at the Temerty Faculty of Medicine of the University of Toronto.

It’s important to have safeguards in place to ensure the privacy of our thoughts. In an age where data is currency, it’s crucial to establish boundaries to preserve our autonomy and prevent exploitation (for example, by private companies or hackers). Although Neuralink and BCIs generally are certainly pushing the boundaries of neural engineering in profound ways, it’s important to note the biological and ethical implications of this technology.

As Dr. Bowman points out, “throughout the entire human story, under the worst of human circumstances, such as captivity and torture, the one safe ground and place for all people has been the privacy of one’s own mind. No one could ever interfere, take away, or be aware of those thoughts. However, this technology challenges one’s own privacy – that this technology (and, by extension, a company) could be aware of those thoughts.”

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

The brain is inarguably the most complex and mysterious organ in the human body.

As the epicenter of intelligence, mastermind of movement, and song for our senses, the brain is more than a 3-lb organ encased in shell and fluid. Rather, it is the crown jewel that defines the self and, broadly, humanity.

©Thinkstock

For decades now, researchers have been exploring the potential for connecting our own astounding biological “computer” with actual physical mainframes. These so-called “brain-computer interfaces” (BCIs) are showing promise in treating an array of conditions, including paralysis, deafness, stroke, and even psychiatric disorders.

Among the big players in this area of research is billionaire entrepreneur Elon Musk, who in 2016 founded Neuralink. The company’s short-term mission is to develop a brain-to-machine interface to help people with neurologic conditions (for example, Parkinson’s disease). The long-term mission is to steer humanity into the era of “superhuman cognition.”

But first, some neuroscience 101.

Neurons are specialized cells that transmit and receive information. The basic structure of a neuron includes the dendrite, soma, and axon. The dendrite is the signal receiver. The soma is the cell body that is connected to the dendrites and serves as a structure to pass signals. The axon, also known as the nerve fiber, transmits the signal away from the soma.

Neurons communicate with each other at the synapse (for example, axon-dendrite connection). Neurons send information to each other through action potentials. An action potential may be defined as an electric impulse that transmits down the axon, causing the release of neurotransmitters, which may consequently either inhibit or excite the next neuron (leading to the initiation of another action potential).

So how will the company and other BCI companies tap into this evolutionarily ancient system to develop an implant that will obtain and decode information output from the brain?

The Neuralink implant is composed of three parts: The Link, neural threads, and the charger.

A robotic system, controlled by a neurosurgeon, will place an implant into the brain. The Link is the central component. It processes and transmits neural signals. The micron-scale neural threads are connected to the Link and other areas of the brain. The threads also contain electrodes, which are responsible for detecting neural signals. The charger ensures the battery is charged via wireless connection.

The invasive nature of this implant allows for precise readouts of electric outputs from the brain – unlike noninvasive devices, which are less sensitive and specific. Additionally, owing to its small size, engineers and neurosurgeons can implant the device in very specific brain regions as well as customize electrode distribution.

The Neuralink implant would be paired with an application via Bluetooth connection. The goal is to enable someone with the implant to control their device or computer by simply thinking. The application offers several exercises to help guide and train individuals on how to use the implant for its intended purpose. This technology would allow people with neurologic difficulties (for example, paralysis) to communicate more easily through text or speech synthesis, as well as partake in creative activities such as photography.

Existing text and speech synthesis technology are already underway. For example, Synchron, a BCI platform company, is investigating the use of Stentrode for people with severe paralysis. This neuroprosthesis was designed to help people associate thought with movement through Bluetooth technology (for example, texting, emailing, shopping, online banking). Preliminary results from a study in which the device was used for patients with amyotrophic lateral sclerosis showed improvements in functional independence via direct thinking.

Software intended to enable high-performance handwriting utilizing BCI technology is being developed by Francis R. Willett, PhD, at Stanford (Calif.) University. The technology has also shown promise.

“We’ve learned that the brain retains its ability to prescribe fine movements a full decade after the body has lost its ability to execute those movements,” says Dr. Willett, who recently reported on results from a BCI study of handwriting conversion in an individual with full-body paralysis. Through a recurrent neural networking decoding approach, the BrainGate study participant was able to type 90 characters per minute – with an impressive 94.1% raw accuracy – using thoughts alone.

Although not a fully implantable brain device, this percutaneous implant has also been studied of its capacity to restore arm function among individuals who suffered from chronic stroke. Preliminary results from the Cortimo trials, led by Mijail D. Serruya, MD, an assistant professor at Thomas Jefferson University, Philadelphia, have been positive. Researchers implanted microelectrode arrays to decode brain signals and power motor function in a participant who had experienced a stroke 2 years earlier. The participant was able to use a powered arm brace on their paralyzed arm.

Neuralink recently released a video demonstrating the use of the interface in a monkey named Pager as it played a game with a joystick. Company researchers inserted a 1024-Electrode neural recording and data transmission device called the N1 Link into the left and right motor cortices. Using the implant, neural activity was sent to a decoder algorithm. Throughout the process, the decoder algorithm was refined and calibrated. After a few minutes, Pager was able to control the cursor on the screen using his mind instead of the joystick.

Mr. Musk hopes to develop Neuralink further to change not only the way we treat neurological disorders but also the way we interact with ourselves and our environment. It’s a lofty goal to be sure, but one that doesn’t seem outside the realm of possibility in the near future.
 

Known unknowns: The ethical dilemmas

One major conundrum facing the future of BCI technology is that researchers don’t fully understand the science regarding how brain signaling, artificial intelligence (AI) software, and prostheses interact. Although offloading computations improves the predictive nature of AI algorithms, there are concerns of identity and personal agency.

How do we know that an action is truly the result of one’s own thinking or, rather, the outcome of AI software? In this context, the autocorrect function while typing can be incredibly useful when we’re in a pinch for time, when we’re using one hand to type, or because of ease. However, it’s also easy to create and send out unintended or inappropriate messages.

These algorithms are designed to learn from our behavior and anticipate our next move. However, a question arises as to whether we are the authors of our own thoughts or whether we are simply the device that delivers messages under the control of external forces.

“People may question whether new personality changes they experience are truly representative of themselves or whether they are now a product of the implant (e.g., ‘Is that really me?’; ‘Have I grown as a person, or is it the technology?’). This then raises questions about agency and who we are as people,” says Kerry Bowman, PhD, a clinical bioethicist and assistant professor at the Temerty Faculty of Medicine of the University of Toronto.

It’s important to have safeguards in place to ensure the privacy of our thoughts. In an age where data is currency, it’s crucial to establish boundaries to preserve our autonomy and prevent exploitation (for example, by private companies or hackers). Although Neuralink and BCIs generally are certainly pushing the boundaries of neural engineering in profound ways, it’s important to note the biological and ethical implications of this technology.

As Dr. Bowman points out, “throughout the entire human story, under the worst of human circumstances, such as captivity and torture, the one safe ground and place for all people has been the privacy of one’s own mind. No one could ever interfere, take away, or be aware of those thoughts. However, this technology challenges one’s own privacy – that this technology (and, by extension, a company) could be aware of those thoughts.”

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

The brain is inarguably the most complex and mysterious organ in the human body.

As the epicenter of intelligence, mastermind of movement, and song for our senses, the brain is more than a 3-lb organ encased in shell and fluid. Rather, it is the crown jewel that defines the self and, broadly, humanity.

©Thinkstock

For decades now, researchers have been exploring the potential for connecting our own astounding biological “computer” with actual physical mainframes. These so-called “brain-computer interfaces” (BCIs) are showing promise in treating an array of conditions, including paralysis, deafness, stroke, and even psychiatric disorders.

Among the big players in this area of research is billionaire entrepreneur Elon Musk, who in 2016 founded Neuralink. The company’s short-term mission is to develop a brain-to-machine interface to help people with neurologic conditions (for example, Parkinson’s disease). The long-term mission is to steer humanity into the era of “superhuman cognition.”

But first, some neuroscience 101.

Neurons are specialized cells that transmit and receive information. The basic structure of a neuron includes the dendrite, soma, and axon. The dendrite is the signal receiver. The soma is the cell body that is connected to the dendrites and serves as a structure to pass signals. The axon, also known as the nerve fiber, transmits the signal away from the soma.

Neurons communicate with each other at the synapse (for example, axon-dendrite connection). Neurons send information to each other through action potentials. An action potential may be defined as an electric impulse that transmits down the axon, causing the release of neurotransmitters, which may consequently either inhibit or excite the next neuron (leading to the initiation of another action potential).

So how will the company and other BCI companies tap into this evolutionarily ancient system to develop an implant that will obtain and decode information output from the brain?

The Neuralink implant is composed of three parts: The Link, neural threads, and the charger.

A robotic system, controlled by a neurosurgeon, will place an implant into the brain. The Link is the central component. It processes and transmits neural signals. The micron-scale neural threads are connected to the Link and other areas of the brain. The threads also contain electrodes, which are responsible for detecting neural signals. The charger ensures the battery is charged via wireless connection.

The invasive nature of this implant allows for precise readouts of electric outputs from the brain – unlike noninvasive devices, which are less sensitive and specific. Additionally, owing to its small size, engineers and neurosurgeons can implant the device in very specific brain regions as well as customize electrode distribution.

The Neuralink implant would be paired with an application via Bluetooth connection. The goal is to enable someone with the implant to control their device or computer by simply thinking. The application offers several exercises to help guide and train individuals on how to use the implant for its intended purpose. This technology would allow people with neurologic difficulties (for example, paralysis) to communicate more easily through text or speech synthesis, as well as partake in creative activities such as photography.

Existing text and speech synthesis technology are already underway. For example, Synchron, a BCI platform company, is investigating the use of Stentrode for people with severe paralysis. This neuroprosthesis was designed to help people associate thought with movement through Bluetooth technology (for example, texting, emailing, shopping, online banking). Preliminary results from a study in which the device was used for patients with amyotrophic lateral sclerosis showed improvements in functional independence via direct thinking.

Software intended to enable high-performance handwriting utilizing BCI technology is being developed by Francis R. Willett, PhD, at Stanford (Calif.) University. The technology has also shown promise.

“We’ve learned that the brain retains its ability to prescribe fine movements a full decade after the body has lost its ability to execute those movements,” says Dr. Willett, who recently reported on results from a BCI study of handwriting conversion in an individual with full-body paralysis. Through a recurrent neural networking decoding approach, the BrainGate study participant was able to type 90 characters per minute – with an impressive 94.1% raw accuracy – using thoughts alone.

Although not a fully implantable brain device, this percutaneous implant has also been studied of its capacity to restore arm function among individuals who suffered from chronic stroke. Preliminary results from the Cortimo trials, led by Mijail D. Serruya, MD, an assistant professor at Thomas Jefferson University, Philadelphia, have been positive. Researchers implanted microelectrode arrays to decode brain signals and power motor function in a participant who had experienced a stroke 2 years earlier. The participant was able to use a powered arm brace on their paralyzed arm.

Neuralink recently released a video demonstrating the use of the interface in a monkey named Pager as it played a game with a joystick. Company researchers inserted a 1024-Electrode neural recording and data transmission device called the N1 Link into the left and right motor cortices. Using the implant, neural activity was sent to a decoder algorithm. Throughout the process, the decoder algorithm was refined and calibrated. After a few minutes, Pager was able to control the cursor on the screen using his mind instead of the joystick.

Mr. Musk hopes to develop Neuralink further to change not only the way we treat neurological disorders but also the way we interact with ourselves and our environment. It’s a lofty goal to be sure, but one that doesn’t seem outside the realm of possibility in the near future.
 

Known unknowns: The ethical dilemmas

One major conundrum facing the future of BCI technology is that researchers don’t fully understand the science regarding how brain signaling, artificial intelligence (AI) software, and prostheses interact. Although offloading computations improves the predictive nature of AI algorithms, there are concerns of identity and personal agency.

How do we know that an action is truly the result of one’s own thinking or, rather, the outcome of AI software? In this context, the autocorrect function while typing can be incredibly useful when we’re in a pinch for time, when we’re using one hand to type, or because of ease. However, it’s also easy to create and send out unintended or inappropriate messages.

These algorithms are designed to learn from our behavior and anticipate our next move. However, a question arises as to whether we are the authors of our own thoughts or whether we are simply the device that delivers messages under the control of external forces.

“People may question whether new personality changes they experience are truly representative of themselves or whether they are now a product of the implant (e.g., ‘Is that really me?’; ‘Have I grown as a person, or is it the technology?’). This then raises questions about agency and who we are as people,” says Kerry Bowman, PhD, a clinical bioethicist and assistant professor at the Temerty Faculty of Medicine of the University of Toronto.

It’s important to have safeguards in place to ensure the privacy of our thoughts. In an age where data is currency, it’s crucial to establish boundaries to preserve our autonomy and prevent exploitation (for example, by private companies or hackers). Although Neuralink and BCIs generally are certainly pushing the boundaries of neural engineering in profound ways, it’s important to note the biological and ethical implications of this technology.

As Dr. Bowman points out, “throughout the entire human story, under the worst of human circumstances, such as captivity and torture, the one safe ground and place for all people has been the privacy of one’s own mind. No one could ever interfere, take away, or be aware of those thoughts. However, this technology challenges one’s own privacy – that this technology (and, by extension, a company) could be aware of those thoughts.”

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

A patient’s lived experience of being in the hospital is shaped by a variety of factors, according to Minesh Patel, MD, Mid-Atlantic regional medical director for the Tacoma, Wash.–based hospitalist performance company Sound Physicians. Some – but not all – of these factors are captured in the “patient experience” questions on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey that is sent to randomly selected patients shortly after their discharge from the hospital.

In March 2020, the COVID-19 pandemic caused hospitals to institute quarantining measures and “no visitor” policies as doctors and other hospital staff donned masks, visors, and other emotionally distancing personal protective equipment (PPE). All of these factors impacted patients’ experience as well as their hospitals’ HCAHPS scores, Dr. Patel said. And since these policies applied to all hospitalized patients, a patient did not need to have COVID-19 to experience many of the same restrictions imposed by the pandemic.

“A lot of the care hospitalists provide involves touch, sitting down and looking at the patient eye to eye, on the same level,” said Dr. Patel, a practicing hospitalist at Frederick (Md.) Health Hospital. “That had to take a back seat to infection control.”

Meanwhile, lengths of stay were longer for COVID-19 patients, who were often very sick and alone in their hospital rooms for prolonged periods, sometimes on mechanical ventilation, isolated without the support of their families. Health care providers tried to minimize time spent at the bedside because of viral exposure risks. Nobody really knew how to treat patients’ severe respiratory distress, especially at first. “So we basically threw the kitchen sink at it, following the evolving CDC guidelines, and hoped it would work,” he explained.

“When we saw our patient experience scores plummeting across the division, we said, ‘This is not good.’ We could see that we weren’t spending as much time at the bedside, and our patients were lonely and scared.” There was also greater fragmentation of care, all of which impacted patients’ experience in partnering hospitals.

Dr. Patel and his team spearheaded a number of processes across their partner hospitals to help patients and their families get the information they needed and understand what was happening during their treatment. “At that moment, real-time feedback was essential,” he explained. “We implemented the TED protocol – Teach back, Empathy and ‘Double-backing,’ which means spending a shorter visit on morning rounds but going back to the patient’s bedside for a second daily visit at the end of the shift, thereby establishing a second touch point.” Teach back is a strategy of asking patients to repeat back in their own words what they understood the doctor to be saying about their care.

The group developed ID buttons – called “Suttons” or Sound Buttons – with a larger picture of the doctor’s smiling face pinned to their medical gowns. The hospitalists started scheduling Zoom calls with families from the ICU rooms of COVID-19 patients. “We employ clinical performance nurses as collaborative influencers. They visit patients’ bedsides and work with staff on improving patient experience,” Dr. Patel said. “And we printed thank-you cards with the doctor’s name, photo, and an individualized message for their patients.” Together these measures measurably improved patient experience scores across partnering hospitals.

Sound Physicians

What is patient experience?

Evaluated by the Agency for Healthcare Research and Quality and endorsed by the National Quality Forum, HCAHPS hospital quality surveys ask patients (or their family members, who may be the ones completing the survey) 29 well-tested questions about the recent hospital stay and how they experienced it. Nineteen of those questions explore critical aspects of the patient’s experience in areas such as communication, responsiveness of staff, information about their diagnosis, medications, and discharge – and if they would recommend the hospital to others.

Surveys can be done by mail, phone, or interactive voice recognition and are offered in seven different languages. They can be administered by the hospital itself or by an approved survey vendor. They are sent between 48 hours and 6 weeks after the patient’s hospital discharge.

Nationwide results from HCAHPS survey have been published since 2008 in a searchable, comparable format on the consumer-focused government website Hospital Compare. The data have been used in a value-based incentive purchasing program since 2012. Hospital Compare also incorporates measures of quality such as mortality, readmission, and hospital-acquired infection rates as well as process measures such as how well facilities provide recommended care.

Starting in 2016, overall hospital quality has been encapsulated in a Star rating, which summarizes a variety of measures across seven areas of quality into a single number from one to five for each hospital. One of those seven areas is patient experience.

Hospitals may choose to ask additional questions of their own along with the HCAHPS survey, to gather additional, actionable quality data for internal purposes. Internal surveys with results closer to real time, instead of the months-to-years lag in posting HCAHPS scores, enable the hospital to respond to issues that emerge.
 

It’s not just the scores

“A lot of leaders in the hospital business will tell you ‘It’s not about the scores,’ ” Dr. Patel related. “But you need scores to tell how your practice is doing. It’s a testament to the kind of care you are providing as a hospital medicine program. These are important questions: Did your doctor listen to you, communicate in ways you understood, and treat you with courtesy?” Scores are scores, he said, but more importantly, are patients getting the information they need? Do they understand what’s going on in their care?

“You have to look at the scores and ask, what can we do differently to impact patient experience? What are we doing wrong? What can we do better? If the scores as a collective experience of hospitalized patients are plummeting, it must mean they’re not feeling good about the care they are receiving, and not recognizing what we’re trying to do for them.”

Declining HCAHPS scores last year could easily be explained by what was going on with COVID-19, Dr. Patel said. “But we want our patient experience to be seamless. We have to put ourselves in the patient’s shoes. For them, it’s about whether they felt they were treated well or not. We had to reinvent ourselves and find new ways to compensate for the limitations imposed by the pandemic,” he said.

“We also recognized that our No. 1 job as a group is to take care of our doctors, so that they can take care of their patients. We provided quarantine pay, implemented a buddy system for doctors, used CME dollars to pay for COVID education and, if they felt ill, we said they needed to stay home, while we paid their shift anyway,” he said. “When you do that kind of thing and engage them in your mission, frontline hospitalists can help to improve quality of care, decrease costs, and increase patient safety.”
 

A sacred encounter

For Sarah Richards, MD, a hospitalist with Nebraska Medicine in Omaha, what happens in the hospital room between the hospitalist and the patient is a sacred encounter. “It’s about relationship and trust,” she said, noting that it’s hard to capture all of that in survey data. It might be better expressed in words: “ ‘How are things going for you?’ To me, that’s the real patient experience. When I talk with physicians about patient experience, I start with why this matters. We know, for example, that when patients trust us, they are more likely to engage with their care and adhere to the treatment plan.”

Dr. Richards said standard hospital quality surveys can be a blunt tool. The HCAHPS survey, conducted around a week after the hospitalization, has a low response rate, and returns are not representative of the demographic served in the hospital. “The inpatient data are not always helpful, but this is what we have to work with. One choice hospitals have is for the leadership to choose not to use the data for individual bonuses, recognition, or discipline, since the questions ask patients about the care they received collectively from all of their doctors,” she said.

But as hospitalists have worked longer shifts under more stress while wearing PPE – which makes it harder to communicate with their patients – there is a dynamic that has emerged, which deserves more study. “I think doctors gave it their all in the pandemic. I’m a hospitalist, and people told me I’m a hero. But did that change my impact at work (on patient experience)?” she said.

Dr. Richards sits on SHM’s Patient Experience Special Interest Group (SIG), which was tasked with providing tools to help mitigate the effects of the pandemic. These include a fact sheet, “Communication Tips for 5 Common Conundrums in the COVID-19 Pandemic”, and a downloadable pocket card called “The 5 Rs of Cultural Humility.”

Also on the SIG is Mark Rudolph, MD, SFHM, Sound Physicians’ chief experience officer, whose job title reflects a growing, systematic attention to patient experience in U.S. hospitals. “Most clinicians are familiar with the surveys and the results of those surveys,” he told The Hospitalist. “People in our field can get frustrated with the surveys, and have a lot to say about the quality of the scores themselves – what is actually being measured. Is the patient upset because the coffee was cold, or due to a bad clinical experience? Is it about the care they received from the hospitalist, or the physical setting of the hospital?”

Doing the right thing

To be a patient hospitalized with an acute illness is a form of suffering, Dr. Rudolph said. “We know patient experience in the hospital since March of 2020 has been frightening and horrible. These people are as sick as can be. Everything about the experience is horrible. Every effort you can make to reduce that suffering is important. If you are a patient in the hospital and don’t know what’s happening to you, that’s terrifying.”

He encourages hospitalists to look beyond the scores or the idea that they are just trying to improve their scores. “Look instead at the actual content of the questions around communication with doctors. The competencies addressed in the survey questions – listening and explaining things clearly, for example – are effective guides for patient experience improvement efforts. You can be confident you’re doing the right thing for the patient by focusing on these skills, even if you don’t see immediate changes in survey scores.”

Hospitals that did not allow visitors had worse clinical outcomes and worse patient experience ratings, and recent research confirms that when family visitors are not allowed, outcomes are worse in areas such as patient ratings of medical staff responsiveness, fall rates, and sepsis rates.¹ “None of that should be surprising. Not having family present just ups the ante. Any hospital patients could benefit from an advocate sitting next to them, helping them to the bathroom, and keeping them from falling out of bed,” Dr. Rudolph said.

“In the past year, we have placed a premium on communicating with these patients with kindness and compassion, to help them understand what’s happening to them,” he said. Out of necessity, hospitals have had to rejigger their processes, which has led to more efficient and better care, although the jury is still out on whether that will persist post pandemic.
 

Communicating with compassion

Swati Mehta, MD, a hospitalist at Sequoia Hospital in Redwood City, Calif., and director of quality performance and patient experience at Vituity, a physician-owned and -led multispecialty partnership, said COVID-19 was a wake-up call for hospitalists. There have been successful models for enhancing hospitalized patients’ experience, but it took the challenges of COVID-19 for many hospitalists to adopt them.

“Early in 2020, our data analysis showed emerging positive trends, reflecting our patients’ appreciation for what doctors were doing in the crisis and awareness of the challenges they faced. But after that uptick, global measures and national data showed drops for health care organizations and providers. Patients’ expectations were not being met. We needed to respond and meet patients where they were at. We needed to do things differently,” she said.

Keeping patients well informed and treating them with respect are paramount – and more important than ever – as reflected in Dr. Mehta’s “6H” model to promote a human connection between doctors and patients.² As chair of SHM’s Patient Experience SIG, she led the creation of COVID-19–specific communication tips for hospitalists based on the 6H model. “I’m very committed to treating patients with compassion,” she said.

For Vituity, those approaches included making greater use of the hospital at home model for patients who reported to the emergency department but met certain criteria for discharge. They would be sent home with daily nursing visits and 24-hour virtual access to hospitalists. Vituity hospitalists also worked more closely with emergency departments to provide emergency psychiatric interventions for anxious patients, and with primary care physicians. Patient care navigators helped to enhance transitions of care. In addition, their hospitalist team added personalized pictures over their gowns so patients could see the hospitalists’ faces despite PPE.

Another Vituity innovation was virtual rounding, with iPads in the patient’s room and the physician in another room. “I did telerounds at our Redwood City hospital with patients with COVID who were very lonely, anxious, and afraid because they couldn’t have family visitors,” Dr. Mehta said. Telerounds offered greater protection and safety for both providers and patients, reduced the need for PPE, and improved collaboration with the nursing team, primary care providers, and families.

A recent perspective published in the New England Journal of Medicine suggests that the Zoom family conference may offer distinct advantages over in-person family conferences.³ It allows for greater participation by primary care clinicians who knew the patient before the current hospitalization and thus might have important contributions to discharge plans.

The pandemic stimulated many hospitals to take a closer look at all areas of their service delivery, Dr. Rudolph concluded. “We’ve made big changes with a lot of fearlessness in a short amount of time, which is not typical for hospitals. We showed that the pace of innovation can be faster if we lower the threshold of risk.”
 

References

1. Silvera GA et al. The influence of COVID-19 visitation restrictions on patient experience and safety outcomes: A critical role for subjective advocates. Patient Experience Journal. 8(1) doi: 10.35680/2372-0247.1596.

2. Mehta S. How to truly connect with your patients: Introducing the ‘6H model.’ The Hospitalist. 2020 Aug 14.

3. Lee TH. Zoom family meeting. N Engl J Med. 2021 Apr 29;384(17):1586-7.

A patient’s lived experience of being in the hospital is shaped by a variety of factors, according to Minesh Patel, MD, Mid-Atlantic regional medical director for the Tacoma, Wash.–based hospitalist performance company Sound Physicians. Some – but not all – of these factors are captured in the “patient experience” questions on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey that is sent to randomly selected patients shortly after their discharge from the hospital.

In March 2020, the COVID-19 pandemic caused hospitals to institute quarantining measures and “no visitor” policies as doctors and other hospital staff donned masks, visors, and other emotionally distancing personal protective equipment (PPE). All of these factors impacted patients’ experience as well as their hospitals’ HCAHPS scores, Dr. Patel said. And since these policies applied to all hospitalized patients, a patient did not need to have COVID-19 to experience many of the same restrictions imposed by the pandemic.

“A lot of the care hospitalists provide involves touch, sitting down and looking at the patient eye to eye, on the same level,” said Dr. Patel, a practicing hospitalist at Frederick (Md.) Health Hospital. “That had to take a back seat to infection control.”

Meanwhile, lengths of stay were longer for COVID-19 patients, who were often very sick and alone in their hospital rooms for prolonged periods, sometimes on mechanical ventilation, isolated without the support of their families. Health care providers tried to minimize time spent at the bedside because of viral exposure risks. Nobody really knew how to treat patients’ severe respiratory distress, especially at first. “So we basically threw the kitchen sink at it, following the evolving CDC guidelines, and hoped it would work,” he explained.

“When we saw our patient experience scores plummeting across the division, we said, ‘This is not good.’ We could see that we weren’t spending as much time at the bedside, and our patients were lonely and scared.” There was also greater fragmentation of care, all of which impacted patients’ experience in partnering hospitals.

Dr. Patel and his team spearheaded a number of processes across their partner hospitals to help patients and their families get the information they needed and understand what was happening during their treatment. “At that moment, real-time feedback was essential,” he explained. “We implemented the TED protocol – Teach back, Empathy and ‘Double-backing,’ which means spending a shorter visit on morning rounds but going back to the patient’s bedside for a second daily visit at the end of the shift, thereby establishing a second touch point.” Teach back is a strategy of asking patients to repeat back in their own words what they understood the doctor to be saying about their care.

The group developed ID buttons – called “Suttons” or Sound Buttons – with a larger picture of the doctor’s smiling face pinned to their medical gowns. The hospitalists started scheduling Zoom calls with families from the ICU rooms of COVID-19 patients. “We employ clinical performance nurses as collaborative influencers. They visit patients’ bedsides and work with staff on improving patient experience,” Dr. Patel said. “And we printed thank-you cards with the doctor’s name, photo, and an individualized message for their patients.” Together these measures measurably improved patient experience scores across partnering hospitals.

Sound Physicians

What is patient experience?

Evaluated by the Agency for Healthcare Research and Quality and endorsed by the National Quality Forum, HCAHPS hospital quality surveys ask patients (or their family members, who may be the ones completing the survey) 29 well-tested questions about the recent hospital stay and how they experienced it. Nineteen of those questions explore critical aspects of the patient’s experience in areas such as communication, responsiveness of staff, information about their diagnosis, medications, and discharge – and if they would recommend the hospital to others.

Surveys can be done by mail, phone, or interactive voice recognition and are offered in seven different languages. They can be administered by the hospital itself or by an approved survey vendor. They are sent between 48 hours and 6 weeks after the patient’s hospital discharge.

Nationwide results from HCAHPS survey have been published since 2008 in a searchable, comparable format on the consumer-focused government website Hospital Compare. The data have been used in a value-based incentive purchasing program since 2012. Hospital Compare also incorporates measures of quality such as mortality, readmission, and hospital-acquired infection rates as well as process measures such as how well facilities provide recommended care.

Starting in 2016, overall hospital quality has been encapsulated in a Star rating, which summarizes a variety of measures across seven areas of quality into a single number from one to five for each hospital. One of those seven areas is patient experience.

Hospitals may choose to ask additional questions of their own along with the HCAHPS survey, to gather additional, actionable quality data for internal purposes. Internal surveys with results closer to real time, instead of the months-to-years lag in posting HCAHPS scores, enable the hospital to respond to issues that emerge.
 

It’s not just the scores

“A lot of leaders in the hospital business will tell you ‘It’s not about the scores,’ ” Dr. Patel related. “But you need scores to tell how your practice is doing. It’s a testament to the kind of care you are providing as a hospital medicine program. These are important questions: Did your doctor listen to you, communicate in ways you understood, and treat you with courtesy?” Scores are scores, he said, but more importantly, are patients getting the information they need? Do they understand what’s going on in their care?

“You have to look at the scores and ask, what can we do differently to impact patient experience? What are we doing wrong? What can we do better? If the scores as a collective experience of hospitalized patients are plummeting, it must mean they’re not feeling good about the care they are receiving, and not recognizing what we’re trying to do for them.”

Declining HCAHPS scores last year could easily be explained by what was going on with COVID-19, Dr. Patel said. “But we want our patient experience to be seamless. We have to put ourselves in the patient’s shoes. For them, it’s about whether they felt they were treated well or not. We had to reinvent ourselves and find new ways to compensate for the limitations imposed by the pandemic,” he said.

“We also recognized that our No. 1 job as a group is to take care of our doctors, so that they can take care of their patients. We provided quarantine pay, implemented a buddy system for doctors, used CME dollars to pay for COVID education and, if they felt ill, we said they needed to stay home, while we paid their shift anyway,” he said. “When you do that kind of thing and engage them in your mission, frontline hospitalists can help to improve quality of care, decrease costs, and increase patient safety.”
 

A sacred encounter

For Sarah Richards, MD, a hospitalist with Nebraska Medicine in Omaha, what happens in the hospital room between the hospitalist and the patient is a sacred encounter. “It’s about relationship and trust,” she said, noting that it’s hard to capture all of that in survey data. It might be better expressed in words: “ ‘How are things going for you?’ To me, that’s the real patient experience. When I talk with physicians about patient experience, I start with why this matters. We know, for example, that when patients trust us, they are more likely to engage with their care and adhere to the treatment plan.”

Dr. Richards said standard hospital quality surveys can be a blunt tool. The HCAHPS survey, conducted around a week after the hospitalization, has a low response rate, and returns are not representative of the demographic served in the hospital. “The inpatient data are not always helpful, but this is what we have to work with. One choice hospitals have is for the leadership to choose not to use the data for individual bonuses, recognition, or discipline, since the questions ask patients about the care they received collectively from all of their doctors,” she said.

But as hospitalists have worked longer shifts under more stress while wearing PPE – which makes it harder to communicate with their patients – there is a dynamic that has emerged, which deserves more study. “I think doctors gave it their all in the pandemic. I’m a hospitalist, and people told me I’m a hero. But did that change my impact at work (on patient experience)?” she said.

Dr. Richards sits on SHM’s Patient Experience Special Interest Group (SIG), which was tasked with providing tools to help mitigate the effects of the pandemic. These include a fact sheet, “Communication Tips for 5 Common Conundrums in the COVID-19 Pandemic”, and a downloadable pocket card called “The 5 Rs of Cultural Humility.”

Also on the SIG is Mark Rudolph, MD, SFHM, Sound Physicians’ chief experience officer, whose job title reflects a growing, systematic attention to patient experience in U.S. hospitals. “Most clinicians are familiar with the surveys and the results of those surveys,” he told The Hospitalist. “People in our field can get frustrated with the surveys, and have a lot to say about the quality of the scores themselves – what is actually being measured. Is the patient upset because the coffee was cold, or due to a bad clinical experience? Is it about the care they received from the hospitalist, or the physical setting of the hospital?”

Doing the right thing

To be a patient hospitalized with an acute illness is a form of suffering, Dr. Rudolph said. “We know patient experience in the hospital since March of 2020 has been frightening and horrible. These people are as sick as can be. Everything about the experience is horrible. Every effort you can make to reduce that suffering is important. If you are a patient in the hospital and don’t know what’s happening to you, that’s terrifying.”

He encourages hospitalists to look beyond the scores or the idea that they are just trying to improve their scores. “Look instead at the actual content of the questions around communication with doctors. The competencies addressed in the survey questions – listening and explaining things clearly, for example – are effective guides for patient experience improvement efforts. You can be confident you’re doing the right thing for the patient by focusing on these skills, even if you don’t see immediate changes in survey scores.”

Hospitals that did not allow visitors had worse clinical outcomes and worse patient experience ratings, and recent research confirms that when family visitors are not allowed, outcomes are worse in areas such as patient ratings of medical staff responsiveness, fall rates, and sepsis rates.¹ “None of that should be surprising. Not having family present just ups the ante. Any hospital patients could benefit from an advocate sitting next to them, helping them to the bathroom, and keeping them from falling out of bed,” Dr. Rudolph said.

“In the past year, we have placed a premium on communicating with these patients with kindness and compassion, to help them understand what’s happening to them,” he said. Out of necessity, hospitals have had to rejigger their processes, which has led to more efficient and better care, although the jury is still out on whether that will persist post pandemic.
 

Communicating with compassion

Swati Mehta, MD, a hospitalist at Sequoia Hospital in Redwood City, Calif., and director of quality performance and patient experience at Vituity, a physician-owned and -led multispecialty partnership, said COVID-19 was a wake-up call for hospitalists. There have been successful models for enhancing hospitalized patients’ experience, but it took the challenges of COVID-19 for many hospitalists to adopt them.

“Early in 2020, our data analysis showed emerging positive trends, reflecting our patients’ appreciation for what doctors were doing in the crisis and awareness of the challenges they faced. But after that uptick, global measures and national data showed drops for health care organizations and providers. Patients’ expectations were not being met. We needed to respond and meet patients where they were at. We needed to do things differently,” she said.

Keeping patients well informed and treating them with respect are paramount – and more important than ever – as reflected in Dr. Mehta’s “6H” model to promote a human connection between doctors and patients.² As chair of SHM’s Patient Experience SIG, she led the creation of COVID-19–specific communication tips for hospitalists based on the 6H model. “I’m very committed to treating patients with compassion,” she said.

For Vituity, those approaches included making greater use of the hospital at home model for patients who reported to the emergency department but met certain criteria for discharge. They would be sent home with daily nursing visits and 24-hour virtual access to hospitalists. Vituity hospitalists also worked more closely with emergency departments to provide emergency psychiatric interventions for anxious patients, and with primary care physicians. Patient care navigators helped to enhance transitions of care. In addition, their hospitalist team added personalized pictures over their gowns so patients could see the hospitalists’ faces despite PPE.

Another Vituity innovation was virtual rounding, with iPads in the patient’s room and the physician in another room. “I did telerounds at our Redwood City hospital with patients with COVID who were very lonely, anxious, and afraid because they couldn’t have family visitors,” Dr. Mehta said. Telerounds offered greater protection and safety for both providers and patients, reduced the need for PPE, and improved collaboration with the nursing team, primary care providers, and families.

A recent perspective published in the New England Journal of Medicine suggests that the Zoom family conference may offer distinct advantages over in-person family conferences.³ It allows for greater participation by primary care clinicians who knew the patient before the current hospitalization and thus might have important contributions to discharge plans.

The pandemic stimulated many hospitals to take a closer look at all areas of their service delivery, Dr. Rudolph concluded. “We’ve made big changes with a lot of fearlessness in a short amount of time, which is not typical for hospitals. We showed that the pace of innovation can be faster if we lower the threshold of risk.”
 

References

1. Silvera GA et al. The influence of COVID-19 visitation restrictions on patient experience and safety outcomes: A critical role for subjective advocates. Patient Experience Journal. 8(1) doi: 10.35680/2372-0247.1596.

2. Mehta S. How to truly connect with your patients: Introducing the ‘6H model.’ The Hospitalist. 2020 Aug 14.

3. Lee TH. Zoom family meeting. N Engl J Med. 2021 Apr 29;384(17):1586-7.

A patient’s lived experience of being in the hospital is shaped by a variety of factors, according to Minesh Patel, MD, Mid-Atlantic regional medical director for the Tacoma, Wash.–based hospitalist performance company Sound Physicians. Some – but not all – of these factors are captured in the “patient experience” questions on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey that is sent to randomly selected patients shortly after their discharge from the hospital.

In March 2020, the COVID-19 pandemic caused hospitals to institute quarantining measures and “no visitor” policies as doctors and other hospital staff donned masks, visors, and other emotionally distancing personal protective equipment (PPE). All of these factors impacted patients’ experience as well as their hospitals’ HCAHPS scores, Dr. Patel said. And since these policies applied to all hospitalized patients, a patient did not need to have COVID-19 to experience many of the same restrictions imposed by the pandemic.

“A lot of the care hospitalists provide involves touch, sitting down and looking at the patient eye to eye, on the same level,” said Dr. Patel, a practicing hospitalist at Frederick (Md.) Health Hospital. “That had to take a back seat to infection control.”

Meanwhile, lengths of stay were longer for COVID-19 patients, who were often very sick and alone in their hospital rooms for prolonged periods, sometimes on mechanical ventilation, isolated without the support of their families. Health care providers tried to minimize time spent at the bedside because of viral exposure risks. Nobody really knew how to treat patients’ severe respiratory distress, especially at first. “So we basically threw the kitchen sink at it, following the evolving CDC guidelines, and hoped it would work,” he explained.

“When we saw our patient experience scores plummeting across the division, we said, ‘This is not good.’ We could see that we weren’t spending as much time at the bedside, and our patients were lonely and scared.” There was also greater fragmentation of care, all of which impacted patients’ experience in partnering hospitals.

Dr. Patel and his team spearheaded a number of processes across their partner hospitals to help patients and their families get the information they needed and understand what was happening during their treatment. “At that moment, real-time feedback was essential,” he explained. “We implemented the TED protocol – Teach back, Empathy and ‘Double-backing,’ which means spending a shorter visit on morning rounds but going back to the patient’s bedside for a second daily visit at the end of the shift, thereby establishing a second touch point.” Teach back is a strategy of asking patients to repeat back in their own words what they understood the doctor to be saying about their care.

The group developed ID buttons – called “Suttons” or Sound Buttons – with a larger picture of the doctor’s smiling face pinned to their medical gowns. The hospitalists started scheduling Zoom calls with families from the ICU rooms of COVID-19 patients. “We employ clinical performance nurses as collaborative influencers. They visit patients’ bedsides and work with staff on improving patient experience,” Dr. Patel said. “And we printed thank-you cards with the doctor’s name, photo, and an individualized message for their patients.” Together these measures measurably improved patient experience scores across partnering hospitals.

Sound Physicians

What is patient experience?

Evaluated by the Agency for Healthcare Research and Quality and endorsed by the National Quality Forum, HCAHPS hospital quality surveys ask patients (or their family members, who may be the ones completing the survey) 29 well-tested questions about the recent hospital stay and how they experienced it. Nineteen of those questions explore critical aspects of the patient’s experience in areas such as communication, responsiveness of staff, information about their diagnosis, medications, and discharge – and if they would recommend the hospital to others.

Surveys can be done by mail, phone, or interactive voice recognition and are offered in seven different languages. They can be administered by the hospital itself or by an approved survey vendor. They are sent between 48 hours and 6 weeks after the patient’s hospital discharge.

Nationwide results from HCAHPS survey have been published since 2008 in a searchable, comparable format on the consumer-focused government website Hospital Compare. The data have been used in a value-based incentive purchasing program since 2012. Hospital Compare also incorporates measures of quality such as mortality, readmission, and hospital-acquired infection rates as well as process measures such as how well facilities provide recommended care.

Starting in 2016, overall hospital quality has been encapsulated in a Star rating, which summarizes a variety of measures across seven areas of quality into a single number from one to five for each hospital. One of those seven areas is patient experience.

Hospitals may choose to ask additional questions of their own along with the HCAHPS survey, to gather additional, actionable quality data for internal purposes. Internal surveys with results closer to real time, instead of the months-to-years lag in posting HCAHPS scores, enable the hospital to respond to issues that emerge.
 

It’s not just the scores

“A lot of leaders in the hospital business will tell you ‘It’s not about the scores,’ ” Dr. Patel related. “But you need scores to tell how your practice is doing. It’s a testament to the kind of care you are providing as a hospital medicine program. These are important questions: Did your doctor listen to you, communicate in ways you understood, and treat you with courtesy?” Scores are scores, he said, but more importantly, are patients getting the information they need? Do they understand what’s going on in their care?

“You have to look at the scores and ask, what can we do differently to impact patient experience? What are we doing wrong? What can we do better? If the scores as a collective experience of hospitalized patients are plummeting, it must mean they’re not feeling good about the care they are receiving, and not recognizing what we’re trying to do for them.”

Declining HCAHPS scores last year could easily be explained by what was going on with COVID-19, Dr. Patel said. “But we want our patient experience to be seamless. We have to put ourselves in the patient’s shoes. For them, it’s about whether they felt they were treated well or not. We had to reinvent ourselves and find new ways to compensate for the limitations imposed by the pandemic,” he said.

“We also recognized that our No. 1 job as a group is to take care of our doctors, so that they can take care of their patients. We provided quarantine pay, implemented a buddy system for doctors, used CME dollars to pay for COVID education and, if they felt ill, we said they needed to stay home, while we paid their shift anyway,” he said. “When you do that kind of thing and engage them in your mission, frontline hospitalists can help to improve quality of care, decrease costs, and increase patient safety.”
 

A sacred encounter

For Sarah Richards, MD, a hospitalist with Nebraska Medicine in Omaha, what happens in the hospital room between the hospitalist and the patient is a sacred encounter. “It’s about relationship and trust,” she said, noting that it’s hard to capture all of that in survey data. It might be better expressed in words: “ ‘How are things going for you?’ To me, that’s the real patient experience. When I talk with physicians about patient experience, I start with why this matters. We know, for example, that when patients trust us, they are more likely to engage with their care and adhere to the treatment plan.”

Dr. Richards said standard hospital quality surveys can be a blunt tool. The HCAHPS survey, conducted around a week after the hospitalization, has a low response rate, and returns are not representative of the demographic served in the hospital. “The inpatient data are not always helpful, but this is what we have to work with. One choice hospitals have is for the leadership to choose not to use the data for individual bonuses, recognition, or discipline, since the questions ask patients about the care they received collectively from all of their doctors,” she said.

But as hospitalists have worked longer shifts under more stress while wearing PPE – which makes it harder to communicate with their patients – there is a dynamic that has emerged, which deserves more study. “I think doctors gave it their all in the pandemic. I’m a hospitalist, and people told me I’m a hero. But did that change my impact at work (on patient experience)?” she said.

Dr. Richards sits on SHM’s Patient Experience Special Interest Group (SIG), which was tasked with providing tools to help mitigate the effects of the pandemic. These include a fact sheet, “Communication Tips for 5 Common Conundrums in the COVID-19 Pandemic”, and a downloadable pocket card called “The 5 Rs of Cultural Humility.”

Also on the SIG is Mark Rudolph, MD, SFHM, Sound Physicians’ chief experience officer, whose job title reflects a growing, systematic attention to patient experience in U.S. hospitals. “Most clinicians are familiar with the surveys and the results of those surveys,” he told The Hospitalist. “People in our field can get frustrated with the surveys, and have a lot to say about the quality of the scores themselves – what is actually being measured. Is the patient upset because the coffee was cold, or due to a bad clinical experience? Is it about the care they received from the hospitalist, or the physical setting of the hospital?”

Doing the right thing

To be a patient hospitalized with an acute illness is a form of suffering, Dr. Rudolph said. “We know patient experience in the hospital since March of 2020 has been frightening and horrible. These people are as sick as can be. Everything about the experience is horrible. Every effort you can make to reduce that suffering is important. If you are a patient in the hospital and don’t know what’s happening to you, that’s terrifying.”

He encourages hospitalists to look beyond the scores or the idea that they are just trying to improve their scores. “Look instead at the actual content of the questions around communication with doctors. The competencies addressed in the survey questions – listening and explaining things clearly, for example – are effective guides for patient experience improvement efforts. You can be confident you’re doing the right thing for the patient by focusing on these skills, even if you don’t see immediate changes in survey scores.”

Hospitals that did not allow visitors had worse clinical outcomes and worse patient experience ratings, and recent research confirms that when family visitors are not allowed, outcomes are worse in areas such as patient ratings of medical staff responsiveness, fall rates, and sepsis rates.¹ “None of that should be surprising. Not having family present just ups the ante. Any hospital patients could benefit from an advocate sitting next to them, helping them to the bathroom, and keeping them from falling out of bed,” Dr. Rudolph said.

“In the past year, we have placed a premium on communicating with these patients with kindness and compassion, to help them understand what’s happening to them,” he said. Out of necessity, hospitals have had to rejigger their processes, which has led to more efficient and better care, although the jury is still out on whether that will persist post pandemic.
 

Communicating with compassion

Swati Mehta, MD, a hospitalist at Sequoia Hospital in Redwood City, Calif., and director of quality performance and patient experience at Vituity, a physician-owned and -led multispecialty partnership, said COVID-19 was a wake-up call for hospitalists. There have been successful models for enhancing hospitalized patients’ experience, but it took the challenges of COVID-19 for many hospitalists to adopt them.

“Early in 2020, our data analysis showed emerging positive trends, reflecting our patients’ appreciation for what doctors were doing in the crisis and awareness of the challenges they faced. But after that uptick, global measures and national data showed drops for health care organizations and providers. Patients’ expectations were not being met. We needed to respond and meet patients where they were at. We needed to do things differently,” she said.

Keeping patients well informed and treating them with respect are paramount – and more important than ever – as reflected in Dr. Mehta’s “6H” model to promote a human connection between doctors and patients.² As chair of SHM’s Patient Experience SIG, she led the creation of COVID-19–specific communication tips for hospitalists based on the 6H model. “I’m very committed to treating patients with compassion,” she said.

For Vituity, those approaches included making greater use of the hospital at home model for patients who reported to the emergency department but met certain criteria for discharge. They would be sent home with daily nursing visits and 24-hour virtual access to hospitalists. Vituity hospitalists also worked more closely with emergency departments to provide emergency psychiatric interventions for anxious patients, and with primary care physicians. Patient care navigators helped to enhance transitions of care. In addition, their hospitalist team added personalized pictures over their gowns so patients could see the hospitalists’ faces despite PPE.

Another Vituity innovation was virtual rounding, with iPads in the patient’s room and the physician in another room. “I did telerounds at our Redwood City hospital with patients with COVID who were very lonely, anxious, and afraid because they couldn’t have family visitors,” Dr. Mehta said. Telerounds offered greater protection and safety for both providers and patients, reduced the need for PPE, and improved collaboration with the nursing team, primary care providers, and families.

A recent perspective published in the New England Journal of Medicine suggests that the Zoom family conference may offer distinct advantages over in-person family conferences.³ It allows for greater participation by primary care clinicians who knew the patient before the current hospitalization and thus might have important contributions to discharge plans.

The pandemic stimulated many hospitals to take a closer look at all areas of their service delivery, Dr. Rudolph concluded. “We’ve made big changes with a lot of fearlessness in a short amount of time, which is not typical for hospitals. We showed that the pace of innovation can be faster if we lower the threshold of risk.”
 

References

1. Silvera GA et al. The influence of COVID-19 visitation restrictions on patient experience and safety outcomes: A critical role for subjective advocates. Patient Experience Journal. 8(1) doi: 10.35680/2372-0247.1596.

2. Mehta S. How to truly connect with your patients: Introducing the ‘6H model.’ The Hospitalist. 2020 Aug 14.

3. Lee TH. Zoom family meeting. N Engl J Med. 2021 Apr 29;384(17):1586-7.

Two models for treating patients with complex psychiatric disorders in primary care are equally effective, new research suggests.

FatCamera/Getty Images

Results from a pragmatic, randomized comparative effectiveness study involving more than 1,000 patients showed that both integrated telepsychiatry collaborative care (TCC) and telepsychiatry/telepsychology enhanced referral (TER) provided “significantly and substantially” improved clinical outcomes, researchers noted.

However, the referral model required substantially more mental health specialist time than does the integrated model.

Therefore, from a societal perspective, the integrated care approach “more efficiently uses this scarce resource,” lead author John Fortney, PhD, department of psychiatry and behavioral sciences, University of Washington, Seattle, told this news organization.

The findings were published online Aug. 25 in JAMA Psychiatry.
 

Clinically meaningful improvement

The Study to Promote Innovation in Rural Integrated Telepsychiatry (SPIRIT) trial included 1,004 adults with untreated posttraumatic stress disorder and/or bipolar disorder. The participants were from 24 primary care clinics in rural and underserved areas in which there were no on-site psychiatrists or psychologists.

In SPIRIT, 508 patients were randomly allocated to TCC, and 496 were assigned to TER.

With TCC, an on-site behavioral health care manager and an off-site telepsychiatrist consultant support the primary care clinician in prescribing medications. With TER, an off-site telepsychiatrist prescribes medication, and an off-site telepsychologist delivers therapy.

The primary outcome was mental health functioning at 12 months, as measured by the Veterans RAND 12-item Health Survey Mental Component Summary (MCS) score. MSC scores range from 0 to 100.

Baseline MCS scores for the study participants were two standard deviations below the national average. The mean MCS scores were 39.7 and 41.2 in the TCC and TER groups, respectively.

There was no significant difference between TCC and TER in 12-month MCS score (beta = 1.0; 95% confidence interval, –0.8 to 2.8; P = .28). In addition, no significant differences in treatment effects were identified.

Patients in both groups experienced “large and clinically meaningful” improvements in MCS scores from baseline to 12 months (Cohen d =  0.81 and 0.90 for TCC and TER, respectively), the researchers report.
 

‘Bit of a surprise’

The comparative effectiveness of both models in this study was “a bit of a surprise,” Dr. Fortney noted.

“We hypothesized that TCC would have better outcomes than TER because we thought patients would be more likely to engage in treatment,” he said.

In collaborative care, the familiar primary care practitioner is the prescriber. The local care manager’s job is to keep patients engaged in care, said Dr. Fortney.

“However, because the medical school telemental health providers were privileged and credentialed to practice in the primary care clinic, the referral process to the telepsychiatrist and telepsychologist was much more successful than it usually is. So engagement was the same in both groups, and thus outcomes were equally as good,” Dr. Fortney said.

He noted that the referral model is used more than the collaborative care model “because it is similar to the more traditional approach to managing complex psychiatric disorders. I would say this is true both before and after COVID-19, but more so after.”

From a health care system perspective, “clinical leadership should implement whichever approach is most sustainable,” the investigators concluded.
 

Good news for clinics

Commenting on the study, Adam C. Powell, PhD, president of Payer+Provider Syndicate, said the “similar efficacy” of teleintegrated care and telereferral care for delivering behavioral health services in primary care is “good news for clinics,” because it suggests that clinicians may pick between the two modes of delivery and achieve similar outcomes.

“The resources available within a clinic may determine which of these approaches is most viable. The teleintegrated care approach requires the clinic to have more extensive resources locally,” Dr. Powell noted.

However, he pointed out that the study did not report relative costs of the two approaches, which may also be a factor in determining which one clinics choose to implement.

“Overall, the study shows that advances in telemedicine are making it possible for patients to access telepsychiatry and to achieve improvements in their mental health. Given the lack of access that many patients face, telepsychiatry offers one potential solution,” Dr. Powell concluded.

The SPIRIT study was funded by a grant from the Patient-Centered Outcomes Research Institute. Dr. Fortney and Dr. Powell have reported no relevant financial relationships.

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

Two models for treating patients with complex psychiatric disorders in primary care are equally effective, new research suggests.

FatCamera/Getty Images

Results from a pragmatic, randomized comparative effectiveness study involving more than 1,000 patients showed that both integrated telepsychiatry collaborative care (TCC) and telepsychiatry/telepsychology enhanced referral (TER) provided “significantly and substantially” improved clinical outcomes, researchers noted.

However, the referral model required substantially more mental health specialist time than does the integrated model.

Therefore, from a societal perspective, the integrated care approach “more efficiently uses this scarce resource,” lead author John Fortney, PhD, department of psychiatry and behavioral sciences, University of Washington, Seattle, told this news organization.

The findings were published online Aug. 25 in JAMA Psychiatry.
 

Clinically meaningful improvement

The Study to Promote Innovation in Rural Integrated Telepsychiatry (SPIRIT) trial included 1,004 adults with untreated posttraumatic stress disorder and/or bipolar disorder. The participants were from 24 primary care clinics in rural and underserved areas in which there were no on-site psychiatrists or psychologists.

In SPIRIT, 508 patients were randomly allocated to TCC, and 496 were assigned to TER.

With TCC, an on-site behavioral health care manager and an off-site telepsychiatrist consultant support the primary care clinician in prescribing medications. With TER, an off-site telepsychiatrist prescribes medication, and an off-site telepsychologist delivers therapy.

The primary outcome was mental health functioning at 12 months, as measured by the Veterans RAND 12-item Health Survey Mental Component Summary (MCS) score. MSC scores range from 0 to 100.

Baseline MCS scores for the study participants were two standard deviations below the national average. The mean MCS scores were 39.7 and 41.2 in the TCC and TER groups, respectively.

There was no significant difference between TCC and TER in 12-month MCS score (beta = 1.0; 95% confidence interval, –0.8 to 2.8; P = .28). In addition, no significant differences in treatment effects were identified.

Patients in both groups experienced “large and clinically meaningful” improvements in MCS scores from baseline to 12 months (Cohen d =  0.81 and 0.90 for TCC and TER, respectively), the researchers report.
 

‘Bit of a surprise’

The comparative effectiveness of both models in this study was “a bit of a surprise,” Dr. Fortney noted.

“We hypothesized that TCC would have better outcomes than TER because we thought patients would be more likely to engage in treatment,” he said.

In collaborative care, the familiar primary care practitioner is the prescriber. The local care manager’s job is to keep patients engaged in care, said Dr. Fortney.

“However, because the medical school telemental health providers were privileged and credentialed to practice in the primary care clinic, the referral process to the telepsychiatrist and telepsychologist was much more successful than it usually is. So engagement was the same in both groups, and thus outcomes were equally as good,” Dr. Fortney said.

He noted that the referral model is used more than the collaborative care model “because it is similar to the more traditional approach to managing complex psychiatric disorders. I would say this is true both before and after COVID-19, but more so after.”

From a health care system perspective, “clinical leadership should implement whichever approach is most sustainable,” the investigators concluded.
 

Good news for clinics

Commenting on the study, Adam C. Powell, PhD, president of Payer+Provider Syndicate, said the “similar efficacy” of teleintegrated care and telereferral care for delivering behavioral health services in primary care is “good news for clinics,” because it suggests that clinicians may pick between the two modes of delivery and achieve similar outcomes.

“The resources available within a clinic may determine which of these approaches is most viable. The teleintegrated care approach requires the clinic to have more extensive resources locally,” Dr. Powell noted.

However, he pointed out that the study did not report relative costs of the two approaches, which may also be a factor in determining which one clinics choose to implement.

“Overall, the study shows that advances in telemedicine are making it possible for patients to access telepsychiatry and to achieve improvements in their mental health. Given the lack of access that many patients face, telepsychiatry offers one potential solution,” Dr. Powell concluded.

The SPIRIT study was funded by a grant from the Patient-Centered Outcomes Research Institute. Dr. Fortney and Dr. Powell have reported no relevant financial relationships.

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

Two models for treating patients with complex psychiatric disorders in primary care are equally effective, new research suggests.

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Results from a pragmatic, randomized comparative effectiveness study involving more than 1,000 patients showed that both integrated telepsychiatry collaborative care (TCC) and telepsychiatry/telepsychology enhanced referral (TER) provided “significantly and substantially” improved clinical outcomes, researchers noted.

However, the referral model required substantially more mental health specialist time than does the integrated model.

Therefore, from a societal perspective, the integrated care approach “more efficiently uses this scarce resource,” lead author John Fortney, PhD, department of psychiatry and behavioral sciences, University of Washington, Seattle, told this news organization.

The findings were published online Aug. 25 in JAMA Psychiatry.
 

Clinically meaningful improvement

The Study to Promote Innovation in Rural Integrated Telepsychiatry (SPIRIT) trial included 1,004 adults with untreated posttraumatic stress disorder and/or bipolar disorder. The participants were from 24 primary care clinics in rural and underserved areas in which there were no on-site psychiatrists or psychologists.

In SPIRIT, 508 patients were randomly allocated to TCC, and 496 were assigned to TER.

With TCC, an on-site behavioral health care manager and an off-site telepsychiatrist consultant support the primary care clinician in prescribing medications. With TER, an off-site telepsychiatrist prescribes medication, and an off-site telepsychologist delivers therapy.

The primary outcome was mental health functioning at 12 months, as measured by the Veterans RAND 12-item Health Survey Mental Component Summary (MCS) score. MSC scores range from 0 to 100.

Baseline MCS scores for the study participants were two standard deviations below the national average. The mean MCS scores were 39.7 and 41.2 in the TCC and TER groups, respectively.

There was no significant difference between TCC and TER in 12-month MCS score (beta = 1.0; 95% confidence interval, –0.8 to 2.8; P = .28). In addition, no significant differences in treatment effects were identified.

Patients in both groups experienced “large and clinically meaningful” improvements in MCS scores from baseline to 12 months (Cohen d =  0.81 and 0.90 for TCC and TER, respectively), the researchers report.
 

‘Bit of a surprise’

The comparative effectiveness of both models in this study was “a bit of a surprise,” Dr. Fortney noted.

“We hypothesized that TCC would have better outcomes than TER because we thought patients would be more likely to engage in treatment,” he said.

In collaborative care, the familiar primary care practitioner is the prescriber. The local care manager’s job is to keep patients engaged in care, said Dr. Fortney.

“However, because the medical school telemental health providers were privileged and credentialed to practice in the primary care clinic, the referral process to the telepsychiatrist and telepsychologist was much more successful than it usually is. So engagement was the same in both groups, and thus outcomes were equally as good,” Dr. Fortney said.

He noted that the referral model is used more than the collaborative care model “because it is similar to the more traditional approach to managing complex psychiatric disorders. I would say this is true both before and after COVID-19, but more so after.”

From a health care system perspective, “clinical leadership should implement whichever approach is most sustainable,” the investigators concluded.
 

Good news for clinics

Commenting on the study, Adam C. Powell, PhD, president of Payer+Provider Syndicate, said the “similar efficacy” of teleintegrated care and telereferral care for delivering behavioral health services in primary care is “good news for clinics,” because it suggests that clinicians may pick between the two modes of delivery and achieve similar outcomes.

“The resources available within a clinic may determine which of these approaches is most viable. The teleintegrated care approach requires the clinic to have more extensive resources locally,” Dr. Powell noted.

However, he pointed out that the study did not report relative costs of the two approaches, which may also be a factor in determining which one clinics choose to implement.

“Overall, the study shows that advances in telemedicine are making it possible for patients to access telepsychiatry and to achieve improvements in their mental health. Given the lack of access that many patients face, telepsychiatry offers one potential solution,” Dr. Powell concluded.

The SPIRIT study was funded by a grant from the Patient-Centered Outcomes Research Institute. Dr. Fortney and Dr. Powell have reported no relevant financial relationships.

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