MDedge Psychiatry

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.

We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.

Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.

We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.

Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:

1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.

2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.

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

The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.

We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.

Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.

We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.

Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:

1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.

2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.

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

The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.

We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.

Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.

We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.

Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:

1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.

2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.

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

A dyadic telehealth intervention to help people with dementia and their caregivers can achieve outcomes similar to those of traditional, in-person approaches. The program combines information, education, and skills training to help participants overcome specific challenges.

“It focuses on individualized problem solving and is tailored to the needs of the person. The focus is not just on educating caregivers, but working on strategies to maintain independence in the person with dementia and support them to remain active and engaged,” said Kate Laver, PhD, who presented the study at the annual meeting of the Alzheimer’s Association International Conference. Dr. Laver is an associate professor in the College of Medicine and Public Health at Flinders University in Adelaide, South Australia.

The program is called Care of Persons with Dementia in Their Environments (COPE), and has previously been demonstrated to improve outcomes when conducted through in-person home visits. Over a maximum of ten sessions in 4 months, COPE employs occupational therapists and individuals with nursing skills to identify environmental stressors that can be modified to reduce sensory, physical, and cognitive demands. It also looks for comorbidities in the person with dementia that could be contributing to poor functioning. The goal of COPE is to encourage the person with dementia to reengage in daily activities, and to reduce caregiver burden as a result.

In a 2020 study, Dr. Laver and colleagues showed that COPE is noninferior when delivered by telehealth compared with in-person delivery. They randomized 63 caregiver-patient dyads to telehealth or home visit delivery of the COPE program. Sixty percent of the persons with dementia were male, and the mean caregiver time was 32 months.

Similar improvements in outcomes were seen in both groups, with no statistically significant differences for the primary outcome of change in Caregiver Mastery Index score at 4 months (mean difference, 0.09; 95% confidence interval, –1.26 to 1.45). Similar changes were also seen in the Perceived Change Scale, which is a 13-item caregiver questionnaire that covers day-to-day care challenges, including feeling overwhelmed or upset, sleeping patterns, and availability of personal time.

Not surprisingly, telehealth implementation led to reduced mean travel time (77.2 minutes vs. 255.9 minutes; P < .0001). The face-to-face time was shorter in the telehealth group (308 vs. 337 minutes), though the difference was not statistically significant. Dr. Laver noted that the consent rate was high at 75%, but there were some missed sessions.
 

Lessons learned

During the presentation, Dr. Laver emphasized some lessons learned from conversion to a telehealth model. These included providing a tablet and stand on loan, a user guide with pictures, and an initial on-site training session. The first two sessions were conducted on site to do an in-person demonstration and to assess the participants and the home environment.

She noted that it was important to have an IT support person on call to help participants use the provided tablet if needed, though this was rarely used.

“Although few people (at the time) had their own devices, they were able to quickly master videoconferencing. We felt that it was important to ensure that the first couple of consultations were in person – this enabled the therapist to develop rapport, practice use of videoconferencing, and get a good idea of the person’s environment and relationship with the person with dementia,” said Dr. Laver.

She noted that telehealth can be more efficient, and even preferred, during times like the COVID-19 pandemic, as well as in rural settings. But home visits will always be needed. “They are important for developing rapport and enabling a comprehensive assessment of the person with dementia, relationships, and environment. They are also preferred by some caregivers,” said Dr. Laver.

The demonstration of equivalence to in-person delivery was welcome, said Ingo Kilimann, MD, who comoderated the session where Dr. Laver presented. “We have to bring help to the families where they are, and not just tell them where they can get the help, because some people are just not able to actually come to some specialists’ centers. So it’s very important information that it does work,” said Dr. Kilimann, who is a dementia neurologist and head of the memory clinic at the The German Center for Neurodegenerative Diseases in Bonn.

He added that mixing of on-site and remote sessions is a good model. “I think that is the way to be most effective – to have someone in person at the person with dementia’s house, and then have online support for the rest of the time, and then it can be as successful as a total in-person intervention,” said Dr. Kilimann.

Dr. Laver had no relevant financial disclosures.

A dyadic telehealth intervention to help people with dementia and their caregivers can achieve outcomes similar to those of traditional, in-person approaches. The program combines information, education, and skills training to help participants overcome specific challenges.

“It focuses on individualized problem solving and is tailored to the needs of the person. The focus is not just on educating caregivers, but working on strategies to maintain independence in the person with dementia and support them to remain active and engaged,” said Kate Laver, PhD, who presented the study at the annual meeting of the Alzheimer’s Association International Conference. Dr. Laver is an associate professor in the College of Medicine and Public Health at Flinders University in Adelaide, South Australia.

The program is called Care of Persons with Dementia in Their Environments (COPE), and has previously been demonstrated to improve outcomes when conducted through in-person home visits. Over a maximum of ten sessions in 4 months, COPE employs occupational therapists and individuals with nursing skills to identify environmental stressors that can be modified to reduce sensory, physical, and cognitive demands. It also looks for comorbidities in the person with dementia that could be contributing to poor functioning. The goal of COPE is to encourage the person with dementia to reengage in daily activities, and to reduce caregiver burden as a result.

In a 2020 study, Dr. Laver and colleagues showed that COPE is noninferior when delivered by telehealth compared with in-person delivery. They randomized 63 caregiver-patient dyads to telehealth or home visit delivery of the COPE program. Sixty percent of the persons with dementia were male, and the mean caregiver time was 32 months.

Similar improvements in outcomes were seen in both groups, with no statistically significant differences for the primary outcome of change in Caregiver Mastery Index score at 4 months (mean difference, 0.09; 95% confidence interval, –1.26 to 1.45). Similar changes were also seen in the Perceived Change Scale, which is a 13-item caregiver questionnaire that covers day-to-day care challenges, including feeling overwhelmed or upset, sleeping patterns, and availability of personal time.

Not surprisingly, telehealth implementation led to reduced mean travel time (77.2 minutes vs. 255.9 minutes; P < .0001). The face-to-face time was shorter in the telehealth group (308 vs. 337 minutes), though the difference was not statistically significant. Dr. Laver noted that the consent rate was high at 75%, but there were some missed sessions.
 

Lessons learned

During the presentation, Dr. Laver emphasized some lessons learned from conversion to a telehealth model. These included providing a tablet and stand on loan, a user guide with pictures, and an initial on-site training session. The first two sessions were conducted on site to do an in-person demonstration and to assess the participants and the home environment.

She noted that it was important to have an IT support person on call to help participants use the provided tablet if needed, though this was rarely used.

“Although few people (at the time) had their own devices, they were able to quickly master videoconferencing. We felt that it was important to ensure that the first couple of consultations were in person – this enabled the therapist to develop rapport, practice use of videoconferencing, and get a good idea of the person’s environment and relationship with the person with dementia,” said Dr. Laver.

She noted that telehealth can be more efficient, and even preferred, during times like the COVID-19 pandemic, as well as in rural settings. But home visits will always be needed. “They are important for developing rapport and enabling a comprehensive assessment of the person with dementia, relationships, and environment. They are also preferred by some caregivers,” said Dr. Laver.

The demonstration of equivalence to in-person delivery was welcome, said Ingo Kilimann, MD, who comoderated the session where Dr. Laver presented. “We have to bring help to the families where they are, and not just tell them where they can get the help, because some people are just not able to actually come to some specialists’ centers. So it’s very important information that it does work,” said Dr. Kilimann, who is a dementia neurologist and head of the memory clinic at the The German Center for Neurodegenerative Diseases in Bonn.

He added that mixing of on-site and remote sessions is a good model. “I think that is the way to be most effective – to have someone in person at the person with dementia’s house, and then have online support for the rest of the time, and then it can be as successful as a total in-person intervention,” said Dr. Kilimann.

Dr. Laver had no relevant financial disclosures.

A dyadic telehealth intervention to help people with dementia and their caregivers can achieve outcomes similar to those of traditional, in-person approaches. The program combines information, education, and skills training to help participants overcome specific challenges.

“It focuses on individualized problem solving and is tailored to the needs of the person. The focus is not just on educating caregivers, but working on strategies to maintain independence in the person with dementia and support them to remain active and engaged,” said Kate Laver, PhD, who presented the study at the annual meeting of the Alzheimer’s Association International Conference. Dr. Laver is an associate professor in the College of Medicine and Public Health at Flinders University in Adelaide, South Australia.

The program is called Care of Persons with Dementia in Their Environments (COPE), and has previously been demonstrated to improve outcomes when conducted through in-person home visits. Over a maximum of ten sessions in 4 months, COPE employs occupational therapists and individuals with nursing skills to identify environmental stressors that can be modified to reduce sensory, physical, and cognitive demands. It also looks for comorbidities in the person with dementia that could be contributing to poor functioning. The goal of COPE is to encourage the person with dementia to reengage in daily activities, and to reduce caregiver burden as a result.

In a 2020 study, Dr. Laver and colleagues showed that COPE is noninferior when delivered by telehealth compared with in-person delivery. They randomized 63 caregiver-patient dyads to telehealth or home visit delivery of the COPE program. Sixty percent of the persons with dementia were male, and the mean caregiver time was 32 months.

Similar improvements in outcomes were seen in both groups, with no statistically significant differences for the primary outcome of change in Caregiver Mastery Index score at 4 months (mean difference, 0.09; 95% confidence interval, –1.26 to 1.45). Similar changes were also seen in the Perceived Change Scale, which is a 13-item caregiver questionnaire that covers day-to-day care challenges, including feeling overwhelmed or upset, sleeping patterns, and availability of personal time.

Not surprisingly, telehealth implementation led to reduced mean travel time (77.2 minutes vs. 255.9 minutes; P < .0001). The face-to-face time was shorter in the telehealth group (308 vs. 337 minutes), though the difference was not statistically significant. Dr. Laver noted that the consent rate was high at 75%, but there were some missed sessions.
 

Lessons learned

During the presentation, Dr. Laver emphasized some lessons learned from conversion to a telehealth model. These included providing a tablet and stand on loan, a user guide with pictures, and an initial on-site training session. The first two sessions were conducted on site to do an in-person demonstration and to assess the participants and the home environment.

She noted that it was important to have an IT support person on call to help participants use the provided tablet if needed, though this was rarely used.

“Although few people (at the time) had their own devices, they were able to quickly master videoconferencing. We felt that it was important to ensure that the first couple of consultations were in person – this enabled the therapist to develop rapport, practice use of videoconferencing, and get a good idea of the person’s environment and relationship with the person with dementia,” said Dr. Laver.

She noted that telehealth can be more efficient, and even preferred, during times like the COVID-19 pandemic, as well as in rural settings. But home visits will always be needed. “They are important for developing rapport and enabling a comprehensive assessment of the person with dementia, relationships, and environment. They are also preferred by some caregivers,” said Dr. Laver.

The demonstration of equivalence to in-person delivery was welcome, said Ingo Kilimann, MD, who comoderated the session where Dr. Laver presented. “We have to bring help to the families where they are, and not just tell them where they can get the help, because some people are just not able to actually come to some specialists’ centers. So it’s very important information that it does work,” said Dr. Kilimann, who is a dementia neurologist and head of the memory clinic at the The German Center for Neurodegenerative Diseases in Bonn.

He added that mixing of on-site and remote sessions is a good model. “I think that is the way to be most effective – to have someone in person at the person with dementia’s house, and then have online support for the rest of the time, and then it can be as successful as a total in-person intervention,” said Dr. Kilimann.

Dr. Laver had no relevant financial disclosures.

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.

With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.

Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.

The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.

“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.

“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.

Mayo and Cleveland Clinic remain tops

Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.

UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.

In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.

Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
 

2021-2022 Best Hospitals honor roll

1. Mayo Clinic, Rochester, Minn.

2. Cleveland Clinic, Cleveland

3. UCLA Medical Center, Los Angeles

4. Johns Hopkins Hospital, Baltimore

5. Massachusetts General Hospital, Boston

6. Cedars-Sinai Medical Center, San Francisco

7. New York–Presbyterian Hospital–Columbia and Cornell, New York

8. NYU Langone Hospitals, New York

9. UCSF Medical Center, San Francisco

10. Northwestern Memorial Hospital, Chicago

11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.

12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.

13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia

14. Brigham and Women’s Hospital, Boston

15. Mayo Clinic–Phoenix, Phoenix

16. Houston Methodist Hospital, Houston

17. (tie) Barnes-Jewish Hospital, St. Louis

17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago

19. Rush University Medical Center, Chicago

20. Vanderbilt University Medical Center, Nashville, Tenn.

For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.

At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty

For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
 

Top five for cancer

1. University of Texas MD Anderson Cancer Center, Houston

2. Memorial Sloan Kettering Cancer Center, New York

3. Mayo Clinic, Rochester, Minn.

4. Dana-Farber/Brigham & Women’s Cancer Center, Boston

5. Cleveland Clinic, Cleveland

Top five for cardiology and heart surgery

1. Cleveland Clinic, Cleveland

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. New York–Presbyterian Hospital–Columbia and Cornell, New York

5. NYU Langone Hospitals, New York

Top five for orthopedics

1. Hospital for Special Surgery, New York

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. NYU Langone Orthopedic Hospital, New York

5. UCLA Medical Center, Los Angeles

The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.

The full report is available online.

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

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.

With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.

Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.

The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.

“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.

“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.

Mayo and Cleveland Clinic remain tops

Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.

UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.

In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.

Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
 

2021-2022 Best Hospitals honor roll

1. Mayo Clinic, Rochester, Minn.

2. Cleveland Clinic, Cleveland

3. UCLA Medical Center, Los Angeles

4. Johns Hopkins Hospital, Baltimore

5. Massachusetts General Hospital, Boston

6. Cedars-Sinai Medical Center, San Francisco

7. New York–Presbyterian Hospital–Columbia and Cornell, New York

8. NYU Langone Hospitals, New York

9. UCSF Medical Center, San Francisco

10. Northwestern Memorial Hospital, Chicago

11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.

12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.

13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia

14. Brigham and Women’s Hospital, Boston

15. Mayo Clinic–Phoenix, Phoenix

16. Houston Methodist Hospital, Houston

17. (tie) Barnes-Jewish Hospital, St. Louis

17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago

19. Rush University Medical Center, Chicago

20. Vanderbilt University Medical Center, Nashville, Tenn.

For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.

At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty

For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
 

Top five for cancer

1. University of Texas MD Anderson Cancer Center, Houston

2. Memorial Sloan Kettering Cancer Center, New York

3. Mayo Clinic, Rochester, Minn.

4. Dana-Farber/Brigham & Women’s Cancer Center, Boston

5. Cleveland Clinic, Cleveland

Top five for cardiology and heart surgery

1. Cleveland Clinic, Cleveland

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. New York–Presbyterian Hospital–Columbia and Cornell, New York

5. NYU Langone Hospitals, New York

Top five for orthopedics

1. Hospital for Special Surgery, New York

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. NYU Langone Orthopedic Hospital, New York

5. UCLA Medical Center, Los Angeles

The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.

The full report is available online.

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

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.

With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.

Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.

The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.

“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.

“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.

Mayo and Cleveland Clinic remain tops

Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.

UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.

In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.

Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
 

2021-2022 Best Hospitals honor roll

1. Mayo Clinic, Rochester, Minn.

2. Cleveland Clinic, Cleveland

3. UCLA Medical Center, Los Angeles

4. Johns Hopkins Hospital, Baltimore

5. Massachusetts General Hospital, Boston

6. Cedars-Sinai Medical Center, San Francisco

7. New York–Presbyterian Hospital–Columbia and Cornell, New York

8. NYU Langone Hospitals, New York

9. UCSF Medical Center, San Francisco

10. Northwestern Memorial Hospital, Chicago

11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.

12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.

13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia

14. Brigham and Women’s Hospital, Boston

15. Mayo Clinic–Phoenix, Phoenix

16. Houston Methodist Hospital, Houston

17. (tie) Barnes-Jewish Hospital, St. Louis

17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago

19. Rush University Medical Center, Chicago

20. Vanderbilt University Medical Center, Nashville, Tenn.

For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.

At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty

For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
 

Top five for cancer

1. University of Texas MD Anderson Cancer Center, Houston

2. Memorial Sloan Kettering Cancer Center, New York

3. Mayo Clinic, Rochester, Minn.

4. Dana-Farber/Brigham & Women’s Cancer Center, Boston

5. Cleveland Clinic, Cleveland

Top five for cardiology and heart surgery

1. Cleveland Clinic, Cleveland

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. New York–Presbyterian Hospital–Columbia and Cornell, New York

5. NYU Langone Hospitals, New York

Top five for orthopedics

1. Hospital for Special Surgery, New York

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. NYU Langone Orthopedic Hospital, New York

5. UCLA Medical Center, Los Angeles

The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.

The full report is available online.

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

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

In type 2 diabetes (T2D), a greater degree of hyperlipidemia and hypertension, although not hyperglycemia, was associated with measurable cognitive impairment even among patients with only a 4-year mean disease duration, according to a substudy of the GRADE trial.

The association of these cardiovascular (CV) risk factors with impairments in cognition has been reported before, but the findings are notable because the mean duration of T2D was short in a relatively healthy study population, reported a multicenter team of investigators.

The relative impairments in cognitive function “may not be clinically significant given the very small size of the differences,” conceded the authors of this study, led by José A. Luchsinger, MD, but they are consistent with previous reports of the same association in older patients with a longer duration of diabetes. In other words, the data suggest the risk of cognitive loss from CV risk factors in T2D patients begins early.

“A potential explanation for the small differences, compared with those previously reported, is that the GRADE cohort is relatively young with a healthier cardiovascular profile and shorter diabetes duration compared with other studies,” reported the investigators, whose results were published online July 20, 2021, in Diabetes Care.
 

99% complete cognitive assessments

In the GRADE (Glycemia Reduction Approaches in Diabetes: Comparative Effectiveness) trial, 5,018 (99.4%) of the 5,047 enrolled patients completed a battery of cognitive assessments at baseline. Patients were excluded from this study if they had any major CV event in the previous year, if they had T2D for more than 10 years, if they had significant renal impairment, and if they had any history of stage 3 or greater heart failure. Their mean age was 56.7 years.

By cross-sectional analysis, cognitive evaluations, including the Digit Symbol Substitution Test (DSST) and the Spanish English Verbal Learning Test, were evaluated in relation to baseline LDL cholesterol levels, systolic and diastolic blood pressure, hemoglobin A1c, and statin use.

Unlike previous studies in T2D patients, no relationship was observed between cognitive function and A1c level at baseline. However, LDL cholesterol greater than 100 mg/dL was associated with cognitive impairment as measured with the DSST after adjustment for age, sex, education, and general health. The mean difference relative to LDL cholesterol below 70 mg/dL was only 1.8 points, but this was highly significant (P < .001).

Similarly, significant but modest cognitive impairment on DSST score after adjustment for variables were seen for those with a systolic BP between 120 mg and <140 mg relative to either <120 mm Hg or at least 140 mm Hg (P = .014). The same was seen for diastolic BPs of 80 to <90 when compared with either <80 mm Hg or to 90 mm Hg or higher (P = .01).

For those taking statins versus no statins at baseline, there was a 1.4-point mean advantage in DSST score after adjusting for variables (P < .001).

Modest cognitive impairments recorded

Again, the absolute mean differences in the DSST cognitive scores, despite their statistical significance, were modest, according to the authors. In general, the mean difference was rarely greater than 2.0 points and often 1.0 point or less. The authors acknowledged that these changes are of an uncertain clinical significance, but they considered the findings consistent with the association of CV risk factors with cognitive deficits in older T2DM patients or T2DM patients with longer duration of disease.

One difference between this GRADE substudy and previous studies was the lack of an association between cognitive impairment and hyperglycemia. In the ACCORD trial for example, increased levels of blood glycemia were associated with lower performance on numerous tests of cognitive function.

In the Diabetes Control and Complications Trial (DCCT), poorer glycemic control was related to poorer performance on tests of executive function.

Both of those studies also linked hypertension and hyperlipidemia with cognitive deficits, but given that patients in ACCORD had T2DM of substantially longer duration and those in DCCT were older, “it seems reasonable to speculate that, in patients with diabetes duration of less than 10 years, the association between hyperglycemia and cognitive performance may not yet be evident,” the GRADE authors reported.
 

GRADE trial compares drugs in four classes

The GRADE trial was conducted to compare four classes of T2D therapies for long-term glycemic control as expressed by A1c control over time. The results of the trial, presented recently at the 2021 annual scientific sessions of the American Diabetes Association, found that insulin glargine and the glucagonlike peptide–1 receptor agonist liraglutide performed best on the primary endpoint of maintaining A1c below 7.0%. Both performed significantly better than the sulfonylurea glimepiride and the dipeptidyl peptidase–4 inhibitor sitagliptin.

This substudy of baseline cognitive function in the relatively large GRADE trial provided a unique opportunity to evaluate the impact of CV risk factors in patients with T2D of relatively short duration.

While the data support the adverse impact of inadequately controlled modifiable risk factors on cognitive function in T2D patients, David R. Matthews, DPhil, BM, BCh, emeritus professor of diabetes medicine at the University of Oxford (England), noted that the association was weak and advised a cautious interpretation.

“The effect size is very small indeed. The data are found as a subset of multiple testing,” he said in an interview. He suggested the associations might be the result of “data farming,” and he emphasized that the relationships between these risk factors and cognitive deficits are associations that do not imply causation.

Nevertheless, and despite their unclear clinical implications, Dr. Matthews said that these data might still have a message.

“It is another reminder that for many reasons we all need to be alert to the need for lowering hyperlipidemia and hypertension to normal levels – the benefits may not just be limited to cardiovascular outcome,” Dr. Matthews stated.

The lead author of the study, Dr. Luchsinger, also cautioned against overinterpreting the data.

While the data show that “lipid and blood pressure control within recommended guidelines are associated with marginally better cognitive function in patients with type 2 diabetes of less than 5 years duration on average,” he added that “the study is limited by its cross-sectional nature.”

He indicated that further analysis will be helpful in assessing the implications.

“Longitudinal analyses of the same group of individuals will be conducted next year,” noted Dr. Luchsinger, associate professor of medicine and epidemiology, Columbia University Medical Center, New York.

Dr. Luchsinger reported financial relationships with vTv therapeutics. Dr. Matthews reported no potential conflicts of interest.

In type 2 diabetes (T2D), a greater degree of hyperlipidemia and hypertension, although not hyperglycemia, was associated with measurable cognitive impairment even among patients with only a 4-year mean disease duration, according to a substudy of the GRADE trial.

The association of these cardiovascular (CV) risk factors with impairments in cognition has been reported before, but the findings are notable because the mean duration of T2D was short in a relatively healthy study population, reported a multicenter team of investigators.

The relative impairments in cognitive function “may not be clinically significant given the very small size of the differences,” conceded the authors of this study, led by José A. Luchsinger, MD, but they are consistent with previous reports of the same association in older patients with a longer duration of diabetes. In other words, the data suggest the risk of cognitive loss from CV risk factors in T2D patients begins early.

“A potential explanation for the small differences, compared with those previously reported, is that the GRADE cohort is relatively young with a healthier cardiovascular profile and shorter diabetes duration compared with other studies,” reported the investigators, whose results were published online July 20, 2021, in Diabetes Care.
 

99% complete cognitive assessments

In the GRADE (Glycemia Reduction Approaches in Diabetes: Comparative Effectiveness) trial, 5,018 (99.4%) of the 5,047 enrolled patients completed a battery of cognitive assessments at baseline. Patients were excluded from this study if they had any major CV event in the previous year, if they had T2D for more than 10 years, if they had significant renal impairment, and if they had any history of stage 3 or greater heart failure. Their mean age was 56.7 years.

By cross-sectional analysis, cognitive evaluations, including the Digit Symbol Substitution Test (DSST) and the Spanish English Verbal Learning Test, were evaluated in relation to baseline LDL cholesterol levels, systolic and diastolic blood pressure, hemoglobin A1c, and statin use.

Unlike previous studies in T2D patients, no relationship was observed between cognitive function and A1c level at baseline. However, LDL cholesterol greater than 100 mg/dL was associated with cognitive impairment as measured with the DSST after adjustment for age, sex, education, and general health. The mean difference relative to LDL cholesterol below 70 mg/dL was only 1.8 points, but this was highly significant (P < .001).

Similarly, significant but modest cognitive impairment on DSST score after adjustment for variables were seen for those with a systolic BP between 120 mg and <140 mg relative to either <120 mm Hg or at least 140 mm Hg (P = .014). The same was seen for diastolic BPs of 80 to <90 when compared with either <80 mm Hg or to 90 mm Hg or higher (P = .01).

For those taking statins versus no statins at baseline, there was a 1.4-point mean advantage in DSST score after adjusting for variables (P < .001).

Modest cognitive impairments recorded

Again, the absolute mean differences in the DSST cognitive scores, despite their statistical significance, were modest, according to the authors. In general, the mean difference was rarely greater than 2.0 points and often 1.0 point or less. The authors acknowledged that these changes are of an uncertain clinical significance, but they considered the findings consistent with the association of CV risk factors with cognitive deficits in older T2DM patients or T2DM patients with longer duration of disease.

One difference between this GRADE substudy and previous studies was the lack of an association between cognitive impairment and hyperglycemia. In the ACCORD trial for example, increased levels of blood glycemia were associated with lower performance on numerous tests of cognitive function.

In the Diabetes Control and Complications Trial (DCCT), poorer glycemic control was related to poorer performance on tests of executive function.

Both of those studies also linked hypertension and hyperlipidemia with cognitive deficits, but given that patients in ACCORD had T2DM of substantially longer duration and those in DCCT were older, “it seems reasonable to speculate that, in patients with diabetes duration of less than 10 years, the association between hyperglycemia and cognitive performance may not yet be evident,” the GRADE authors reported.
 

GRADE trial compares drugs in four classes

The GRADE trial was conducted to compare four classes of T2D therapies for long-term glycemic control as expressed by A1c control over time. The results of the trial, presented recently at the 2021 annual scientific sessions of the American Diabetes Association, found that insulin glargine and the glucagonlike peptide–1 receptor agonist liraglutide performed best on the primary endpoint of maintaining A1c below 7.0%. Both performed significantly better than the sulfonylurea glimepiride and the dipeptidyl peptidase–4 inhibitor sitagliptin.

This substudy of baseline cognitive function in the relatively large GRADE trial provided a unique opportunity to evaluate the impact of CV risk factors in patients with T2D of relatively short duration.

While the data support the adverse impact of inadequately controlled modifiable risk factors on cognitive function in T2D patients, David R. Matthews, DPhil, BM, BCh, emeritus professor of diabetes medicine at the University of Oxford (England), noted that the association was weak and advised a cautious interpretation.

“The effect size is very small indeed. The data are found as a subset of multiple testing,” he said in an interview. He suggested the associations might be the result of “data farming,” and he emphasized that the relationships between these risk factors and cognitive deficits are associations that do not imply causation.

Nevertheless, and despite their unclear clinical implications, Dr. Matthews said that these data might still have a message.

“It is another reminder that for many reasons we all need to be alert to the need for lowering hyperlipidemia and hypertension to normal levels – the benefits may not just be limited to cardiovascular outcome,” Dr. Matthews stated.

The lead author of the study, Dr. Luchsinger, also cautioned against overinterpreting the data.

While the data show that “lipid and blood pressure control within recommended guidelines are associated with marginally better cognitive function in patients with type 2 diabetes of less than 5 years duration on average,” he added that “the study is limited by its cross-sectional nature.”

He indicated that further analysis will be helpful in assessing the implications.

“Longitudinal analyses of the same group of individuals will be conducted next year,” noted Dr. Luchsinger, associate professor of medicine and epidemiology, Columbia University Medical Center, New York.

Dr. Luchsinger reported financial relationships with vTv therapeutics. Dr. Matthews reported no potential conflicts of interest.

In type 2 diabetes (T2D), a greater degree of hyperlipidemia and hypertension, although not hyperglycemia, was associated with measurable cognitive impairment even among patients with only a 4-year mean disease duration, according to a substudy of the GRADE trial.

The association of these cardiovascular (CV) risk factors with impairments in cognition has been reported before, but the findings are notable because the mean duration of T2D was short in a relatively healthy study population, reported a multicenter team of investigators.

The relative impairments in cognitive function “may not be clinically significant given the very small size of the differences,” conceded the authors of this study, led by José A. Luchsinger, MD, but they are consistent with previous reports of the same association in older patients with a longer duration of diabetes. In other words, the data suggest the risk of cognitive loss from CV risk factors in T2D patients begins early.

“A potential explanation for the small differences, compared with those previously reported, is that the GRADE cohort is relatively young with a healthier cardiovascular profile and shorter diabetes duration compared with other studies,” reported the investigators, whose results were published online July 20, 2021, in Diabetes Care.
 

99% complete cognitive assessments

In the GRADE (Glycemia Reduction Approaches in Diabetes: Comparative Effectiveness) trial, 5,018 (99.4%) of the 5,047 enrolled patients completed a battery of cognitive assessments at baseline. Patients were excluded from this study if they had any major CV event in the previous year, if they had T2D for more than 10 years, if they had significant renal impairment, and if they had any history of stage 3 or greater heart failure. Their mean age was 56.7 years.

By cross-sectional analysis, cognitive evaluations, including the Digit Symbol Substitution Test (DSST) and the Spanish English Verbal Learning Test, were evaluated in relation to baseline LDL cholesterol levels, systolic and diastolic blood pressure, hemoglobin A1c, and statin use.

Unlike previous studies in T2D patients, no relationship was observed between cognitive function and A1c level at baseline. However, LDL cholesterol greater than 100 mg/dL was associated with cognitive impairment as measured with the DSST after adjustment for age, sex, education, and general health. The mean difference relative to LDL cholesterol below 70 mg/dL was only 1.8 points, but this was highly significant (P < .001).

Similarly, significant but modest cognitive impairment on DSST score after adjustment for variables were seen for those with a systolic BP between 120 mg and <140 mg relative to either <120 mm Hg or at least 140 mm Hg (P = .014). The same was seen for diastolic BPs of 80 to <90 when compared with either <80 mm Hg or to 90 mm Hg or higher (P = .01).

For those taking statins versus no statins at baseline, there was a 1.4-point mean advantage in DSST score after adjusting for variables (P < .001).

Modest cognitive impairments recorded

Again, the absolute mean differences in the DSST cognitive scores, despite their statistical significance, were modest, according to the authors. In general, the mean difference was rarely greater than 2.0 points and often 1.0 point or less. The authors acknowledged that these changes are of an uncertain clinical significance, but they considered the findings consistent with the association of CV risk factors with cognitive deficits in older T2DM patients or T2DM patients with longer duration of disease.

One difference between this GRADE substudy and previous studies was the lack of an association between cognitive impairment and hyperglycemia. In the ACCORD trial for example, increased levels of blood glycemia were associated with lower performance on numerous tests of cognitive function.

In the Diabetes Control and Complications Trial (DCCT), poorer glycemic control was related to poorer performance on tests of executive function.

Both of those studies also linked hypertension and hyperlipidemia with cognitive deficits, but given that patients in ACCORD had T2DM of substantially longer duration and those in DCCT were older, “it seems reasonable to speculate that, in patients with diabetes duration of less than 10 years, the association between hyperglycemia and cognitive performance may not yet be evident,” the GRADE authors reported.
 

GRADE trial compares drugs in four classes

The GRADE trial was conducted to compare four classes of T2D therapies for long-term glycemic control as expressed by A1c control over time. The results of the trial, presented recently at the 2021 annual scientific sessions of the American Diabetes Association, found that insulin glargine and the glucagonlike peptide–1 receptor agonist liraglutide performed best on the primary endpoint of maintaining A1c below 7.0%. Both performed significantly better than the sulfonylurea glimepiride and the dipeptidyl peptidase–4 inhibitor sitagliptin.

This substudy of baseline cognitive function in the relatively large GRADE trial provided a unique opportunity to evaluate the impact of CV risk factors in patients with T2D of relatively short duration.

While the data support the adverse impact of inadequately controlled modifiable risk factors on cognitive function in T2D patients, David R. Matthews, DPhil, BM, BCh, emeritus professor of diabetes medicine at the University of Oxford (England), noted that the association was weak and advised a cautious interpretation.

“The effect size is very small indeed. The data are found as a subset of multiple testing,” he said in an interview. He suggested the associations might be the result of “data farming,” and he emphasized that the relationships between these risk factors and cognitive deficits are associations that do not imply causation.

Nevertheless, and despite their unclear clinical implications, Dr. Matthews said that these data might still have a message.

“It is another reminder that for many reasons we all need to be alert to the need for lowering hyperlipidemia and hypertension to normal levels – the benefits may not just be limited to cardiovascular outcome,” Dr. Matthews stated.

The lead author of the study, Dr. Luchsinger, also cautioned against overinterpreting the data.

While the data show that “lipid and blood pressure control within recommended guidelines are associated with marginally better cognitive function in patients with type 2 diabetes of less than 5 years duration on average,” he added that “the study is limited by its cross-sectional nature.”

He indicated that further analysis will be helpful in assessing the implications.

“Longitudinal analyses of the same group of individuals will be conducted next year,” noted Dr. Luchsinger, associate professor of medicine and epidemiology, Columbia University Medical Center, New York.

Dr. Luchsinger reported financial relationships with vTv therapeutics. Dr. Matthews reported no potential conflicts of interest.

Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

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

Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

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

Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

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

The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

“A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

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

The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

“A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

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

The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

“A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

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

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Exposure to deprivation in early life was significantly associated with impaired executive functioning in children and adolescents, based on data from a systematic review and meta-analysis of 91 studies.

Previous research has shown connections between early-life adversity (ELA) and changes in psychological, cognitive, and neurobiological development, including increased risk of anxiety, depression, attention-deficit/hyperactivity disorder, conduct disorder, suicidality, and substance use disorder; however, research focusing on the associations between different types of ELA and specific processes is limited, wrote Dylan Johnson, MSc, of the University of Toronto and colleagues.

“We directly addressed this gap in the literature by examining the association between the type of ELA and executive functioning in children and youth,” they said.

In a study published in JAMA Pediatrics, the researchers identified 91 articles including 82 unique cohorts and 31,188 unique individuals aged 1-18 years.

The articles were selected from Embase, ERIC, MEDLINE, and PsycInfo databases and published up to Dec. 31, 2020. The primary outcomes were measures of the three domains of executive functioning: cognitive flexibility, inhibitory control, and working memory. To correct for small sample sizes in some studies, the researchers standardized their measures of association into Hedges g effect sizes.

Overall, the pooled estimates of the association of any childhood adversity with the three domains of executive functioning showed significant heterogeneity, with Hedges g effects of –0.49 for cognitive flexibility, –0.39 for inhibitory control, and –0.47 for working memory.

The researchers also examined a subsample of ELA–executive functioning associations in categories of early-life exposure to threat, compared with early-life deprivation, including 56 of the original 91 articles. In this analysis, significantly lower inhibitory control was associated with deprivation compared to threat (Hedges g –0.43 vs. –0.27). Similarly, significantly lower working memory was associated with deprivation, compared with threat (Hedges g –0.54 vs. Hedges g –0.28). For both inhibitory control and working memory, the association of adversity was not moderated by the age or sex of the study participants, study design, outcome quality, or selection quality, the researchers noted.

No significant difference in affect of exposure threat vs. deprivation was noted for the association with cognitive flexibility. The reason for this discrepancy remains unclear, the researchers said. “Some evidence suggests that individuals who grow up in unpredictable environments may have reduced inhibitory control but enhanced cognitive flexibility,” they noted.

However, the overall results suggest that exposure to deprivation may be associated with neurodevelopmental changes that support the development of executive functioning, they said.

The study findings were limited by several factors, including the substantial heterogeneity in the pooled estimates and the need to consider variation in study design, the researchers noted. In addition, the cross-sectional design of many studies prevented conclusions about causality between ELA and executive functioning, they said.

“Future research should explore the differences between threat and deprivation when emotionally salient executive functioning measures are used,” the researchers emphasized. “Threat experiences are often associated with alterations in emotional processing, and different findings may be observed when investigating emotionally salient executive functioning outcomes,” they concluded.
 

Prevention and intervention plans needed

“Although numerous studies have examined associations between ELA and executive functioning, the associations of threat and deprivation with specific executive functioning domains (e.g., cognitive flexibility, inhibitory control, and working memory) have not been explored comprehensively,” wrote Beth S. Slomine, PhD, and Nikeea Copeland-Linder, PhD, of the Kennedy Krieger Institute, Johns Hopkins University School, Baltimore, in an accompanying editorial.

The study is “critical and timely” because of the impact of the COVID-19 pandemic on children’s exposure to deprivation, the authors said. “Many children have experienced the death of family members or friends, food and housing insecurity owing to the economic recession, school closures, loss of critical support services, and increased isolation because of social distancing measures,” and these effects are even greater for children already living in poverty and those with developmental disabilities, they noted.

More resources are needed to develop and implement ELA prevention policies, as well as early intervention plans, the editorialists said.

“Early intervention programs have a great potential to reduce the risk of ELA and promote executive functioning development,” they said. “These programs, such as family support and preschool services, are viable solutions for children and their families,” they added. Although the pandemic prevented the use of many support services for children at risk, the adoption of telehealth technology means that “it is now more feasible for cognitive rehabilitation experts to implement the telehealth technology to train parents and school staff on how to assist with the delivery of interventions in real-world settings and how to promote executive functioning in daily life,” they noted.

Overall, the study findings highlight the urgency of identifying ELA and implementing strategies to reduce and prevent ELA, and to provide early intervention to mitigate the impact of ELA on executive function in children, the editorialists emphasized.
 

Data bring understanding, but barriers remain

“At this point, there are data demonstrating the significant impact that adverse childhood experiences have on health outcomes – from worsened mental health to an increased risk for cancer and diabetes,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview.

“Physicians – myself included – tend to lump all these experiences together when thinking about future health outcomes,” Dr. Curran said. “However, there are evolving data that neurocognitive outcomes may be different based on the type of early-life adversity experienced. This meta-analysis examines the risk of different neurocognitive impact of threat versus deprivation types of adversity, which is important to pediatricians because it helps us to better understand the risks that our patients may experience,” she explained. 

“The results of this meta-analysis were especially intriguing because I hadn’t previously considered the impact that different types of adversity had on neurocognitive development,” said Dr. Curran. “This study caused me to think about these experiences differently, and as I reflect on the patients I have cared for over the years, I can see the difference in their outcomes,” she said.

Many barriers persist in addressing the effects of early-life deprivation on executive function, Dr. Curran said.

“First are barriers around identification of these children and adolescents, who may not have regular contact with the medical system. Additionally, it’s important to provide resources for parents and caregivers – this includes creating a strong support network and providing education about the impact of these experiences,” she noted. “There are also barriers to identifying and connecting with what resources will help children at risk of poor neurodevelopmental outcomes,” she added.

“Now that we know that children who have experienced early-life deprivation are at increased risk of worsened neurodevelopmental outcomes, it will be important to understand what interventions can help improve their outcomes,” Dr. Curran said.

The study was supported by a Connaught New Researcher Award from the University of Toronto. The researchers had no financial conflicts to disclose.

Dr. Slomine disclosed book royalties from Cambridge University Press unrelated to this study. Dr. Curran had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.

Black individuals who received mental health services through a church-based program reported high levels of satisfaction, data from a small, qualitative study show.

“This model of providing mental health services adjacent to or supported by a trusted institution, with providers who may have a more nuanced and intimate knowledge of the experiences of and perceptions held by community members, may facilitate important therapy-mediating factors, such as trust,” wrote Angela Coombs, MD, of Columbia University, New York, and colleagues.

Black Americans continue to face barriers to mental health services, and fewer than one-third of Black Americans with a mental health condition receive formal mental health care, Dr. Coombs and colleagues reported. Barriers to treatment include stigma and distrust of medical institutions, and strategies are needed to address these barriers to improve access. Consequently, “one approach includes the development of mental health programming and supports with trusted institutions, such as churches,” they said. Data are limited, however, on the perspectives of individuals who have used church-based services.

In the study, published in Psychiatric Services, Dr. Coombs and colleagues recruited 15 adults aged 27-69 years who were receiving or had received mental health services at the HOPE (Healing On Purpose and Evolving) Center, a freestanding mental health clinic affiliated with the First Corinthian Baptist Church in Harlem, New York. At the time of the study in 2019, those attending the center (referred to as “innovators” rather than patients or clients to reduce stigma) received 10 free sessions of evidence-based psychotherapy.

Treatment included cognitive-behavioral therapy (CBT), religiously integrated CBT, and interpersonal psychotherapy (IPT) to individuals, couples, and families. Group psychotherapy also was an option. Clinicians at the HOPE Center included licensed social workers with doctoral and master’s-level degrees, as well as supervised social work student interns.

Study participants took part in a 30-minute interview, in person or by phone, with a female psychiatrist who was not employed by the HOPE Center or involved in treating the patients. There were 15 participants: 13 women and 2 men, with mean ages of 48 and 51 years, respectively; 14 identified as Black, non-Hispanic. Most (13 individuals) identified as heterosexual, 11 had never married, and 14 had some college or technical school education.

Notably, 11 participants reported attending church once a week, and 13 said they considered religion or spirituality highly important. Participants “reported that services that could integrate their spiritual beliefs with their current mental health challenges enhanced the therapeutic experience,” the researchers said.

Positive messaging about mental health care from the church and senior pastor also encouraged the participants to take advantage of the HOPE Center services.

As one participant said, “I’ve always believed that I can handle my own issues ... but listening to the pastor always talking about the [HOPE] Center and not to be ashamed if you have weaknesses, that’s when I said, ‘You know what, let me just start seeking mental health services because I really need [them].’ ”

Overall, study participants said that they learned skills during their therapy that they could apply in daily life, including recognizing cycles of unproductive behavior, processing traumatic experiences and learning self-love, and embracing meditation at home.

“A common theme among participants was that the HOPE Center provided them with tools to destress, process trauma, and manage anxiety,” the researchers wrote. In particular, several participants cited group sessions on teaching and practicing mindfulness as their favorite services. They described the HOPE Center as a positive, peaceful, and welcoming environment where they felt safe.

Cost issues were important as well. Participants noted that the HOPE Center’s ability to provide services that were free made it easier for them to attend. “Although participants said that it was helpful that the HOPE Center provided referrals to external providers and agencies for additional services, some said they wished that the HOPE Center would provide long-term therapy,” the researchers noted.

Overall, “most participants said that establishing more mental health resources within faith-based spaces could accelerate normalization of seeking and receiving mental health care within religious Black communities,” they said.

The study findings were limited by the absence of clinical data – and data on participants’ frequency and location of church attendance, the researchers noted. In addition, the positive results could be tied to selection bias, Dr. Coombs and colleagues said. Another possible limitation is the overrepresentation of cisgender women among the participants. Still, “the perspectives shared by participants suggest that this model of care may address several important barriers to care faced by some Black American populations,” the researchers wrote.
 

Bridging gap between spirituality and mental health

In an interview, Atasha Jordan, MD, said Black Americans with mental illnesses have long lacked equal access to mental health services. “However, in light of the COVID-19 pandemic, published studies have shown that rates of mental illness increased concurrently with a rise in spirituality and faith. That said, we currently live in a time where mental health and spirituality are more likely to intersect,” noted Dr. Jordan, of the University of Pennsylvania, Philadelphia.

She said it is not surprising that the study participants felt more comfortable receiving mental health services at a clinic that was church affiliated.

“We have known for years that people of faith are more likely to seek comfort for psychological distress from clergy, rather than mental health professionals. Providing a more familiar entry point to mental health services through a church-affiliated mental health clinic helps to bridge the existing gap between spirituality and mental health,” Dr. Jordan said. “For many Black Americans, spirituality is a central component of culturally-informed mental health care.

“Mental health providers may find improved service utilization and outcomes for their patients by collaborating with faith-based organizations or investing time to learn spiritually-based psychotherapies.”

Recently published data, notably a study published May 1, 2021, in Psychiatric Services, continue to support the existing knowledge “that many patients with psychiatric illnesses want increased attention paid to spirituality during their mental health care,” Dr. Jordan noted. “Moreover, they showed that nonreligious clinicians may be more apt than religious clinicians to provide objective, spiritually-oriented mental health care. In this vein, further research aimed at understanding the most effective methods to address spiritual health in times of mental distress can help all mental health providers better meet their patients’ psychiatric and psychological needs.”
 

Overcoming stigma, mistrust

During the pandemic, clinicians have seen an increase in mental health distress in the form of anxiety, depression, and trauma symptoms, Lorenzo Norris, MD, of George Washington University, Washington, said in an interview.

“Historically, African Americans have faced numerous barriers to mental health care, including stigma and mistrust of medical institutions,” Dr. Norris said. “At this time, perhaps more than in recent decades, novel ways of eliminating and navigating these barriers must be explored in an evidence-based fashion that will inform future interventions.”

Dr. Norris also found that the study findings make sense.

“Historically, the Black church has been a central institution in the community,” he said. “In my personal experience, the church served in a variety of roles, including but not limited to advocacy, employment, social services, peer support, and notably a trusted source of advice pertaining to health. In addition, Black churches may be in an ideal position to serve as culturally sensitive facilitators to build trust,” he said.

The study’s message for clinicians, according to Dr. Norris, is to “carefully consider partnering with faith-based organizations and community leaders if you want to supplement your efforts at decreasing mental health care disparities in the African American community.”

He pointed out, however, that in addition to the small number of participants, the study did not examine clinical outcomes. “So we must be careful how much we take from the initial conclusions,” Dr. Norris said.

Additional research is needed on a much larger scale to add support to the study findings, he said. “This study focused on one church and its particular program,” Dr. Norris noted. “There is likely a great deal of heterogeneity with Black churches and definitely among church members they serve,” he said. “Although it may be tempting to go with an ‘of course it will work’ approach, it is best to have additional qualitative and quantitative research of a much larger scale, with clinical controls that examine the ability of Black churches to address barriers African Americans face in receiving and utilizing mental health services,” he concluded.

Dr. Jordan disclosed receiving a 2021-2022 American Psychiatric Association/Substance Abuse and Mental Health Services Administration Minority Fellowship Program grant to study mental health literacy in the Black church. Dr. Norris disclosed serving as CEO of the Cleveland Clergy Alliance, a nonprofit organization providing outreach assistance as a mechanism to help seniors and the disabled population through community programming. The study authors reported no disclosures.