Clinical Endocrinology News

Depending on the data you’re looking at, 40%-60% of physicians are burned out.

Research studies and the eye test reveal the painfully obvious: Colleagues are tired, winded, spent, and at times way past burned out. People aren’t asking me if they’re burned out. They know they’re burned out; heck, they can even recite the Maslach burnout inventory, forward and backward, in a mask, or while completing a COVID quarantine. A fair share of people know the key steps to prevent burnout and promote recovery.

What I’m starting to see more of is, “Why should I even bother to recover from this? Why pick myself up again just to get another occupational stress injury (burnout, demoralization, moral injury, etc.)?” In other words, it’s not just simply about negating burnout; it’s about supporting and facilitating the motivation to work.

We’ve been through so much with COVID that it might be challenging to remember when you saw a truly engaged work environment. No doubt, we have outstanding professionals across medicine who answer the bell every day. However, if you’ve been looking closely, many teams/units have lost a bit of the zip and pep. The synergy and trust aren’t as smooth, and at noon, everyone counts the hours to the end of the shift.

You may be thinking, Well, of course, they are; we’re still amid a pandemic, and people have been through hell. Your observation would be correct, except I’ve personally seen some teams weather the pandemic storm and still remain engaged (some even more involved).

The No. 1 consult result for the GW Resiliency and Well-Being Center, where I work, has been on lectures for burnout. The R&WC has given so many of these lectures that my dreams take the form of a PowerPoint presentation. Overall the talks have gone very well. We’ve added skills sections on practices of whole-person care. We’ve blitzed the daylights out of restorative sleep, yet I know we are still searching for the correct narrative.

Motivated staff, faculty, and students will genuinely take in the information and follow the recommendations; however, they still struggle to find that drive and zest for work. Yes, moving from burnout to neutral is reasonable but likely won’t move the needle of your professional or personal life. We need to have the emotional energy and the clear desire to utilize that energy for a meaningful purpose.

Talking about burnout in specific ways is straightforward and, in my opinion, much easier than talking about engagement. Part of the challenge when trying to discuss engagement is that people can feel invalidated or that you’re telling them to be stoic. Or worse yet, that the problem of burnout primarily lies with them. It’s essential to recognize the role of an organizational factor in burnout (approximately 80%, depending on the study); still, even if you address burnout, people may not be miserable, but it doesn’t mean they will stay at their current job (please cue intro music for the Great Resignation).

Engagement models have existed for some time and certainly have gained much more attention in health care settings over the past 2 decades. Engagement can be described as having three components: dedication, vigor, and absorption. When a person is filling all three of these components over time, presto – you get the much-sought-after state of the supremely engaged professional.

These models definitely give us excellent starting points to approach engagement from a pre-COVID era. In COVID and beyond, I’m not sure how these models will stand up in a hybrid work environment, where autonomy and flexibility could be more valued than ever. Personally, COVID revealed some things I was missing in my work pre-COVID:

• Time to think and process. This was one of the great things about being a consultation-liaison psychiatrist; it was literally feast or famine.
• Doing what I’m talented at and really enjoy.
• Time is short, and I want to be more present in the life of my family.
• Growth and curiosity are vitally important to me. These have to be part of my daily ritual and practice.

The list above isn’t exhaustive, but I’ve found them to be my own personal recipe for being engaged. Over the next series of articles, I’m going to focus on engagement and factors related to key resilience. These articles will be informed by a front-line view from my colleagues, and hopefully start to separate the myth from reality on the subject of health professional engagement and resilience.

Everyone be safe and well!

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

Depending on the data you’re looking at, 40%-60% of physicians are burned out.

Research studies and the eye test reveal the painfully obvious: Colleagues are tired, winded, spent, and at times way past burned out. People aren’t asking me if they’re burned out. They know they’re burned out; heck, they can even recite the Maslach burnout inventory, forward and backward, in a mask, or while completing a COVID quarantine. A fair share of people know the key steps to prevent burnout and promote recovery.

What I’m starting to see more of is, “Why should I even bother to recover from this? Why pick myself up again just to get another occupational stress injury (burnout, demoralization, moral injury, etc.)?” In other words, it’s not just simply about negating burnout; it’s about supporting and facilitating the motivation to work.

We’ve been through so much with COVID that it might be challenging to remember when you saw a truly engaged work environment. No doubt, we have outstanding professionals across medicine who answer the bell every day. However, if you’ve been looking closely, many teams/units have lost a bit of the zip and pep. The synergy and trust aren’t as smooth, and at noon, everyone counts the hours to the end of the shift.

You may be thinking, Well, of course, they are; we’re still amid a pandemic, and people have been through hell. Your observation would be correct, except I’ve personally seen some teams weather the pandemic storm and still remain engaged (some even more involved).

The No. 1 consult result for the GW Resiliency and Well-Being Center, where I work, has been on lectures for burnout. The R&WC has given so many of these lectures that my dreams take the form of a PowerPoint presentation. Overall the talks have gone very well. We’ve added skills sections on practices of whole-person care. We’ve blitzed the daylights out of restorative sleep, yet I know we are still searching for the correct narrative.

Motivated staff, faculty, and students will genuinely take in the information and follow the recommendations; however, they still struggle to find that drive and zest for work. Yes, moving from burnout to neutral is reasonable but likely won’t move the needle of your professional or personal life. We need to have the emotional energy and the clear desire to utilize that energy for a meaningful purpose.

Talking about burnout in specific ways is straightforward and, in my opinion, much easier than talking about engagement. Part of the challenge when trying to discuss engagement is that people can feel invalidated or that you’re telling them to be stoic. Or worse yet, that the problem of burnout primarily lies with them. It’s essential to recognize the role of an organizational factor in burnout (approximately 80%, depending on the study); still, even if you address burnout, people may not be miserable, but it doesn’t mean they will stay at their current job (please cue intro music for the Great Resignation).

Engagement models have existed for some time and certainly have gained much more attention in health care settings over the past 2 decades. Engagement can be described as having three components: dedication, vigor, and absorption. When a person is filling all three of these components over time, presto – you get the much-sought-after state of the supremely engaged professional.

These models definitely give us excellent starting points to approach engagement from a pre-COVID era. In COVID and beyond, I’m not sure how these models will stand up in a hybrid work environment, where autonomy and flexibility could be more valued than ever. Personally, COVID revealed some things I was missing in my work pre-COVID:

• Time to think and process. This was one of the great things about being a consultation-liaison psychiatrist; it was literally feast or famine.
• Doing what I’m talented at and really enjoy.
• Time is short, and I want to be more present in the life of my family.
• Growth and curiosity are vitally important to me. These have to be part of my daily ritual and practice.

The list above isn’t exhaustive, but I’ve found them to be my own personal recipe for being engaged. Over the next series of articles, I’m going to focus on engagement and factors related to key resilience. These articles will be informed by a front-line view from my colleagues, and hopefully start to separate the myth from reality on the subject of health professional engagement and resilience.

Everyone be safe and well!

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

Depending on the data you’re looking at, 40%-60% of physicians are burned out.

Research studies and the eye test reveal the painfully obvious: Colleagues are tired, winded, spent, and at times way past burned out. People aren’t asking me if they’re burned out. They know they’re burned out; heck, they can even recite the Maslach burnout inventory, forward and backward, in a mask, or while completing a COVID quarantine. A fair share of people know the key steps to prevent burnout and promote recovery.

What I’m starting to see more of is, “Why should I even bother to recover from this? Why pick myself up again just to get another occupational stress injury (burnout, demoralization, moral injury, etc.)?” In other words, it’s not just simply about negating burnout; it’s about supporting and facilitating the motivation to work.

We’ve been through so much with COVID that it might be challenging to remember when you saw a truly engaged work environment. No doubt, we have outstanding professionals across medicine who answer the bell every day. However, if you’ve been looking closely, many teams/units have lost a bit of the zip and pep. The synergy and trust aren’t as smooth, and at noon, everyone counts the hours to the end of the shift.

You may be thinking, Well, of course, they are; we’re still amid a pandemic, and people have been through hell. Your observation would be correct, except I’ve personally seen some teams weather the pandemic storm and still remain engaged (some even more involved).

The No. 1 consult result for the GW Resiliency and Well-Being Center, where I work, has been on lectures for burnout. The R&WC has given so many of these lectures that my dreams take the form of a PowerPoint presentation. Overall the talks have gone very well. We’ve added skills sections on practices of whole-person care. We’ve blitzed the daylights out of restorative sleep, yet I know we are still searching for the correct narrative.

Motivated staff, faculty, and students will genuinely take in the information and follow the recommendations; however, they still struggle to find that drive and zest for work. Yes, moving from burnout to neutral is reasonable but likely won’t move the needle of your professional or personal life. We need to have the emotional energy and the clear desire to utilize that energy for a meaningful purpose.

Talking about burnout in specific ways is straightforward and, in my opinion, much easier than talking about engagement. Part of the challenge when trying to discuss engagement is that people can feel invalidated or that you’re telling them to be stoic. Or worse yet, that the problem of burnout primarily lies with them. It’s essential to recognize the role of an organizational factor in burnout (approximately 80%, depending on the study); still, even if you address burnout, people may not be miserable, but it doesn’t mean they will stay at their current job (please cue intro music for the Great Resignation).

Engagement models have existed for some time and certainly have gained much more attention in health care settings over the past 2 decades. Engagement can be described as having three components: dedication, vigor, and absorption. When a person is filling all three of these components over time, presto – you get the much-sought-after state of the supremely engaged professional.

These models definitely give us excellent starting points to approach engagement from a pre-COVID era. In COVID and beyond, I’m not sure how these models will stand up in a hybrid work environment, where autonomy and flexibility could be more valued than ever. Personally, COVID revealed some things I was missing in my work pre-COVID:

• Time to think and process. This was one of the great things about being a consultation-liaison psychiatrist; it was literally feast or famine.
• Doing what I’m talented at and really enjoy.
• Time is short, and I want to be more present in the life of my family.
• Growth and curiosity are vitally important to me. These have to be part of my daily ritual and practice.

The list above isn’t exhaustive, but I’ve found them to be my own personal recipe for being engaged. Over the next series of articles, I’m going to focus on engagement and factors related to key resilience. These articles will be informed by a front-line view from my colleagues, and hopefully start to separate the myth from reality on the subject of health professional engagement and resilience.

Everyone be safe and well!

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

Two new studies from different parts of the world have identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons still aren’t clear.

The findings from the two studies, in Germany and the United States, align closely, endocrinologist Jane J. Kim, MD, professor of pediatrics and principal investigator of the U.S. study, told this news organization. “I think that the general conclusion based on their data and our data is that there appears to be an increased rate of new type 1 diabetes diagnoses in children since the onset of the pandemic.”

Dr. Kim noted that because her group’s data pertain to just a single center, she is “heartened to see that the [German team’s] general conclusions are the same as ours.” Moreover, she pointed out that other studies examining this question came from Europe early in the pandemic, whereas “now both they [the German group] and we have had the opportunity to look at what’s happening over a longer period of time.”

But the reason for the association remains unclear. Some answers may be forthcoming from a database designed in mid-2020 specifically to examine the relationship between COVID-19 and new-onset diabetes. Called CoviDiab, the registry aims “to establish the extent and characteristics of new-onset, COVID-19–related diabetes and to investigate its pathogenesis, management, and outcomes,” according to the website.

The first new study, a multicenter German diabetes registry study, was published online Jan. 17 in Diabetes Care by Clemens Kamrath, MD, of Justus Liebig University, Giessen, Germany, and colleagues.

The other, from Rady Children’s Hospital of San Diego, was published online Jan. 24 in JAMA Pediatrics by Bethany L. Gottesman, MD, and colleagues, all with the University of California, San Diego.
 

Mechanisms likely to differ for type 1 versus type 2 diabetes

Neither the German nor the U.S. investigators were able to directly correlate current or prior SARS-CoV-2 infection in children with the subsequent development of type 1 diabetes.

Earlier this month, a study from the U.S. Centers for Disease Control and Prevention did examine that issue, but it also included youth with type 2 diabetes and did not separate out the two groups.

Dr. Kim said her institution has also seen an increase in type 2 diabetes among youth since the COVID-19 pandemic began but did not include that in their current article.

“When we started looking at our data, diabetes and COVID-19 in adults had been relatively well established. To see an increase in type 2 [diabetes] was not so surprising to our group. But we had the sense we were seeing more patients with type 1, and when we looked at our hospital that was very much the case. I think that was a surprise to people,” said Dr. Kim.

Although a direct effect of SARS-CoV-2 on pancreatic beta cells has been proposed, in both the German and San Diego datasets the diagnosis of type 1 diabetes was confirmed with autoantibodies that are typically present years prior to the onset of clinical symptoms.

The German group suggests possible other explanations for the link, including the lack of immune system exposure to other common pediatric infections during pandemic-necessitated social distancing – the so-called hygiene hypothesis – as well as the possible role of psychological stress, which several studies have linked to type 1 diabetes.

But as of now, Dr. Kim said, “Nobody really knows.” 
 

Is the effect direct or indirect?

Using data from the multicenter German Diabetes Prospective Follow-up Registry, Dr. Kamrath and colleagues compared the incidence of type 1 diabetes in children and adolescents from Jan. 1, 2020 through June 30, 2021 with the incidence in 2011-2019.

During the pandemic period, a total of 5,162 youth were newly diagnosed with type 1 diabetes at 236 German centers. That incidence, 24.4 per 100,000 patient-years, was significantly higher than the 21.2 per 100,000 patient-years expected based on the prior decade, with an incidence rate ratio of 1.15 (P < .001). The increase was similar in both males and females.

There was a difference by age, however, as the phenomenon appeared to be limited to the preadolescent age groups. The incidence rate ratios (IRRs) for ages below 6 years and 6-11 years were 1.23 and 1.18 (both P < .001), respectively, compared to a nonsignificant IRR of 1.06 (P = .13) in those aged 12-17 years.

Compared with the expected monthly incidence, the observed incidence was significantly higher in June 2020 (IRR, 1.43; P = .003), July 2020 (IRR, 1.48; P < 0.001), March 2021 (IRR, 1.29; P = .028), and June 2021 (IRR, 1.39; P = .01).

Among the 3,851 patients for whom data on type 1 diabetes-associated autoantibodies were available, the adjusted rates of autoantibody negativity did not differ from 2018-2019 during the entire pandemic period or during the year 2020 or the first half of 2021.  

“Therefore, the increase in the incidence of type 1 diabetes in children appears to be due to immune-mediated type 1 diabetes. However, because autoimmunity and progressive beta-cell destruction typically begin long before the clinical diagnosis of type 1 diabetes, we were surprised to see the incidence of type 1 diabetes followed the peak incidence of COVID-19 and also the pandemic containment measures by only approximately 3 months,” Dr. Kamrath and colleagues write.

Taken together, they say, the data suggest that “the impact on type 1 diabetes incidence is not due to infection with SARS-CoV-2 but rather a consequence of environmental changes resulting from the pandemic itself or pandemic containment measures.”
 

Similar findings at a U.S. children’s hospital

In the cross-sectional study in San Diego, Dr. Gottesman and colleagues looked at the electronic medical records (EMRs) at Rady Children’s Hospital for patients aged younger than 19 years with at least one positive type 1 diabetes antibody titer.

During March 19, 2020 to March 18, 2021, a total of 187 children were admitted for new-onset type 1 diabetes, compared with just 119 the previous year, a 57% increase.

From July 2020 through February 2021, the number of new type 1 diabetes diagnoses significantly exceeded the number expected based on a quarterly moving average of each of the preceding 5 years.

Only four of the 187 patients (2.1%) diagnosed during the pandemic period had a COVID-19 infection at the time of presentation. Antibody testing to assess prior infection wasn’t feasible, and now that children are receiving the vaccine – and therefore most will have antibodies – “we’ve lost our window of opportunity to look at that question,” Dr. Kim noted.   

As has been previously shown, there was an increase in the percentage of patients presenting with diabetic ketoacidosis during the pandemic compared with the prior 5 years (49.7% vs. 40.7% requiring insulin infusion). However, there was no difference in mean age at presentation, body mass index, A1c, or percentage requiring admission to intensive care.

Because these data only go through March 2021, Dr. Kim noted, “We need to see what’s happening with these different variants. We’ll have a chance to look in a month or two to see the effects of Omicron on the rates of diabetes in the hospital.”
 

Will CoviDiab answer the question?

Data from CoviDiab will include diabetes type in adults and children, registry coprincipal investigator Francesco Rubino, MD, of King’s College London, told this news organization.

“We aimed at having as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c. By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19 as this also speaks about mechanisms of action.”

Dr. Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or that the hyperglycemia may be stress-induced and temporary.

“We’re looking at this question with a skeptical eye ... Is it just an association, or does the virus have a role in inducing diabetes from scratch, or can the virus advance pathophysiology in a way that it ends up in full-blown diabetes in predisposed individuals?”

While no single study will prove that SARS-CoV-2 causes diabetes, “combining observations from various studies and approaches we may get a higher degree of certainty,” Dr. Rubino said, noting that the CoviDiab team plans to publish data from the first 800 cases “soon.”

Dr. Kim has reported no relevant financial relationships. Dr. Rubino has reported receiving grants from Ethicon and Medtronic, personal fees from GI Dynamic, Keyron, Novo Nordisk, Ethicon, and Medtronic.

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

Two new studies from different parts of the world have identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons still aren’t clear.

The findings from the two studies, in Germany and the United States, align closely, endocrinologist Jane J. Kim, MD, professor of pediatrics and principal investigator of the U.S. study, told this news organization. “I think that the general conclusion based on their data and our data is that there appears to be an increased rate of new type 1 diabetes diagnoses in children since the onset of the pandemic.”

Dr. Kim noted that because her group’s data pertain to just a single center, she is “heartened to see that the [German team’s] general conclusions are the same as ours.” Moreover, she pointed out that other studies examining this question came from Europe early in the pandemic, whereas “now both they [the German group] and we have had the opportunity to look at what’s happening over a longer period of time.”

But the reason for the association remains unclear. Some answers may be forthcoming from a database designed in mid-2020 specifically to examine the relationship between COVID-19 and new-onset diabetes. Called CoviDiab, the registry aims “to establish the extent and characteristics of new-onset, COVID-19–related diabetes and to investigate its pathogenesis, management, and outcomes,” according to the website.

The first new study, a multicenter German diabetes registry study, was published online Jan. 17 in Diabetes Care by Clemens Kamrath, MD, of Justus Liebig University, Giessen, Germany, and colleagues.

The other, from Rady Children’s Hospital of San Diego, was published online Jan. 24 in JAMA Pediatrics by Bethany L. Gottesman, MD, and colleagues, all with the University of California, San Diego.
 

Mechanisms likely to differ for type 1 versus type 2 diabetes

Neither the German nor the U.S. investigators were able to directly correlate current or prior SARS-CoV-2 infection in children with the subsequent development of type 1 diabetes.

Earlier this month, a study from the U.S. Centers for Disease Control and Prevention did examine that issue, but it also included youth with type 2 diabetes and did not separate out the two groups.

Dr. Kim said her institution has also seen an increase in type 2 diabetes among youth since the COVID-19 pandemic began but did not include that in their current article.

“When we started looking at our data, diabetes and COVID-19 in adults had been relatively well established. To see an increase in type 2 [diabetes] was not so surprising to our group. But we had the sense we were seeing more patients with type 1, and when we looked at our hospital that was very much the case. I think that was a surprise to people,” said Dr. Kim.

Although a direct effect of SARS-CoV-2 on pancreatic beta cells has been proposed, in both the German and San Diego datasets the diagnosis of type 1 diabetes was confirmed with autoantibodies that are typically present years prior to the onset of clinical symptoms.

The German group suggests possible other explanations for the link, including the lack of immune system exposure to other common pediatric infections during pandemic-necessitated social distancing – the so-called hygiene hypothesis – as well as the possible role of psychological stress, which several studies have linked to type 1 diabetes.

But as of now, Dr. Kim said, “Nobody really knows.” 
 

Is the effect direct or indirect?

Using data from the multicenter German Diabetes Prospective Follow-up Registry, Dr. Kamrath and colleagues compared the incidence of type 1 diabetes in children and adolescents from Jan. 1, 2020 through June 30, 2021 with the incidence in 2011-2019.

During the pandemic period, a total of 5,162 youth were newly diagnosed with type 1 diabetes at 236 German centers. That incidence, 24.4 per 100,000 patient-years, was significantly higher than the 21.2 per 100,000 patient-years expected based on the prior decade, with an incidence rate ratio of 1.15 (P < .001). The increase was similar in both males and females.

There was a difference by age, however, as the phenomenon appeared to be limited to the preadolescent age groups. The incidence rate ratios (IRRs) for ages below 6 years and 6-11 years were 1.23 and 1.18 (both P < .001), respectively, compared to a nonsignificant IRR of 1.06 (P = .13) in those aged 12-17 years.

Compared with the expected monthly incidence, the observed incidence was significantly higher in June 2020 (IRR, 1.43; P = .003), July 2020 (IRR, 1.48; P < 0.001), March 2021 (IRR, 1.29; P = .028), and June 2021 (IRR, 1.39; P = .01).

Among the 3,851 patients for whom data on type 1 diabetes-associated autoantibodies were available, the adjusted rates of autoantibody negativity did not differ from 2018-2019 during the entire pandemic period or during the year 2020 or the first half of 2021.  

“Therefore, the increase in the incidence of type 1 diabetes in children appears to be due to immune-mediated type 1 diabetes. However, because autoimmunity and progressive beta-cell destruction typically begin long before the clinical diagnosis of type 1 diabetes, we were surprised to see the incidence of type 1 diabetes followed the peak incidence of COVID-19 and also the pandemic containment measures by only approximately 3 months,” Dr. Kamrath and colleagues write.

Taken together, they say, the data suggest that “the impact on type 1 diabetes incidence is not due to infection with SARS-CoV-2 but rather a consequence of environmental changes resulting from the pandemic itself or pandemic containment measures.”
 

Similar findings at a U.S. children’s hospital

In the cross-sectional study in San Diego, Dr. Gottesman and colleagues looked at the electronic medical records (EMRs) at Rady Children’s Hospital for patients aged younger than 19 years with at least one positive type 1 diabetes antibody titer.

During March 19, 2020 to March 18, 2021, a total of 187 children were admitted for new-onset type 1 diabetes, compared with just 119 the previous year, a 57% increase.

From July 2020 through February 2021, the number of new type 1 diabetes diagnoses significantly exceeded the number expected based on a quarterly moving average of each of the preceding 5 years.

Only four of the 187 patients (2.1%) diagnosed during the pandemic period had a COVID-19 infection at the time of presentation. Antibody testing to assess prior infection wasn’t feasible, and now that children are receiving the vaccine – and therefore most will have antibodies – “we’ve lost our window of opportunity to look at that question,” Dr. Kim noted.   

As has been previously shown, there was an increase in the percentage of patients presenting with diabetic ketoacidosis during the pandemic compared with the prior 5 years (49.7% vs. 40.7% requiring insulin infusion). However, there was no difference in mean age at presentation, body mass index, A1c, or percentage requiring admission to intensive care.

Because these data only go through March 2021, Dr. Kim noted, “We need to see what’s happening with these different variants. We’ll have a chance to look in a month or two to see the effects of Omicron on the rates of diabetes in the hospital.”
 

Will CoviDiab answer the question?

Data from CoviDiab will include diabetes type in adults and children, registry coprincipal investigator Francesco Rubino, MD, of King’s College London, told this news organization.

“We aimed at having as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c. By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19 as this also speaks about mechanisms of action.”

Dr. Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or that the hyperglycemia may be stress-induced and temporary.

“We’re looking at this question with a skeptical eye ... Is it just an association, or does the virus have a role in inducing diabetes from scratch, or can the virus advance pathophysiology in a way that it ends up in full-blown diabetes in predisposed individuals?”

While no single study will prove that SARS-CoV-2 causes diabetes, “combining observations from various studies and approaches we may get a higher degree of certainty,” Dr. Rubino said, noting that the CoviDiab team plans to publish data from the first 800 cases “soon.”

Dr. Kim has reported no relevant financial relationships. Dr. Rubino has reported receiving grants from Ethicon and Medtronic, personal fees from GI Dynamic, Keyron, Novo Nordisk, Ethicon, and Medtronic.

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

Two new studies from different parts of the world have identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons still aren’t clear.

The findings from the two studies, in Germany and the United States, align closely, endocrinologist Jane J. Kim, MD, professor of pediatrics and principal investigator of the U.S. study, told this news organization. “I think that the general conclusion based on their data and our data is that there appears to be an increased rate of new type 1 diabetes diagnoses in children since the onset of the pandemic.”

Dr. Kim noted that because her group’s data pertain to just a single center, she is “heartened to see that the [German team’s] general conclusions are the same as ours.” Moreover, she pointed out that other studies examining this question came from Europe early in the pandemic, whereas “now both they [the German group] and we have had the opportunity to look at what’s happening over a longer period of time.”

But the reason for the association remains unclear. Some answers may be forthcoming from a database designed in mid-2020 specifically to examine the relationship between COVID-19 and new-onset diabetes. Called CoviDiab, the registry aims “to establish the extent and characteristics of new-onset, COVID-19–related diabetes and to investigate its pathogenesis, management, and outcomes,” according to the website.

The first new study, a multicenter German diabetes registry study, was published online Jan. 17 in Diabetes Care by Clemens Kamrath, MD, of Justus Liebig University, Giessen, Germany, and colleagues.

The other, from Rady Children’s Hospital of San Diego, was published online Jan. 24 in JAMA Pediatrics by Bethany L. Gottesman, MD, and colleagues, all with the University of California, San Diego.
 

Mechanisms likely to differ for type 1 versus type 2 diabetes

Neither the German nor the U.S. investigators were able to directly correlate current or prior SARS-CoV-2 infection in children with the subsequent development of type 1 diabetes.

Earlier this month, a study from the U.S. Centers for Disease Control and Prevention did examine that issue, but it also included youth with type 2 diabetes and did not separate out the two groups.

Dr. Kim said her institution has also seen an increase in type 2 diabetes among youth since the COVID-19 pandemic began but did not include that in their current article.

“When we started looking at our data, diabetes and COVID-19 in adults had been relatively well established. To see an increase in type 2 [diabetes] was not so surprising to our group. But we had the sense we were seeing more patients with type 1, and when we looked at our hospital that was very much the case. I think that was a surprise to people,” said Dr. Kim.

Although a direct effect of SARS-CoV-2 on pancreatic beta cells has been proposed, in both the German and San Diego datasets the diagnosis of type 1 diabetes was confirmed with autoantibodies that are typically present years prior to the onset of clinical symptoms.

The German group suggests possible other explanations for the link, including the lack of immune system exposure to other common pediatric infections during pandemic-necessitated social distancing – the so-called hygiene hypothesis – as well as the possible role of psychological stress, which several studies have linked to type 1 diabetes.

But as of now, Dr. Kim said, “Nobody really knows.” 
 

Is the effect direct or indirect?

Using data from the multicenter German Diabetes Prospective Follow-up Registry, Dr. Kamrath and colleagues compared the incidence of type 1 diabetes in children and adolescents from Jan. 1, 2020 through June 30, 2021 with the incidence in 2011-2019.

During the pandemic period, a total of 5,162 youth were newly diagnosed with type 1 diabetes at 236 German centers. That incidence, 24.4 per 100,000 patient-years, was significantly higher than the 21.2 per 100,000 patient-years expected based on the prior decade, with an incidence rate ratio of 1.15 (P < .001). The increase was similar in both males and females.

There was a difference by age, however, as the phenomenon appeared to be limited to the preadolescent age groups. The incidence rate ratios (IRRs) for ages below 6 years and 6-11 years were 1.23 and 1.18 (both P < .001), respectively, compared to a nonsignificant IRR of 1.06 (P = .13) in those aged 12-17 years.

Compared with the expected monthly incidence, the observed incidence was significantly higher in June 2020 (IRR, 1.43; P = .003), July 2020 (IRR, 1.48; P < 0.001), March 2021 (IRR, 1.29; P = .028), and June 2021 (IRR, 1.39; P = .01).

Among the 3,851 patients for whom data on type 1 diabetes-associated autoantibodies were available, the adjusted rates of autoantibody negativity did not differ from 2018-2019 during the entire pandemic period or during the year 2020 or the first half of 2021.  

“Therefore, the increase in the incidence of type 1 diabetes in children appears to be due to immune-mediated type 1 diabetes. However, because autoimmunity and progressive beta-cell destruction typically begin long before the clinical diagnosis of type 1 diabetes, we were surprised to see the incidence of type 1 diabetes followed the peak incidence of COVID-19 and also the pandemic containment measures by only approximately 3 months,” Dr. Kamrath and colleagues write.

Taken together, they say, the data suggest that “the impact on type 1 diabetes incidence is not due to infection with SARS-CoV-2 but rather a consequence of environmental changes resulting from the pandemic itself or pandemic containment measures.”
 

Similar findings at a U.S. children’s hospital

In the cross-sectional study in San Diego, Dr. Gottesman and colleagues looked at the electronic medical records (EMRs) at Rady Children’s Hospital for patients aged younger than 19 years with at least one positive type 1 diabetes antibody titer.

During March 19, 2020 to March 18, 2021, a total of 187 children were admitted for new-onset type 1 diabetes, compared with just 119 the previous year, a 57% increase.

From July 2020 through February 2021, the number of new type 1 diabetes diagnoses significantly exceeded the number expected based on a quarterly moving average of each of the preceding 5 years.

Only four of the 187 patients (2.1%) diagnosed during the pandemic period had a COVID-19 infection at the time of presentation. Antibody testing to assess prior infection wasn’t feasible, and now that children are receiving the vaccine – and therefore most will have antibodies – “we’ve lost our window of opportunity to look at that question,” Dr. Kim noted.   

As has been previously shown, there was an increase in the percentage of patients presenting with diabetic ketoacidosis during the pandemic compared with the prior 5 years (49.7% vs. 40.7% requiring insulin infusion). However, there was no difference in mean age at presentation, body mass index, A1c, or percentage requiring admission to intensive care.

Because these data only go through March 2021, Dr. Kim noted, “We need to see what’s happening with these different variants. We’ll have a chance to look in a month or two to see the effects of Omicron on the rates of diabetes in the hospital.”
 

Will CoviDiab answer the question?

Data from CoviDiab will include diabetes type in adults and children, registry coprincipal investigator Francesco Rubino, MD, of King’s College London, told this news organization.

“We aimed at having as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c. By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19 as this also speaks about mechanisms of action.”

Dr. Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or that the hyperglycemia may be stress-induced and temporary.

“We’re looking at this question with a skeptical eye ... Is it just an association, or does the virus have a role in inducing diabetes from scratch, or can the virus advance pathophysiology in a way that it ends up in full-blown diabetes in predisposed individuals?”

While no single study will prove that SARS-CoV-2 causes diabetes, “combining observations from various studies and approaches we may get a higher degree of certainty,” Dr. Rubino said, noting that the CoviDiab team plans to publish data from the first 800 cases “soon.”

Dr. Kim has reported no relevant financial relationships. Dr. Rubino has reported receiving grants from Ethicon and Medtronic, personal fees from GI Dynamic, Keyron, Novo Nordisk, Ethicon, and Medtronic.

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

The widely held notion that consuming small to moderate amounts of alcohol is good for cardiovascular health is not supported by the data, the World Heart Federation says in a new policy brief.

In fact, the evidence is clear that any level of drinking can contribute to loss of a healthy life, the organization says.

“Over the past several decades, the prevalence of cardiovascular disease has nearly doubled, and alcohol has played a major role in the incidence of much of it,” the WHF said in the brief.

“The portrayal of alcohol as necessary for a vibrant social life has diverted attention from the harms of alcohol use, as have the frequent and widely publicized claims that moderate drinking, such as a glass of red wine a day, can offer protection against cardiovascular disease,” Monika Arora, PhD, member of the WHF advocacy committee and coauthor of the brief, said in a news release.

“These claims are at best misinformed and at worst an attempt by the alcohol industry to mislead the public about the danger of their product,” Dr. Arora added.

The WHF conclusions follow a report in the Lancet based on the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), which found that there is no safe level of alcohol consumption.

In 2019, nearly 2.4 million deaths were attributed to alcohol, accounting for 4.3% of all deaths globally and 12.6% of deaths in men 15 to 49 years of age.

Even small amounts of alcohol have been shown to raise the risk for cardiovascular disease, including coronary disease, stroke, heart failure, hypertensive heart disease, cardiomyopathy, atrial fibrillation, and aneurysm, the WHF notes.

Studies that claim otherwise are largely based on purely observational research, which fails to account for relevant cofactors, the organization writes.

Based on their summary of the evidence to date, there is no reliable correlation between moderate alcohol consumption and a lower risk for cardiovascular disease.

Alcohol use is also a “major avoidable risk factor” for cancer, digestive diseases, intentional and unintentional injuries, and several infectious diseases, the WHF says.

Alcohol use also has significant economic and social costs, which include costs to individuals and health systems, productivity losses, as well as the increased risk for violence, homelessness, and criminal activity.

The WHF policy brief calls for “urgent and decisive action” to tackle the unprecedented rise in alcohol-related death and disability worldwide.

Recommended actions include boosting restrictions on alcohol availability; advancing and enforcing drinking and driving countermeasures; increasing access to screening, brief interventions, and treatment for alcohol use disorder; enforcing bans on alcohol advertising; establishing a uniform minimum legal drinking age; and mandating health warnings on alcohol products.

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

The widely held notion that consuming small to moderate amounts of alcohol is good for cardiovascular health is not supported by the data, the World Heart Federation says in a new policy brief.

In fact, the evidence is clear that any level of drinking can contribute to loss of a healthy life, the organization says.

“Over the past several decades, the prevalence of cardiovascular disease has nearly doubled, and alcohol has played a major role in the incidence of much of it,” the WHF said in the brief.

“The portrayal of alcohol as necessary for a vibrant social life has diverted attention from the harms of alcohol use, as have the frequent and widely publicized claims that moderate drinking, such as a glass of red wine a day, can offer protection against cardiovascular disease,” Monika Arora, PhD, member of the WHF advocacy committee and coauthor of the brief, said in a news release.

“These claims are at best misinformed and at worst an attempt by the alcohol industry to mislead the public about the danger of their product,” Dr. Arora added.

The WHF conclusions follow a report in the Lancet based on the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), which found that there is no safe level of alcohol consumption.

In 2019, nearly 2.4 million deaths were attributed to alcohol, accounting for 4.3% of all deaths globally and 12.6% of deaths in men 15 to 49 years of age.

Even small amounts of alcohol have been shown to raise the risk for cardiovascular disease, including coronary disease, stroke, heart failure, hypertensive heart disease, cardiomyopathy, atrial fibrillation, and aneurysm, the WHF notes.

Studies that claim otherwise are largely based on purely observational research, which fails to account for relevant cofactors, the organization writes.

Based on their summary of the evidence to date, there is no reliable correlation between moderate alcohol consumption and a lower risk for cardiovascular disease.

Alcohol use is also a “major avoidable risk factor” for cancer, digestive diseases, intentional and unintentional injuries, and several infectious diseases, the WHF says.

Alcohol use also has significant economic and social costs, which include costs to individuals and health systems, productivity losses, as well as the increased risk for violence, homelessness, and criminal activity.

The WHF policy brief calls for “urgent and decisive action” to tackle the unprecedented rise in alcohol-related death and disability worldwide.

Recommended actions include boosting restrictions on alcohol availability; advancing and enforcing drinking and driving countermeasures; increasing access to screening, brief interventions, and treatment for alcohol use disorder; enforcing bans on alcohol advertising; establishing a uniform minimum legal drinking age; and mandating health warnings on alcohol products.

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

The widely held notion that consuming small to moderate amounts of alcohol is good for cardiovascular health is not supported by the data, the World Heart Federation says in a new policy brief.

In fact, the evidence is clear that any level of drinking can contribute to loss of a healthy life, the organization says.

“Over the past several decades, the prevalence of cardiovascular disease has nearly doubled, and alcohol has played a major role in the incidence of much of it,” the WHF said in the brief.

“The portrayal of alcohol as necessary for a vibrant social life has diverted attention from the harms of alcohol use, as have the frequent and widely publicized claims that moderate drinking, such as a glass of red wine a day, can offer protection against cardiovascular disease,” Monika Arora, PhD, member of the WHF advocacy committee and coauthor of the brief, said in a news release.

“These claims are at best misinformed and at worst an attempt by the alcohol industry to mislead the public about the danger of their product,” Dr. Arora added.

The WHF conclusions follow a report in the Lancet based on the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), which found that there is no safe level of alcohol consumption.

In 2019, nearly 2.4 million deaths were attributed to alcohol, accounting for 4.3% of all deaths globally and 12.6% of deaths in men 15 to 49 years of age.

Even small amounts of alcohol have been shown to raise the risk for cardiovascular disease, including coronary disease, stroke, heart failure, hypertensive heart disease, cardiomyopathy, atrial fibrillation, and aneurysm, the WHF notes.

Studies that claim otherwise are largely based on purely observational research, which fails to account for relevant cofactors, the organization writes.

Based on their summary of the evidence to date, there is no reliable correlation between moderate alcohol consumption and a lower risk for cardiovascular disease.

Alcohol use is also a “major avoidable risk factor” for cancer, digestive diseases, intentional and unintentional injuries, and several infectious diseases, the WHF says.

Alcohol use also has significant economic and social costs, which include costs to individuals and health systems, productivity losses, as well as the increased risk for violence, homelessness, and criminal activity.

The WHF policy brief calls for “urgent and decisive action” to tackle the unprecedented rise in alcohol-related death and disability worldwide.

Recommended actions include boosting restrictions on alcohol availability; advancing and enforcing drinking and driving countermeasures; increasing access to screening, brief interventions, and treatment for alcohol use disorder; enforcing bans on alcohol advertising; establishing a uniform minimum legal drinking age; and mandating health warnings on alcohol products.

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

Disruption of the bacteria in the gut is linked with susceptibility to long COVID-19 syndrome, according to new findings.

While links have been found between the gut’s microbiome and COVID-19, as well as other diseases, this is the first published research to show a link specifically to COVID’s long-term effects, the investigators, based at the Chinese University of Hong Kong, wrote in Gut.

Courtesy Dr. Siew Ng

“To our knowledge, this is the first study to show that altered gut microbiome composition is strongly associated with persistent symptoms in patients with COVID-19 up to 6 months after clearance of SARS-CoV-2 virus,” said Siew Ng, MBBS, PhD, associate director at the university’s Center for Gut Microbiota Research.

At three hospitals, the researchers enrolled 106 patients with COVID-19 from February to August 2020 with stool samples at admission and at 1 month and 6 months after discharge, and compared them with people who did not have COVID, recruited in 2019. The severity of COVID in the enrolled patients was mostly mild to moderate.

At 3 months, 86 of the patients with COVID had post–acute COVID-19 syndrome (PACS) – defined as at least one persistent, otherwise unexplained symptom 4 weeks after clearance of the virus. And 81 patients had PACS at 6 months, most commonly fatigue, poor memory, hair loss, anxiety, and trouble sleeping.

Using stool samples for their analysis, the researchers found that, broadly, the diversity of the types of bacteria, and the abundance of these bacteria, were significantly lower at 6 months for those with PACS, compared with those without PACS and with controls (P < .05 and P < .0001, respectively). Among those with PACS, 28 bacteria species were diminished and 14 were enriched, both at baseline and follow-up. Those patients who had COVID but not PACS showed just 25 alterations of bacteria species at the time of hospital admission, and they all normalized by 6 months.

Having respiratory symptoms at 6 months was linked with higher levels of opportunistic pathogens such as Streptococcus anginosus and S. vestibularis. Neuropsychiatric symptoms and fatigue were associated with nosocomial pathogens that are linked to opportunistic infections, such as Clostridium innocuum and Actinomyces naeslundii (P < .05).

Bacteria known for producing butyrate, a beneficial fatty acid, were significantly depleted in those patients with hair loss. And certain of these bacteria, including Bifidobacterium pseudocatenulatum and Faecalibacterium prausnitzii, had the largest inverse correlations with PACS at 6 months (P < .05), the researchers found.

“Particular gut microbial profiles may indicate heightened susceptibility,” Dr. Ng said.

Although the findings were drawn from patients with earlier strains of the COVID-19 virus, the findings still apply to new variants, including Omicron, since these pose the same problem of persistent disruption of the immune system, Dr. Ng said.

Her group is conducting trials to look at how modulating the microbiome might prevent long COVID and boost antibodies after vaccination in high-risk people, she said.

“Gut microbiota influences the health of the host,” Dr. Ng said. “It provides crucial benefits in the form of immune system development, prevention of infections, nutrient acquisition, and brain and nervous system functionality. Considering the millions of people infected during the ongoing pandemic, our findings are a strong impetus for consideration of microbiota modulation to facilitate timely recovery and reduce the burden of post–acute COVID-19 syndrome.”

Courtesy Dr. John Haran

John Haran, MD, PhD, associate professor of microbiology and physiological systems and emergency medicine at the University of Massachusetts, Worcester, said the research adds to the evidence base on the gut microbiome’s links to COVID, but there was likely be no clinical impact yet. Still, he said the findings linking specific species to specific symptoms was particularly interesting.

“Very early on during hospitalization, [the researchers] saw these differences and correlated out with people who have longer symptoms, and especially different groups of people that have longer symptoms, too,” said Dr. Haran, who has done research on the topic. “It’s very different if you have different symptoms, for example, you keep coughing for months versus you have brain fog and fatigue, or other debilitating symptoms.”

Dr. Haran noted that the findings didn’t identify bacteria types especially linked to COVID, but rather species that have already been found to be associated with a “bad” microbiome. He also pointed out that the patients enrolled in the study were not vaccinated, because vaccines weren’t available at the time. Still, further study to see whether modulation of gut bacteria can be a therapy seems worthwhile.

“Microbiome modulation is pretty safe, and that’s really the next big step that needs to be taken in this,” he said.

For now, the findings don’t give the clinician much new ammunition for treatment.

“We’re not there yet,” he added. “It’s not as if clinicians are going to tell their COVID patients: ‘Go out and buy some kale.’ ”

Eugene Chang, MD, professor of medicine at the University of Chicago, who has studied the gut microbiome and gastrointestinal disease, said it’s “too preliminary” to say whether the findings could lead to a clinical impact. The measures used merely identify the microbes present, but not what they are doing.

“These measures are unlikely to perform well enough to be useful for risk assessment or predicting clinical outcomes,” he said. “That being said, advances in technology are being made where next generations of metrics could be developed and useful as stratifiers and predictors of risk.”

Seeing shifting patterns associated with certain symptoms, he said, is “notable because it suggests that the disturbances of the gut microbiota in PACS are significant.”

But he said it’s important to know whether these changes are a cause of PACS in some way or just an effect of it.

“If causative or contributory – this has to be proven – then ‘microbiota modulation’ would make sense and could be a priority for development,” he said. “If merely an effect, these metrics and better ones to come could be useful as predictors or measures of the patient’s general state of health.”

As seen in his group’s work and other work, he said, “the gut microbiota is highly sensitive to changes in their ecosystem, which is influenced by the health state of the patient.”

Dr. Ng, Dr. Haran, and Dr. Chang reported no relevant disclosures.

This article was updated Jan. 27, 2022.

Disruption of the bacteria in the gut is linked with susceptibility to long COVID-19 syndrome, according to new findings.

While links have been found between the gut’s microbiome and COVID-19, as well as other diseases, this is the first published research to show a link specifically to COVID’s long-term effects, the investigators, based at the Chinese University of Hong Kong, wrote in Gut.

Courtesy Dr. Siew Ng

“To our knowledge, this is the first study to show that altered gut microbiome composition is strongly associated with persistent symptoms in patients with COVID-19 up to 6 months after clearance of SARS-CoV-2 virus,” said Siew Ng, MBBS, PhD, associate director at the university’s Center for Gut Microbiota Research.

At three hospitals, the researchers enrolled 106 patients with COVID-19 from February to August 2020 with stool samples at admission and at 1 month and 6 months after discharge, and compared them with people who did not have COVID, recruited in 2019. The severity of COVID in the enrolled patients was mostly mild to moderate.

At 3 months, 86 of the patients with COVID had post–acute COVID-19 syndrome (PACS) – defined as at least one persistent, otherwise unexplained symptom 4 weeks after clearance of the virus. And 81 patients had PACS at 6 months, most commonly fatigue, poor memory, hair loss, anxiety, and trouble sleeping.

Using stool samples for their analysis, the researchers found that, broadly, the diversity of the types of bacteria, and the abundance of these bacteria, were significantly lower at 6 months for those with PACS, compared with those without PACS and with controls (P < .05 and P < .0001, respectively). Among those with PACS, 28 bacteria species were diminished and 14 were enriched, both at baseline and follow-up. Those patients who had COVID but not PACS showed just 25 alterations of bacteria species at the time of hospital admission, and they all normalized by 6 months.

Having respiratory symptoms at 6 months was linked with higher levels of opportunistic pathogens such as Streptococcus anginosus and S. vestibularis. Neuropsychiatric symptoms and fatigue were associated with nosocomial pathogens that are linked to opportunistic infections, such as Clostridium innocuum and Actinomyces naeslundii (P < .05).

Bacteria known for producing butyrate, a beneficial fatty acid, were significantly depleted in those patients with hair loss. And certain of these bacteria, including Bifidobacterium pseudocatenulatum and Faecalibacterium prausnitzii, had the largest inverse correlations with PACS at 6 months (P < .05), the researchers found.

“Particular gut microbial profiles may indicate heightened susceptibility,” Dr. Ng said.

Although the findings were drawn from patients with earlier strains of the COVID-19 virus, the findings still apply to new variants, including Omicron, since these pose the same problem of persistent disruption of the immune system, Dr. Ng said.

Her group is conducting trials to look at how modulating the microbiome might prevent long COVID and boost antibodies after vaccination in high-risk people, she said.

“Gut microbiota influences the health of the host,” Dr. Ng said. “It provides crucial benefits in the form of immune system development, prevention of infections, nutrient acquisition, and brain and nervous system functionality. Considering the millions of people infected during the ongoing pandemic, our findings are a strong impetus for consideration of microbiota modulation to facilitate timely recovery and reduce the burden of post–acute COVID-19 syndrome.”

Courtesy Dr. John Haran

John Haran, MD, PhD, associate professor of microbiology and physiological systems and emergency medicine at the University of Massachusetts, Worcester, said the research adds to the evidence base on the gut microbiome’s links to COVID, but there was likely be no clinical impact yet. Still, he said the findings linking specific species to specific symptoms was particularly interesting.

“Very early on during hospitalization, [the researchers] saw these differences and correlated out with people who have longer symptoms, and especially different groups of people that have longer symptoms, too,” said Dr. Haran, who has done research on the topic. “It’s very different if you have different symptoms, for example, you keep coughing for months versus you have brain fog and fatigue, or other debilitating symptoms.”

Dr. Haran noted that the findings didn’t identify bacteria types especially linked to COVID, but rather species that have already been found to be associated with a “bad” microbiome. He also pointed out that the patients enrolled in the study were not vaccinated, because vaccines weren’t available at the time. Still, further study to see whether modulation of gut bacteria can be a therapy seems worthwhile.

“Microbiome modulation is pretty safe, and that’s really the next big step that needs to be taken in this,” he said.

For now, the findings don’t give the clinician much new ammunition for treatment.

“We’re not there yet,” he added. “It’s not as if clinicians are going to tell their COVID patients: ‘Go out and buy some kale.’ ”

Eugene Chang, MD, professor of medicine at the University of Chicago, who has studied the gut microbiome and gastrointestinal disease, said it’s “too preliminary” to say whether the findings could lead to a clinical impact. The measures used merely identify the microbes present, but not what they are doing.

“These measures are unlikely to perform well enough to be useful for risk assessment or predicting clinical outcomes,” he said. “That being said, advances in technology are being made where next generations of metrics could be developed and useful as stratifiers and predictors of risk.”

Seeing shifting patterns associated with certain symptoms, he said, is “notable because it suggests that the disturbances of the gut microbiota in PACS are significant.”

But he said it’s important to know whether these changes are a cause of PACS in some way or just an effect of it.

“If causative or contributory – this has to be proven – then ‘microbiota modulation’ would make sense and could be a priority for development,” he said. “If merely an effect, these metrics and better ones to come could be useful as predictors or measures of the patient’s general state of health.”

As seen in his group’s work and other work, he said, “the gut microbiota is highly sensitive to changes in their ecosystem, which is influenced by the health state of the patient.”

Dr. Ng, Dr. Haran, and Dr. Chang reported no relevant disclosures.

This article was updated Jan. 27, 2022.

Disruption of the bacteria in the gut is linked with susceptibility to long COVID-19 syndrome, according to new findings.

While links have been found between the gut’s microbiome and COVID-19, as well as other diseases, this is the first published research to show a link specifically to COVID’s long-term effects, the investigators, based at the Chinese University of Hong Kong, wrote in Gut.

Courtesy Dr. Siew Ng

“To our knowledge, this is the first study to show that altered gut microbiome composition is strongly associated with persistent symptoms in patients with COVID-19 up to 6 months after clearance of SARS-CoV-2 virus,” said Siew Ng, MBBS, PhD, associate director at the university’s Center for Gut Microbiota Research.

At three hospitals, the researchers enrolled 106 patients with COVID-19 from February to August 2020 with stool samples at admission and at 1 month and 6 months after discharge, and compared them with people who did not have COVID, recruited in 2019. The severity of COVID in the enrolled patients was mostly mild to moderate.

At 3 months, 86 of the patients with COVID had post–acute COVID-19 syndrome (PACS) – defined as at least one persistent, otherwise unexplained symptom 4 weeks after clearance of the virus. And 81 patients had PACS at 6 months, most commonly fatigue, poor memory, hair loss, anxiety, and trouble sleeping.

Using stool samples for their analysis, the researchers found that, broadly, the diversity of the types of bacteria, and the abundance of these bacteria, were significantly lower at 6 months for those with PACS, compared with those without PACS and with controls (P < .05 and P < .0001, respectively). Among those with PACS, 28 bacteria species were diminished and 14 were enriched, both at baseline and follow-up. Those patients who had COVID but not PACS showed just 25 alterations of bacteria species at the time of hospital admission, and they all normalized by 6 months.

Having respiratory symptoms at 6 months was linked with higher levels of opportunistic pathogens such as Streptococcus anginosus and S. vestibularis. Neuropsychiatric symptoms and fatigue were associated with nosocomial pathogens that are linked to opportunistic infections, such as Clostridium innocuum and Actinomyces naeslundii (P < .05).

Bacteria known for producing butyrate, a beneficial fatty acid, were significantly depleted in those patients with hair loss. And certain of these bacteria, including Bifidobacterium pseudocatenulatum and Faecalibacterium prausnitzii, had the largest inverse correlations with PACS at 6 months (P < .05), the researchers found.

“Particular gut microbial profiles may indicate heightened susceptibility,” Dr. Ng said.

Although the findings were drawn from patients with earlier strains of the COVID-19 virus, the findings still apply to new variants, including Omicron, since these pose the same problem of persistent disruption of the immune system, Dr. Ng said.

Her group is conducting trials to look at how modulating the microbiome might prevent long COVID and boost antibodies after vaccination in high-risk people, she said.

“Gut microbiota influences the health of the host,” Dr. Ng said. “It provides crucial benefits in the form of immune system development, prevention of infections, nutrient acquisition, and brain and nervous system functionality. Considering the millions of people infected during the ongoing pandemic, our findings are a strong impetus for consideration of microbiota modulation to facilitate timely recovery and reduce the burden of post–acute COVID-19 syndrome.”

Courtesy Dr. John Haran

John Haran, MD, PhD, associate professor of microbiology and physiological systems and emergency medicine at the University of Massachusetts, Worcester, said the research adds to the evidence base on the gut microbiome’s links to COVID, but there was likely be no clinical impact yet. Still, he said the findings linking specific species to specific symptoms was particularly interesting.

“Very early on during hospitalization, [the researchers] saw these differences and correlated out with people who have longer symptoms, and especially different groups of people that have longer symptoms, too,” said Dr. Haran, who has done research on the topic. “It’s very different if you have different symptoms, for example, you keep coughing for months versus you have brain fog and fatigue, or other debilitating symptoms.”

Dr. Haran noted that the findings didn’t identify bacteria types especially linked to COVID, but rather species that have already been found to be associated with a “bad” microbiome. He also pointed out that the patients enrolled in the study were not vaccinated, because vaccines weren’t available at the time. Still, further study to see whether modulation of gut bacteria can be a therapy seems worthwhile.

“Microbiome modulation is pretty safe, and that’s really the next big step that needs to be taken in this,” he said.

For now, the findings don’t give the clinician much new ammunition for treatment.

“We’re not there yet,” he added. “It’s not as if clinicians are going to tell their COVID patients: ‘Go out and buy some kale.’ ”

Eugene Chang, MD, professor of medicine at the University of Chicago, who has studied the gut microbiome and gastrointestinal disease, said it’s “too preliminary” to say whether the findings could lead to a clinical impact. The measures used merely identify the microbes present, but not what they are doing.

“These measures are unlikely to perform well enough to be useful for risk assessment or predicting clinical outcomes,” he said. “That being said, advances in technology are being made where next generations of metrics could be developed and useful as stratifiers and predictors of risk.”

Seeing shifting patterns associated with certain symptoms, he said, is “notable because it suggests that the disturbances of the gut microbiota in PACS are significant.”

But he said it’s important to know whether these changes are a cause of PACS in some way or just an effect of it.

“If causative or contributory – this has to be proven – then ‘microbiota modulation’ would make sense and could be a priority for development,” he said. “If merely an effect, these metrics and better ones to come could be useful as predictors or measures of the patient’s general state of health.”

As seen in his group’s work and other work, he said, “the gut microbiota is highly sensitive to changes in their ecosystem, which is influenced by the health state of the patient.”

Dr. Ng, Dr. Haran, and Dr. Chang reported no relevant disclosures.

This article was updated Jan. 27, 2022.

Can you tell which of the following statements are true and which are false?

COVID-19 is not a threat to younger people, and only those who have other medical conditions are dying from it.

The mRNA vaccines developed to prevent the coronavirus alter your genes, can make your body “magnetic,” and are killing more people than the virus itself.

President Joe Biden’s climate change plan calls for a ban on meat consumption to cut greenhouse gas emissions.

The 2020 presidential election was rigged and stolen.

If you guessed that all of these claims are false, you’re right – take a bow. Not a single one of these statements has any factual support, according to scientific research, legal rulings, and legitimate government authorities.

And yet public opinion surveys show millions of Americans, and others around the world, believe some of these falsehoods are true and can’t be convinced otherwise.

Social media, politicians and partisan websites, TV programs, and commentators have widely circulated these and other unfounded claims so frequently that many people say they simply can’t tell what’s objectively true and not anymore.

So much so, the authors of a fascinating new research study have concluded we are living in a “post-truth era,” with baseless beliefs and subjective opinions given a higher priority than verifiable facts.

The new study – The Rise and Fall of Rationality in Language, published in the Proceedings of the National Academy of Sciences – found that facts have become less important in public discourse.

As a result, unsupported beliefs have taken precedent over readily identifiable truths in discussions of health, science, and politics. The upshot: “Feelings trump facts” in social media, news reports, books, and other sources of information.

And here’s the kicker: The trend did not begin with the rise of former President Donald Trump, the COVID-19 pandemic, or the advent of social media; in fact, it has been growing for much longer than you might think.

“While the current ‘post-truth era’ has taken many by surprise, the study shows that over the past 40 years, public interest has undergone an accelerating shift from the collective to the individual, and from rationality towards emotion,” concluded the researchers from Indiana University and Wageningen University & Research in the Netherlands.

“Our work suggests that the societal balance between emotion and reason has shifted back to what it used to be around 150 years ago,” says lead researcher Marten Scheffer, PhD, a professor in the department of environmental sciences at WUR. “This implies that scientists, experts, and policymakers will have to think about the best way to respond to that social change.”
 

Researchers surprised by findings

The findings are based on a very detailed analysis of language from millions of books, newspaper articles, Google searches, TV reports, social media posts, and other sources dating back to 1850.

The researchers analyzed how often the 5,000 most used words appeared over the past 170 years and found that the use of those having to do with facts and reasoning, such as “determine” and “conclusion,” has fallen dramatically since 1980. Meanwhile, the use of words related to human emotion, such as “feel” and “believe,” have skyrocketed.

Dr. Scheffer notes rapid developments in science and technology from 1850 to 1980 had profound social and economic benefits that helped boost the status of the scientific approach. That shift in public attitudes had ripple effects on culture, society, education, politics, and religion – and “the role of spiritualism dwindled” in the modern world, he says.

But since 1980, that trend has seen a major reversal, with beliefs becoming more important than facts to many people, he says. At the same time, trust in science and scientists has fallen.

Dr. Scheffer says the researchers expected to find some evidence of a swing toward more belief-based sentiments during the Trump era but were surprised to discover how strong it is and that the trend has actually been a long time coming.

“The shift in interest from rational to intuitive/emotional is pretty obvious now in the post-truth political and social media discussion,” he says. “However, our work shows that it already started in the 1980s. For me personally, that went under the radar, except perhaps for the rise of alternative (to religion) forms of spirituality.

“We were especially struck by how strong the patterns are and how universal they appear across languages, nonfiction and fiction, and even in The New York Times.”

In the political world, the implications are significant enough – impacting policies and politicians on both sides of the aisle and across the globe. Just look at the deepening political divisions during the Trump presidency.

But for health and science, the spread of misinformation and falsehoods can be matters of life or death, as we have seen in the politically charged debates over how best to combat COVID-19 and global climate change.

“Our public debate seems increasingly driven by what people want to be true rather than what is actually true. As a scientist, that worries me,” says study co-author Johan Bollen, PhD, a professor of informatics at Indiana University.

“As a society, we are now faced with major collective problems that we need to approach from a pragmatic, rational, and objective perspective to be successful,” he says. “After all, global warming doesn’t care about whether you believe in it or not … but we will all suffer as a society if we fail to take adequate measures.”

For WUR co-researcher Ingrid van de Leemput, the trend isn’t merely academic; she’s seen it play out in her personal life.

“I do speak to people that, for instance, think the vaccines are poison,” she says. “I’m also on Twitter, and there, I’m every day surprised about how easily many people form their opinions, based on feelings, on what others say, or on some unfounded source.”

Public health experts say the embrace of personal beliefs over facts is one reason only 63% of Americans have been vaccinated against COVID-19. The result: millions of preventable infections among those who downplay the risks of the virus and reject the strong scientific evidence of vaccine safety and effectiveness.

“None of this really surprises me,” Johns Hopkins University social and behavioral scientist Rupali Limaye, PhD, says of the new study findings. Dr. Limaye coauthored a paper in 2016 in JAMA Pediatrics about how to talk to parents about vaccine hesitancy and the fact that we’re living in what they called “this post-truth era.”

Dr. Limaye says the trend has made it difficult for doctors, scientists, and health authorities to make fact-based arguments for COVID-19 vaccination, mask-wearing, social distancing, and other measures to control the virus.

“It’s been really hard being a scientist to hear people say, ‘Well, that’s not true’ when we say something very basic that I think all of us can agree on – like the grass is green,” she says. “To be honest, I worry that a lot of scientists are going to quit being in science because they’re exhausted.”
 

What’s driving the trend?

So, what’s behind the embrace of “alternative facts,” as former White House counselor Kellyanne Conway put it so brazenly in 2017, in defending the White House’s false claims that Trump’s inauguration crowd was the largest ever?

Dr. Scheffer and colleagues identified a handful of things that have encouraged the embrace of falsehoods over facts in recent years.

• The Internet: Its rise in the late 1980s, and its growing role as a primary source of news and information, has allowed more belief-based misinformation to flourish and spread like wildfire.
• Social media: The new study found the use of sentiment- and intuition-related words accelerated around 2007, along with a global surge in social media that catapulted Facebook, Twitter, and others into the mainstream, replacing more traditional fact-based media (i.e., newspapers and magazines).
• The 2007 financial crisis: The downturn in the global economy meant more people were dealing with job stress, investment losses, and other problems that fed the interest in belief-based, anti-establishment social media posts.
• Conspiracy theories: Falsehoods involving hidden political agendas, shadow “elites,” and wealthy people with dark motives tend to thrive during times of crisis and societal anxiety. “Conspiracy theories originate particularly in times of uncertainty and crisis and generally depict established institutions as hiding the truth and sustaining an unfair situation,” the researchers noted. “As a result, they may find fertile grounds on social media platforms promulgating a sense of unfairness, subsequently feeding anti-system sentiments.”

Dr. Scheffer says that growing political divisions during the Trump era have widened the fact-vs.-fiction divide. The ex-president voiced many anti-science views on global climate change, for instance, and spread so many falsehoods about COVID-19 and the 2020 election that Facebook, Twitter, and YouTube suspended his accounts.

Yet Trump remains a popular figure among Republicans, with most saying in a December poll they believe his baseless claims that the 2020 election was “rigged” and “stolen,” despite all credible, easily accessible evidence that it was secure, according to a recent poll by the University of Massachusetts at Amherst.

More than 60 courts have rejected Trump’s lawsuits seeking to overturn the election results. All 50 states, the District of Columbia, and both branches of Congress have certified the election results, giving Biden the White House. Even Trump’s own Justice Department confirmed that the 2020 election was free and fair.

Nevertheless, the University of Massachusetts survey found that most Republicans believe one or more conspiracy theories floated by the former president and those pushing his “big lie” that Democrats rigged the election to elect Biden.

Ed Berliner, an Emmy Award-winning broadcast journalist and media consultant, suggests something else is driving the spread of misinformation: the pursuit of ratings by cable TV and media companies to boost ad and subscriber revenues.

As a former executive producer and syndicated cable TV show host, he says he has seen firsthand how facts are often lost in opinion-driven news programs, even on network programs claiming to offer “fair and balanced” journalism.

“Propaganda is the new currency in America, and those who do not fight back against it are doomed to be overrun by the misinformation,” says Mr. Berliner, host of The Man in the Arena and CEO of Entourage Media LLC.

“The broadcast news media has to stop this incessant ‘infotainment’ prattle, stop trying to nuzzle up to a soft side, and bear down on hard facts, exposing the lies and refusing to back down.”
 

Public health implications

Public health and media experts alike say the PNAS study findings are disheartening but underscore the need for doctors and scientists to do a better job of communicating about COVID-19 and other pressing issues.

Dr. Limaye, from Johns Hopkins, is particularly concerned about the rise in conspiracy theories that has led to COVID-19 vaccine hesitancy.

“When we speak to individuals about getting the COVID vaccine…the types of concerns that come up now are very different than they were 8 years ago,” she says. “The comments we used to hear were much more related to vaccine safety. [People] would say, ‘I’m worried about an ingredient in the vaccine’ or ‘I’m worried that my kiddo has to get three different shots within 6 months to have a series dose completed.’”

But now, a lot of comments they receive are about government and pharma conspiracies.

What that means is doctors and scientists must do more than simply say “here are the facts” and “trust me, I’m a doctor or a scientist,” she says. And these approaches don’t only apply to public health.

“It’s funny, because when we talk to climate change scientists, as vaccine [specialists], we’ll say we can’t believe that people think COVID is a hoax,” she says. “And they’re like, ‘Hold my beer, we’ve been dealing with this for 20 years. Hello, it’s just your guys’ turn to deal with this public denial of science.’”

Dr. Limaye is also concerned about the impacts on funding for scientific research.

“There’s always been a really strong bipartisan effort with regards to funding for science, when you look at Congress and when you look at appropriations,” she says. “But what ended up happening, especially with the Trump administration, was that there was a real shift in that. We’ve never really seen that before in past generations.”

So, what’s the big take-home message?

Dr. Limaye believes doctors and public health experts must show more empathy – and not be combative or arrogant – in communicating science in one-on-one conversations. This month, she’s launching a new course for parents, school administrators, and nurses on how to do precisely that.

“It’s really all about how to have hard conversations with people who might be anti-science,” she says. “It’s being empathetic and not being dismissive. But it’s hard work, and I think a lot of people are just not cut out for it and just don’t have the time for it…You can’t just say, ‘Well, this is science, and I’m a doctor’ – that doesn’t work anymore.”

Brendan Nyhan, PhD, a Dartmouth College political scientist, echoes those sentiments in a separate paper recently published in the Proceedings of the National Academy of Sciences. In fact, he suggests that providing accurate, fact-based information to counter false claims may actually backfire and reinforce some people’s unfounded beliefs.

“One response to the prevalence of mistaken beliefs is to try to set the record straight by providing accurate information – for instance, by providing evidence of the scientific consensus on climate change,” he writes. “The failures of this approach, which is sometimes referred to as the ‘deficit model’ in science communication, are well-known.”

Dr. Nyhan argues two things make some people more prone to believe falsehoods:

What scientists call “ingrouping,” a kind of tribal mentality that makes some people choose social identity or politics over truth-seeking and demonize others who don’t agree with their views

The rise of high-profile political figures, such as Trump, who encourage their followers to indulge in their desire for “identify-affirming misinformation”

Dr. Scheffer says the most important thing for doctors, health experts, and scientists to recognize is that it’s crucial to gain the trust of someone who may believe fictions over facts to make any persuasive argument on COVID-19 or any other issue.

He also has a standard response to those who present falsehoods to him as facts that he suggests anyone can use: “That is interesting. Would you mind helping me understand how you came to that opinion?”

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

Can you tell which of the following statements are true and which are false?

COVID-19 is not a threat to younger people, and only those who have other medical conditions are dying from it.

The mRNA vaccines developed to prevent the coronavirus alter your genes, can make your body “magnetic,” and are killing more people than the virus itself.

President Joe Biden’s climate change plan calls for a ban on meat consumption to cut greenhouse gas emissions.

The 2020 presidential election was rigged and stolen.

If you guessed that all of these claims are false, you’re right – take a bow. Not a single one of these statements has any factual support, according to scientific research, legal rulings, and legitimate government authorities.

And yet public opinion surveys show millions of Americans, and others around the world, believe some of these falsehoods are true and can’t be convinced otherwise.

Social media, politicians and partisan websites, TV programs, and commentators have widely circulated these and other unfounded claims so frequently that many people say they simply can’t tell what’s objectively true and not anymore.

So much so, the authors of a fascinating new research study have concluded we are living in a “post-truth era,” with baseless beliefs and subjective opinions given a higher priority than verifiable facts.

The new study – The Rise and Fall of Rationality in Language, published in the Proceedings of the National Academy of Sciences – found that facts have become less important in public discourse.

As a result, unsupported beliefs have taken precedent over readily identifiable truths in discussions of health, science, and politics. The upshot: “Feelings trump facts” in social media, news reports, books, and other sources of information.

And here’s the kicker: The trend did not begin with the rise of former President Donald Trump, the COVID-19 pandemic, or the advent of social media; in fact, it has been growing for much longer than you might think.

“While the current ‘post-truth era’ has taken many by surprise, the study shows that over the past 40 years, public interest has undergone an accelerating shift from the collective to the individual, and from rationality towards emotion,” concluded the researchers from Indiana University and Wageningen University & Research in the Netherlands.

“Our work suggests that the societal balance between emotion and reason has shifted back to what it used to be around 150 years ago,” says lead researcher Marten Scheffer, PhD, a professor in the department of environmental sciences at WUR. “This implies that scientists, experts, and policymakers will have to think about the best way to respond to that social change.”
 

Researchers surprised by findings

The findings are based on a very detailed analysis of language from millions of books, newspaper articles, Google searches, TV reports, social media posts, and other sources dating back to 1850.

The researchers analyzed how often the 5,000 most used words appeared over the past 170 years and found that the use of those having to do with facts and reasoning, such as “determine” and “conclusion,” has fallen dramatically since 1980. Meanwhile, the use of words related to human emotion, such as “feel” and “believe,” have skyrocketed.

Dr. Scheffer notes rapid developments in science and technology from 1850 to 1980 had profound social and economic benefits that helped boost the status of the scientific approach. That shift in public attitudes had ripple effects on culture, society, education, politics, and religion – and “the role of spiritualism dwindled” in the modern world, he says.

But since 1980, that trend has seen a major reversal, with beliefs becoming more important than facts to many people, he says. At the same time, trust in science and scientists has fallen.

Dr. Scheffer says the researchers expected to find some evidence of a swing toward more belief-based sentiments during the Trump era but were surprised to discover how strong it is and that the trend has actually been a long time coming.

“The shift in interest from rational to intuitive/emotional is pretty obvious now in the post-truth political and social media discussion,” he says. “However, our work shows that it already started in the 1980s. For me personally, that went under the radar, except perhaps for the rise of alternative (to religion) forms of spirituality.

“We were especially struck by how strong the patterns are and how universal they appear across languages, nonfiction and fiction, and even in The New York Times.”

In the political world, the implications are significant enough – impacting policies and politicians on both sides of the aisle and across the globe. Just look at the deepening political divisions during the Trump presidency.

But for health and science, the spread of misinformation and falsehoods can be matters of life or death, as we have seen in the politically charged debates over how best to combat COVID-19 and global climate change.

“Our public debate seems increasingly driven by what people want to be true rather than what is actually true. As a scientist, that worries me,” says study co-author Johan Bollen, PhD, a professor of informatics at Indiana University.

“As a society, we are now faced with major collective problems that we need to approach from a pragmatic, rational, and objective perspective to be successful,” he says. “After all, global warming doesn’t care about whether you believe in it or not … but we will all suffer as a society if we fail to take adequate measures.”

For WUR co-researcher Ingrid van de Leemput, the trend isn’t merely academic; she’s seen it play out in her personal life.

“I do speak to people that, for instance, think the vaccines are poison,” she says. “I’m also on Twitter, and there, I’m every day surprised about how easily many people form their opinions, based on feelings, on what others say, or on some unfounded source.”

Public health experts say the embrace of personal beliefs over facts is one reason only 63% of Americans have been vaccinated against COVID-19. The result: millions of preventable infections among those who downplay the risks of the virus and reject the strong scientific evidence of vaccine safety and effectiveness.

“None of this really surprises me,” Johns Hopkins University social and behavioral scientist Rupali Limaye, PhD, says of the new study findings. Dr. Limaye coauthored a paper in 2016 in JAMA Pediatrics about how to talk to parents about vaccine hesitancy and the fact that we’re living in what they called “this post-truth era.”

Dr. Limaye says the trend has made it difficult for doctors, scientists, and health authorities to make fact-based arguments for COVID-19 vaccination, mask-wearing, social distancing, and other measures to control the virus.

“It’s been really hard being a scientist to hear people say, ‘Well, that’s not true’ when we say something very basic that I think all of us can agree on – like the grass is green,” she says. “To be honest, I worry that a lot of scientists are going to quit being in science because they’re exhausted.”
 

What’s driving the trend?

So, what’s behind the embrace of “alternative facts,” as former White House counselor Kellyanne Conway put it so brazenly in 2017, in defending the White House’s false claims that Trump’s inauguration crowd was the largest ever?

Dr. Scheffer and colleagues identified a handful of things that have encouraged the embrace of falsehoods over facts in recent years.

• The Internet: Its rise in the late 1980s, and its growing role as a primary source of news and information, has allowed more belief-based misinformation to flourish and spread like wildfire.
• Social media: The new study found the use of sentiment- and intuition-related words accelerated around 2007, along with a global surge in social media that catapulted Facebook, Twitter, and others into the mainstream, replacing more traditional fact-based media (i.e., newspapers and magazines).
• The 2007 financial crisis: The downturn in the global economy meant more people were dealing with job stress, investment losses, and other problems that fed the interest in belief-based, anti-establishment social media posts.
• Conspiracy theories: Falsehoods involving hidden political agendas, shadow “elites,” and wealthy people with dark motives tend to thrive during times of crisis and societal anxiety. “Conspiracy theories originate particularly in times of uncertainty and crisis and generally depict established institutions as hiding the truth and sustaining an unfair situation,” the researchers noted. “As a result, they may find fertile grounds on social media platforms promulgating a sense of unfairness, subsequently feeding anti-system sentiments.”

Dr. Scheffer says that growing political divisions during the Trump era have widened the fact-vs.-fiction divide. The ex-president voiced many anti-science views on global climate change, for instance, and spread so many falsehoods about COVID-19 and the 2020 election that Facebook, Twitter, and YouTube suspended his accounts.

Yet Trump remains a popular figure among Republicans, with most saying in a December poll they believe his baseless claims that the 2020 election was “rigged” and “stolen,” despite all credible, easily accessible evidence that it was secure, according to a recent poll by the University of Massachusetts at Amherst.

More than 60 courts have rejected Trump’s lawsuits seeking to overturn the election results. All 50 states, the District of Columbia, and both branches of Congress have certified the election results, giving Biden the White House. Even Trump’s own Justice Department confirmed that the 2020 election was free and fair.

Nevertheless, the University of Massachusetts survey found that most Republicans believe one or more conspiracy theories floated by the former president and those pushing his “big lie” that Democrats rigged the election to elect Biden.

Ed Berliner, an Emmy Award-winning broadcast journalist and media consultant, suggests something else is driving the spread of misinformation: the pursuit of ratings by cable TV and media companies to boost ad and subscriber revenues.

As a former executive producer and syndicated cable TV show host, he says he has seen firsthand how facts are often lost in opinion-driven news programs, even on network programs claiming to offer “fair and balanced” journalism.

“Propaganda is the new currency in America, and those who do not fight back against it are doomed to be overrun by the misinformation,” says Mr. Berliner, host of The Man in the Arena and CEO of Entourage Media LLC.

“The broadcast news media has to stop this incessant ‘infotainment’ prattle, stop trying to nuzzle up to a soft side, and bear down on hard facts, exposing the lies and refusing to back down.”
 

Public health implications

Public health and media experts alike say the PNAS study findings are disheartening but underscore the need for doctors and scientists to do a better job of communicating about COVID-19 and other pressing issues.

Dr. Limaye, from Johns Hopkins, is particularly concerned about the rise in conspiracy theories that has led to COVID-19 vaccine hesitancy.

“When we speak to individuals about getting the COVID vaccine…the types of concerns that come up now are very different than they were 8 years ago,” she says. “The comments we used to hear were much more related to vaccine safety. [People] would say, ‘I’m worried about an ingredient in the vaccine’ or ‘I’m worried that my kiddo has to get three different shots within 6 months to have a series dose completed.’”

But now, a lot of comments they receive are about government and pharma conspiracies.

What that means is doctors and scientists must do more than simply say “here are the facts” and “trust me, I’m a doctor or a scientist,” she says. And these approaches don’t only apply to public health.

“It’s funny, because when we talk to climate change scientists, as vaccine [specialists], we’ll say we can’t believe that people think COVID is a hoax,” she says. “And they’re like, ‘Hold my beer, we’ve been dealing with this for 20 years. Hello, it’s just your guys’ turn to deal with this public denial of science.’”

Dr. Limaye is also concerned about the impacts on funding for scientific research.

“There’s always been a really strong bipartisan effort with regards to funding for science, when you look at Congress and when you look at appropriations,” she says. “But what ended up happening, especially with the Trump administration, was that there was a real shift in that. We’ve never really seen that before in past generations.”

So, what’s the big take-home message?

Dr. Limaye believes doctors and public health experts must show more empathy – and not be combative or arrogant – in communicating science in one-on-one conversations. This month, she’s launching a new course for parents, school administrators, and nurses on how to do precisely that.

“It’s really all about how to have hard conversations with people who might be anti-science,” she says. “It’s being empathetic and not being dismissive. But it’s hard work, and I think a lot of people are just not cut out for it and just don’t have the time for it…You can’t just say, ‘Well, this is science, and I’m a doctor’ – that doesn’t work anymore.”

Brendan Nyhan, PhD, a Dartmouth College political scientist, echoes those sentiments in a separate paper recently published in the Proceedings of the National Academy of Sciences. In fact, he suggests that providing accurate, fact-based information to counter false claims may actually backfire and reinforce some people’s unfounded beliefs.

“One response to the prevalence of mistaken beliefs is to try to set the record straight by providing accurate information – for instance, by providing evidence of the scientific consensus on climate change,” he writes. “The failures of this approach, which is sometimes referred to as the ‘deficit model’ in science communication, are well-known.”

Dr. Nyhan argues two things make some people more prone to believe falsehoods:

What scientists call “ingrouping,” a kind of tribal mentality that makes some people choose social identity or politics over truth-seeking and demonize others who don’t agree with their views

The rise of high-profile political figures, such as Trump, who encourage their followers to indulge in their desire for “identify-affirming misinformation”

Dr. Scheffer says the most important thing for doctors, health experts, and scientists to recognize is that it’s crucial to gain the trust of someone who may believe fictions over facts to make any persuasive argument on COVID-19 or any other issue.

He also has a standard response to those who present falsehoods to him as facts that he suggests anyone can use: “That is interesting. Would you mind helping me understand how you came to that opinion?”

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

Can you tell which of the following statements are true and which are false?

COVID-19 is not a threat to younger people, and only those who have other medical conditions are dying from it.

The mRNA vaccines developed to prevent the coronavirus alter your genes, can make your body “magnetic,” and are killing more people than the virus itself.

President Joe Biden’s climate change plan calls for a ban on meat consumption to cut greenhouse gas emissions.

The 2020 presidential election was rigged and stolen.

If you guessed that all of these claims are false, you’re right – take a bow. Not a single one of these statements has any factual support, according to scientific research, legal rulings, and legitimate government authorities.

And yet public opinion surveys show millions of Americans, and others around the world, believe some of these falsehoods are true and can’t be convinced otherwise.

Social media, politicians and partisan websites, TV programs, and commentators have widely circulated these and other unfounded claims so frequently that many people say they simply can’t tell what’s objectively true and not anymore.

So much so, the authors of a fascinating new research study have concluded we are living in a “post-truth era,” with baseless beliefs and subjective opinions given a higher priority than verifiable facts.

The new study – The Rise and Fall of Rationality in Language, published in the Proceedings of the National Academy of Sciences – found that facts have become less important in public discourse.

As a result, unsupported beliefs have taken precedent over readily identifiable truths in discussions of health, science, and politics. The upshot: “Feelings trump facts” in social media, news reports, books, and other sources of information.

And here’s the kicker: The trend did not begin with the rise of former President Donald Trump, the COVID-19 pandemic, or the advent of social media; in fact, it has been growing for much longer than you might think.

“While the current ‘post-truth era’ has taken many by surprise, the study shows that over the past 40 years, public interest has undergone an accelerating shift from the collective to the individual, and from rationality towards emotion,” concluded the researchers from Indiana University and Wageningen University & Research in the Netherlands.

“Our work suggests that the societal balance between emotion and reason has shifted back to what it used to be around 150 years ago,” says lead researcher Marten Scheffer, PhD, a professor in the department of environmental sciences at WUR. “This implies that scientists, experts, and policymakers will have to think about the best way to respond to that social change.”
 

Researchers surprised by findings

The findings are based on a very detailed analysis of language from millions of books, newspaper articles, Google searches, TV reports, social media posts, and other sources dating back to 1850.

The researchers analyzed how often the 5,000 most used words appeared over the past 170 years and found that the use of those having to do with facts and reasoning, such as “determine” and “conclusion,” has fallen dramatically since 1980. Meanwhile, the use of words related to human emotion, such as “feel” and “believe,” have skyrocketed.

Dr. Scheffer notes rapid developments in science and technology from 1850 to 1980 had profound social and economic benefits that helped boost the status of the scientific approach. That shift in public attitudes had ripple effects on culture, society, education, politics, and religion – and “the role of spiritualism dwindled” in the modern world, he says.

But since 1980, that trend has seen a major reversal, with beliefs becoming more important than facts to many people, he says. At the same time, trust in science and scientists has fallen.

Dr. Scheffer says the researchers expected to find some evidence of a swing toward more belief-based sentiments during the Trump era but were surprised to discover how strong it is and that the trend has actually been a long time coming.

“The shift in interest from rational to intuitive/emotional is pretty obvious now in the post-truth political and social media discussion,” he says. “However, our work shows that it already started in the 1980s. For me personally, that went under the radar, except perhaps for the rise of alternative (to religion) forms of spirituality.

“We were especially struck by how strong the patterns are and how universal they appear across languages, nonfiction and fiction, and even in The New York Times.”

In the political world, the implications are significant enough – impacting policies and politicians on both sides of the aisle and across the globe. Just look at the deepening political divisions during the Trump presidency.

But for health and science, the spread of misinformation and falsehoods can be matters of life or death, as we have seen in the politically charged debates over how best to combat COVID-19 and global climate change.

“Our public debate seems increasingly driven by what people want to be true rather than what is actually true. As a scientist, that worries me,” says study co-author Johan Bollen, PhD, a professor of informatics at Indiana University.

“As a society, we are now faced with major collective problems that we need to approach from a pragmatic, rational, and objective perspective to be successful,” he says. “After all, global warming doesn’t care about whether you believe in it or not … but we will all suffer as a society if we fail to take adequate measures.”

For WUR co-researcher Ingrid van de Leemput, the trend isn’t merely academic; she’s seen it play out in her personal life.

“I do speak to people that, for instance, think the vaccines are poison,” she says. “I’m also on Twitter, and there, I’m every day surprised about how easily many people form their opinions, based on feelings, on what others say, or on some unfounded source.”

Public health experts say the embrace of personal beliefs over facts is one reason only 63% of Americans have been vaccinated against COVID-19. The result: millions of preventable infections among those who downplay the risks of the virus and reject the strong scientific evidence of vaccine safety and effectiveness.

“None of this really surprises me,” Johns Hopkins University social and behavioral scientist Rupali Limaye, PhD, says of the new study findings. Dr. Limaye coauthored a paper in 2016 in JAMA Pediatrics about how to talk to parents about vaccine hesitancy and the fact that we’re living in what they called “this post-truth era.”

Dr. Limaye says the trend has made it difficult for doctors, scientists, and health authorities to make fact-based arguments for COVID-19 vaccination, mask-wearing, social distancing, and other measures to control the virus.

“It’s been really hard being a scientist to hear people say, ‘Well, that’s not true’ when we say something very basic that I think all of us can agree on – like the grass is green,” she says. “To be honest, I worry that a lot of scientists are going to quit being in science because they’re exhausted.”
 

What’s driving the trend?

So, what’s behind the embrace of “alternative facts,” as former White House counselor Kellyanne Conway put it so brazenly in 2017, in defending the White House’s false claims that Trump’s inauguration crowd was the largest ever?

Dr. Scheffer and colleagues identified a handful of things that have encouraged the embrace of falsehoods over facts in recent years.

• The Internet: Its rise in the late 1980s, and its growing role as a primary source of news and information, has allowed more belief-based misinformation to flourish and spread like wildfire.
• Social media: The new study found the use of sentiment- and intuition-related words accelerated around 2007, along with a global surge in social media that catapulted Facebook, Twitter, and others into the mainstream, replacing more traditional fact-based media (i.e., newspapers and magazines).
• The 2007 financial crisis: The downturn in the global economy meant more people were dealing with job stress, investment losses, and other problems that fed the interest in belief-based, anti-establishment social media posts.
• Conspiracy theories: Falsehoods involving hidden political agendas, shadow “elites,” and wealthy people with dark motives tend to thrive during times of crisis and societal anxiety. “Conspiracy theories originate particularly in times of uncertainty and crisis and generally depict established institutions as hiding the truth and sustaining an unfair situation,” the researchers noted. “As a result, they may find fertile grounds on social media platforms promulgating a sense of unfairness, subsequently feeding anti-system sentiments.”

Dr. Scheffer says that growing political divisions during the Trump era have widened the fact-vs.-fiction divide. The ex-president voiced many anti-science views on global climate change, for instance, and spread so many falsehoods about COVID-19 and the 2020 election that Facebook, Twitter, and YouTube suspended his accounts.

Yet Trump remains a popular figure among Republicans, with most saying in a December poll they believe his baseless claims that the 2020 election was “rigged” and “stolen,” despite all credible, easily accessible evidence that it was secure, according to a recent poll by the University of Massachusetts at Amherst.

More than 60 courts have rejected Trump’s lawsuits seeking to overturn the election results. All 50 states, the District of Columbia, and both branches of Congress have certified the election results, giving Biden the White House. Even Trump’s own Justice Department confirmed that the 2020 election was free and fair.

Nevertheless, the University of Massachusetts survey found that most Republicans believe one or more conspiracy theories floated by the former president and those pushing his “big lie” that Democrats rigged the election to elect Biden.

Ed Berliner, an Emmy Award-winning broadcast journalist and media consultant, suggests something else is driving the spread of misinformation: the pursuit of ratings by cable TV and media companies to boost ad and subscriber revenues.

As a former executive producer and syndicated cable TV show host, he says he has seen firsthand how facts are often lost in opinion-driven news programs, even on network programs claiming to offer “fair and balanced” journalism.

“Propaganda is the new currency in America, and those who do not fight back against it are doomed to be overrun by the misinformation,” says Mr. Berliner, host of The Man in the Arena and CEO of Entourage Media LLC.

“The broadcast news media has to stop this incessant ‘infotainment’ prattle, stop trying to nuzzle up to a soft side, and bear down on hard facts, exposing the lies and refusing to back down.”
 

Public health implications

Public health and media experts alike say the PNAS study findings are disheartening but underscore the need for doctors and scientists to do a better job of communicating about COVID-19 and other pressing issues.

Dr. Limaye, from Johns Hopkins, is particularly concerned about the rise in conspiracy theories that has led to COVID-19 vaccine hesitancy.

“When we speak to individuals about getting the COVID vaccine…the types of concerns that come up now are very different than they were 8 years ago,” she says. “The comments we used to hear were much more related to vaccine safety. [People] would say, ‘I’m worried about an ingredient in the vaccine’ or ‘I’m worried that my kiddo has to get three different shots within 6 months to have a series dose completed.’”

But now, a lot of comments they receive are about government and pharma conspiracies.

What that means is doctors and scientists must do more than simply say “here are the facts” and “trust me, I’m a doctor or a scientist,” she says. And these approaches don’t only apply to public health.

“It’s funny, because when we talk to climate change scientists, as vaccine [specialists], we’ll say we can’t believe that people think COVID is a hoax,” she says. “And they’re like, ‘Hold my beer, we’ve been dealing with this for 20 years. Hello, it’s just your guys’ turn to deal with this public denial of science.’”

Dr. Limaye is also concerned about the impacts on funding for scientific research.

“There’s always been a really strong bipartisan effort with regards to funding for science, when you look at Congress and when you look at appropriations,” she says. “But what ended up happening, especially with the Trump administration, was that there was a real shift in that. We’ve never really seen that before in past generations.”

So, what’s the big take-home message?

Dr. Limaye believes doctors and public health experts must show more empathy – and not be combative or arrogant – in communicating science in one-on-one conversations. This month, she’s launching a new course for parents, school administrators, and nurses on how to do precisely that.

“It’s really all about how to have hard conversations with people who might be anti-science,” she says. “It’s being empathetic and not being dismissive. But it’s hard work, and I think a lot of people are just not cut out for it and just don’t have the time for it…You can’t just say, ‘Well, this is science, and I’m a doctor’ – that doesn’t work anymore.”

Brendan Nyhan, PhD, a Dartmouth College political scientist, echoes those sentiments in a separate paper recently published in the Proceedings of the National Academy of Sciences. In fact, he suggests that providing accurate, fact-based information to counter false claims may actually backfire and reinforce some people’s unfounded beliefs.

“One response to the prevalence of mistaken beliefs is to try to set the record straight by providing accurate information – for instance, by providing evidence of the scientific consensus on climate change,” he writes. “The failures of this approach, which is sometimes referred to as the ‘deficit model’ in science communication, are well-known.”

Dr. Nyhan argues two things make some people more prone to believe falsehoods:

What scientists call “ingrouping,” a kind of tribal mentality that makes some people choose social identity or politics over truth-seeking and demonize others who don’t agree with their views

The rise of high-profile political figures, such as Trump, who encourage their followers to indulge in their desire for “identify-affirming misinformation”

Dr. Scheffer says the most important thing for doctors, health experts, and scientists to recognize is that it’s crucial to gain the trust of someone who may believe fictions over facts to make any persuasive argument on COVID-19 or any other issue.

He also has a standard response to those who present falsehoods to him as facts that he suggests anyone can use: “That is interesting. Would you mind helping me understand how you came to that opinion?”

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

In another salvo in the heated debate over treatment for kids who believe they’re transgender, a study published in PLoS One suggests that transgender adults who received hormone therapy as teenagers are mentally healthier in a pair of ways than those who didn’t.

The study, which only looks at transgender adults, doesn’t confirm that hormone therapy in childhood is a beneficial treatment. Still, “we found that for all age groups, access to [adolescent] gender-affirming hormone initiation was associated with lower odds of past-year suicidal ideation and past-month severe psychological distress measured in adulthood,” said lead author Jack Turban, MD, chief fellow in child and adolescent psychiatry at Stanford (Calif.) University, in an interview. “We also found better mental-health outcomes for those who started gender-affirming hormones as adolescents when compared to those who didn’t start them until they were adults.”

The use of hormone treatment and puberty blockers by transgender teens is extremely controversial. Critics say the treatments are harmful and unnecessary, and Republican politicians are trying to ban their use in some states. Last spring, Arkansas became the first state to ban the treatments. The law is on hold amid a legal challenge.

The researchers launched the study to gain more insight into the impact of hormone therapy on children. “There have been several longitudinal studies showing that mental health improves following gender-affirming medical care for transgender youth, but there has been less research looking at the relationship between when these medications are started and adult mental health outcomes,” Dr. Turban said. “This is the first study to look at various ages of initiation of gender-affirming hormones and compare outcomes between those who started gender-affirming hormones during adolescence and those who did not start them until adulthood.”

For the new study, the authors analyzed the findings of the 2015 U.S. Transgender Survey of 27,715 adults and focused on 21,598 who said they’d wanted hormone therapy (40% aged 18-24, 83% White, 35% transgender male, 41% transgender female, with the rest using other terms such as “queer” or “nonbinary” to describe themselves).

Of these subjects, 41.0% never received hormone therapy, 0.6% underwent therapy in early adolescence, 1.7% received it in late adolescence, and 56.8% got it as adults.

The researchers made various adjustments for confounders – age, partnership status, employment status, K-12 harassment, and experience of gender identity conversion efforts. Those who received hormone therapy had lower odds of past-year suicidal ideation vs. those who didn’t: adjusted odds ratio, 0.4; 95% confidence interval, 0.2-0.6; P < .0001 for therapy that occurred from age 14 to 15, aOR, 0.5; 95% CI, 0.4-0.7; P < .0001, for therapy that occurred from age 16 to 17, and aOR, 0.8; 95% CI, 0.7-0.8; P < .0001 for therapy that occurred in adulthood.

However, there was no statistically significant link between hormone therapy and past-year suicidal ideation with a plan or past-year suicide attempt.

The study also found lower rates of past-month severe psychological distress: aOR. 0.3; 95% CI, 0.2-0.4; P < .0001 for therapy from age 14 to 15, aOR, 0.3; 95% CI, 0.3-0.4; P < .0001 for therapy from age 16 to 17, and aOR, 0.6 (95% CI, 0.5-0.6; P < .0001) for therapy in adulthood.

There was no statistically significant link between hormone therapy and past-month binge drinking or lifetime illicit drug use.

“The findings indicate that clinicians caring for adolescents need to be properly trained in gender-affirming medical care, including hormone therapy, in order to help promote good mental health outcomes for transgender people. Comprehensive training in gender-affirming care is currently not part of standard medical education curricula,” said study coauthor Alex Keuroghlian, MD, MPH, director of the National LGBTQIA+ Health Education Center at the Fenway Institute and associate professor of psychiatry at Harvard Medical School, Boston, in an interview.

The study has limitations. The survey population doesn’t include anyone who committed suicide, nor does it include people who had gender dysphoria as children but didn’t go on to identify as transgender as adults. It is also retrospective. “There is a general consensus that, given the data we have so far, it would be unethical to conduct a randomized controlled trial in this space,” said study lead author Dr. Turban.

Several critics of hormone therapy in teens support a psychotherapy-based approach to gender dysphoria that considers whether other factors are at play than transgender orientation. They’ve united to attack research based on the 2015 transgender survey. In a 2021 report in Archives of Sexual Behavior, they called it “a highly skewed sample” and objected to “a conflation of ethical nonaffirmative psychotherapy with conversion therapy.”

In an interview, one of the critics – developmental psychologist and retired University of Sydney professor Dianna Kenny, PhD – said the new study’s “serious problem of recall bias” about hormone therapy in the survey is “insurmountable.” The survey, she said, also fails to explore why participants who wanted hormone therapy didn’t get it.

Dr. Kenny, who believes all hormone therapy in teens with gender dysphoria outside of clinical trials is inappropriate, also pointed out that hormone therapy has many side effects. She added that young people with gender dysphoria often “realize through a process of cognitive and psychosocial maturation that they were not ‘genuinely’ trans but suffering from other conditions that needed treatment – e.g., internalized homophobia, trauma, including sexual abuse, attention-deficit/hyperactivity disorder, autism spectrum disorder, etc.”

No specific funding is reported, although two of the authors report receiving various grants, fellowship and research funding. Dr. Turban discloses textbook royalties from Springer Nature and expert witness payments from the ACLU. Dr. Keuroghlian discloses textbook royalties from McGraw Hill. Dr. Kenny reports no disclosures.

In another salvo in the heated debate over treatment for kids who believe they’re transgender, a study published in PLoS One suggests that transgender adults who received hormone therapy as teenagers are mentally healthier in a pair of ways than those who didn’t.

The study, which only looks at transgender adults, doesn’t confirm that hormone therapy in childhood is a beneficial treatment. Still, “we found that for all age groups, access to [adolescent] gender-affirming hormone initiation was associated with lower odds of past-year suicidal ideation and past-month severe psychological distress measured in adulthood,” said lead author Jack Turban, MD, chief fellow in child and adolescent psychiatry at Stanford (Calif.) University, in an interview. “We also found better mental-health outcomes for those who started gender-affirming hormones as adolescents when compared to those who didn’t start them until they were adults.”

The use of hormone treatment and puberty blockers by transgender teens is extremely controversial. Critics say the treatments are harmful and unnecessary, and Republican politicians are trying to ban their use in some states. Last spring, Arkansas became the first state to ban the treatments. The law is on hold amid a legal challenge.

The researchers launched the study to gain more insight into the impact of hormone therapy on children. “There have been several longitudinal studies showing that mental health improves following gender-affirming medical care for transgender youth, but there has been less research looking at the relationship between when these medications are started and adult mental health outcomes,” Dr. Turban said. “This is the first study to look at various ages of initiation of gender-affirming hormones and compare outcomes between those who started gender-affirming hormones during adolescence and those who did not start them until adulthood.”

For the new study, the authors analyzed the findings of the 2015 U.S. Transgender Survey of 27,715 adults and focused on 21,598 who said they’d wanted hormone therapy (40% aged 18-24, 83% White, 35% transgender male, 41% transgender female, with the rest using other terms such as “queer” or “nonbinary” to describe themselves).

Of these subjects, 41.0% never received hormone therapy, 0.6% underwent therapy in early adolescence, 1.7% received it in late adolescence, and 56.8% got it as adults.

The researchers made various adjustments for confounders – age, partnership status, employment status, K-12 harassment, and experience of gender identity conversion efforts. Those who received hormone therapy had lower odds of past-year suicidal ideation vs. those who didn’t: adjusted odds ratio, 0.4; 95% confidence interval, 0.2-0.6; P < .0001 for therapy that occurred from age 14 to 15, aOR, 0.5; 95% CI, 0.4-0.7; P < .0001, for therapy that occurred from age 16 to 17, and aOR, 0.8; 95% CI, 0.7-0.8; P < .0001 for therapy that occurred in adulthood.

However, there was no statistically significant link between hormone therapy and past-year suicidal ideation with a plan or past-year suicide attempt.

The study also found lower rates of past-month severe psychological distress: aOR. 0.3; 95% CI, 0.2-0.4; P < .0001 for therapy from age 14 to 15, aOR, 0.3; 95% CI, 0.3-0.4; P < .0001 for therapy from age 16 to 17, and aOR, 0.6 (95% CI, 0.5-0.6; P < .0001) for therapy in adulthood.

There was no statistically significant link between hormone therapy and past-month binge drinking or lifetime illicit drug use.

“The findings indicate that clinicians caring for adolescents need to be properly trained in gender-affirming medical care, including hormone therapy, in order to help promote good mental health outcomes for transgender people. Comprehensive training in gender-affirming care is currently not part of standard medical education curricula,” said study coauthor Alex Keuroghlian, MD, MPH, director of the National LGBTQIA+ Health Education Center at the Fenway Institute and associate professor of psychiatry at Harvard Medical School, Boston, in an interview.

The study has limitations. The survey population doesn’t include anyone who committed suicide, nor does it include people who had gender dysphoria as children but didn’t go on to identify as transgender as adults. It is also retrospective. “There is a general consensus that, given the data we have so far, it would be unethical to conduct a randomized controlled trial in this space,” said study lead author Dr. Turban.

Several critics of hormone therapy in teens support a psychotherapy-based approach to gender dysphoria that considers whether other factors are at play than transgender orientation. They’ve united to attack research based on the 2015 transgender survey. In a 2021 report in Archives of Sexual Behavior, they called it “a highly skewed sample” and objected to “a conflation of ethical nonaffirmative psychotherapy with conversion therapy.”

In an interview, one of the critics – developmental psychologist and retired University of Sydney professor Dianna Kenny, PhD – said the new study’s “serious problem of recall bias” about hormone therapy in the survey is “insurmountable.” The survey, she said, also fails to explore why participants who wanted hormone therapy didn’t get it.

Dr. Kenny, who believes all hormone therapy in teens with gender dysphoria outside of clinical trials is inappropriate, also pointed out that hormone therapy has many side effects. She added that young people with gender dysphoria often “realize through a process of cognitive and psychosocial maturation that they were not ‘genuinely’ trans but suffering from other conditions that needed treatment – e.g., internalized homophobia, trauma, including sexual abuse, attention-deficit/hyperactivity disorder, autism spectrum disorder, etc.”

No specific funding is reported, although two of the authors report receiving various grants, fellowship and research funding. Dr. Turban discloses textbook royalties from Springer Nature and expert witness payments from the ACLU. Dr. Keuroghlian discloses textbook royalties from McGraw Hill. Dr. Kenny reports no disclosures.

In another salvo in the heated debate over treatment for kids who believe they’re transgender, a study published in PLoS One suggests that transgender adults who received hormone therapy as teenagers are mentally healthier in a pair of ways than those who didn’t.

The study, which only looks at transgender adults, doesn’t confirm that hormone therapy in childhood is a beneficial treatment. Still, “we found that for all age groups, access to [adolescent] gender-affirming hormone initiation was associated with lower odds of past-year suicidal ideation and past-month severe psychological distress measured in adulthood,” said lead author Jack Turban, MD, chief fellow in child and adolescent psychiatry at Stanford (Calif.) University, in an interview. “We also found better mental-health outcomes for those who started gender-affirming hormones as adolescents when compared to those who didn’t start them until they were adults.”

The use of hormone treatment and puberty blockers by transgender teens is extremely controversial. Critics say the treatments are harmful and unnecessary, and Republican politicians are trying to ban their use in some states. Last spring, Arkansas became the first state to ban the treatments. The law is on hold amid a legal challenge.

The researchers launched the study to gain more insight into the impact of hormone therapy on children. “There have been several longitudinal studies showing that mental health improves following gender-affirming medical care for transgender youth, but there has been less research looking at the relationship between when these medications are started and adult mental health outcomes,” Dr. Turban said. “This is the first study to look at various ages of initiation of gender-affirming hormones and compare outcomes between those who started gender-affirming hormones during adolescence and those who did not start them until adulthood.”

For the new study, the authors analyzed the findings of the 2015 U.S. Transgender Survey of 27,715 adults and focused on 21,598 who said they’d wanted hormone therapy (40% aged 18-24, 83% White, 35% transgender male, 41% transgender female, with the rest using other terms such as “queer” or “nonbinary” to describe themselves).

Of these subjects, 41.0% never received hormone therapy, 0.6% underwent therapy in early adolescence, 1.7% received it in late adolescence, and 56.8% got it as adults.

The researchers made various adjustments for confounders – age, partnership status, employment status, K-12 harassment, and experience of gender identity conversion efforts. Those who received hormone therapy had lower odds of past-year suicidal ideation vs. those who didn’t: adjusted odds ratio, 0.4; 95% confidence interval, 0.2-0.6; P < .0001 for therapy that occurred from age 14 to 15, aOR, 0.5; 95% CI, 0.4-0.7; P < .0001, for therapy that occurred from age 16 to 17, and aOR, 0.8; 95% CI, 0.7-0.8; P < .0001 for therapy that occurred in adulthood.

However, there was no statistically significant link between hormone therapy and past-year suicidal ideation with a plan or past-year suicide attempt.

The study also found lower rates of past-month severe psychological distress: aOR. 0.3; 95% CI, 0.2-0.4; P < .0001 for therapy from age 14 to 15, aOR, 0.3; 95% CI, 0.3-0.4; P < .0001 for therapy from age 16 to 17, and aOR, 0.6 (95% CI, 0.5-0.6; P < .0001) for therapy in adulthood.

There was no statistically significant link between hormone therapy and past-month binge drinking or lifetime illicit drug use.

“The findings indicate that clinicians caring for adolescents need to be properly trained in gender-affirming medical care, including hormone therapy, in order to help promote good mental health outcomes for transgender people. Comprehensive training in gender-affirming care is currently not part of standard medical education curricula,” said study coauthor Alex Keuroghlian, MD, MPH, director of the National LGBTQIA+ Health Education Center at the Fenway Institute and associate professor of psychiatry at Harvard Medical School, Boston, in an interview.

The study has limitations. The survey population doesn’t include anyone who committed suicide, nor does it include people who had gender dysphoria as children but didn’t go on to identify as transgender as adults. It is also retrospective. “There is a general consensus that, given the data we have so far, it would be unethical to conduct a randomized controlled trial in this space,” said study lead author Dr. Turban.

Several critics of hormone therapy in teens support a psychotherapy-based approach to gender dysphoria that considers whether other factors are at play than transgender orientation. They’ve united to attack research based on the 2015 transgender survey. In a 2021 report in Archives of Sexual Behavior, they called it “a highly skewed sample” and objected to “a conflation of ethical nonaffirmative psychotherapy with conversion therapy.”

In an interview, one of the critics – developmental psychologist and retired University of Sydney professor Dianna Kenny, PhD – said the new study’s “serious problem of recall bias” about hormone therapy in the survey is “insurmountable.” The survey, she said, also fails to explore why participants who wanted hormone therapy didn’t get it.

Dr. Kenny, who believes all hormone therapy in teens with gender dysphoria outside of clinical trials is inappropriate, also pointed out that hormone therapy has many side effects. She added that young people with gender dysphoria often “realize through a process of cognitive and psychosocial maturation that they were not ‘genuinely’ trans but suffering from other conditions that needed treatment – e.g., internalized homophobia, trauma, including sexual abuse, attention-deficit/hyperactivity disorder, autism spectrum disorder, etc.”

No specific funding is reported, although two of the authors report receiving various grants, fellowship and research funding. Dr. Turban discloses textbook royalties from Springer Nature and expert witness payments from the ACLU. Dr. Keuroghlian discloses textbook royalties from McGraw Hill. Dr. Kenny reports no disclosures.

In 2020, it was hard to imagine that the situation could get worse for doctors.

But 2021 presented a new set of challenges. As quarantines lifted and physicians tried to get back to work, they were forced to deal with reduced staff, continuing COVID stress, and pandemic-related anxieties about family and loved ones.

olm26250/Thinkstock

Medscape’s National Burnout and Depression Report 2022 asked more than 13,000 physicians from 29 specialties to share details about their lives and struggles with burnout and depression in 2021. The results paint a picture of physicians trying to fulfill their mission to care for patients, but struggling to maintain their own well-being amid a global pandemic.
 

Burnout bump

In 2021’s report, 42% of physicians said they were burned out. In 2022, that number increased to 47%. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, increasing from 43% to 60%. Critical care (56%), ob.gyn. (53%), and infectious disease and family medicine (both at 51%) rounded out the top five specialties with doctors experiencing burnout in 2021.

Burnout has typically been a greater problem for women than men physicians, and the pandemic hasn’t changed that. “There’s no question that women have reported far more role strain during the pandemic than men,” says Carol A. Bernstein, MD, psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at the Albert Einstein College of Medicine, both in New York. And indeed, 56% of women and 41% of men reported burnout in the 2022 survey.

The causes, however, weren’t especially pandemic related – or at least not directly. As in previous surveys, the major contributing factor to burnout was too much paperwork (60%), such as charting and other bureaucratic tasks. Treating COVID-19 patients was cited as the major source of stress by 10% of respondents. About 34% said too many hours at work was the biggest contributing factor to burnout.
 

The nature of the beast

What is burnout like for these doctors? One described the conditions that lead to burnout like this: “I barely spend enough time with most patients, just running from one to the next; and then after work, I spend hours documenting, charting, dealing with reports. I feel like an overpaid clerk.” Another said: “Where’s the relationships with patients that used to make this worthwhile?” Others fingered staffing shortages at work or an overwhelming home life: “Staff calls in sick; we’re all running around trying to find things and get things done. It never ends.”

Of those who do experience burnout, the problem reaches beyond the workplace, with 54% saying that their burnout has a strong/severe impact on life and 68% reporting that burnout affects their relationships. One respondent said: “I’m always tired; I have trouble concentrating, no time for the children, more arguments with my hubby.” Another put it this way: “Home is just as busy and chaotic as work. I can never relax.”

It doesn’t help matters that physicians are likely to think they’re the only professionals experiencing job burnout. For example, only 36% of respondents believe teachers experience comparable burnout, yet more than 41% of teachers leave the profession within 5 years of starting – often because of burnout.

When it comes to methods for coping with burnout, exercise is the clear favorite, with 63% of respondents saying exercise helps maintain their mental health. About 41% talk with family members or close friends. However, less healthy coping mechanisms were cited as well, such as isolating themselves from others (45%), sleeping (41%), and eating junk food (35%) or drinking alcohol (24%).

When it comes to trying to alleviate burnout, 29% have tried meditation or similar stress-reduction techniques, while others have reduced their work hours (29%) or changed their work settings (19%).
 

‘Now I feel like there’s no hope’

About a fifth of physicians (21%) said they suffered from clinical depression, and 64% reported feeling “blue, down, or sad.” One physician characterized their depression this way: “I used to think my life would be great. Now I feel like there’s no hope, this will never get better, I’ll never be happy.”

Of doctors reporting depression, 53% said their illness did not affect their interactions with patients, while 34% said depression caused them to be more easily exasperated by patients.

When asked about seeking help for depression, about half (49%) said they believed they could deal with emotional stress on their own. Unfortunately, fear of medical boards finding out keeps 43% of physicians from reaching out for help, according to the survey.

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

In 2020, it was hard to imagine that the situation could get worse for doctors.

But 2021 presented a new set of challenges. As quarantines lifted and physicians tried to get back to work, they were forced to deal with reduced staff, continuing COVID stress, and pandemic-related anxieties about family and loved ones.

olm26250/Thinkstock

Medscape’s National Burnout and Depression Report 2022 asked more than 13,000 physicians from 29 specialties to share details about their lives and struggles with burnout and depression in 2021. The results paint a picture of physicians trying to fulfill their mission to care for patients, but struggling to maintain their own well-being amid a global pandemic.
 

Burnout bump

In 2021’s report, 42% of physicians said they were burned out. In 2022, that number increased to 47%. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, increasing from 43% to 60%. Critical care (56%), ob.gyn. (53%), and infectious disease and family medicine (both at 51%) rounded out the top five specialties with doctors experiencing burnout in 2021.

Burnout has typically been a greater problem for women than men physicians, and the pandemic hasn’t changed that. “There’s no question that women have reported far more role strain during the pandemic than men,” says Carol A. Bernstein, MD, psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at the Albert Einstein College of Medicine, both in New York. And indeed, 56% of women and 41% of men reported burnout in the 2022 survey.

The causes, however, weren’t especially pandemic related – or at least not directly. As in previous surveys, the major contributing factor to burnout was too much paperwork (60%), such as charting and other bureaucratic tasks. Treating COVID-19 patients was cited as the major source of stress by 10% of respondents. About 34% said too many hours at work was the biggest contributing factor to burnout.
 

The nature of the beast

What is burnout like for these doctors? One described the conditions that lead to burnout like this: “I barely spend enough time with most patients, just running from one to the next; and then after work, I spend hours documenting, charting, dealing with reports. I feel like an overpaid clerk.” Another said: “Where’s the relationships with patients that used to make this worthwhile?” Others fingered staffing shortages at work or an overwhelming home life: “Staff calls in sick; we’re all running around trying to find things and get things done. It never ends.”

Of those who do experience burnout, the problem reaches beyond the workplace, with 54% saying that their burnout has a strong/severe impact on life and 68% reporting that burnout affects their relationships. One respondent said: “I’m always tired; I have trouble concentrating, no time for the children, more arguments with my hubby.” Another put it this way: “Home is just as busy and chaotic as work. I can never relax.”

It doesn’t help matters that physicians are likely to think they’re the only professionals experiencing job burnout. For example, only 36% of respondents believe teachers experience comparable burnout, yet more than 41% of teachers leave the profession within 5 years of starting – often because of burnout.

When it comes to methods for coping with burnout, exercise is the clear favorite, with 63% of respondents saying exercise helps maintain their mental health. About 41% talk with family members or close friends. However, less healthy coping mechanisms were cited as well, such as isolating themselves from others (45%), sleeping (41%), and eating junk food (35%) or drinking alcohol (24%).

When it comes to trying to alleviate burnout, 29% have tried meditation or similar stress-reduction techniques, while others have reduced their work hours (29%) or changed their work settings (19%).
 

‘Now I feel like there’s no hope’

About a fifth of physicians (21%) said they suffered from clinical depression, and 64% reported feeling “blue, down, or sad.” One physician characterized their depression this way: “I used to think my life would be great. Now I feel like there’s no hope, this will never get better, I’ll never be happy.”

Of doctors reporting depression, 53% said their illness did not affect their interactions with patients, while 34% said depression caused them to be more easily exasperated by patients.

When asked about seeking help for depression, about half (49%) said they believed they could deal with emotional stress on their own. Unfortunately, fear of medical boards finding out keeps 43% of physicians from reaching out for help, according to the survey.

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

In 2020, it was hard to imagine that the situation could get worse for doctors.

But 2021 presented a new set of challenges. As quarantines lifted and physicians tried to get back to work, they were forced to deal with reduced staff, continuing COVID stress, and pandemic-related anxieties about family and loved ones.

olm26250/Thinkstock

Medscape’s National Burnout and Depression Report 2022 asked more than 13,000 physicians from 29 specialties to share details about their lives and struggles with burnout and depression in 2021. The results paint a picture of physicians trying to fulfill their mission to care for patients, but struggling to maintain their own well-being amid a global pandemic.
 

Burnout bump

In 2021’s report, 42% of physicians said they were burned out. In 2022, that number increased to 47%. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, increasing from 43% to 60%. Critical care (56%), ob.gyn. (53%), and infectious disease and family medicine (both at 51%) rounded out the top five specialties with doctors experiencing burnout in 2021.

Burnout has typically been a greater problem for women than men physicians, and the pandemic hasn’t changed that. “There’s no question that women have reported far more role strain during the pandemic than men,” says Carol A. Bernstein, MD, psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at the Albert Einstein College of Medicine, both in New York. And indeed, 56% of women and 41% of men reported burnout in the 2022 survey.

The causes, however, weren’t especially pandemic related – or at least not directly. As in previous surveys, the major contributing factor to burnout was too much paperwork (60%), such as charting and other bureaucratic tasks. Treating COVID-19 patients was cited as the major source of stress by 10% of respondents. About 34% said too many hours at work was the biggest contributing factor to burnout.
 

The nature of the beast

What is burnout like for these doctors? One described the conditions that lead to burnout like this: “I barely spend enough time with most patients, just running from one to the next; and then after work, I spend hours documenting, charting, dealing with reports. I feel like an overpaid clerk.” Another said: “Where’s the relationships with patients that used to make this worthwhile?” Others fingered staffing shortages at work or an overwhelming home life: “Staff calls in sick; we’re all running around trying to find things and get things done. It never ends.”

Of those who do experience burnout, the problem reaches beyond the workplace, with 54% saying that their burnout has a strong/severe impact on life and 68% reporting that burnout affects their relationships. One respondent said: “I’m always tired; I have trouble concentrating, no time for the children, more arguments with my hubby.” Another put it this way: “Home is just as busy and chaotic as work. I can never relax.”

It doesn’t help matters that physicians are likely to think they’re the only professionals experiencing job burnout. For example, only 36% of respondents believe teachers experience comparable burnout, yet more than 41% of teachers leave the profession within 5 years of starting – often because of burnout.

When it comes to methods for coping with burnout, exercise is the clear favorite, with 63% of respondents saying exercise helps maintain their mental health. About 41% talk with family members or close friends. However, less healthy coping mechanisms were cited as well, such as isolating themselves from others (45%), sleeping (41%), and eating junk food (35%) or drinking alcohol (24%).

When it comes to trying to alleviate burnout, 29% have tried meditation or similar stress-reduction techniques, while others have reduced their work hours (29%) or changed their work settings (19%).
 

‘Now I feel like there’s no hope’

About a fifth of physicians (21%) said they suffered from clinical depression, and 64% reported feeling “blue, down, or sad.” One physician characterized their depression this way: “I used to think my life would be great. Now I feel like there’s no hope, this will never get better, I’ll never be happy.”

Of doctors reporting depression, 53% said their illness did not affect their interactions with patients, while 34% said depression caused them to be more easily exasperated by patients.

When asked about seeking help for depression, about half (49%) said they believed they could deal with emotional stress on their own. Unfortunately, fear of medical boards finding out keeps 43% of physicians from reaching out for help, according to the survey.

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

“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.

Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.

Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.

“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”

In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”

This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.

Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
 

Challenges when transitioning from pediatric to adult care

During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.

When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.

The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.

Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.

At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.  

“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.

As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
 

Engage with kid, not disease; don’t palm them off on new recruits

“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”

“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.

Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.

“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.  

And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.

Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.

But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”

He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.

This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”

In short, it must be someone experienced who loves working with this age group.  

Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”

And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
 

Preparing for the transition

To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.

This should also include transferring management responsibilities to the young adult rather than their parent.

The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.

And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.

Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.

Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.

“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.

What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
 

Be a guide, not a gatekeeper

Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”

“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”

Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”

“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’ 

“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”

Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.

“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”

Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.

While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.

“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.

“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.

One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.

“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.

Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.

As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.

The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.

Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
 

“This is high priority”  

Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.

“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.

“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”

And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”

Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”

Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.

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

“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.

Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.

Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.

“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”

In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”

This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.

Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
 

Challenges when transitioning from pediatric to adult care

During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.

When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.

The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.

Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.

At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.  

“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.

As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
 

Engage with kid, not disease; don’t palm them off on new recruits

“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”

“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.

Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.

“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.  

And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.

Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.

But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”

He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.

This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”

In short, it must be someone experienced who loves working with this age group.  

Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”

And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
 

Preparing for the transition

To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.

This should also include transferring management responsibilities to the young adult rather than their parent.

The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.

And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.

Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.

Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.

“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.

What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
 

Be a guide, not a gatekeeper

Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”

“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”

Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”

“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’ 

“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”

Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.

“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”

Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.

While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.

“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.

“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.

One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.

“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.

Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.

As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.

The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.

Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
 

“This is high priority”  

Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.

“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.

“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”

And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”

Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”

Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.

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

“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.

Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.

Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.

“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”

In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”

This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.

Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
 

Challenges when transitioning from pediatric to adult care

During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.

When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.

The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.

Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.

At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.  

“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.

As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
 

Engage with kid, not disease; don’t palm them off on new recruits

“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”

“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.

Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.

“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.  

And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.

Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.

But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”

He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.

This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”

In short, it must be someone experienced who loves working with this age group.  

Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”

And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
 

Preparing for the transition

To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.

This should also include transferring management responsibilities to the young adult rather than their parent.

The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.

And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.

Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.

Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.

“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.

What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
 

Be a guide, not a gatekeeper

Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”

“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”

Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”

“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’ 

“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”

Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.

“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”

Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.

While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.

“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.

“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.

One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.

“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.

Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.

As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.

The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.

Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
 

“This is high priority”  

Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.

“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.

“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”

And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”

Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”

Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.

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

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

New research suggests serial coronary CT angiography (CCTA) can provide novel insights into the association between lipoprotein(a) and plaque progression over time in patients with advanced coronary artery disease.

Researchers examined data from 191 individuals with multivessel coronary disease receiving preventive statin (95%) and antiplatelet (100%) therapy in the single-center Scottish DIAMOND trial and compared CCTA at baseline and 12 months available for 160 patients.

As reported in the Journal of the American College of Cardiology, patients with high Lp(a), defined as at least 70 mg/dL, had higher baseline high-density lipoprotein cholesterol and ASSIGN scores than those with low Lp(a) but had comparable coronary artery calcium (CAC) scores and total, calcific, noncalcific, and low-attenuation plaque (LAP) volumes.

At 1 year, however, LAP volume – a marker for necrotic core – increased by 26.2 mm3 in the high-Lp(a) group and decreased by –0.7 mm3 in the low-Lp(a) group (P = .020).

There was no significant difference in change in total, calcific, and noncalcific plaque volumes between groups.

In multivariate linear regression analysis adjusting for body mass index, ASSIGN score, and segment involvement score, LAP volume increased by 10.5% for each 50 mg/dL increment in Lp(a) (P = .034).

“It’s an exciting observation, because we’ve done previous studies where we’ve demonstrated the association of that particular plaque type with future myocardial infarction,” senior author Marc R. Dweck, MD, PhD, University of Amsterdam, told this news organization. “So, you’ve potentially got an explanation for the adverse prognosis associated with high lipoprotein(a) and its link to cardiovascular events and, in particular, myocardial infarction.”

The team’s recent SCOT-HEART analysis found that LAP burden was a stronger predictor of myocardial infarction (MI) than cardiovascular risk scores, stenosis severity, and CAC scoring, with MI risk nearly five-fold higher if LAP was above 4%.

As to why total, calcific, and noncalcific plaque volumes didn’t change significantly on repeat CCTA in the present study, Dr. Dweck said it’s possible that the sample was too small and follow-up too short but also that “total plaque volume is really dominated by the fibrous plaque, which doesn’t appear affected by Lp(a).” Nevertheless, Lp(a)’s effect on low-attenuation plaque was clearly present and supported by the change in fibro-fatty plaque, the next-most unstable plaque type.

At 1 year, fibro-fatty plaque volume was 55.0 mm3 in the high-Lp(a) group versus –25.0 mm3 in the low-Lp(a) group (P = .020).

Lp(a) was associated with fibro-fatty plaque progression in univariate analysis (β = 6.7%; P = .034) and showed a trend in multivariable analysis (β = 6.0%; P = .062).

“This study shows you can track changes in plaque over time and highlight important disease mechanisms and use them to understand the pathology of the disease,” Dr. Dweck said. “I’m very encouraged by this.”

What’s novel in the present study is that “it represents the beginning of our understanding of the role of Lp(a) in plaque progression,” Sotirios Tsimikas, MD, University of California, San Diego, and Jagat Narula, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, say in an accompanying commentary.

They note that prior studies, including the Dallas Heart Study, have struggled to find a strong association between Lp(a) with the extent or progression of CAC, despite elevated Lp(a) and CAC identifying higher-risk patients.

Similarly, a meta-analysis of intravascular ultrasound trials turned up only a 1.2% absolute difference in atheroma volume in patients with elevated Lp(a), and a recent optical coherence tomography study found an association of Lp(a) with thin-cap fibroatheromas but not lipid core.

With just 36 patients with elevated Lp(a), however, the current findings need validation in a larger data set, Dr. Tsimikas and Dr. Narula say.

Although Lp(a) is genetically elevated in about one in five individuals and measurement is recommended in European dyslipidemia guidelines, testing rates are low, in part because the argument has been that there are no Lp(a)-lowering therapies available, Dr. Dweck observed. That may change with the phase 3 cardiovascular outcomes Lp(a)HORIZON trial, which follows strong phase 2 results with the antisense agent AKCEA-APO(a)-LRx and is enrolling patients similar to the current cohort.

“Ultimately it comes down to that fundamental thing, that you need an action once you’ve done the test and then insurers will be happy to pay for it and clinicians will ask for it. That’s why that trial is so important,” Dr. Dweck said.

Dr. Tsimikas and Dr. Narula also point to the eagerly awaited results of that trial, expected in 2025. “A positive trial is likely to lead to additional trials and new drugs that may reinvigorate the use of imaging modalities that could go beyond plaque volume and atherosclerosis to also predict clinically relevant inflammation and atherothrombosis,” they conclude.

Dr. Dweck is supported by the British Heart Foundation and is the recipient of the Sir Jules Thorn Award for Biomedical Research 2015; has received speaker fees from Pfizer and Novartis; and has received consultancy fees from Novartis, Jupiter Bioventures, and Silence Therapeutics. Coauthor disclosures are listed in the paper. Dr. Tsimikas has a dual appointment at the University of California, San Diego, (UCSD) and Ionis Pharmaceuticals; is a coinventor and receives royalties from patents owned by UCSD; and is a cofounder and has an equity interest in Oxitope and its affiliates, Kleanthi Diagnostics, and Covicept Therapeutics. Dr. Narula reports having no relevant financial relationships.

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

New research suggests serial coronary CT angiography (CCTA) can provide novel insights into the association between lipoprotein(a) and plaque progression over time in patients with advanced coronary artery disease.

Researchers examined data from 191 individuals with multivessel coronary disease receiving preventive statin (95%) and antiplatelet (100%) therapy in the single-center Scottish DIAMOND trial and compared CCTA at baseline and 12 months available for 160 patients.

As reported in the Journal of the American College of Cardiology, patients with high Lp(a), defined as at least 70 mg/dL, had higher baseline high-density lipoprotein cholesterol and ASSIGN scores than those with low Lp(a) but had comparable coronary artery calcium (CAC) scores and total, calcific, noncalcific, and low-attenuation plaque (LAP) volumes.

At 1 year, however, LAP volume – a marker for necrotic core – increased by 26.2 mm3 in the high-Lp(a) group and decreased by –0.7 mm3 in the low-Lp(a) group (P = .020).

There was no significant difference in change in total, calcific, and noncalcific plaque volumes between groups.

In multivariate linear regression analysis adjusting for body mass index, ASSIGN score, and segment involvement score, LAP volume increased by 10.5% for each 50 mg/dL increment in Lp(a) (P = .034).

“It’s an exciting observation, because we’ve done previous studies where we’ve demonstrated the association of that particular plaque type with future myocardial infarction,” senior author Marc R. Dweck, MD, PhD, University of Amsterdam, told this news organization. “So, you’ve potentially got an explanation for the adverse prognosis associated with high lipoprotein(a) and its link to cardiovascular events and, in particular, myocardial infarction.”

The team’s recent SCOT-HEART analysis found that LAP burden was a stronger predictor of myocardial infarction (MI) than cardiovascular risk scores, stenosis severity, and CAC scoring, with MI risk nearly five-fold higher if LAP was above 4%.

As to why total, calcific, and noncalcific plaque volumes didn’t change significantly on repeat CCTA in the present study, Dr. Dweck said it’s possible that the sample was too small and follow-up too short but also that “total plaque volume is really dominated by the fibrous plaque, which doesn’t appear affected by Lp(a).” Nevertheless, Lp(a)’s effect on low-attenuation plaque was clearly present and supported by the change in fibro-fatty plaque, the next-most unstable plaque type.

At 1 year, fibro-fatty plaque volume was 55.0 mm3 in the high-Lp(a) group versus –25.0 mm3 in the low-Lp(a) group (P = .020).

Lp(a) was associated with fibro-fatty plaque progression in univariate analysis (β = 6.7%; P = .034) and showed a trend in multivariable analysis (β = 6.0%; P = .062).

“This study shows you can track changes in plaque over time and highlight important disease mechanisms and use them to understand the pathology of the disease,” Dr. Dweck said. “I’m very encouraged by this.”

What’s novel in the present study is that “it represents the beginning of our understanding of the role of Lp(a) in plaque progression,” Sotirios Tsimikas, MD, University of California, San Diego, and Jagat Narula, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, say in an accompanying commentary.

They note that prior studies, including the Dallas Heart Study, have struggled to find a strong association between Lp(a) with the extent or progression of CAC, despite elevated Lp(a) and CAC identifying higher-risk patients.

Similarly, a meta-analysis of intravascular ultrasound trials turned up only a 1.2% absolute difference in atheroma volume in patients with elevated Lp(a), and a recent optical coherence tomography study found an association of Lp(a) with thin-cap fibroatheromas but not lipid core.

With just 36 patients with elevated Lp(a), however, the current findings need validation in a larger data set, Dr. Tsimikas and Dr. Narula say.

Although Lp(a) is genetically elevated in about one in five individuals and measurement is recommended in European dyslipidemia guidelines, testing rates are low, in part because the argument has been that there are no Lp(a)-lowering therapies available, Dr. Dweck observed. That may change with the phase 3 cardiovascular outcomes Lp(a)HORIZON trial, which follows strong phase 2 results with the antisense agent AKCEA-APO(a)-LRx and is enrolling patients similar to the current cohort.

“Ultimately it comes down to that fundamental thing, that you need an action once you’ve done the test and then insurers will be happy to pay for it and clinicians will ask for it. That’s why that trial is so important,” Dr. Dweck said.

Dr. Tsimikas and Dr. Narula also point to the eagerly awaited results of that trial, expected in 2025. “A positive trial is likely to lead to additional trials and new drugs that may reinvigorate the use of imaging modalities that could go beyond plaque volume and atherosclerosis to also predict clinically relevant inflammation and atherothrombosis,” they conclude.

Dr. Dweck is supported by the British Heart Foundation and is the recipient of the Sir Jules Thorn Award for Biomedical Research 2015; has received speaker fees from Pfizer and Novartis; and has received consultancy fees from Novartis, Jupiter Bioventures, and Silence Therapeutics. Coauthor disclosures are listed in the paper. Dr. Tsimikas has a dual appointment at the University of California, San Diego, (UCSD) and Ionis Pharmaceuticals; is a coinventor and receives royalties from patents owned by UCSD; and is a cofounder and has an equity interest in Oxitope and its affiliates, Kleanthi Diagnostics, and Covicept Therapeutics. Dr. Narula reports having no relevant financial relationships.

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

New research suggests serial coronary CT angiography (CCTA) can provide novel insights into the association between lipoprotein(a) and plaque progression over time in patients with advanced coronary artery disease.

Researchers examined data from 191 individuals with multivessel coronary disease receiving preventive statin (95%) and antiplatelet (100%) therapy in the single-center Scottish DIAMOND trial and compared CCTA at baseline and 12 months available for 160 patients.

As reported in the Journal of the American College of Cardiology, patients with high Lp(a), defined as at least 70 mg/dL, had higher baseline high-density lipoprotein cholesterol and ASSIGN scores than those with low Lp(a) but had comparable coronary artery calcium (CAC) scores and total, calcific, noncalcific, and low-attenuation plaque (LAP) volumes.

At 1 year, however, LAP volume – a marker for necrotic core – increased by 26.2 mm3 in the high-Lp(a) group and decreased by –0.7 mm3 in the low-Lp(a) group (P = .020).

There was no significant difference in change in total, calcific, and noncalcific plaque volumes between groups.

In multivariate linear regression analysis adjusting for body mass index, ASSIGN score, and segment involvement score, LAP volume increased by 10.5% for each 50 mg/dL increment in Lp(a) (P = .034).

“It’s an exciting observation, because we’ve done previous studies where we’ve demonstrated the association of that particular plaque type with future myocardial infarction,” senior author Marc R. Dweck, MD, PhD, University of Amsterdam, told this news organization. “So, you’ve potentially got an explanation for the adverse prognosis associated with high lipoprotein(a) and its link to cardiovascular events and, in particular, myocardial infarction.”

The team’s recent SCOT-HEART analysis found that LAP burden was a stronger predictor of myocardial infarction (MI) than cardiovascular risk scores, stenosis severity, and CAC scoring, with MI risk nearly five-fold higher if LAP was above 4%.

As to why total, calcific, and noncalcific plaque volumes didn’t change significantly on repeat CCTA in the present study, Dr. Dweck said it’s possible that the sample was too small and follow-up too short but also that “total plaque volume is really dominated by the fibrous plaque, which doesn’t appear affected by Lp(a).” Nevertheless, Lp(a)’s effect on low-attenuation plaque was clearly present and supported by the change in fibro-fatty plaque, the next-most unstable plaque type.

At 1 year, fibro-fatty plaque volume was 55.0 mm3 in the high-Lp(a) group versus –25.0 mm3 in the low-Lp(a) group (P = .020).

Lp(a) was associated with fibro-fatty plaque progression in univariate analysis (β = 6.7%; P = .034) and showed a trend in multivariable analysis (β = 6.0%; P = .062).

“This study shows you can track changes in plaque over time and highlight important disease mechanisms and use them to understand the pathology of the disease,” Dr. Dweck said. “I’m very encouraged by this.”

What’s novel in the present study is that “it represents the beginning of our understanding of the role of Lp(a) in plaque progression,” Sotirios Tsimikas, MD, University of California, San Diego, and Jagat Narula, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, say in an accompanying commentary.

They note that prior studies, including the Dallas Heart Study, have struggled to find a strong association between Lp(a) with the extent or progression of CAC, despite elevated Lp(a) and CAC identifying higher-risk patients.

Similarly, a meta-analysis of intravascular ultrasound trials turned up only a 1.2% absolute difference in atheroma volume in patients with elevated Lp(a), and a recent optical coherence tomography study found an association of Lp(a) with thin-cap fibroatheromas but not lipid core.

With just 36 patients with elevated Lp(a), however, the current findings need validation in a larger data set, Dr. Tsimikas and Dr. Narula say.

Although Lp(a) is genetically elevated in about one in five individuals and measurement is recommended in European dyslipidemia guidelines, testing rates are low, in part because the argument has been that there are no Lp(a)-lowering therapies available, Dr. Dweck observed. That may change with the phase 3 cardiovascular outcomes Lp(a)HORIZON trial, which follows strong phase 2 results with the antisense agent AKCEA-APO(a)-LRx and is enrolling patients similar to the current cohort.

“Ultimately it comes down to that fundamental thing, that you need an action once you’ve done the test and then insurers will be happy to pay for it and clinicians will ask for it. That’s why that trial is so important,” Dr. Dweck said.

Dr. Tsimikas and Dr. Narula also point to the eagerly awaited results of that trial, expected in 2025. “A positive trial is likely to lead to additional trials and new drugs that may reinvigorate the use of imaging modalities that could go beyond plaque volume and atherosclerosis to also predict clinically relevant inflammation and atherothrombosis,” they conclude.

Dr. Dweck is supported by the British Heart Foundation and is the recipient of the Sir Jules Thorn Award for Biomedical Research 2015; has received speaker fees from Pfizer and Novartis; and has received consultancy fees from Novartis, Jupiter Bioventures, and Silence Therapeutics. Coauthor disclosures are listed in the paper. Dr. Tsimikas has a dual appointment at the University of California, San Diego, (UCSD) and Ionis Pharmaceuticals; is a coinventor and receives royalties from patents owned by UCSD; and is a cofounder and has an equity interest in Oxitope and its affiliates, Kleanthi Diagnostics, and Covicept Therapeutics. Dr. Narula reports having no relevant financial relationships.

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