One in 5. It almost seems unimaginable that this is the real number of people who are struggling with long COVID, especially considering how many people in the United States have had COVID-19 at this point (more than 96 million). Yet I continue to hear of people who are struggling, and we continue to see a flood of people in the long COVID clinic. It isn’t over, and long COVID is the new pandemic.

Even more unimaginable at this time is that it’s happening to me. I’ve experienced not only the disabling effects of long COVID, but I’ve also seen, firsthand, the frustration of navigating diagnosis and treatment. It’s given me a taste of what millions of other patients are going through.
 

Vaxxed, masked, and (too) relaxed

I caught COVID-19 (probably Omicron BA.5) that presented as sniffles, making me think it was probably just allergies. However, my resting heart rate was up on my Garmin watch, so of course I got tested and was positive.

With my symptoms virtually nonexistent, it seemed, at the time, merely an inconvenience, because I was forced to isolate away from family and friends, who all stayed negative.

But 2 weeks later, I began to have urticaria – hives – after physical exertion. Did that mean my mast cells were angry? There’s some evidence these immune cells become overactivated in some patients with COVID. Next, I began to experience lightheadedness and the rapid heartbeat of tachycardia. The tachycardia was especially bad any time I physically exerted myself, including on a walk. Imagine me – a lover of all bargain shopping – cutting short a trip to the outlet mall on a particularly bad day when my heart rate was 140 after taking just a few steps. This was orthostatic intolerance.

Then came the severe worsening of my migraines – which are often vestibular, making me nauseated and dizzy on top of the throbbing.

I was of course familiar with these symptoms, as professor and chair of the department of rehabilitation medicine at the Joe R. and Teresa Lozano Long School of Medicine at University of Texas Health Science Center, San Antonio. I developed a post-COVID recovery clinic to help patients.

So I knew about postexertional malaise (PEM) and postexertional symptom exacerbation (PESE), but I was now experiencing these distressing symptoms firsthand.

Clinicians really need to look for this cardinal sign of long COVID as well as evidence of myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). ME/CFS is marked by exacerbation of fatigue or symptoms after an activity that could previously be done without these aftereffects. In my case, as an All-American Masters miler with several marathons under my belt, running 5 miles is a walk in the park. But now, I pay for those 5 miles for the rest of the day on the couch or with palpitations, dizziness, and fatigue the following day. Busy clinic day full of procedures? I would have to be sitting by the end of it. Bed by 9 PM was not always early enough.
 

Becoming a statistic

Here I am, one of the leading experts in the country on caring for people with long COVID, featured in the national news and having testified in front of Congress, and now I am part of that lived experience. Me – a healthy athlete, with no comorbidities, a normal BMI, vaccinated and boosted, and after an almost asymptomatic bout of COVID-19, a victim to long COVID.

You just never know how your body is going to react. Neuroinflammation occurred in studies with mice with mild respiratory COVID and could be happening to me. I did not want a chronic immune-mediated vasculopathy.

So, I did what any other hyperaware physician-researcher would do. I enrolled in the RECOVER trial – a study my own institution is taking part in and one that I recommend to my own patients.

I also decided that I need to access care and not just ignore my symptoms or try to treat them myself.

That’s when things got difficult. There was a wait of at least a month to see my primary care provider – but I was able to use my privileged position as a physician to get in sooner.

My provider said that she had limited knowledge of long COVID, and she hesitated to order some of the tests and treatments that I recommended because they were not yet considered standard of care. I can understand the hesitation. It is engrained in medical education to follow evidence based on the highest-quality research studies. We are slowly learning more about long COVID, but acknowledging the learning curve offers little to patients who need help now.

This has made me realize that we cannot wait on an evidence-based approach – which can take decades to develop – while people are suffering. And it’s important that everyone on the front line learn about some of the manifestations and disease management of long COVID.

I left this first physician visit feeling more defeated than anything and decided to try to push through. That, I quickly realized, was not the right thing to do.

So again, after a couple of significant crashes and days of severe migraines, I phoned a friend: Ratna Bhavaraju-Sanka, MD, the amazing neurologist who treats patients with long COVID alongside me. She squeezed me in on a non-clinic day. Again, I had the privilege to see a specialist most people wait half a year to see. I was diagnosed with both autonomic dysfunction and intractable migraine.

She ordered some intravenous fluids and IV magnesium that would probably help both. But then another obstacle arose. My institution’s infusion center is focused on patients with cancer, and I was unable to schedule treatments there.

Luckily, I knew about the concierge mobile IV hydration therapy companies that come to your house – mostly offering a hangover treatment service. And I am thankful that I had the health literacy and financial ability to pay for some fluids at home.

On another particularly bad day, I phoned other friends – higher-ups at the hospital – who expedited a slot at the hospital infusion center and approval for the IV magnesium.

Thanks to my access, knowledge, and other privileges, I got fairly quick if imperfect care, enrolled in a research trial, and received medications. I knew to pace myself. The vast majority of others with long COVID lack these advantages.
 

The patient with long COVID

Things I have learned that others can learn, too:

• Acknowledge and recognize that long COVID is a disease that is affecting 1 in 5 Americans who catch COVID. Many look completely “normal on the outside.” Please listen to your patients.
• Autonomic dysfunction is a common manifestation of long COVID. A 10-minute stand test goes a long way in diagnosing this condition, from the American Academy of Physical Medicine and Rehabilitation. It is not just anxiety.
• “That’s only in research” is dismissive and harmful. Think outside the box. Follow guidelines. Consider encouraging patients to sign up for trials.
• Screen for PEM/PESE and teach your patients to pace themselves, because pushing through it or doing graded exercises will be harmful.
• We need to train more physicians to treat postacute sequelae of SARS-CoV-2 infection () and other postinfectious conditions, such as ME/CFS.

If long COVID is hard for physicians to understand and deal with, imagine how difficult it is for patients with no expertise in this area.

It is exponentially harder for those with fewer resources, time, and health literacy. My lived experience with long COVID has shown me that being a patient is never easy. You put your body and fate into the hands of trusted professionals and expect validation and assistance, not gaslighting or gatekeeping.

Along with millions of others, I am tired of waiting.

Dr. Gutierrez is Professor and Distinguished Chair, department of rehabilitation medicine, University of Texas Health Science Center at San Antonio. She reported receiving honoraria for lecturing on long COVID and receiving a research grant from Co-PI for the NIH RECOVER trial.

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

One in 5. It almost seems unimaginable that this is the real number of people who are struggling with long COVID, especially considering how many people in the United States have had COVID-19 at this point (more than 96 million). Yet I continue to hear of people who are struggling, and we continue to see a flood of people in the long COVID clinic. It isn’t over, and long COVID is the new pandemic.

Even more unimaginable at this time is that it’s happening to me. I’ve experienced not only the disabling effects of long COVID, but I’ve also seen, firsthand, the frustration of navigating diagnosis and treatment. It’s given me a taste of what millions of other patients are going through.
 

Vaxxed, masked, and (too) relaxed

I caught COVID-19 (probably Omicron BA.5) that presented as sniffles, making me think it was probably just allergies. However, my resting heart rate was up on my Garmin watch, so of course I got tested and was positive.

With my symptoms virtually nonexistent, it seemed, at the time, merely an inconvenience, because I was forced to isolate away from family and friends, who all stayed negative.

But 2 weeks later, I began to have urticaria – hives – after physical exertion. Did that mean my mast cells were angry? There’s some evidence these immune cells become overactivated in some patients with COVID. Next, I began to experience lightheadedness and the rapid heartbeat of tachycardia. The tachycardia was especially bad any time I physically exerted myself, including on a walk. Imagine me – a lover of all bargain shopping – cutting short a trip to the outlet mall on a particularly bad day when my heart rate was 140 after taking just a few steps. This was orthostatic intolerance.

Then came the severe worsening of my migraines – which are often vestibular, making me nauseated and dizzy on top of the throbbing.

I was of course familiar with these symptoms, as professor and chair of the department of rehabilitation medicine at the Joe R. and Teresa Lozano Long School of Medicine at University of Texas Health Science Center, San Antonio. I developed a post-COVID recovery clinic to help patients.

So I knew about postexertional malaise (PEM) and postexertional symptom exacerbation (PESE), but I was now experiencing these distressing symptoms firsthand.

Clinicians really need to look for this cardinal sign of long COVID as well as evidence of myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). ME/CFS is marked by exacerbation of fatigue or symptoms after an activity that could previously be done without these aftereffects. In my case, as an All-American Masters miler with several marathons under my belt, running 5 miles is a walk in the park. But now, I pay for those 5 miles for the rest of the day on the couch or with palpitations, dizziness, and fatigue the following day. Busy clinic day full of procedures? I would have to be sitting by the end of it. Bed by 9 PM was not always early enough.
 

Becoming a statistic

Here I am, one of the leading experts in the country on caring for people with long COVID, featured in the national news and having testified in front of Congress, and now I am part of that lived experience. Me – a healthy athlete, with no comorbidities, a normal BMI, vaccinated and boosted, and after an almost asymptomatic bout of COVID-19, a victim to long COVID.

You just never know how your body is going to react. Neuroinflammation occurred in studies with mice with mild respiratory COVID and could be happening to me. I did not want a chronic immune-mediated vasculopathy.

So, I did what any other hyperaware physician-researcher would do. I enrolled in the RECOVER trial – a study my own institution is taking part in and one that I recommend to my own patients.

I also decided that I need to access care and not just ignore my symptoms or try to treat them myself.

That’s when things got difficult. There was a wait of at least a month to see my primary care provider – but I was able to use my privileged position as a physician to get in sooner.

My provider said that she had limited knowledge of long COVID, and she hesitated to order some of the tests and treatments that I recommended because they were not yet considered standard of care. I can understand the hesitation. It is engrained in medical education to follow evidence based on the highest-quality research studies. We are slowly learning more about long COVID, but acknowledging the learning curve offers little to patients who need help now.

This has made me realize that we cannot wait on an evidence-based approach – which can take decades to develop – while people are suffering. And it’s important that everyone on the front line learn about some of the manifestations and disease management of long COVID.

I left this first physician visit feeling more defeated than anything and decided to try to push through. That, I quickly realized, was not the right thing to do.

So again, after a couple of significant crashes and days of severe migraines, I phoned a friend: Ratna Bhavaraju-Sanka, MD, the amazing neurologist who treats patients with long COVID alongside me. She squeezed me in on a non-clinic day. Again, I had the privilege to see a specialist most people wait half a year to see. I was diagnosed with both autonomic dysfunction and intractable migraine.

She ordered some intravenous fluids and IV magnesium that would probably help both. But then another obstacle arose. My institution’s infusion center is focused on patients with cancer, and I was unable to schedule treatments there.

Luckily, I knew about the concierge mobile IV hydration therapy companies that come to your house – mostly offering a hangover treatment service. And I am thankful that I had the health literacy and financial ability to pay for some fluids at home.

On another particularly bad day, I phoned other friends – higher-ups at the hospital – who expedited a slot at the hospital infusion center and approval for the IV magnesium.

Thanks to my access, knowledge, and other privileges, I got fairly quick if imperfect care, enrolled in a research trial, and received medications. I knew to pace myself. The vast majority of others with long COVID lack these advantages.
 

The patient with long COVID

Things I have learned that others can learn, too:

• Acknowledge and recognize that long COVID is a disease that is affecting 1 in 5 Americans who catch COVID. Many look completely “normal on the outside.” Please listen to your patients.
• Autonomic dysfunction is a common manifestation of long COVID. A 10-minute stand test goes a long way in diagnosing this condition, from the American Academy of Physical Medicine and Rehabilitation. It is not just anxiety.
• “That’s only in research” is dismissive and harmful. Think outside the box. Follow guidelines. Consider encouraging patients to sign up for trials.
• Screen for PEM/PESE and teach your patients to pace themselves, because pushing through it or doing graded exercises will be harmful.
• We need to train more physicians to treat postacute sequelae of SARS-CoV-2 infection () and other postinfectious conditions, such as ME/CFS.

If long COVID is hard for physicians to understand and deal with, imagine how difficult it is for patients with no expertise in this area.

It is exponentially harder for those with fewer resources, time, and health literacy. My lived experience with long COVID has shown me that being a patient is never easy. You put your body and fate into the hands of trusted professionals and expect validation and assistance, not gaslighting or gatekeeping.

Along with millions of others, I am tired of waiting.

Dr. Gutierrez is Professor and Distinguished Chair, department of rehabilitation medicine, University of Texas Health Science Center at San Antonio. She reported receiving honoraria for lecturing on long COVID and receiving a research grant from Co-PI for the NIH RECOVER trial.

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

One in 5. It almost seems unimaginable that this is the real number of people who are struggling with long COVID, especially considering how many people in the United States have had COVID-19 at this point (more than 96 million). Yet I continue to hear of people who are struggling, and we continue to see a flood of people in the long COVID clinic. It isn’t over, and long COVID is the new pandemic.

Even more unimaginable at this time is that it’s happening to me. I’ve experienced not only the disabling effects of long COVID, but I’ve also seen, firsthand, the frustration of navigating diagnosis and treatment. It’s given me a taste of what millions of other patients are going through.
 

Vaxxed, masked, and (too) relaxed

I caught COVID-19 (probably Omicron BA.5) that presented as sniffles, making me think it was probably just allergies. However, my resting heart rate was up on my Garmin watch, so of course I got tested and was positive.

With my symptoms virtually nonexistent, it seemed, at the time, merely an inconvenience, because I was forced to isolate away from family and friends, who all stayed negative.

But 2 weeks later, I began to have urticaria – hives – after physical exertion. Did that mean my mast cells were angry? There’s some evidence these immune cells become overactivated in some patients with COVID. Next, I began to experience lightheadedness and the rapid heartbeat of tachycardia. The tachycardia was especially bad any time I physically exerted myself, including on a walk. Imagine me – a lover of all bargain shopping – cutting short a trip to the outlet mall on a particularly bad day when my heart rate was 140 after taking just a few steps. This was orthostatic intolerance.

Then came the severe worsening of my migraines – which are often vestibular, making me nauseated and dizzy on top of the throbbing.

I was of course familiar with these symptoms, as professor and chair of the department of rehabilitation medicine at the Joe R. and Teresa Lozano Long School of Medicine at University of Texas Health Science Center, San Antonio. I developed a post-COVID recovery clinic to help patients.

So I knew about postexertional malaise (PEM) and postexertional symptom exacerbation (PESE), but I was now experiencing these distressing symptoms firsthand.

Clinicians really need to look for this cardinal sign of long COVID as well as evidence of myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). ME/CFS is marked by exacerbation of fatigue or symptoms after an activity that could previously be done without these aftereffects. In my case, as an All-American Masters miler with several marathons under my belt, running 5 miles is a walk in the park. But now, I pay for those 5 miles for the rest of the day on the couch or with palpitations, dizziness, and fatigue the following day. Busy clinic day full of procedures? I would have to be sitting by the end of it. Bed by 9 PM was not always early enough.
 

Becoming a statistic

Here I am, one of the leading experts in the country on caring for people with long COVID, featured in the national news and having testified in front of Congress, and now I am part of that lived experience. Me – a healthy athlete, with no comorbidities, a normal BMI, vaccinated and boosted, and after an almost asymptomatic bout of COVID-19, a victim to long COVID.

You just never know how your body is going to react. Neuroinflammation occurred in studies with mice with mild respiratory COVID and could be happening to me. I did not want a chronic immune-mediated vasculopathy.

So, I did what any other hyperaware physician-researcher would do. I enrolled in the RECOVER trial – a study my own institution is taking part in and one that I recommend to my own patients.

I also decided that I need to access care and not just ignore my symptoms or try to treat them myself.

That’s when things got difficult. There was a wait of at least a month to see my primary care provider – but I was able to use my privileged position as a physician to get in sooner.

My provider said that she had limited knowledge of long COVID, and she hesitated to order some of the tests and treatments that I recommended because they were not yet considered standard of care. I can understand the hesitation. It is engrained in medical education to follow evidence based on the highest-quality research studies. We are slowly learning more about long COVID, but acknowledging the learning curve offers little to patients who need help now.

This has made me realize that we cannot wait on an evidence-based approach – which can take decades to develop – while people are suffering. And it’s important that everyone on the front line learn about some of the manifestations and disease management of long COVID.

I left this first physician visit feeling more defeated than anything and decided to try to push through. That, I quickly realized, was not the right thing to do.

So again, after a couple of significant crashes and days of severe migraines, I phoned a friend: Ratna Bhavaraju-Sanka, MD, the amazing neurologist who treats patients with long COVID alongside me. She squeezed me in on a non-clinic day. Again, I had the privilege to see a specialist most people wait half a year to see. I was diagnosed with both autonomic dysfunction and intractable migraine.

She ordered some intravenous fluids and IV magnesium that would probably help both. But then another obstacle arose. My institution’s infusion center is focused on patients with cancer, and I was unable to schedule treatments there.

Luckily, I knew about the concierge mobile IV hydration therapy companies that come to your house – mostly offering a hangover treatment service. And I am thankful that I had the health literacy and financial ability to pay for some fluids at home.

On another particularly bad day, I phoned other friends – higher-ups at the hospital – who expedited a slot at the hospital infusion center and approval for the IV magnesium.

Thanks to my access, knowledge, and other privileges, I got fairly quick if imperfect care, enrolled in a research trial, and received medications. I knew to pace myself. The vast majority of others with long COVID lack these advantages.
 

The patient with long COVID

Things I have learned that others can learn, too:

• Acknowledge and recognize that long COVID is a disease that is affecting 1 in 5 Americans who catch COVID. Many look completely “normal on the outside.” Please listen to your patients.
• Autonomic dysfunction is a common manifestation of long COVID. A 10-minute stand test goes a long way in diagnosing this condition, from the American Academy of Physical Medicine and Rehabilitation. It is not just anxiety.
• “That’s only in research” is dismissive and harmful. Think outside the box. Follow guidelines. Consider encouraging patients to sign up for trials.
• Screen for PEM/PESE and teach your patients to pace themselves, because pushing through it or doing graded exercises will be harmful.
• We need to train more physicians to treat postacute sequelae of SARS-CoV-2 infection () and other postinfectious conditions, such as ME/CFS.

If long COVID is hard for physicians to understand and deal with, imagine how difficult it is for patients with no expertise in this area.

It is exponentially harder for those with fewer resources, time, and health literacy. My lived experience with long COVID has shown me that being a patient is never easy. You put your body and fate into the hands of trusted professionals and expect validation and assistance, not gaslighting or gatekeeping.

Along with millions of others, I am tired of waiting.

Dr. Gutierrez is Professor and Distinguished Chair, department of rehabilitation medicine, University of Texas Health Science Center at San Antonio. She reported receiving honoraria for lecturing on long COVID and receiving a research grant from Co-PI for the NIH RECOVER trial.

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

Psychiatric patients with impaired communication abilities were significantly more likely to be admitted involuntarily to inpatient care and to experience coercive measures after admission, based on data from more than 1,500 individuals.

Despite improvements in reducing coercive measures in psychiatric inpatient care, both involuntary admission and coercive measures remain in use in many countries worldwide, wrote Celline Cole, MSc, a doctoral candidate at Charité Universitätsmedizin, Berlin, and colleagues. Such measures are considered “severe violations of a person’s rights to self-determination and personal freedom,” they wrote.

Previous studies have identified characteristics that increase the risk of involuntary inpatient admission, but the association between patients’ communication ability and coercive measures has not been explored, they noted.

In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 1,556 adults who were admitted to psychiatric inpatient care at a single center in Germany in 2019. Patients’ communication ability was defined and recorded as one of the following: perfect; limited because of language or other reasons; or impossible because of language or other reasons (no communication).

Overall, 23% of patients were admitted involuntarily; the most common reasons for referral to inpatient care in the study population were physical aggression against individuals (8%) or objects (4%), and verbal aggression (7%). A total of 1,085 patients (70%) were able or willing to communicate.

Patients with limited or no communication ability because of language issues were three to four times more likely to be admitted involuntarily (odds ratios, 3.08 and 4.02, respectively), while those with limited or no communication ability because of nonlanguage issues were even more likely to be admitted involuntarily (ORs, 3.10 and 13.71, respectively), compared with patients without communication problems.

Patients with limited communication ability because of language issues also were significantly more likely than those without communication issues to experience coercive measures (OR, 4.53), as were patients with either limited or no communication ability because of no-language issues (ORs, 1.58 and 3.55, respectively).

Involuntary admission was defined as provisional detention, detention initiated by the patient’s legal guardian followed by a court order, or detention by court order “according to the Mental Health Law of the State of Berlin,” the researchers said. The average length of inpatient stay was 19 days. The age of the patients ranged from 18 to 96 years, with a mean age of 41.5 years, and 63% identified as male. Approximately two-thirds (62%) were unemployed or job-seeking during their treatment period, 38% were living alone, and 17% were homeless.

Although most of the study population (84%) was of German nationality, nearly half (48%) had a first- or second-generation migration background, the researchers noted.

“When thinking about effectively targeting this issue it is crucial to consider the different reasons why patients are limited in their ability to communicate,” the researchers wrote in their discussion. “Considering the rising numbers of refugees and persons with a migration background in Germany and many other countries worldwide, it is likely that more and more individuals with a language barrier will present at psychiatric emergency rooms,” they emphasized.

The findings were limited by several factors including the retrospective design, the relatively small number of patients with limitations or complete inability to communicate, and the use of data from a single hospital, and the incomplete data on nonlanguage reasons for limited or no communication ability, the researchers noted. Future studies should include more complete measures for recording these reasons, and data on forced medication, they added.

However, the results were strengthened by the range of sociodemographic, clinical, and admission-related variables in a large and representative sample, and highlight the need for appropriate interventions for patients with communication challenges, they said.

“Adequate financial and human resources need to be allocated to psychiatric hospitals that allow for high quality, available, and accessible interpretation services as well as mobilization of patients’ support networks during and after admission,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Psychiatric patients with impaired communication abilities were significantly more likely to be admitted involuntarily to inpatient care and to experience coercive measures after admission, based on data from more than 1,500 individuals.

Despite improvements in reducing coercive measures in psychiatric inpatient care, both involuntary admission and coercive measures remain in use in many countries worldwide, wrote Celline Cole, MSc, a doctoral candidate at Charité Universitätsmedizin, Berlin, and colleagues. Such measures are considered “severe violations of a person’s rights to self-determination and personal freedom,” they wrote.

Previous studies have identified characteristics that increase the risk of involuntary inpatient admission, but the association between patients’ communication ability and coercive measures has not been explored, they noted.

In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 1,556 adults who were admitted to psychiatric inpatient care at a single center in Germany in 2019. Patients’ communication ability was defined and recorded as one of the following: perfect; limited because of language or other reasons; or impossible because of language or other reasons (no communication).

Overall, 23% of patients were admitted involuntarily; the most common reasons for referral to inpatient care in the study population were physical aggression against individuals (8%) or objects (4%), and verbal aggression (7%). A total of 1,085 patients (70%) were able or willing to communicate.

Patients with limited or no communication ability because of language issues were three to four times more likely to be admitted involuntarily (odds ratios, 3.08 and 4.02, respectively), while those with limited or no communication ability because of nonlanguage issues were even more likely to be admitted involuntarily (ORs, 3.10 and 13.71, respectively), compared with patients without communication problems.

Patients with limited communication ability because of language issues also were significantly more likely than those without communication issues to experience coercive measures (OR, 4.53), as were patients with either limited or no communication ability because of no-language issues (ORs, 1.58 and 3.55, respectively).

Involuntary admission was defined as provisional detention, detention initiated by the patient’s legal guardian followed by a court order, or detention by court order “according to the Mental Health Law of the State of Berlin,” the researchers said. The average length of inpatient stay was 19 days. The age of the patients ranged from 18 to 96 years, with a mean age of 41.5 years, and 63% identified as male. Approximately two-thirds (62%) were unemployed or job-seeking during their treatment period, 38% were living alone, and 17% were homeless.

Although most of the study population (84%) was of German nationality, nearly half (48%) had a first- or second-generation migration background, the researchers noted.

“When thinking about effectively targeting this issue it is crucial to consider the different reasons why patients are limited in their ability to communicate,” the researchers wrote in their discussion. “Considering the rising numbers of refugees and persons with a migration background in Germany and many other countries worldwide, it is likely that more and more individuals with a language barrier will present at psychiatric emergency rooms,” they emphasized.

The findings were limited by several factors including the retrospective design, the relatively small number of patients with limitations or complete inability to communicate, and the use of data from a single hospital, and the incomplete data on nonlanguage reasons for limited or no communication ability, the researchers noted. Future studies should include more complete measures for recording these reasons, and data on forced medication, they added.

However, the results were strengthened by the range of sociodemographic, clinical, and admission-related variables in a large and representative sample, and highlight the need for appropriate interventions for patients with communication challenges, they said.

“Adequate financial and human resources need to be allocated to psychiatric hospitals that allow for high quality, available, and accessible interpretation services as well as mobilization of patients’ support networks during and after admission,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Psychiatric patients with impaired communication abilities were significantly more likely to be admitted involuntarily to inpatient care and to experience coercive measures after admission, based on data from more than 1,500 individuals.

Despite improvements in reducing coercive measures in psychiatric inpatient care, both involuntary admission and coercive measures remain in use in many countries worldwide, wrote Celline Cole, MSc, a doctoral candidate at Charité Universitätsmedizin, Berlin, and colleagues. Such measures are considered “severe violations of a person’s rights to self-determination and personal freedom,” they wrote.

Previous studies have identified characteristics that increase the risk of involuntary inpatient admission, but the association between patients’ communication ability and coercive measures has not been explored, they noted.

In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 1,556 adults who were admitted to psychiatric inpatient care at a single center in Germany in 2019. Patients’ communication ability was defined and recorded as one of the following: perfect; limited because of language or other reasons; or impossible because of language or other reasons (no communication).

Overall, 23% of patients were admitted involuntarily; the most common reasons for referral to inpatient care in the study population were physical aggression against individuals (8%) or objects (4%), and verbal aggression (7%). A total of 1,085 patients (70%) were able or willing to communicate.

Patients with limited or no communication ability because of language issues were three to four times more likely to be admitted involuntarily (odds ratios, 3.08 and 4.02, respectively), while those with limited or no communication ability because of nonlanguage issues were even more likely to be admitted involuntarily (ORs, 3.10 and 13.71, respectively), compared with patients without communication problems.

Patients with limited communication ability because of language issues also were significantly more likely than those without communication issues to experience coercive measures (OR, 4.53), as were patients with either limited or no communication ability because of no-language issues (ORs, 1.58 and 3.55, respectively).

Involuntary admission was defined as provisional detention, detention initiated by the patient’s legal guardian followed by a court order, or detention by court order “according to the Mental Health Law of the State of Berlin,” the researchers said. The average length of inpatient stay was 19 days. The age of the patients ranged from 18 to 96 years, with a mean age of 41.5 years, and 63% identified as male. Approximately two-thirds (62%) were unemployed or job-seeking during their treatment period, 38% were living alone, and 17% were homeless.

Although most of the study population (84%) was of German nationality, nearly half (48%) had a first- or second-generation migration background, the researchers noted.

“When thinking about effectively targeting this issue it is crucial to consider the different reasons why patients are limited in their ability to communicate,” the researchers wrote in their discussion. “Considering the rising numbers of refugees and persons with a migration background in Germany and many other countries worldwide, it is likely that more and more individuals with a language barrier will present at psychiatric emergency rooms,” they emphasized.

The findings were limited by several factors including the retrospective design, the relatively small number of patients with limitations or complete inability to communicate, and the use of data from a single hospital, and the incomplete data on nonlanguage reasons for limited or no communication ability, the researchers noted. Future studies should include more complete measures for recording these reasons, and data on forced medication, they added.

However, the results were strengthened by the range of sociodemographic, clinical, and admission-related variables in a large and representative sample, and highlight the need for appropriate interventions for patients with communication challenges, they said.

“Adequate financial and human resources need to be allocated to psychiatric hospitals that allow for high quality, available, and accessible interpretation services as well as mobilization of patients’ support networks during and after admission,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

The McDonald criteria for diagnosing multiple sclerosis (MS) has been around since 2001, with revisions in 2005, 2010, and 2017. They focus on lesions disseminated in space (DIS) and disseminated in time (DIT). As with any diagnostic, new science and methods inform changes. Although optic nerve lesions (ONL) have been considered in past revisions, they have yet to be adopted as a key diagnostic measure of MS.

At the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), several speakers made the case for the addition of ONL to the next McDonald revision. Arguments ranged from the inherent injustice that patients with a diagnosis of optic lesions should have to meet three symptoms of MS to get a diagnosis, while other patients require only two, to the possibility that early presentation with ocular symptoms could be an indicator of a more severe prognosis.

Still, many conditions can mimic the symptoms of ONL, so it is critical to be sure of the diagnosis before considering it a symptom of MS. For example, central serious maculopathy in young to middle-aged patients is often painless and could lead to an inadvertent MS diagnosis if it were added to the criteria. However, treatment with steroids can make it worse, according to Laura Balcer, MD, who spoke at the session. Dr. Balcer is a neuro-ophthalmologist at NYU Langone Health.
 

Adding ONL to McDonald

In the first talk of the session, Frederik Barkhof, MD, PhD, discussed some of the history of the McDonald criteria and laid a groundwork for why it should be updated. He began by pointing out that the latest criteria require either symptomatic or asymptomatic MRI lesions to determine DIS or DIT.

Dr. Barkhof has led the Magnetic Imaging in Multiple Sclerosis (MAGNIMS) group, which had some doubts about the 2017 revision to the McDonald criteria. “We discussed this and said, ‘Well, that is interesting. So you can have a brainstem lesion, which can be the symptomatic lesion and then you need one further region, so you have two regions, and then you have MS. But now if you have an optic nerve presentation, and you can find the optic nerve, it doesn’t count, and then you need two more regions. So there’s a bit of an imbalance. Why would you need three regions if you have an optic nerve, and only two if you have a spinal cord or a brainstem presentation?” recalled Dr. Barkhof, professor of radiology and neuroscience at Vrije Universiteit Amsterdam.

Identifying optic nerve lesions requires a good MRI that should use fat-saturation techniques.

Dr. Barkhof pointed out that the ONLs are a common presentation among MS patients. “We’re now preparing for the next revisions of the McDonnell criteria, and I’m confident and hopeful that we’ll make it this time,” said Dr. Barkhof.
 

Confirm the MS diagnosis

In the second talk, Angela Vidal-Jordana, MD, PhD, discussed ways to implement ONLs in the clinic. She emphasized the importance of ruling out other causes. “Even when a patient comes to us with a diagnosis of optic neuritis, we should question that. Different studies have shown that the optic neuritis overdiagnosis rate at referral might be as high as 60% of the cases,” said Dr. Vidal-Jordana, a neurologist at Centre d’Esclerosi Multiple de Catalunya in Barcelona. Studies show that about half of those are due to misinterpretation of the clinical history and examination, she said.

“So when presenting new visual symptoms, we should ask whether this is suggestive of an inflammatory etiology or not, and whether they are typical for MS or not. If both answers to these questions are yes, then we should apply the diagnostic criteria,” said Dr. Vidal-Jordana.

She presented results from a longitudinal, prospective study conducted within the MAGNIMS network supporting the inclusion of ONL into DIS criteria for MS. It included use of optic nerve MRI, OCT, and VEP [visual evoked potential]. “All of the modified DIS criteria, that is including one of the tests at each time, or a combination of them, led to a higher sensitivity of the diagnostic criteria (when optic nerve involvement was included), albeit with a small decrease in specificity which mainly was due to the fact that we only had 3 years of follow-up. The same held true when analyzing the secondary outcome of new T2 lesions or second relapse during the follow up,” said Dr. Vidal-Jordana.

“As a summary, I would say for sure we will need first of all an MRI, and we need to know if we can evaluate the optic nerve by MRI or not. If not, and we still do not have a diagnosis of a MS, maybe we can order VEP or OCT and then the test selection should be based on the time elapsed since first CIS [clinically isolated syndrome]. If it’s less than 3 months, I would go for a VEP. If it’s more than 3 months, then I probably want to go for OCT,” said Dr. Vidal-Jordana.
 

An aid to earlier diagnosis

In the last talk, Dr. Balcer discussed non-MRI methods for assessing ONLs. She noted that in about 25% of MS patients, ONLs are the first clinical demyelinating event. “Adding the optic nerve to the MS diagnostic criteria will allow us to diagnose our patients even earlier, (it) may help their vision, and could also help us to reduce the overall burden of MS disability over a lifetime. Importantly, entry into MS diagnosis can be delayed among patients for whom optic neuritis or even asymptomatic optic nerve lesions are noted at presentation, and there has been an enormous amount of data that have emerged over the past 5 years demonstrating the importance of the optic nerve in the MS diagnosis with implications for early therapy,” said Dr. Balcer.

She discussed optical coherence tomography (OCT), which is a key technique for diagnosing optic neuropathy. It measures the thickness of the retinal nerve fiber and ganglion cell layers, which have been associated with vision impairment and can reveal asymptomatic involvement of optic nerves in MS.
 

Beware of misdiagnosis

In the Q&A period following the talks, much of the discussion turned to reliability of ONL diagnoses.

“Misdiagnosis is a huge problem. That’s my experience: People who are referred to me with optic neuritis often don’t have optic neuritis,” said comoderator Wallace Brownlee, MBChB, PhD, a consultant neurologist at Cleveland Clinic London. Misha Pless, MD, spoke up from the audience to second that. “I’m delighted that the optic nerve will finally get a place at the table. I’ve been practicing neuro-ophthalmology and I have also [been] an MS doctor for about 25 years. What I see here in this fantastic discussion is that a lot of neurologists are going to be – I hate to use the word ‘misled’ – into relying on technology like OCT, VEP, and MRI to make the diagnosis. I will submit to this panel that that will lead to a number of MS misdiagnoses because I have been doing this for 25 years and the number of patients that I’ve received with rule-out optic neuritis that had macular disease, optical changes, or corneal abrasions are too numerous to count. If you’re going to add optic neuritis in the list of criteria [for MS], you definitely have to have a little asterisk in my opinion and say, ‘with prior blessing from an ophthalmologist to rule out ocular disease,’ because I don’t know any neurologist that knows how to look in the back of the eye, and I don’t know any neurologist that has an OCT in their office,” said Dr. Pless, professor of ophthalmology and a neurologist at Mayo Clinic in Jacksonville, Fla.

The panelists generally agreed with his point, although the hot mic picked up when one panelist whispered to another, ‘I have one,’ referring to an office OCT. “Using OCT in that regard, but also collaborating with your neuro-ophthalmologist and ophthalmologist is critical,” said Dr. Balcer.

Dr. Barkhof has financial relationships with Biogen, Merck, Roche, EISAI, Prothena, IXICO, Jansen, Combinostics, Novartis, GE, Queen Square, and Analytics. Dr. Vidal-Jordana has financial relationships with Roche, Novartis, Merck, and Sanofi. Dr. Balcer has no relevant financial disclosures. Dr. Brownlee has financial relationships with Biogen, Celgene, Merck, Mylan, Novartis, Roche, and Sanofi.

The McDonald criteria for diagnosing multiple sclerosis (MS) has been around since 2001, with revisions in 2005, 2010, and 2017. They focus on lesions disseminated in space (DIS) and disseminated in time (DIT). As with any diagnostic, new science and methods inform changes. Although optic nerve lesions (ONL) have been considered in past revisions, they have yet to be adopted as a key diagnostic measure of MS.

At the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), several speakers made the case for the addition of ONL to the next McDonald revision. Arguments ranged from the inherent injustice that patients with a diagnosis of optic lesions should have to meet three symptoms of MS to get a diagnosis, while other patients require only two, to the possibility that early presentation with ocular symptoms could be an indicator of a more severe prognosis.

Still, many conditions can mimic the symptoms of ONL, so it is critical to be sure of the diagnosis before considering it a symptom of MS. For example, central serious maculopathy in young to middle-aged patients is often painless and could lead to an inadvertent MS diagnosis if it were added to the criteria. However, treatment with steroids can make it worse, according to Laura Balcer, MD, who spoke at the session. Dr. Balcer is a neuro-ophthalmologist at NYU Langone Health.
 

Adding ONL to McDonald

In the first talk of the session, Frederik Barkhof, MD, PhD, discussed some of the history of the McDonald criteria and laid a groundwork for why it should be updated. He began by pointing out that the latest criteria require either symptomatic or asymptomatic MRI lesions to determine DIS or DIT.

Dr. Barkhof has led the Magnetic Imaging in Multiple Sclerosis (MAGNIMS) group, which had some doubts about the 2017 revision to the McDonald criteria. “We discussed this and said, ‘Well, that is interesting. So you can have a brainstem lesion, which can be the symptomatic lesion and then you need one further region, so you have two regions, and then you have MS. But now if you have an optic nerve presentation, and you can find the optic nerve, it doesn’t count, and then you need two more regions. So there’s a bit of an imbalance. Why would you need three regions if you have an optic nerve, and only two if you have a spinal cord or a brainstem presentation?” recalled Dr. Barkhof, professor of radiology and neuroscience at Vrije Universiteit Amsterdam.

Identifying optic nerve lesions requires a good MRI that should use fat-saturation techniques.

Dr. Barkhof pointed out that the ONLs are a common presentation among MS patients. “We’re now preparing for the next revisions of the McDonnell criteria, and I’m confident and hopeful that we’ll make it this time,” said Dr. Barkhof.
 

Confirm the MS diagnosis

In the second talk, Angela Vidal-Jordana, MD, PhD, discussed ways to implement ONLs in the clinic. She emphasized the importance of ruling out other causes. “Even when a patient comes to us with a diagnosis of optic neuritis, we should question that. Different studies have shown that the optic neuritis overdiagnosis rate at referral might be as high as 60% of the cases,” said Dr. Vidal-Jordana, a neurologist at Centre d’Esclerosi Multiple de Catalunya in Barcelona. Studies show that about half of those are due to misinterpretation of the clinical history and examination, she said.

“So when presenting new visual symptoms, we should ask whether this is suggestive of an inflammatory etiology or not, and whether they are typical for MS or not. If both answers to these questions are yes, then we should apply the diagnostic criteria,” said Dr. Vidal-Jordana.

She presented results from a longitudinal, prospective study conducted within the MAGNIMS network supporting the inclusion of ONL into DIS criteria for MS. It included use of optic nerve MRI, OCT, and VEP [visual evoked potential]. “All of the modified DIS criteria, that is including one of the tests at each time, or a combination of them, led to a higher sensitivity of the diagnostic criteria (when optic nerve involvement was included), albeit with a small decrease in specificity which mainly was due to the fact that we only had 3 years of follow-up. The same held true when analyzing the secondary outcome of new T2 lesions or second relapse during the follow up,” said Dr. Vidal-Jordana.

“As a summary, I would say for sure we will need first of all an MRI, and we need to know if we can evaluate the optic nerve by MRI or not. If not, and we still do not have a diagnosis of a MS, maybe we can order VEP or OCT and then the test selection should be based on the time elapsed since first CIS [clinically isolated syndrome]. If it’s less than 3 months, I would go for a VEP. If it’s more than 3 months, then I probably want to go for OCT,” said Dr. Vidal-Jordana.
 

An aid to earlier diagnosis

In the last talk, Dr. Balcer discussed non-MRI methods for assessing ONLs. She noted that in about 25% of MS patients, ONLs are the first clinical demyelinating event. “Adding the optic nerve to the MS diagnostic criteria will allow us to diagnose our patients even earlier, (it) may help their vision, and could also help us to reduce the overall burden of MS disability over a lifetime. Importantly, entry into MS diagnosis can be delayed among patients for whom optic neuritis or even asymptomatic optic nerve lesions are noted at presentation, and there has been an enormous amount of data that have emerged over the past 5 years demonstrating the importance of the optic nerve in the MS diagnosis with implications for early therapy,” said Dr. Balcer.

She discussed optical coherence tomography (OCT), which is a key technique for diagnosing optic neuropathy. It measures the thickness of the retinal nerve fiber and ganglion cell layers, which have been associated with vision impairment and can reveal asymptomatic involvement of optic nerves in MS.
 

Beware of misdiagnosis

In the Q&A period following the talks, much of the discussion turned to reliability of ONL diagnoses.

“Misdiagnosis is a huge problem. That’s my experience: People who are referred to me with optic neuritis often don’t have optic neuritis,” said comoderator Wallace Brownlee, MBChB, PhD, a consultant neurologist at Cleveland Clinic London. Misha Pless, MD, spoke up from the audience to second that. “I’m delighted that the optic nerve will finally get a place at the table. I’ve been practicing neuro-ophthalmology and I have also [been] an MS doctor for about 25 years. What I see here in this fantastic discussion is that a lot of neurologists are going to be – I hate to use the word ‘misled’ – into relying on technology like OCT, VEP, and MRI to make the diagnosis. I will submit to this panel that that will lead to a number of MS misdiagnoses because I have been doing this for 25 years and the number of patients that I’ve received with rule-out optic neuritis that had macular disease, optical changes, or corneal abrasions are too numerous to count. If you’re going to add optic neuritis in the list of criteria [for MS], you definitely have to have a little asterisk in my opinion and say, ‘with prior blessing from an ophthalmologist to rule out ocular disease,’ because I don’t know any neurologist that knows how to look in the back of the eye, and I don’t know any neurologist that has an OCT in their office,” said Dr. Pless, professor of ophthalmology and a neurologist at Mayo Clinic in Jacksonville, Fla.

The panelists generally agreed with his point, although the hot mic picked up when one panelist whispered to another, ‘I have one,’ referring to an office OCT. “Using OCT in that regard, but also collaborating with your neuro-ophthalmologist and ophthalmologist is critical,” said Dr. Balcer.

Dr. Barkhof has financial relationships with Biogen, Merck, Roche, EISAI, Prothena, IXICO, Jansen, Combinostics, Novartis, GE, Queen Square, and Analytics. Dr. Vidal-Jordana has financial relationships with Roche, Novartis, Merck, and Sanofi. Dr. Balcer has no relevant financial disclosures. Dr. Brownlee has financial relationships with Biogen, Celgene, Merck, Mylan, Novartis, Roche, and Sanofi.

The McDonald criteria for diagnosing multiple sclerosis (MS) has been around since 2001, with revisions in 2005, 2010, and 2017. They focus on lesions disseminated in space (DIS) and disseminated in time (DIT). As with any diagnostic, new science and methods inform changes. Although optic nerve lesions (ONL) have been considered in past revisions, they have yet to be adopted as a key diagnostic measure of MS.

At the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), several speakers made the case for the addition of ONL to the next McDonald revision. Arguments ranged from the inherent injustice that patients with a diagnosis of optic lesions should have to meet three symptoms of MS to get a diagnosis, while other patients require only two, to the possibility that early presentation with ocular symptoms could be an indicator of a more severe prognosis.

Still, many conditions can mimic the symptoms of ONL, so it is critical to be sure of the diagnosis before considering it a symptom of MS. For example, central serious maculopathy in young to middle-aged patients is often painless and could lead to an inadvertent MS diagnosis if it were added to the criteria. However, treatment with steroids can make it worse, according to Laura Balcer, MD, who spoke at the session. Dr. Balcer is a neuro-ophthalmologist at NYU Langone Health.
 

Adding ONL to McDonald

In the first talk of the session, Frederik Barkhof, MD, PhD, discussed some of the history of the McDonald criteria and laid a groundwork for why it should be updated. He began by pointing out that the latest criteria require either symptomatic or asymptomatic MRI lesions to determine DIS or DIT.

Dr. Barkhof has led the Magnetic Imaging in Multiple Sclerosis (MAGNIMS) group, which had some doubts about the 2017 revision to the McDonald criteria. “We discussed this and said, ‘Well, that is interesting. So you can have a brainstem lesion, which can be the symptomatic lesion and then you need one further region, so you have two regions, and then you have MS. But now if you have an optic nerve presentation, and you can find the optic nerve, it doesn’t count, and then you need two more regions. So there’s a bit of an imbalance. Why would you need three regions if you have an optic nerve, and only two if you have a spinal cord or a brainstem presentation?” recalled Dr. Barkhof, professor of radiology and neuroscience at Vrije Universiteit Amsterdam.

Identifying optic nerve lesions requires a good MRI that should use fat-saturation techniques.

Dr. Barkhof pointed out that the ONLs are a common presentation among MS patients. “We’re now preparing for the next revisions of the McDonnell criteria, and I’m confident and hopeful that we’ll make it this time,” said Dr. Barkhof.
 

Confirm the MS diagnosis

In the second talk, Angela Vidal-Jordana, MD, PhD, discussed ways to implement ONLs in the clinic. She emphasized the importance of ruling out other causes. “Even when a patient comes to us with a diagnosis of optic neuritis, we should question that. Different studies have shown that the optic neuritis overdiagnosis rate at referral might be as high as 60% of the cases,” said Dr. Vidal-Jordana, a neurologist at Centre d’Esclerosi Multiple de Catalunya in Barcelona. Studies show that about half of those are due to misinterpretation of the clinical history and examination, she said.

“So when presenting new visual symptoms, we should ask whether this is suggestive of an inflammatory etiology or not, and whether they are typical for MS or not. If both answers to these questions are yes, then we should apply the diagnostic criteria,” said Dr. Vidal-Jordana.

She presented results from a longitudinal, prospective study conducted within the MAGNIMS network supporting the inclusion of ONL into DIS criteria for MS. It included use of optic nerve MRI, OCT, and VEP [visual evoked potential]. “All of the modified DIS criteria, that is including one of the tests at each time, or a combination of them, led to a higher sensitivity of the diagnostic criteria (when optic nerve involvement was included), albeit with a small decrease in specificity which mainly was due to the fact that we only had 3 years of follow-up. The same held true when analyzing the secondary outcome of new T2 lesions or second relapse during the follow up,” said Dr. Vidal-Jordana.

“As a summary, I would say for sure we will need first of all an MRI, and we need to know if we can evaluate the optic nerve by MRI or not. If not, and we still do not have a diagnosis of a MS, maybe we can order VEP or OCT and then the test selection should be based on the time elapsed since first CIS [clinically isolated syndrome]. If it’s less than 3 months, I would go for a VEP. If it’s more than 3 months, then I probably want to go for OCT,” said Dr. Vidal-Jordana.
 

An aid to earlier diagnosis

In the last talk, Dr. Balcer discussed non-MRI methods for assessing ONLs. She noted that in about 25% of MS patients, ONLs are the first clinical demyelinating event. “Adding the optic nerve to the MS diagnostic criteria will allow us to diagnose our patients even earlier, (it) may help their vision, and could also help us to reduce the overall burden of MS disability over a lifetime. Importantly, entry into MS diagnosis can be delayed among patients for whom optic neuritis or even asymptomatic optic nerve lesions are noted at presentation, and there has been an enormous amount of data that have emerged over the past 5 years demonstrating the importance of the optic nerve in the MS diagnosis with implications for early therapy,” said Dr. Balcer.

She discussed optical coherence tomography (OCT), which is a key technique for diagnosing optic neuropathy. It measures the thickness of the retinal nerve fiber and ganglion cell layers, which have been associated with vision impairment and can reveal asymptomatic involvement of optic nerves in MS.
 

Beware of misdiagnosis

In the Q&A period following the talks, much of the discussion turned to reliability of ONL diagnoses.

“Misdiagnosis is a huge problem. That’s my experience: People who are referred to me with optic neuritis often don’t have optic neuritis,” said comoderator Wallace Brownlee, MBChB, PhD, a consultant neurologist at Cleveland Clinic London. Misha Pless, MD, spoke up from the audience to second that. “I’m delighted that the optic nerve will finally get a place at the table. I’ve been practicing neuro-ophthalmology and I have also [been] an MS doctor for about 25 years. What I see here in this fantastic discussion is that a lot of neurologists are going to be – I hate to use the word ‘misled’ – into relying on technology like OCT, VEP, and MRI to make the diagnosis. I will submit to this panel that that will lead to a number of MS misdiagnoses because I have been doing this for 25 years and the number of patients that I’ve received with rule-out optic neuritis that had macular disease, optical changes, or corneal abrasions are too numerous to count. If you’re going to add optic neuritis in the list of criteria [for MS], you definitely have to have a little asterisk in my opinion and say, ‘with prior blessing from an ophthalmologist to rule out ocular disease,’ because I don’t know any neurologist that knows how to look in the back of the eye, and I don’t know any neurologist that has an OCT in their office,” said Dr. Pless, professor of ophthalmology and a neurologist at Mayo Clinic in Jacksonville, Fla.

The panelists generally agreed with his point, although the hot mic picked up when one panelist whispered to another, ‘I have one,’ referring to an office OCT. “Using OCT in that regard, but also collaborating with your neuro-ophthalmologist and ophthalmologist is critical,” said Dr. Balcer.

Dr. Barkhof has financial relationships with Biogen, Merck, Roche, EISAI, Prothena, IXICO, Jansen, Combinostics, Novartis, GE, Queen Square, and Analytics. Dr. Vidal-Jordana has financial relationships with Roche, Novartis, Merck, and Sanofi. Dr. Balcer has no relevant financial disclosures. Dr. Brownlee has financial relationships with Biogen, Celgene, Merck, Mylan, Novartis, Roche, and Sanofi.

Comprehensive evaluation, multidisciplinary care, individualized treatment, and ongoing follow-up are all key to the management of pediatric thyroid nodules and differentiated thyroid carcinoma (DTC), according to the first European guidelines for this rare disease.

The guidelines were recently published in the European Thyroid Journal.

Lead author Chantal A. Lebbink told this news organization one of the key takeaways for clinicians is that management of pediatric thyroid nodules and DTC is «challenging and cannot be captured in a one-size-fits-all model.”

She also underlined the need for a “multidisciplinary approach in pediatric thyroid cancer expertise centers.”

Above all, Ms. Lebbink, who is a PhD student in the department of pediatric endocrinology, Wilhelmina Children’s Hospital, Utrecht, the Netherlands, said that pediatric DTC “is not adult DTC in a small person; it has different genetics and a different clinical behavior.”

The authors noted that DTC may be a rare disease, but its worldwide incidence is rising. It has several histologic subtypes, although the “vast majority” of cases are papillary thyroid carcinoma.

Crucially, there are “important differences” between adult and pediatric DTC in terms of their clinical, molecular, and pathologic characteristics, with pediatric patients commonly presenting with more advanced disease with greater lymph node involvement, distant metastases, and multifocal disease.

“However, despite the aggressive presentation, the overall survival rates are excellent,” Ms. Lebbink said.

There are also differences in genetic alterations between adult and pediatric patients. RET-PTC and NTRK fusions are more common in pediatric patients, while mutations in BRAF V600E and RAS point mutations are less frequent.
 

First European guidelines on thyroid cancer, thyroid nodules in children

Despite these differences, and the existence of U.S. guidelines, until now there have been no European recommendations on the management of pediatric thyroid nodules and DTC.

The European Thyroid Association therefore convened a panel of experts in pediatric and adult endocrinology, pathology, endocrine surgery, nuclear medicine, clinical genetics, and oncology, and tasked them with looking at diagnostics and staging, treatment, and follow-up.

The 2015 American Thyroid Association pediatric guideline was used as framework for the European guideline, with the expert panel identifying areas of discordance and outstanding clinical questions (Thyroid. 2015 Jul;25[7]:716-59).

To answer these questions, they searched PubMed and identified 3,251 studies, of which 45 studies met the inclusion criteria. From this they developed a comprehensive set of recommendations. These include that a child with suspected or proven cancer be referred to an experienced multidisciplinary team and their likely benefit from higher- versus lower-intensity treatment be established.

In addition, children should undergo a preoperative evaluation, with neck palpation, comprehensive neck ultrasonography, and laboratory work-up as a minimum, with further testing suggested in case of a family history or extensive disease.

Total thyroidectomy is the recommended treatment, although the authors call for further studies to assess the impact of limited surgery, and they suggest that prophylactic central lymph node dissection be reserved for advanced cases.

Crucially, all children “should be operated on by high-volume pediatric thyroid cancer surgeons with experience in pediatric thyroid cancer and who are embedded in a center with expertise in the management of DTC,” they wrote.
 

RAI therapy recommended for all children, in contrast to ATA guidelines

Radioactive iodine (I-131) therapy is recommended for all children following total thyroidectomy, with treatment following an individual patient-based approach.

This differs slightly from the ATA guidelines, which recommend against radioactive iodine (RAI) therapy for children with low-risk differentiated thyroid cancer that is mostly confined to the thyroid (N0 or minimal N1a disease). A study presented at the recent 2022 annual meeting of the ATA found that such children who were spared RAI showed no increases in risk of remission compared with those who did receive it.

The ETA guidelines then go on to recommend that children should be followed up with thyroid-stimulating hormone monitoring and suppression to low-normal levels, as well as serum thyroglobulin measurement and neck ultrasound, although other imaging modalities are not recommended.

In children with persistent or recurrent cervical disease, “surgery or I-131 therapy are indicated depending on the size, tumor load, and degree of progression,” and the authors said that cases of radioactive refractory disease should be “thoroughly investigated.”

Patients should also be counseled on the risk of the late effects of treatment for DTC and undergo monitoring, with follow-up continued for at least 10 years. Any subsequent follow-up should be “the result of shared decision-making between the physician and the patient.”
 

Evidence for molecular testing is scarce

Ms. Lebbink said that developing the guidelines nevertheless revealed a series of gaps in current knowledge, notably that the evidence for molecular testing “and the clinical implications in the preoperative stage are scarce.”

Specifically, the “positive and negative predictive value of molecular testing in fine needle biopsy specimen for the presence of DTC in a thyroid nodule must be further investigated.»

She also said that there has been a shift towards less aggressive treatment, due to a reluctance to performed prophylactic central neck dissection, and to offer I-131 therapy after surgery.

“However, before less aggressive treatment could be recommended,” Ms. Lebbink said, “it first must be investigated if there are differences in outcomes,” such as recurrence rates, disease-free survival rates, and survival rates between patients who do and do not receive the treatments.

No funding was declared. One author has reported relationships with Sanofi, AstraZeneca, Bayer, and GE. No other relevant financial relationships were reported.

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

Comprehensive evaluation, multidisciplinary care, individualized treatment, and ongoing follow-up are all key to the management of pediatric thyroid nodules and differentiated thyroid carcinoma (DTC), according to the first European guidelines for this rare disease.

The guidelines were recently published in the European Thyroid Journal.

Lead author Chantal A. Lebbink told this news organization one of the key takeaways for clinicians is that management of pediatric thyroid nodules and DTC is «challenging and cannot be captured in a one-size-fits-all model.”

She also underlined the need for a “multidisciplinary approach in pediatric thyroid cancer expertise centers.”

Above all, Ms. Lebbink, who is a PhD student in the department of pediatric endocrinology, Wilhelmina Children’s Hospital, Utrecht, the Netherlands, said that pediatric DTC “is not adult DTC in a small person; it has different genetics and a different clinical behavior.”

The authors noted that DTC may be a rare disease, but its worldwide incidence is rising. It has several histologic subtypes, although the “vast majority” of cases are papillary thyroid carcinoma.

Crucially, there are “important differences” between adult and pediatric DTC in terms of their clinical, molecular, and pathologic characteristics, with pediatric patients commonly presenting with more advanced disease with greater lymph node involvement, distant metastases, and multifocal disease.

“However, despite the aggressive presentation, the overall survival rates are excellent,” Ms. Lebbink said.

There are also differences in genetic alterations between adult and pediatric patients. RET-PTC and NTRK fusions are more common in pediatric patients, while mutations in BRAF V600E and RAS point mutations are less frequent.
 

First European guidelines on thyroid cancer, thyroid nodules in children

Despite these differences, and the existence of U.S. guidelines, until now there have been no European recommendations on the management of pediatric thyroid nodules and DTC.

The European Thyroid Association therefore convened a panel of experts in pediatric and adult endocrinology, pathology, endocrine surgery, nuclear medicine, clinical genetics, and oncology, and tasked them with looking at diagnostics and staging, treatment, and follow-up.

The 2015 American Thyroid Association pediatric guideline was used as framework for the European guideline, with the expert panel identifying areas of discordance and outstanding clinical questions (Thyroid. 2015 Jul;25[7]:716-59).

To answer these questions, they searched PubMed and identified 3,251 studies, of which 45 studies met the inclusion criteria. From this they developed a comprehensive set of recommendations. These include that a child with suspected or proven cancer be referred to an experienced multidisciplinary team and their likely benefit from higher- versus lower-intensity treatment be established.

In addition, children should undergo a preoperative evaluation, with neck palpation, comprehensive neck ultrasonography, and laboratory work-up as a minimum, with further testing suggested in case of a family history or extensive disease.

Total thyroidectomy is the recommended treatment, although the authors call for further studies to assess the impact of limited surgery, and they suggest that prophylactic central lymph node dissection be reserved for advanced cases.

Crucially, all children “should be operated on by high-volume pediatric thyroid cancer surgeons with experience in pediatric thyroid cancer and who are embedded in a center with expertise in the management of DTC,” they wrote.
 

RAI therapy recommended for all children, in contrast to ATA guidelines

Radioactive iodine (I-131) therapy is recommended for all children following total thyroidectomy, with treatment following an individual patient-based approach.

This differs slightly from the ATA guidelines, which recommend against radioactive iodine (RAI) therapy for children with low-risk differentiated thyroid cancer that is mostly confined to the thyroid (N0 or minimal N1a disease). A study presented at the recent 2022 annual meeting of the ATA found that such children who were spared RAI showed no increases in risk of remission compared with those who did receive it.

The ETA guidelines then go on to recommend that children should be followed up with thyroid-stimulating hormone monitoring and suppression to low-normal levels, as well as serum thyroglobulin measurement and neck ultrasound, although other imaging modalities are not recommended.

In children with persistent or recurrent cervical disease, “surgery or I-131 therapy are indicated depending on the size, tumor load, and degree of progression,” and the authors said that cases of radioactive refractory disease should be “thoroughly investigated.”

Patients should also be counseled on the risk of the late effects of treatment for DTC and undergo monitoring, with follow-up continued for at least 10 years. Any subsequent follow-up should be “the result of shared decision-making between the physician and the patient.”
 

Evidence for molecular testing is scarce

Ms. Lebbink said that developing the guidelines nevertheless revealed a series of gaps in current knowledge, notably that the evidence for molecular testing “and the clinical implications in the preoperative stage are scarce.”

Specifically, the “positive and negative predictive value of molecular testing in fine needle biopsy specimen for the presence of DTC in a thyroid nodule must be further investigated.»

She also said that there has been a shift towards less aggressive treatment, due to a reluctance to performed prophylactic central neck dissection, and to offer I-131 therapy after surgery.

“However, before less aggressive treatment could be recommended,” Ms. Lebbink said, “it first must be investigated if there are differences in outcomes,” such as recurrence rates, disease-free survival rates, and survival rates between patients who do and do not receive the treatments.

No funding was declared. One author has reported relationships with Sanofi, AstraZeneca, Bayer, and GE. No other relevant financial relationships were reported.

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

Comprehensive evaluation, multidisciplinary care, individualized treatment, and ongoing follow-up are all key to the management of pediatric thyroid nodules and differentiated thyroid carcinoma (DTC), according to the first European guidelines for this rare disease.

The guidelines were recently published in the European Thyroid Journal.

Lead author Chantal A. Lebbink told this news organization one of the key takeaways for clinicians is that management of pediatric thyroid nodules and DTC is «challenging and cannot be captured in a one-size-fits-all model.”

She also underlined the need for a “multidisciplinary approach in pediatric thyroid cancer expertise centers.”

Above all, Ms. Lebbink, who is a PhD student in the department of pediatric endocrinology, Wilhelmina Children’s Hospital, Utrecht, the Netherlands, said that pediatric DTC “is not adult DTC in a small person; it has different genetics and a different clinical behavior.”

The authors noted that DTC may be a rare disease, but its worldwide incidence is rising. It has several histologic subtypes, although the “vast majority” of cases are papillary thyroid carcinoma.

Crucially, there are “important differences” between adult and pediatric DTC in terms of their clinical, molecular, and pathologic characteristics, with pediatric patients commonly presenting with more advanced disease with greater lymph node involvement, distant metastases, and multifocal disease.

“However, despite the aggressive presentation, the overall survival rates are excellent,” Ms. Lebbink said.

There are also differences in genetic alterations between adult and pediatric patients. RET-PTC and NTRK fusions are more common in pediatric patients, while mutations in BRAF V600E and RAS point mutations are less frequent.
 

First European guidelines on thyroid cancer, thyroid nodules in children

Despite these differences, and the existence of U.S. guidelines, until now there have been no European recommendations on the management of pediatric thyroid nodules and DTC.

The European Thyroid Association therefore convened a panel of experts in pediatric and adult endocrinology, pathology, endocrine surgery, nuclear medicine, clinical genetics, and oncology, and tasked them with looking at diagnostics and staging, treatment, and follow-up.

The 2015 American Thyroid Association pediatric guideline was used as framework for the European guideline, with the expert panel identifying areas of discordance and outstanding clinical questions (Thyroid. 2015 Jul;25[7]:716-59).

To answer these questions, they searched PubMed and identified 3,251 studies, of which 45 studies met the inclusion criteria. From this they developed a comprehensive set of recommendations. These include that a child with suspected or proven cancer be referred to an experienced multidisciplinary team and their likely benefit from higher- versus lower-intensity treatment be established.

In addition, children should undergo a preoperative evaluation, with neck palpation, comprehensive neck ultrasonography, and laboratory work-up as a minimum, with further testing suggested in case of a family history or extensive disease.

Total thyroidectomy is the recommended treatment, although the authors call for further studies to assess the impact of limited surgery, and they suggest that prophylactic central lymph node dissection be reserved for advanced cases.

Crucially, all children “should be operated on by high-volume pediatric thyroid cancer surgeons with experience in pediatric thyroid cancer and who are embedded in a center with expertise in the management of DTC,” they wrote.
 

RAI therapy recommended for all children, in contrast to ATA guidelines

Radioactive iodine (I-131) therapy is recommended for all children following total thyroidectomy, with treatment following an individual patient-based approach.

This differs slightly from the ATA guidelines, which recommend against radioactive iodine (RAI) therapy for children with low-risk differentiated thyroid cancer that is mostly confined to the thyroid (N0 or minimal N1a disease). A study presented at the recent 2022 annual meeting of the ATA found that such children who were spared RAI showed no increases in risk of remission compared with those who did receive it.

The ETA guidelines then go on to recommend that children should be followed up with thyroid-stimulating hormone monitoring and suppression to low-normal levels, as well as serum thyroglobulin measurement and neck ultrasound, although other imaging modalities are not recommended.

In children with persistent or recurrent cervical disease, “surgery or I-131 therapy are indicated depending on the size, tumor load, and degree of progression,” and the authors said that cases of radioactive refractory disease should be “thoroughly investigated.”

Patients should also be counseled on the risk of the late effects of treatment for DTC and undergo monitoring, with follow-up continued for at least 10 years. Any subsequent follow-up should be “the result of shared decision-making between the physician and the patient.”
 

Evidence for molecular testing is scarce

Ms. Lebbink said that developing the guidelines nevertheless revealed a series of gaps in current knowledge, notably that the evidence for molecular testing “and the clinical implications in the preoperative stage are scarce.”

Specifically, the “positive and negative predictive value of molecular testing in fine needle biopsy specimen for the presence of DTC in a thyroid nodule must be further investigated.»

She also said that there has been a shift towards less aggressive treatment, due to a reluctance to performed prophylactic central neck dissection, and to offer I-131 therapy after surgery.

“However, before less aggressive treatment could be recommended,” Ms. Lebbink said, “it first must be investigated if there are differences in outcomes,” such as recurrence rates, disease-free survival rates, and survival rates between patients who do and do not receive the treatments.

No funding was declared. One author has reported relationships with Sanofi, AstraZeneca, Bayer, and GE. No other relevant financial relationships were reported.

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

In a subgroup of patients with hepatorenal syndrome type 1 (HRS) who received a liver transplant, terlipressin treatment appears to reduce the need for renal replacement therapy (RRT) through 12 months of follow-up, according to a study presented at the annual meeting of the American College of Gastroenterology.

Among transplant recipients, overall 12-month survival was 11% higher for those treated with terlipressin compared with placebo, said K. Rajender Reddy, MD, director of hepatology and medical director of liver transplantation at the University of Pennsylvania, Philadelphia.

“Hepatorenal syndrome type 1 is a potentially reversible form of acute kidney injury that occurs in the setting of end-stage liver disease,” he said.

Liver transplantation, which eliminates end-stage liver disease, is the only definitive treatment for HRS. However, renal replacement therapy is common and associated with poor clinical outcomes and low patient survival rates in both the pretransplant and posttransplant settings, he noted.

Terlipressin, an injectable synthetic vasopressin analogue, restores renal blood flow and reverses HRS in 20%-40% of patients, Dr. Reddy said. In September, the U.S. Food and Drug Administration approved terlipressin (Terlivaz) for patients with HRS type 1. The label has a boxed warning for serious or fatal respiratory failure.

The safety and efficacy were assessed in the phase 3 CONFIRM trial, which Dr. Reddy and colleagues previously published. The randomized, placebo-controlled study demonstrated that terlipressin reversed HRS and reduced the need for RRT through day 30. The reversal of HRS with terlipressin did not improve 90-day survival as compared with placebo, which researchers attributed to a higher death rate within 90 days after the first dose despite improved kidney function.

A closer look at the liver transplant patients

In the subgroup analysis of the CONFIRM study, Dr. Reddy and colleagues analyzed the clinical outcomes through 12 months of follow-up in patients with HRS who received a liver transplant. They looked at the incidence of verified HRS reversal, HRS reversal, need for RRT, and overall survival.

Verified HRS reversal was defined as two consecutive serum creatinine measurements of 1.5 mg/dL or less at least 2 hours apart up to day 14 and survival without RRT for at least 10 days. HRS reversal was defined as a serum creatinine level of 1.5 mg/dL or less while on treatment. In addition, the need for RRT and overall survival were assessed at days 30, 60, 90, 180, and 365.

RRT was defined as any procedure that replaced nonendocrine kidney function, including continuous hemofiltration and hemodialysis, intermittent hemodialysis, peritoneal dialysis, ultrafiltration, or other dialysis and filtration techniques.

In the CONFIRM study, 199 patients with HRS were treated with terlipressin plus albumin, and 101 patients were treated with placebo plus albumin for up to 14 days. In the terlipressin group, 46 patients received liver transplants within the first 2 months of the study, as did 29 in the placebo group. Two patients in the terlipressin group and one in the placebo group received a simultaneous liver-kidney transplant.
 

Meaningful clinical outcomes

In the 12-month follow-up subgroup analysis, verified HRS reversal was statistically comparable between the groups, with a 30% decrease in the terlipressin group and 17% decrease in the placebo group, Dr. Reddy reported.

HRS reversal was higher in the terlipressin group, at 37%, as compared with 14% in the placebo group.

The pretransplant need for RRT was lower in the terlipressin group, at 30%, as compared with 62% in the placebo group. The posttransplant need for RRT remained numerically lower in the terlipressin group at all time points and was significantly lower at day 180 and day 365.

Overall survival for transplant recipients in the terlipressin group was 94%, as compared with 83% in the placebo group. Posttreatment adverse events and severe adverse events were similar between the groups.

“Collectively, these data indicate that terlipressin treatment in patients with HRS led to better long-term clinical outcomes in those who received a liver transplant,” Dr. Reddy said.

The study was funded by Mallinckrodt Pharmaceuticals, which manufactures terlipressin. One author is an employee of Mallinckrodt, and the other authors have served in an advisory role or received grant support from Mallinckrodt. The authors also disclosed consultant roles and research support from several other pharmaceutical companies.

In a subgroup of patients with hepatorenal syndrome type 1 (HRS) who received a liver transplant, terlipressin treatment appears to reduce the need for renal replacement therapy (RRT) through 12 months of follow-up, according to a study presented at the annual meeting of the American College of Gastroenterology.

Among transplant recipients, overall 12-month survival was 11% higher for those treated with terlipressin compared with placebo, said K. Rajender Reddy, MD, director of hepatology and medical director of liver transplantation at the University of Pennsylvania, Philadelphia.

“Hepatorenal syndrome type 1 is a potentially reversible form of acute kidney injury that occurs in the setting of end-stage liver disease,” he said.

Liver transplantation, which eliminates end-stage liver disease, is the only definitive treatment for HRS. However, renal replacement therapy is common and associated with poor clinical outcomes and low patient survival rates in both the pretransplant and posttransplant settings, he noted.

Terlipressin, an injectable synthetic vasopressin analogue, restores renal blood flow and reverses HRS in 20%-40% of patients, Dr. Reddy said. In September, the U.S. Food and Drug Administration approved terlipressin (Terlivaz) for patients with HRS type 1. The label has a boxed warning for serious or fatal respiratory failure.

The safety and efficacy were assessed in the phase 3 CONFIRM trial, which Dr. Reddy and colleagues previously published. The randomized, placebo-controlled study demonstrated that terlipressin reversed HRS and reduced the need for RRT through day 30. The reversal of HRS with terlipressin did not improve 90-day survival as compared with placebo, which researchers attributed to a higher death rate within 90 days after the first dose despite improved kidney function.

A closer look at the liver transplant patients

In the subgroup analysis of the CONFIRM study, Dr. Reddy and colleagues analyzed the clinical outcomes through 12 months of follow-up in patients with HRS who received a liver transplant. They looked at the incidence of verified HRS reversal, HRS reversal, need for RRT, and overall survival.

Verified HRS reversal was defined as two consecutive serum creatinine measurements of 1.5 mg/dL or less at least 2 hours apart up to day 14 and survival without RRT for at least 10 days. HRS reversal was defined as a serum creatinine level of 1.5 mg/dL or less while on treatment. In addition, the need for RRT and overall survival were assessed at days 30, 60, 90, 180, and 365.

RRT was defined as any procedure that replaced nonendocrine kidney function, including continuous hemofiltration and hemodialysis, intermittent hemodialysis, peritoneal dialysis, ultrafiltration, or other dialysis and filtration techniques.

In the CONFIRM study, 199 patients with HRS were treated with terlipressin plus albumin, and 101 patients were treated with placebo plus albumin for up to 14 days. In the terlipressin group, 46 patients received liver transplants within the first 2 months of the study, as did 29 in the placebo group. Two patients in the terlipressin group and one in the placebo group received a simultaneous liver-kidney transplant.
 

Meaningful clinical outcomes

In the 12-month follow-up subgroup analysis, verified HRS reversal was statistically comparable between the groups, with a 30% decrease in the terlipressin group and 17% decrease in the placebo group, Dr. Reddy reported.

HRS reversal was higher in the terlipressin group, at 37%, as compared with 14% in the placebo group.

The pretransplant need for RRT was lower in the terlipressin group, at 30%, as compared with 62% in the placebo group. The posttransplant need for RRT remained numerically lower in the terlipressin group at all time points and was significantly lower at day 180 and day 365.

Overall survival for transplant recipients in the terlipressin group was 94%, as compared with 83% in the placebo group. Posttreatment adverse events and severe adverse events were similar between the groups.

“Collectively, these data indicate that terlipressin treatment in patients with HRS led to better long-term clinical outcomes in those who received a liver transplant,” Dr. Reddy said.

The study was funded by Mallinckrodt Pharmaceuticals, which manufactures terlipressin. One author is an employee of Mallinckrodt, and the other authors have served in an advisory role or received grant support from Mallinckrodt. The authors also disclosed consultant roles and research support from several other pharmaceutical companies.

In a subgroup of patients with hepatorenal syndrome type 1 (HRS) who received a liver transplant, terlipressin treatment appears to reduce the need for renal replacement therapy (RRT) through 12 months of follow-up, according to a study presented at the annual meeting of the American College of Gastroenterology.

Among transplant recipients, overall 12-month survival was 11% higher for those treated with terlipressin compared with placebo, said K. Rajender Reddy, MD, director of hepatology and medical director of liver transplantation at the University of Pennsylvania, Philadelphia.

“Hepatorenal syndrome type 1 is a potentially reversible form of acute kidney injury that occurs in the setting of end-stage liver disease,” he said.

Liver transplantation, which eliminates end-stage liver disease, is the only definitive treatment for HRS. However, renal replacement therapy is common and associated with poor clinical outcomes and low patient survival rates in both the pretransplant and posttransplant settings, he noted.

Terlipressin, an injectable synthetic vasopressin analogue, restores renal blood flow and reverses HRS in 20%-40% of patients, Dr. Reddy said. In September, the U.S. Food and Drug Administration approved terlipressin (Terlivaz) for patients with HRS type 1. The label has a boxed warning for serious or fatal respiratory failure.

The safety and efficacy were assessed in the phase 3 CONFIRM trial, which Dr. Reddy and colleagues previously published. The randomized, placebo-controlled study demonstrated that terlipressin reversed HRS and reduced the need for RRT through day 30. The reversal of HRS with terlipressin did not improve 90-day survival as compared with placebo, which researchers attributed to a higher death rate within 90 days after the first dose despite improved kidney function.

A closer look at the liver transplant patients

In the subgroup analysis of the CONFIRM study, Dr. Reddy and colleagues analyzed the clinical outcomes through 12 months of follow-up in patients with HRS who received a liver transplant. They looked at the incidence of verified HRS reversal, HRS reversal, need for RRT, and overall survival.

Verified HRS reversal was defined as two consecutive serum creatinine measurements of 1.5 mg/dL or less at least 2 hours apart up to day 14 and survival without RRT for at least 10 days. HRS reversal was defined as a serum creatinine level of 1.5 mg/dL or less while on treatment. In addition, the need for RRT and overall survival were assessed at days 30, 60, 90, 180, and 365.

RRT was defined as any procedure that replaced nonendocrine kidney function, including continuous hemofiltration and hemodialysis, intermittent hemodialysis, peritoneal dialysis, ultrafiltration, or other dialysis and filtration techniques.

In the CONFIRM study, 199 patients with HRS were treated with terlipressin plus albumin, and 101 patients were treated with placebo plus albumin for up to 14 days. In the terlipressin group, 46 patients received liver transplants within the first 2 months of the study, as did 29 in the placebo group. Two patients in the terlipressin group and one in the placebo group received a simultaneous liver-kidney transplant.
 

Meaningful clinical outcomes

In the 12-month follow-up subgroup analysis, verified HRS reversal was statistically comparable between the groups, with a 30% decrease in the terlipressin group and 17% decrease in the placebo group, Dr. Reddy reported.

HRS reversal was higher in the terlipressin group, at 37%, as compared with 14% in the placebo group.

The pretransplant need for RRT was lower in the terlipressin group, at 30%, as compared with 62% in the placebo group. The posttransplant need for RRT remained numerically lower in the terlipressin group at all time points and was significantly lower at day 180 and day 365.

Overall survival for transplant recipients in the terlipressin group was 94%, as compared with 83% in the placebo group. Posttreatment adverse events and severe adverse events were similar between the groups.

“Collectively, these data indicate that terlipressin treatment in patients with HRS led to better long-term clinical outcomes in those who received a liver transplant,” Dr. Reddy said.

The study was funded by Mallinckrodt Pharmaceuticals, which manufactures terlipressin. One author is an employee of Mallinckrodt, and the other authors have served in an advisory role or received grant support from Mallinckrodt. The authors also disclosed consultant roles and research support from several other pharmaceutical companies.

CHARLOTTE, N.C. – RBX2660 could be a new option for people who experience recurrent, debilitating Clostridioides difficile infections.

Following a standard course of antibiotics, a one-time treatment with RBX2660 was successful for three quarters of participants at 8 weeks, according to a new study. It also prevented additional bouts, with 84% of these initial responders remaining free of C. difficile infection at 6 months.

The ongoing phase 3, open-label PUNCH CD3-OLS study expands on clinical trial experience by treating more “real-world” patients. People who might have been excluded from previous research because of comorbidities, such as irritable bowel syndrome, inflammatory bowel disease, and immunosuppression, were included.

The study also placed no limit on the number of previous rounds of C. difficile infections.

“Even when you expand the patient population to make it more generalizable, we’re still seeing both a high cure rate and a high success rate,” Sahil Khanna, MBBS, a gastroenterologist and hepatologist at the Mayo Clinic in Rochester, Minn., said in an interview.

“We also are not seeing any kind of safety signals that can be attributed to this particular product,” he said.

Dr. Khanna presented the findings during the annual meeting of the American College of Gastroenterology, which were also published simultaneously in the journal Drugs. The research by Dr. Khanna and associates received an ACG Outstanding Research Award in the colon category.
 

Study design and results

RBX2660 (Rebyota) is a microbiota-based live biotherapeutic in development from Ferring Pharmaceuticals. The treatment contains human stool collected from prescreened, qualified donors and is prepared according to good manufacturing standards.

After standard-of-care antibiotics and a 72-hour washout period, participants received a single 150-mL dose rectally by enema. RBX2660 is administered by a health care professional.

The median age of study participants was 63 years, with 45% aged 65 years or older, and 70% were women. Overall, 37% of participants had Crohn’s disease and 4% had ulcerative colitis.

At the time of screening, about half of participants had a history of one or two infections with C. difficile, and the remaining half reported three or more episodes.

Of the 402 participants whose outcomes could be analyzed, 75% reported treatment success, meaning no further C. difficile infections at 8 weeks. This was consistent with the 75% of 60 participants free of C. difficile in the interim analysis reported in 2021. Efficacy results were based on a modified intent-to-treat analysis.

Of the 300 participants who responded to RBX2660 at 8 weeks, 262 were followed up to 6 months, with 84% of these reporting no C. difficile recurrence.

“If you succeeded to 8 weeks, there was a high likelihood that you would succeed up to 6 months,” Dr. Khanna said.

For the subset of participants with inflammatory bowel disease, Dr. Khanna noted that the success rates were in the 80% range, which is higher than what is seen in clinic fecal microbiota transplantation programs.
 

Adverse events

Of the participants, 63% reported treatment-emergent adverse events. Most events were mild to moderate in severity, the researchers reported, with diarrhea and abdominal pain being the most common.

“When you look at the treatment-emergent adverse events, it’s important to put them into context in terms of this patient population,” Dr. Khanna said. “This recurrent population has developed underlying gastrointestinal symptoms like abdominal pain, diarrhea, nausea, vomiting, and weight loss.”

Some of these adverse events persist beyond resolution of the C. difficile infection, and the adverse-event profile with RBX2660 is consistent with what is seen following fecal microbiota transplantation, he added.

The serious adverse events “were very, very few,” Dr. Khanna said.

Overall, 11% of participants reported a serious adverse event. The majority were related to the C. difficile infection or an underlying comorbidity, he noted.
 

“Excruciating for patients to deal with”

Traditionally, there could be “some hesitation on the patient’s part [to undergo therapy] just because it’s delivered rectally,” session comoderator Lisa Malter, MD, said in an interview.

However, C. difficile can be “excruciating for patients to deal with,” said Dr. Malter, a gastroenterologist and professor of medicine at New York University Langone Health. They “may be more than willing to take [this agent] because it gets them feeling better.”

“This is a positive adjunct to our current therapies for C. diff in terms of trying to knock it out once a standard course of antibiotics has been administered,” she added.

Currently, people with recurrent C. difficile seek fecal microbiota material from a biobank or from a close friend or loved one.

But Dr. Malter noted that asking someone you know to donate fecal matter for transplantation requires several steps. Donors are screened to make sure they are free of gastrointestinal illness, are not taking any contraindicated medications, and do not have active infection.

Fecal microbiota samples from a biobank are more standardized, but there have been intermittent shutdowns and availability has been limited during the pandemic, she said.

Dr. Malter added that one unanswered question is how much of the colon is covered by therapy delivery via enema compared with colonoscope delivery during fecal microbiota transplantation.

“If it’s delivered colonoscopically, you get the entire colon. In contrast with an enema, you really only hit the left side of the colon,” she said.
 

FDA advisory committee nod

On Sept. 26, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee reviewed evidence for RBX2660. The committee voted 13 to 4 that data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of C. difficile infection in adults following antibiotic treatment for recurrent infections.

Members also voted 12 to 4, with one abstention, that the data were adequate to support the product’s safety.

The FDA often follows its advisory committee recommendations but is not required to do so.

“The hope would be that this would get through the usual FDA pipeline of an approval in the near future,” Dr. Khanna said.

The study was funded by Ferring Pharmaceuticals. Dr. Khanna reported receiving grant and research funding from Ferring. Dr. Malter reported no relevant financial relationships.

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

CHARLOTTE, N.C. – RBX2660 could be a new option for people who experience recurrent, debilitating Clostridioides difficile infections.

Following a standard course of antibiotics, a one-time treatment with RBX2660 was successful for three quarters of participants at 8 weeks, according to a new study. It also prevented additional bouts, with 84% of these initial responders remaining free of C. difficile infection at 6 months.

The ongoing phase 3, open-label PUNCH CD3-OLS study expands on clinical trial experience by treating more “real-world” patients. People who might have been excluded from previous research because of comorbidities, such as irritable bowel syndrome, inflammatory bowel disease, and immunosuppression, were included.

The study also placed no limit on the number of previous rounds of C. difficile infections.

“Even when you expand the patient population to make it more generalizable, we’re still seeing both a high cure rate and a high success rate,” Sahil Khanna, MBBS, a gastroenterologist and hepatologist at the Mayo Clinic in Rochester, Minn., said in an interview.

“We also are not seeing any kind of safety signals that can be attributed to this particular product,” he said.

Dr. Khanna presented the findings during the annual meeting of the American College of Gastroenterology, which were also published simultaneously in the journal Drugs. The research by Dr. Khanna and associates received an ACG Outstanding Research Award in the colon category.
 

Study design and results

RBX2660 (Rebyota) is a microbiota-based live biotherapeutic in development from Ferring Pharmaceuticals. The treatment contains human stool collected from prescreened, qualified donors and is prepared according to good manufacturing standards.

After standard-of-care antibiotics and a 72-hour washout period, participants received a single 150-mL dose rectally by enema. RBX2660 is administered by a health care professional.

The median age of study participants was 63 years, with 45% aged 65 years or older, and 70% were women. Overall, 37% of participants had Crohn’s disease and 4% had ulcerative colitis.

At the time of screening, about half of participants had a history of one or two infections with C. difficile, and the remaining half reported three or more episodes.

Of the 402 participants whose outcomes could be analyzed, 75% reported treatment success, meaning no further C. difficile infections at 8 weeks. This was consistent with the 75% of 60 participants free of C. difficile in the interim analysis reported in 2021. Efficacy results were based on a modified intent-to-treat analysis.

Of the 300 participants who responded to RBX2660 at 8 weeks, 262 were followed up to 6 months, with 84% of these reporting no C. difficile recurrence.

“If you succeeded to 8 weeks, there was a high likelihood that you would succeed up to 6 months,” Dr. Khanna said.

For the subset of participants with inflammatory bowel disease, Dr. Khanna noted that the success rates were in the 80% range, which is higher than what is seen in clinic fecal microbiota transplantation programs.
 

Adverse events

Of the participants, 63% reported treatment-emergent adverse events. Most events were mild to moderate in severity, the researchers reported, with diarrhea and abdominal pain being the most common.

“When you look at the treatment-emergent adverse events, it’s important to put them into context in terms of this patient population,” Dr. Khanna said. “This recurrent population has developed underlying gastrointestinal symptoms like abdominal pain, diarrhea, nausea, vomiting, and weight loss.”

Some of these adverse events persist beyond resolution of the C. difficile infection, and the adverse-event profile with RBX2660 is consistent with what is seen following fecal microbiota transplantation, he added.

The serious adverse events “were very, very few,” Dr. Khanna said.

Overall, 11% of participants reported a serious adverse event. The majority were related to the C. difficile infection or an underlying comorbidity, he noted.
 

“Excruciating for patients to deal with”

Traditionally, there could be “some hesitation on the patient’s part [to undergo therapy] just because it’s delivered rectally,” session comoderator Lisa Malter, MD, said in an interview.

However, C. difficile can be “excruciating for patients to deal with,” said Dr. Malter, a gastroenterologist and professor of medicine at New York University Langone Health. They “may be more than willing to take [this agent] because it gets them feeling better.”

“This is a positive adjunct to our current therapies for C. diff in terms of trying to knock it out once a standard course of antibiotics has been administered,” she added.

Currently, people with recurrent C. difficile seek fecal microbiota material from a biobank or from a close friend or loved one.

But Dr. Malter noted that asking someone you know to donate fecal matter for transplantation requires several steps. Donors are screened to make sure they are free of gastrointestinal illness, are not taking any contraindicated medications, and do not have active infection.

Fecal microbiota samples from a biobank are more standardized, but there have been intermittent shutdowns and availability has been limited during the pandemic, she said.

Dr. Malter added that one unanswered question is how much of the colon is covered by therapy delivery via enema compared with colonoscope delivery during fecal microbiota transplantation.

“If it’s delivered colonoscopically, you get the entire colon. In contrast with an enema, you really only hit the left side of the colon,” she said.
 

FDA advisory committee nod

On Sept. 26, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee reviewed evidence for RBX2660. The committee voted 13 to 4 that data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of C. difficile infection in adults following antibiotic treatment for recurrent infections.

Members also voted 12 to 4, with one abstention, that the data were adequate to support the product’s safety.

The FDA often follows its advisory committee recommendations but is not required to do so.

“The hope would be that this would get through the usual FDA pipeline of an approval in the near future,” Dr. Khanna said.

The study was funded by Ferring Pharmaceuticals. Dr. Khanna reported receiving grant and research funding from Ferring. Dr. Malter reported no relevant financial relationships.

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

CHARLOTTE, N.C. – RBX2660 could be a new option for people who experience recurrent, debilitating Clostridioides difficile infections.

Following a standard course of antibiotics, a one-time treatment with RBX2660 was successful for three quarters of participants at 8 weeks, according to a new study. It also prevented additional bouts, with 84% of these initial responders remaining free of C. difficile infection at 6 months.

The ongoing phase 3, open-label PUNCH CD3-OLS study expands on clinical trial experience by treating more “real-world” patients. People who might have been excluded from previous research because of comorbidities, such as irritable bowel syndrome, inflammatory bowel disease, and immunosuppression, were included.

The study also placed no limit on the number of previous rounds of C. difficile infections.

“Even when you expand the patient population to make it more generalizable, we’re still seeing both a high cure rate and a high success rate,” Sahil Khanna, MBBS, a gastroenterologist and hepatologist at the Mayo Clinic in Rochester, Minn., said in an interview.

“We also are not seeing any kind of safety signals that can be attributed to this particular product,” he said.

Dr. Khanna presented the findings during the annual meeting of the American College of Gastroenterology, which were also published simultaneously in the journal Drugs. The research by Dr. Khanna and associates received an ACG Outstanding Research Award in the colon category.
 

Study design and results

RBX2660 (Rebyota) is a microbiota-based live biotherapeutic in development from Ferring Pharmaceuticals. The treatment contains human stool collected from prescreened, qualified donors and is prepared according to good manufacturing standards.

After standard-of-care antibiotics and a 72-hour washout period, participants received a single 150-mL dose rectally by enema. RBX2660 is administered by a health care professional.

The median age of study participants was 63 years, with 45% aged 65 years or older, and 70% were women. Overall, 37% of participants had Crohn’s disease and 4% had ulcerative colitis.

At the time of screening, about half of participants had a history of one or two infections with C. difficile, and the remaining half reported three or more episodes.

Of the 402 participants whose outcomes could be analyzed, 75% reported treatment success, meaning no further C. difficile infections at 8 weeks. This was consistent with the 75% of 60 participants free of C. difficile in the interim analysis reported in 2021. Efficacy results were based on a modified intent-to-treat analysis.

Of the 300 participants who responded to RBX2660 at 8 weeks, 262 were followed up to 6 months, with 84% of these reporting no C. difficile recurrence.

“If you succeeded to 8 weeks, there was a high likelihood that you would succeed up to 6 months,” Dr. Khanna said.

For the subset of participants with inflammatory bowel disease, Dr. Khanna noted that the success rates were in the 80% range, which is higher than what is seen in clinic fecal microbiota transplantation programs.
 

Adverse events

Of the participants, 63% reported treatment-emergent adverse events. Most events were mild to moderate in severity, the researchers reported, with diarrhea and abdominal pain being the most common.

“When you look at the treatment-emergent adverse events, it’s important to put them into context in terms of this patient population,” Dr. Khanna said. “This recurrent population has developed underlying gastrointestinal symptoms like abdominal pain, diarrhea, nausea, vomiting, and weight loss.”

Some of these adverse events persist beyond resolution of the C. difficile infection, and the adverse-event profile with RBX2660 is consistent with what is seen following fecal microbiota transplantation, he added.

The serious adverse events “were very, very few,” Dr. Khanna said.

Overall, 11% of participants reported a serious adverse event. The majority were related to the C. difficile infection or an underlying comorbidity, he noted.
 

“Excruciating for patients to deal with”

Traditionally, there could be “some hesitation on the patient’s part [to undergo therapy] just because it’s delivered rectally,” session comoderator Lisa Malter, MD, said in an interview.

However, C. difficile can be “excruciating for patients to deal with,” said Dr. Malter, a gastroenterologist and professor of medicine at New York University Langone Health. They “may be more than willing to take [this agent] because it gets them feeling better.”

“This is a positive adjunct to our current therapies for C. diff in terms of trying to knock it out once a standard course of antibiotics has been administered,” she added.

Currently, people with recurrent C. difficile seek fecal microbiota material from a biobank or from a close friend or loved one.

But Dr. Malter noted that asking someone you know to donate fecal matter for transplantation requires several steps. Donors are screened to make sure they are free of gastrointestinal illness, are not taking any contraindicated medications, and do not have active infection.

Fecal microbiota samples from a biobank are more standardized, but there have been intermittent shutdowns and availability has been limited during the pandemic, she said.

Dr. Malter added that one unanswered question is how much of the colon is covered by therapy delivery via enema compared with colonoscope delivery during fecal microbiota transplantation.

“If it’s delivered colonoscopically, you get the entire colon. In contrast with an enema, you really only hit the left side of the colon,” she said.
 

FDA advisory committee nod

On Sept. 26, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee reviewed evidence for RBX2660. The committee voted 13 to 4 that data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of C. difficile infection in adults following antibiotic treatment for recurrent infections.

Members also voted 12 to 4, with one abstention, that the data were adequate to support the product’s safety.

The FDA often follows its advisory committee recommendations but is not required to do so.

“The hope would be that this would get through the usual FDA pipeline of an approval in the near future,” Dr. Khanna said.

The study was funded by Ferring Pharmaceuticals. Dr. Khanna reported receiving grant and research funding from Ferring. Dr. Malter reported no relevant financial relationships.

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

Patients with relapsing-remitting multiple sclerosis (MS) treated with autologous hematopoietic stem cell transplantation (AHSCT) were 74% more likely than were those taking fingolimod to be relapse free 1 year after treatment, a new study suggests.

The multicenter observational study showed that AHSCT was associated with a better overall annual relapse rate and significantly greater disability improvement versus fingolimod. Stem cell transplantation also offered a slight advantage compared with natalizumab but showed no benefit over ocrelizumab.

“Based on these results, we can conclude that in this observational study AHSCT is substantially superior to fingolimod and marginally superior to natalizumab in reducing the risk of posttreatment relapses,” study investigator Tomas Kalincik, MD, PhD, said at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Research gap

Prior studies have suggested that AHSCT is associated with better disability outcomes than other immunotherapies in patients with active secondary progressive MS. Findings from another study on long-term efficacy in relapse prevention are also promising.

“The information that we are still lacking is the head-to-head comparison of the effectiveness of AHSCT in relapsing-remitting disease to concrete, highly effective therapies, which is the aim of this current study,” said Dr. Kalincik, professor of neurology at the University of Melbourne and head of the Multiple Sclerosis and Neuroimmunology Service at the Royal Melbourne Hospital, Australia.

The study included 167 patients with relapsing-remitting MS from six centers in Ottawa, Uppsala, Sheffield, Bergen, Sydney, and Melbourne, combined with 1,675 patients from MSBase. Patients were included if they were treated with AHSCT or fingolimod (n = 769), natalizumab (n = 730) or ocrelizumab (n = 343).

Researchers used propensity matching to ensure the AHSCT and disease-modifying therapy (DMT) groups had similar relapse rates and disability scores at baseline. At 1 year, patients who underwent AHSCT were 74% more likely than were those on fingolimod to be relapse free (hazard ratio [HR], 0.26; P < .0001).

The AHSCT group had a lower overall annualized relapse rate (0.09 vs. 0.19, respectively; P < .0001) and a higher cumulative probability of remaining relapse free at 2 years (90% vs. 68%, respectively) and 5 years (85% vs. 54%, respectively). AHSCT was associated with significantly better confirmed disability improvement at 6 months compared with fingolimod (HR, 2.70; P < .0001).

The researchers found better outcomes with AHSCT compared with natalizumab, but the results weren’t as promising. The annual relapse rate with AHSCT was statistically significant (P = .03) but the clinical benefit was marginal, Dr. Kalincik said. However, the confirmed disability improvement was significantly better with AHSCT (HR, 2.68; P < .0001).

There was no significant difference in outcomes with AHSCT compared to ocrelizumab.

Adverse events were common with stem cell transplantation, a sticking point for at least one conference attendee who raised safety concerns. Among those treated with AHSCT, 23% had febrile neutropenia, 11% had serum sickness, and 36% experienced complications after discharge, mostly infection. There was one AHSCT treatment-related death.

“We’re showing that AHSCT is a highly potent therapy that definitely is competitive vis a vis the most potent standard conventional disease modifying therapies,” said Dr. Kalincik, who noted the high rate of adverse events. Still, treatment-related mortality from AHSCT has improved since the therapy was first used in MS patients, he added.

“I’m hoping the data provides some evidence to convince you that this treatment still has a place in our armamentarium,” Dr. Kalincik said.
 

Questions remain

Eva Kubala Havrdová, MD, PhD, professor of neurology in the Multiple Sclerosis Center at Charles University in Prague, Czech Republic, said the results add to a growing body of data on the efficacy of AHSCT in patients with highly active relapsing-remitting MS, but questions remain.

“It is important to understand that AHSCT provides advantage in terms of effectiveness compared with most of the DMTs,” Dr. Kubala Havrdová said. “However, it is a therapy associated with high risk of adverse events and this needs to be considered when one decides whether other, less invasive options have been exploited.”

Study funding was not reported. Dr. Kalincik disclosed ties with BioCSL, Biogen, BMS, Celgene, Eisai, Janssen, Merck, Novartis, Roche, Sanofi Genzyme, Teva, and WebMD Global. Dr. Kubala Havrdová reported no relevant financial relationships.

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

Patients with relapsing-remitting multiple sclerosis (MS) treated with autologous hematopoietic stem cell transplantation (AHSCT) were 74% more likely than were those taking fingolimod to be relapse free 1 year after treatment, a new study suggests.

The multicenter observational study showed that AHSCT was associated with a better overall annual relapse rate and significantly greater disability improvement versus fingolimod. Stem cell transplantation also offered a slight advantage compared with natalizumab but showed no benefit over ocrelizumab.

“Based on these results, we can conclude that in this observational study AHSCT is substantially superior to fingolimod and marginally superior to natalizumab in reducing the risk of posttreatment relapses,” study investigator Tomas Kalincik, MD, PhD, said at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Research gap

Prior studies have suggested that AHSCT is associated with better disability outcomes than other immunotherapies in patients with active secondary progressive MS. Findings from another study on long-term efficacy in relapse prevention are also promising.

“The information that we are still lacking is the head-to-head comparison of the effectiveness of AHSCT in relapsing-remitting disease to concrete, highly effective therapies, which is the aim of this current study,” said Dr. Kalincik, professor of neurology at the University of Melbourne and head of the Multiple Sclerosis and Neuroimmunology Service at the Royal Melbourne Hospital, Australia.

The study included 167 patients with relapsing-remitting MS from six centers in Ottawa, Uppsala, Sheffield, Bergen, Sydney, and Melbourne, combined with 1,675 patients from MSBase. Patients were included if they were treated with AHSCT or fingolimod (n = 769), natalizumab (n = 730) or ocrelizumab (n = 343).

Researchers used propensity matching to ensure the AHSCT and disease-modifying therapy (DMT) groups had similar relapse rates and disability scores at baseline. At 1 year, patients who underwent AHSCT were 74% more likely than were those on fingolimod to be relapse free (hazard ratio [HR], 0.26; P < .0001).

The AHSCT group had a lower overall annualized relapse rate (0.09 vs. 0.19, respectively; P < .0001) and a higher cumulative probability of remaining relapse free at 2 years (90% vs. 68%, respectively) and 5 years (85% vs. 54%, respectively). AHSCT was associated with significantly better confirmed disability improvement at 6 months compared with fingolimod (HR, 2.70; P < .0001).

The researchers found better outcomes with AHSCT compared with natalizumab, but the results weren’t as promising. The annual relapse rate with AHSCT was statistically significant (P = .03) but the clinical benefit was marginal, Dr. Kalincik said. However, the confirmed disability improvement was significantly better with AHSCT (HR, 2.68; P < .0001).

There was no significant difference in outcomes with AHSCT compared to ocrelizumab.

Adverse events were common with stem cell transplantation, a sticking point for at least one conference attendee who raised safety concerns. Among those treated with AHSCT, 23% had febrile neutropenia, 11% had serum sickness, and 36% experienced complications after discharge, mostly infection. There was one AHSCT treatment-related death.

“We’re showing that AHSCT is a highly potent therapy that definitely is competitive vis a vis the most potent standard conventional disease modifying therapies,” said Dr. Kalincik, who noted the high rate of adverse events. Still, treatment-related mortality from AHSCT has improved since the therapy was first used in MS patients, he added.

“I’m hoping the data provides some evidence to convince you that this treatment still has a place in our armamentarium,” Dr. Kalincik said.
 

Questions remain

Eva Kubala Havrdová, MD, PhD, professor of neurology in the Multiple Sclerosis Center at Charles University in Prague, Czech Republic, said the results add to a growing body of data on the efficacy of AHSCT in patients with highly active relapsing-remitting MS, but questions remain.

“It is important to understand that AHSCT provides advantage in terms of effectiveness compared with most of the DMTs,” Dr. Kubala Havrdová said. “However, it is a therapy associated with high risk of adverse events and this needs to be considered when one decides whether other, less invasive options have been exploited.”

Study funding was not reported. Dr. Kalincik disclosed ties with BioCSL, Biogen, BMS, Celgene, Eisai, Janssen, Merck, Novartis, Roche, Sanofi Genzyme, Teva, and WebMD Global. Dr. Kubala Havrdová reported no relevant financial relationships.

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

Patients with relapsing-remitting multiple sclerosis (MS) treated with autologous hematopoietic stem cell transplantation (AHSCT) were 74% more likely than were those taking fingolimod to be relapse free 1 year after treatment, a new study suggests.

The multicenter observational study showed that AHSCT was associated with a better overall annual relapse rate and significantly greater disability improvement versus fingolimod. Stem cell transplantation also offered a slight advantage compared with natalizumab but showed no benefit over ocrelizumab.

“Based on these results, we can conclude that in this observational study AHSCT is substantially superior to fingolimod and marginally superior to natalizumab in reducing the risk of posttreatment relapses,” study investigator Tomas Kalincik, MD, PhD, said at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Research gap

Prior studies have suggested that AHSCT is associated with better disability outcomes than other immunotherapies in patients with active secondary progressive MS. Findings from another study on long-term efficacy in relapse prevention are also promising.

“The information that we are still lacking is the head-to-head comparison of the effectiveness of AHSCT in relapsing-remitting disease to concrete, highly effective therapies, which is the aim of this current study,” said Dr. Kalincik, professor of neurology at the University of Melbourne and head of the Multiple Sclerosis and Neuroimmunology Service at the Royal Melbourne Hospital, Australia.

The study included 167 patients with relapsing-remitting MS from six centers in Ottawa, Uppsala, Sheffield, Bergen, Sydney, and Melbourne, combined with 1,675 patients from MSBase. Patients were included if they were treated with AHSCT or fingolimod (n = 769), natalizumab (n = 730) or ocrelizumab (n = 343).

Researchers used propensity matching to ensure the AHSCT and disease-modifying therapy (DMT) groups had similar relapse rates and disability scores at baseline. At 1 year, patients who underwent AHSCT were 74% more likely than were those on fingolimod to be relapse free (hazard ratio [HR], 0.26; P < .0001).

The AHSCT group had a lower overall annualized relapse rate (0.09 vs. 0.19, respectively; P < .0001) and a higher cumulative probability of remaining relapse free at 2 years (90% vs. 68%, respectively) and 5 years (85% vs. 54%, respectively). AHSCT was associated with significantly better confirmed disability improvement at 6 months compared with fingolimod (HR, 2.70; P < .0001).

The researchers found better outcomes with AHSCT compared with natalizumab, but the results weren’t as promising. The annual relapse rate with AHSCT was statistically significant (P = .03) but the clinical benefit was marginal, Dr. Kalincik said. However, the confirmed disability improvement was significantly better with AHSCT (HR, 2.68; P < .0001).

There was no significant difference in outcomes with AHSCT compared to ocrelizumab.

Adverse events were common with stem cell transplantation, a sticking point for at least one conference attendee who raised safety concerns. Among those treated with AHSCT, 23% had febrile neutropenia, 11% had serum sickness, and 36% experienced complications after discharge, mostly infection. There was one AHSCT treatment-related death.

“We’re showing that AHSCT is a highly potent therapy that definitely is competitive vis a vis the most potent standard conventional disease modifying therapies,” said Dr. Kalincik, who noted the high rate of adverse events. Still, treatment-related mortality from AHSCT has improved since the therapy was first used in MS patients, he added.

“I’m hoping the data provides some evidence to convince you that this treatment still has a place in our armamentarium,” Dr. Kalincik said.
 

Questions remain

Eva Kubala Havrdová, MD, PhD, professor of neurology in the Multiple Sclerosis Center at Charles University in Prague, Czech Republic, said the results add to a growing body of data on the efficacy of AHSCT in patients with highly active relapsing-remitting MS, but questions remain.

“It is important to understand that AHSCT provides advantage in terms of effectiveness compared with most of the DMTs,” Dr. Kubala Havrdová said. “However, it is a therapy associated with high risk of adverse events and this needs to be considered when one decides whether other, less invasive options have been exploited.”

Study funding was not reported. Dr. Kalincik disclosed ties with BioCSL, Biogen, BMS, Celgene, Eisai, Janssen, Merck, Novartis, Roche, Sanofi Genzyme, Teva, and WebMD Global. Dr. Kubala Havrdová reported no relevant financial relationships.

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

DENVER – When Arisa E. Ortiz, MD, meets with patients who seek treatment options for scars, the first thing she explains is that she can’t erase them.

“It’s important to manage expectations,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual meeting of the American Society for Dermatologic Surgery. “I tell them I can improve their scar and make it look less noticeable, but I can’t make it look like normal skin. It’s going to require multiple treatments. It’s not a one-time thing; it’s going to take several months to see the full benefit. And, it’s an investment of time and money.”

Nonablative, ablative, and fractional resurfacing stimulates dermal fibroblasts to replace lost collagen and elastin. Traditional lasers offer impressive clinical results for scars but are associated with significant preprocedural discomfort, prolonged recovery, and a significant risk of side effects, Dr. Ortiz said, while nonablative lasers are more tolerable with shorter recovery times.

Multiple sessions are required, and results are often less clinically impressive. “It’s often difficult for patients to have a lot of downtime with each treatment so often I prefer to use the nonablative laser, especially for acne scarring,” she said.

Mounting evidence suggests that the sooner scars are treated after they are formed, the better. That may not be feasible for patients with a long history of acne scars, but for surgical scars, Dr. Ortiz prefers to start treatment on the day of suture removal. “Whenever I do that, I always get better results,” she said.

Outcomes may also improve by combining different treatment options, but the type of scar drives the type of modality to consider. There are red scars from postinflammatory erythema, hyperpigmented scars, hypopigmented scars, atrophic scars, hypertrophic scars, spread scars, pin cushion scars, and keloid scars, “which are the most difficult to treat,” she said. “When I’m using a combination approach, I start with the redness component of the scar, because you don’t want to exacerbate nonspecific erythema, or it’ll be difficult to see where the redness is. So, I always use vascular laser first, then a pigment-specific laser, followed by resurfacing, and augmentation with filler if needed.”

Red scars generally fade with time, but that can take several months to more than a year. “If you use a laser, that can speed up the recovery,” said Dr. Ortiz, who is the vice president of the American Society for Laser Medicine and Surgery. “A vascular laser will work, such as KTP, or intense pulsed light. Studies favor a low fluence and a short pulse duration. Pulsed dye laser (PDL) penetrates deeper than KTP, so theoretically you get a bit of collagen remodeling because it can increase TGF-beta [transforming growth factor–beta], so theoretically, PDL is a little bit better than KTP for red scars, but both will work.”

In a comparative study, researchers used purpuric and nonpurpuric parameters to treat surgical scars but found no significant differences between the two treatment settings. “I tend to stick to short pulse duration and low fluence settings,” said Dr. Ortiz, who was not affiliated with the study.

A separate, single-blinded, split scar study, which compared the efficacy of KTP to 595 nm PDL in reduction of erythema in surgical scars, found no significant difference between the two approaches. A review of available therapeutic lasers for acne scarring found that the thermal energy delivered by KTP extends only to the papillary dermis, making it useful for postinflammatory erythema without significant effects on collagen remodeling.
 

Hyperpigmentation

Use of concomitant bleaching cream can also help as a preventive strategy for hyperpigmentation. But one study of 100 patients found that pretreatment with a bleaching regimen prior to undergoing CO₂ laser resurfacing made no significant difference in hyperpigmentation compared with those who received no pretreatment regimen.

When Dr. Ortiz is concerned about hyperpigmentation after laser treatment, she prescribes post-treatment tranexamic acid 325 mg twice daily for 6 months or longer. “I don’t do any kind of workup or labs, but I do not prescribe it if a patient has increased risk of clotting,” she said. Those at increased risk include smokers, those on birth control pills, those on hormonal supplementation, those with a current malignancy, and those with a history of a cerebrovascular accident or deep vein thrombosis.

Hypopigmented, atrophic scars

In Dr. Ortiz’s clinical experience, hypopigmented scars respond well to treatment with the 1550 nonablative laser. “The idea is that you’re removing some of the scarred collagen and it allows the melanocytes to migrate in and repigment,” she said. Following laser treatment, consider applying topical bimatoprost 0.03% twice daily for at least 3 months to optimize results, she added.

For atrophic scars, options include subcision, laser treatment, radiofrequency microneedling, fillers, or biostimulators. “I caution against using permanent fillers because there is a higher risk of granuloma formation,” Dr. Ortiz said. “I tend to use hyaluronic acid fillers, which have a low G prime. I inject superficially.”

She shared a technique she learned from Mathew Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. It entails spreading the skin with one’s fingers for a scar, especially an acne scar. “If it improves when you spread the skin, then you know it’s amenable to laser treatment,” Dr. Ortiz said. “But if it doesn’t improve when you spread the skin, it probably needs a little subcision. Insert an 18- or 20-gauge tribeveled hypodermic needle or an 18-gauge Nokor under the scar to sever the fibrous components that anchor the scar. This can take more than one treatment. I’ll often do this immediately before resurfacing.”

For hypertrophic scars, consider laser-assisted drug delivery, which creates vertical channels that assist the delivery of topically applied drugs into the skin. “You never want to use something that isn’t meant to be injected into the skin because you can get a granulomatous reaction,” she warned. “I often use topical triamcinolone acetonide, 5-FU, or poly-l-lactic acid.”

Dr. Ortiz noted that botulinum toxin type A may be helpful for scars, despite the paucity of evidence regarding specific mechanisms of action. “There is some thought that it can modulate TGF-beta,” she said. “It also may modulate collagen deposition. Currently we’re looking into Botox alone for keloid scars. The initial results look just okay.”

Dr. Ortiz disclosed that she has received consulting fees from Alastin, Cutera, and Sciton, and honoraria from BTL and Procter & Gamble. She is also a member of the advisory board for Aerolase, Allergan, Bausch Health, Endo, Galderma, Rodan + Fields, and Sciton, and has received equipment from BTL, Sciton, and SmartGraft.

DENVER – When Arisa E. Ortiz, MD, meets with patients who seek treatment options for scars, the first thing she explains is that she can’t erase them.

“It’s important to manage expectations,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual meeting of the American Society for Dermatologic Surgery. “I tell them I can improve their scar and make it look less noticeable, but I can’t make it look like normal skin. It’s going to require multiple treatments. It’s not a one-time thing; it’s going to take several months to see the full benefit. And, it’s an investment of time and money.”

Nonablative, ablative, and fractional resurfacing stimulates dermal fibroblasts to replace lost collagen and elastin. Traditional lasers offer impressive clinical results for scars but are associated with significant preprocedural discomfort, prolonged recovery, and a significant risk of side effects, Dr. Ortiz said, while nonablative lasers are more tolerable with shorter recovery times.

Multiple sessions are required, and results are often less clinically impressive. “It’s often difficult for patients to have a lot of downtime with each treatment so often I prefer to use the nonablative laser, especially for acne scarring,” she said.

Mounting evidence suggests that the sooner scars are treated after they are formed, the better. That may not be feasible for patients with a long history of acne scars, but for surgical scars, Dr. Ortiz prefers to start treatment on the day of suture removal. “Whenever I do that, I always get better results,” she said.

Outcomes may also improve by combining different treatment options, but the type of scar drives the type of modality to consider. There are red scars from postinflammatory erythema, hyperpigmented scars, hypopigmented scars, atrophic scars, hypertrophic scars, spread scars, pin cushion scars, and keloid scars, “which are the most difficult to treat,” she said. “When I’m using a combination approach, I start with the redness component of the scar, because you don’t want to exacerbate nonspecific erythema, or it’ll be difficult to see where the redness is. So, I always use vascular laser first, then a pigment-specific laser, followed by resurfacing, and augmentation with filler if needed.”

Red scars generally fade with time, but that can take several months to more than a year. “If you use a laser, that can speed up the recovery,” said Dr. Ortiz, who is the vice president of the American Society for Laser Medicine and Surgery. “A vascular laser will work, such as KTP, or intense pulsed light. Studies favor a low fluence and a short pulse duration. Pulsed dye laser (PDL) penetrates deeper than KTP, so theoretically you get a bit of collagen remodeling because it can increase TGF-beta [transforming growth factor–beta], so theoretically, PDL is a little bit better than KTP for red scars, but both will work.”

In a comparative study, researchers used purpuric and nonpurpuric parameters to treat surgical scars but found no significant differences between the two treatment settings. “I tend to stick to short pulse duration and low fluence settings,” said Dr. Ortiz, who was not affiliated with the study.

A separate, single-blinded, split scar study, which compared the efficacy of KTP to 595 nm PDL in reduction of erythema in surgical scars, found no significant difference between the two approaches. A review of available therapeutic lasers for acne scarring found that the thermal energy delivered by KTP extends only to the papillary dermis, making it useful for postinflammatory erythema without significant effects on collagen remodeling.
 

Hyperpigmentation

Use of concomitant bleaching cream can also help as a preventive strategy for hyperpigmentation. But one study of 100 patients found that pretreatment with a bleaching regimen prior to undergoing CO₂ laser resurfacing made no significant difference in hyperpigmentation compared with those who received no pretreatment regimen.

When Dr. Ortiz is concerned about hyperpigmentation after laser treatment, she prescribes post-treatment tranexamic acid 325 mg twice daily for 6 months or longer. “I don’t do any kind of workup or labs, but I do not prescribe it if a patient has increased risk of clotting,” she said. Those at increased risk include smokers, those on birth control pills, those on hormonal supplementation, those with a current malignancy, and those with a history of a cerebrovascular accident or deep vein thrombosis.

Hypopigmented, atrophic scars

In Dr. Ortiz’s clinical experience, hypopigmented scars respond well to treatment with the 1550 nonablative laser. “The idea is that you’re removing some of the scarred collagen and it allows the melanocytes to migrate in and repigment,” she said. Following laser treatment, consider applying topical bimatoprost 0.03% twice daily for at least 3 months to optimize results, she added.

For atrophic scars, options include subcision, laser treatment, radiofrequency microneedling, fillers, or biostimulators. “I caution against using permanent fillers because there is a higher risk of granuloma formation,” Dr. Ortiz said. “I tend to use hyaluronic acid fillers, which have a low G prime. I inject superficially.”

She shared a technique she learned from Mathew Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. It entails spreading the skin with one’s fingers for a scar, especially an acne scar. “If it improves when you spread the skin, then you know it’s amenable to laser treatment,” Dr. Ortiz said. “But if it doesn’t improve when you spread the skin, it probably needs a little subcision. Insert an 18- or 20-gauge tribeveled hypodermic needle or an 18-gauge Nokor under the scar to sever the fibrous components that anchor the scar. This can take more than one treatment. I’ll often do this immediately before resurfacing.”

For hypertrophic scars, consider laser-assisted drug delivery, which creates vertical channels that assist the delivery of topically applied drugs into the skin. “You never want to use something that isn’t meant to be injected into the skin because you can get a granulomatous reaction,” she warned. “I often use topical triamcinolone acetonide, 5-FU, or poly-l-lactic acid.”

Dr. Ortiz noted that botulinum toxin type A may be helpful for scars, despite the paucity of evidence regarding specific mechanisms of action. “There is some thought that it can modulate TGF-beta,” she said. “It also may modulate collagen deposition. Currently we’re looking into Botox alone for keloid scars. The initial results look just okay.”

Dr. Ortiz disclosed that she has received consulting fees from Alastin, Cutera, and Sciton, and honoraria from BTL and Procter & Gamble. She is also a member of the advisory board for Aerolase, Allergan, Bausch Health, Endo, Galderma, Rodan + Fields, and Sciton, and has received equipment from BTL, Sciton, and SmartGraft.

DENVER – When Arisa E. Ortiz, MD, meets with patients who seek treatment options for scars, the first thing she explains is that she can’t erase them.

“It’s important to manage expectations,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual meeting of the American Society for Dermatologic Surgery. “I tell them I can improve their scar and make it look less noticeable, but I can’t make it look like normal skin. It’s going to require multiple treatments. It’s not a one-time thing; it’s going to take several months to see the full benefit. And, it’s an investment of time and money.”

Nonablative, ablative, and fractional resurfacing stimulates dermal fibroblasts to replace lost collagen and elastin. Traditional lasers offer impressive clinical results for scars but are associated with significant preprocedural discomfort, prolonged recovery, and a significant risk of side effects, Dr. Ortiz said, while nonablative lasers are more tolerable with shorter recovery times.

Multiple sessions are required, and results are often less clinically impressive. “It’s often difficult for patients to have a lot of downtime with each treatment so often I prefer to use the nonablative laser, especially for acne scarring,” she said.

Mounting evidence suggests that the sooner scars are treated after they are formed, the better. That may not be feasible for patients with a long history of acne scars, but for surgical scars, Dr. Ortiz prefers to start treatment on the day of suture removal. “Whenever I do that, I always get better results,” she said.

Outcomes may also improve by combining different treatment options, but the type of scar drives the type of modality to consider. There are red scars from postinflammatory erythema, hyperpigmented scars, hypopigmented scars, atrophic scars, hypertrophic scars, spread scars, pin cushion scars, and keloid scars, “which are the most difficult to treat,” she said. “When I’m using a combination approach, I start with the redness component of the scar, because you don’t want to exacerbate nonspecific erythema, or it’ll be difficult to see where the redness is. So, I always use vascular laser first, then a pigment-specific laser, followed by resurfacing, and augmentation with filler if needed.”

Red scars generally fade with time, but that can take several months to more than a year. “If you use a laser, that can speed up the recovery,” said Dr. Ortiz, who is the vice president of the American Society for Laser Medicine and Surgery. “A vascular laser will work, such as KTP, or intense pulsed light. Studies favor a low fluence and a short pulse duration. Pulsed dye laser (PDL) penetrates deeper than KTP, so theoretically you get a bit of collagen remodeling because it can increase TGF-beta [transforming growth factor–beta], so theoretically, PDL is a little bit better than KTP for red scars, but both will work.”

In a comparative study, researchers used purpuric and nonpurpuric parameters to treat surgical scars but found no significant differences between the two treatment settings. “I tend to stick to short pulse duration and low fluence settings,” said Dr. Ortiz, who was not affiliated with the study.

A separate, single-blinded, split scar study, which compared the efficacy of KTP to 595 nm PDL in reduction of erythema in surgical scars, found no significant difference between the two approaches. A review of available therapeutic lasers for acne scarring found that the thermal energy delivered by KTP extends only to the papillary dermis, making it useful for postinflammatory erythema without significant effects on collagen remodeling.
 

Hyperpigmentation

Use of concomitant bleaching cream can also help as a preventive strategy for hyperpigmentation. But one study of 100 patients found that pretreatment with a bleaching regimen prior to undergoing CO₂ laser resurfacing made no significant difference in hyperpigmentation compared with those who received no pretreatment regimen.

When Dr. Ortiz is concerned about hyperpigmentation after laser treatment, she prescribes post-treatment tranexamic acid 325 mg twice daily for 6 months or longer. “I don’t do any kind of workup or labs, but I do not prescribe it if a patient has increased risk of clotting,” she said. Those at increased risk include smokers, those on birth control pills, those on hormonal supplementation, those with a current malignancy, and those with a history of a cerebrovascular accident or deep vein thrombosis.

Hypopigmented, atrophic scars

In Dr. Ortiz’s clinical experience, hypopigmented scars respond well to treatment with the 1550 nonablative laser. “The idea is that you’re removing some of the scarred collagen and it allows the melanocytes to migrate in and repigment,” she said. Following laser treatment, consider applying topical bimatoprost 0.03% twice daily for at least 3 months to optimize results, she added.

For atrophic scars, options include subcision, laser treatment, radiofrequency microneedling, fillers, or biostimulators. “I caution against using permanent fillers because there is a higher risk of granuloma formation,” Dr. Ortiz said. “I tend to use hyaluronic acid fillers, which have a low G prime. I inject superficially.”

She shared a technique she learned from Mathew Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. It entails spreading the skin with one’s fingers for a scar, especially an acne scar. “If it improves when you spread the skin, then you know it’s amenable to laser treatment,” Dr. Ortiz said. “But if it doesn’t improve when you spread the skin, it probably needs a little subcision. Insert an 18- or 20-gauge tribeveled hypodermic needle or an 18-gauge Nokor under the scar to sever the fibrous components that anchor the scar. This can take more than one treatment. I’ll often do this immediately before resurfacing.”

For hypertrophic scars, consider laser-assisted drug delivery, which creates vertical channels that assist the delivery of topically applied drugs into the skin. “You never want to use something that isn’t meant to be injected into the skin because you can get a granulomatous reaction,” she warned. “I often use topical triamcinolone acetonide, 5-FU, or poly-l-lactic acid.”

Dr. Ortiz noted that botulinum toxin type A may be helpful for scars, despite the paucity of evidence regarding specific mechanisms of action. “There is some thought that it can modulate TGF-beta,” she said. “It also may modulate collagen deposition. Currently we’re looking into Botox alone for keloid scars. The initial results look just okay.”

Dr. Ortiz disclosed that she has received consulting fees from Alastin, Cutera, and Sciton, and honoraria from BTL and Procter & Gamble. She is also a member of the advisory board for Aerolase, Allergan, Bausch Health, Endo, Galderma, Rodan + Fields, and Sciton, and has received equipment from BTL, Sciton, and SmartGraft.

DENVER – Patients who continued to undergo routine minimally invasive cosmetic procedures during the COVID-19 Omicron outbreak in 2021 were happier and more satisfied with life overall compared with the general population, according to a study of 42 individuals. However, these treatments did not improve their baseline happiness or life satisfaction scores at follow-up.

Those are key findings from the study that lead author Rishi Chopra, MD, MS, presented during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“These are interesting and surprising results,” said Dr. Chopra, a dermatologist and laser and cosmetic dermatologic surgery fellow at Harvard Medical School and Massachusetts General Hospital in Boston. “Patients are seeking consultations with us with the hope that the treatments we offer may potentially help them feel happier, but are we really delivering on that?”

In a pivotal 2018 study that examined patient motivations for undergoing cosmetic dermatology procedures, investigators found that 67.2% did so to “feel happier and more confident or improve total quality of life”. Moreover, 38.5% cited the desire to “feel happier, better overall, or improve total quality of life” as the key reason for pursuing cosmetic procedures.

Prior published evidence validates this benefit of procedures, as neuromodulators have repeatedly demonstrated to improve mood and depression, including a 2020 randomized, single-blind crossover study that examined the impact of neuromodulators on mood and appearance during the COVID-19 pandemic. It found that patients who received treatment with neuromodulators prior to the pandemic, stopped during the pandemic, and restarted again, reported increased happiness, self-satisfaction with appearance, and overall treatment satisfaction.

“However, studies evaluating the effect of filler on happiness have failed to demonstrate an impact,” Dr. Chopra said. “Thus, the jury is still out.”

Study evaluated 42 patients

In what he said is the first study of its kind, he and his colleagues evaluated the impact of minimally invasive cosmetic procedures on the happiness of 42 treatment non-naive patients (those who regularly undergo cosmetic procedures) with a mean age of 47 years who were surveyed in November and December of 2021 during the COVID-19 Omicron subvariant outbreak at the cosmetic dermatology practices of Sabrina G. Fabi, MD, in San Diego, and Nicole Kanaris, MBBCh, in Johannesburg, South Africa.

“On average, these patients were undergoing six treatments per year during four visits per year, so these were frequent flyers,” Dr. Chopra said. “We set out to assess: Are patients who seek cosmetic procedures happy at baseline? And, do cosmetic procedures make us happier or more satisfied with life?”

Prior to treatment, patients completed the Subjective Happiness Scale (SHS) and Satisfaction With Life Scale (SWLS). Three weeks later, patients completed the SHS, SWLS, the Global Aesthetic Improvement Scale (GAIS) and a 5-point satisfaction score. The researchers used paired and unpaired t-tests, independent sample t-tests, and Spearman rank correlations to conduct statistical analyses.

The baseline SHS score of study participants was an average of 5.87, which Dr. Chopra said is higher than the worldwide population range between 4.57 and 5.33, and 5.05 in the U.S. population. “The patients in our study were very happy to begin with,” an important point to consider, he said. Following their treatments, respondents felt “improved” or “much improved” on the GAIS (a mean score of 3.64) and “somewhat satisfied” or “very satisfied” based on the SWLS (a mean score of 4.4). “So overall, they viewed their treatments as a success,” Dr. Chopra said.

In terms of happiness, however, the researchers observed no significant differences between pre- and posttreatment scores on the SHS (a mean of 5.87 vs. 6.61, respectively; P = .634) nor on the SWLS (a mean of 29.62 vs. 29.1; P = .709). On stratified analysis, no significant differences in the SHS, SWLS, and the GAIS were observed when the researchers accounted for the aggressiveness of the procedure, the number of treatments, the number of sites treated, the type of treatment, and whether the respondents were happier or sadder at baseline. “Surprisingly, this had no effect whatsoever on happiness,” he said. “Not only that, these factors didn’t improve a patient’s perception of the efficacy or satisfaction with a treatment either.”

“In addition, only two locations were surveyed, so the results could have location bias. I think it would be a great idea to replicate this survey of experienced cosmetic treatment patients with many locations and to include survey responses based on the procedure that was done. That said, it is interesting that overall, investigator satisfaction did not correlate with patient happiness from the treatments.”

Dr. Chopra reported having no financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Patients who continued to undergo routine minimally invasive cosmetic procedures during the COVID-19 Omicron outbreak in 2021 were happier and more satisfied with life overall compared with the general population, according to a study of 42 individuals. However, these treatments did not improve their baseline happiness or life satisfaction scores at follow-up.

Those are key findings from the study that lead author Rishi Chopra, MD, MS, presented during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“These are interesting and surprising results,” said Dr. Chopra, a dermatologist and laser and cosmetic dermatologic surgery fellow at Harvard Medical School and Massachusetts General Hospital in Boston. “Patients are seeking consultations with us with the hope that the treatments we offer may potentially help them feel happier, but are we really delivering on that?”

In a pivotal 2018 study that examined patient motivations for undergoing cosmetic dermatology procedures, investigators found that 67.2% did so to “feel happier and more confident or improve total quality of life”. Moreover, 38.5% cited the desire to “feel happier, better overall, or improve total quality of life” as the key reason for pursuing cosmetic procedures.

Prior published evidence validates this benefit of procedures, as neuromodulators have repeatedly demonstrated to improve mood and depression, including a 2020 randomized, single-blind crossover study that examined the impact of neuromodulators on mood and appearance during the COVID-19 pandemic. It found that patients who received treatment with neuromodulators prior to the pandemic, stopped during the pandemic, and restarted again, reported increased happiness, self-satisfaction with appearance, and overall treatment satisfaction.

“However, studies evaluating the effect of filler on happiness have failed to demonstrate an impact,” Dr. Chopra said. “Thus, the jury is still out.”

Study evaluated 42 patients

In what he said is the first study of its kind, he and his colleagues evaluated the impact of minimally invasive cosmetic procedures on the happiness of 42 treatment non-naive patients (those who regularly undergo cosmetic procedures) with a mean age of 47 years who were surveyed in November and December of 2021 during the COVID-19 Omicron subvariant outbreak at the cosmetic dermatology practices of Sabrina G. Fabi, MD, in San Diego, and Nicole Kanaris, MBBCh, in Johannesburg, South Africa.

“On average, these patients were undergoing six treatments per year during four visits per year, so these were frequent flyers,” Dr. Chopra said. “We set out to assess: Are patients who seek cosmetic procedures happy at baseline? And, do cosmetic procedures make us happier or more satisfied with life?”

Prior to treatment, patients completed the Subjective Happiness Scale (SHS) and Satisfaction With Life Scale (SWLS). Three weeks later, patients completed the SHS, SWLS, the Global Aesthetic Improvement Scale (GAIS) and a 5-point satisfaction score. The researchers used paired and unpaired t-tests, independent sample t-tests, and Spearman rank correlations to conduct statistical analyses.

The baseline SHS score of study participants was an average of 5.87, which Dr. Chopra said is higher than the worldwide population range between 4.57 and 5.33, and 5.05 in the U.S. population. “The patients in our study were very happy to begin with,” an important point to consider, he said. Following their treatments, respondents felt “improved” or “much improved” on the GAIS (a mean score of 3.64) and “somewhat satisfied” or “very satisfied” based on the SWLS (a mean score of 4.4). “So overall, they viewed their treatments as a success,” Dr. Chopra said.

In terms of happiness, however, the researchers observed no significant differences between pre- and posttreatment scores on the SHS (a mean of 5.87 vs. 6.61, respectively; P = .634) nor on the SWLS (a mean of 29.62 vs. 29.1; P = .709). On stratified analysis, no significant differences in the SHS, SWLS, and the GAIS were observed when the researchers accounted for the aggressiveness of the procedure, the number of treatments, the number of sites treated, the type of treatment, and whether the respondents were happier or sadder at baseline. “Surprisingly, this had no effect whatsoever on happiness,” he said. “Not only that, these factors didn’t improve a patient’s perception of the efficacy or satisfaction with a treatment either.”

“In addition, only two locations were surveyed, so the results could have location bias. I think it would be a great idea to replicate this survey of experienced cosmetic treatment patients with many locations and to include survey responses based on the procedure that was done. That said, it is interesting that overall, investigator satisfaction did not correlate with patient happiness from the treatments.”

Dr. Chopra reported having no financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Patients who continued to undergo routine minimally invasive cosmetic procedures during the COVID-19 Omicron outbreak in 2021 were happier and more satisfied with life overall compared with the general population, according to a study of 42 individuals. However, these treatments did not improve their baseline happiness or life satisfaction scores at follow-up.

Those are key findings from the study that lead author Rishi Chopra, MD, MS, presented during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“These are interesting and surprising results,” said Dr. Chopra, a dermatologist and laser and cosmetic dermatologic surgery fellow at Harvard Medical School and Massachusetts General Hospital in Boston. “Patients are seeking consultations with us with the hope that the treatments we offer may potentially help them feel happier, but are we really delivering on that?”

In a pivotal 2018 study that examined patient motivations for undergoing cosmetic dermatology procedures, investigators found that 67.2% did so to “feel happier and more confident or improve total quality of life”. Moreover, 38.5% cited the desire to “feel happier, better overall, or improve total quality of life” as the key reason for pursuing cosmetic procedures.

Prior published evidence validates this benefit of procedures, as neuromodulators have repeatedly demonstrated to improve mood and depression, including a 2020 randomized, single-blind crossover study that examined the impact of neuromodulators on mood and appearance during the COVID-19 pandemic. It found that patients who received treatment with neuromodulators prior to the pandemic, stopped during the pandemic, and restarted again, reported increased happiness, self-satisfaction with appearance, and overall treatment satisfaction.

“However, studies evaluating the effect of filler on happiness have failed to demonstrate an impact,” Dr. Chopra said. “Thus, the jury is still out.”

Study evaluated 42 patients

In what he said is the first study of its kind, he and his colleagues evaluated the impact of minimally invasive cosmetic procedures on the happiness of 42 treatment non-naive patients (those who regularly undergo cosmetic procedures) with a mean age of 47 years who were surveyed in November and December of 2021 during the COVID-19 Omicron subvariant outbreak at the cosmetic dermatology practices of Sabrina G. Fabi, MD, in San Diego, and Nicole Kanaris, MBBCh, in Johannesburg, South Africa.

“On average, these patients were undergoing six treatments per year during four visits per year, so these were frequent flyers,” Dr. Chopra said. “We set out to assess: Are patients who seek cosmetic procedures happy at baseline? And, do cosmetic procedures make us happier or more satisfied with life?”

Prior to treatment, patients completed the Subjective Happiness Scale (SHS) and Satisfaction With Life Scale (SWLS). Three weeks later, patients completed the SHS, SWLS, the Global Aesthetic Improvement Scale (GAIS) and a 5-point satisfaction score. The researchers used paired and unpaired t-tests, independent sample t-tests, and Spearman rank correlations to conduct statistical analyses.

The baseline SHS score of study participants was an average of 5.87, which Dr. Chopra said is higher than the worldwide population range between 4.57 and 5.33, and 5.05 in the U.S. population. “The patients in our study were very happy to begin with,” an important point to consider, he said. Following their treatments, respondents felt “improved” or “much improved” on the GAIS (a mean score of 3.64) and “somewhat satisfied” or “very satisfied” based on the SWLS (a mean score of 4.4). “So overall, they viewed their treatments as a success,” Dr. Chopra said.

In terms of happiness, however, the researchers observed no significant differences between pre- and posttreatment scores on the SHS (a mean of 5.87 vs. 6.61, respectively; P = .634) nor on the SWLS (a mean of 29.62 vs. 29.1; P = .709). On stratified analysis, no significant differences in the SHS, SWLS, and the GAIS were observed when the researchers accounted for the aggressiveness of the procedure, the number of treatments, the number of sites treated, the type of treatment, and whether the respondents were happier or sadder at baseline. “Surprisingly, this had no effect whatsoever on happiness,” he said. “Not only that, these factors didn’t improve a patient’s perception of the efficacy or satisfaction with a treatment either.”

“In addition, only two locations were surveyed, so the results could have location bias. I think it would be a great idea to replicate this survey of experienced cosmetic treatment patients with many locations and to include survey responses based on the procedure that was done. That said, it is interesting that overall, investigator satisfaction did not correlate with patient happiness from the treatments.”

Dr. Chopra reported having no financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

CHARLOTTE, N.C.– Performing high-quality index colonoscopies may pay off later in your patients’ reduced risk for advanced neoplasia, investigators report.

A study of registry data on more than 2,200 patients who had an index colonoscopy showing no evidence of neoplasia found that, on repeat colonoscopy 10 years later, the absolute risk for advanced neoplasia outcomes was lower for those with a high-quality index exam, compared with those who had a lesser-quality index colonoscopy.

Neil Osterweil/MDedge News

The adjusted odds ratio for patients who underwent high-quality index exams was 0.59%, reported Joseph Anderson, MD, from the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“These data demonstrate that high-quality index colonoscopy provides better protection from interval lesions than low-quality exams with no polyps detected at that index exam,” he said in an oral abstract presentation at the annual meeting of the American College of Gastroenterology.

“These data support the importance of high-quality index exams in the prevention of interval colorectal cancer, and support the 10-year interval for normal exams,” Dr. Anderson added.

He recommended that endoscopists focus on the quality of their exams by using adequate scope withdrawal time – 8-10 minutes – to ensure optimal adenoma detection, and by ensuring the use of optimal bowel preparation in their practices.

Registry study

Dr. Anderson and colleagues studied how the quality of index colonoscopies could affect the risk of advanced outcomes in low-risk patients at the 10-year or later follow-up. They used records from the New Hampshire Colonoscopy Registry, which includes data from 2004 to the present on more than 250,000 exams performed by more than 150 endoscopists in more than 30 Granite State practices.

The investigators also looked at data on patients with less than 5 years of follow-up, and those with follow-up from 5 to less than 10 years.

The study sample included patients with no adenoma or significant serrated polyps on their index exams who had at least one follow-up exam 12 months or more after the index exams. Patients with inflammatory bowel disease or familial colon cancer syndromes were excluded.

They defined a high-quality colonoscopy as an exam complete to cecum, with adequate bowel preparation, and performed by an endoscopist with an adenoma detection rate of 25 or higher.

The adenoma detection rate is calculated as the number of screening colonoscopies with at least one adenoma divided by the total number of screening colonoscopies.

The definition of advanced outcomes included advanced adenomas, colorectal cancer, and/or large serrated polyps (1 cm or greater).

Of the 14,011 patients in the sample, 2,283 had a follow-up exam at 10 years. The absolute risk for advanced outcomes among patients who had a high quality index exam was 4.0% vs. 6.7% for those with lower quality exams.

Among patients with low-quality index exams – but not patients with high quality exams – there was a statistically significant increase in the absolute risk for advanced outcomes at all time periods, from 5.1% in the less than 5-year follow-up group, to 6.7% in the 10-years or more follow-up group.

Patients with initial high-quality exams also had a lower risk for postcolonoscopy colorectal cancer, compared with patients who had low-quality index exams: 0.4% vs. 0.8%. This difference translated into an adjusted hazard ratio for colorectal cancer after a high-quality exam of 0.53.
 

It’s getting better all the time

In an interview, Daniel J. Pambianco, MD, FACG from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that Dr. Anderson and colleagues highlighted the importance of the quality of the bowel prep and the quality of the examination itself.

He noted that the use of devices such as colonoscopy caps can help further improve adenoma detection rates and pointed to up-and-coming developments such as the use of artificial intelligence algorithms to aid human endoscopists.

Dr. Pambianco comoderated the session where the data were presented.

The investigators did not report a study funding source. Dr. Anderson and Dr. Pambianco reported having no relevant financial disclosures.

CHARLOTTE, N.C.– Performing high-quality index colonoscopies may pay off later in your patients’ reduced risk for advanced neoplasia, investigators report.

A study of registry data on more than 2,200 patients who had an index colonoscopy showing no evidence of neoplasia found that, on repeat colonoscopy 10 years later, the absolute risk for advanced neoplasia outcomes was lower for those with a high-quality index exam, compared with those who had a lesser-quality index colonoscopy.

Neil Osterweil/MDedge News

The adjusted odds ratio for patients who underwent high-quality index exams was 0.59%, reported Joseph Anderson, MD, from the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“These data demonstrate that high-quality index colonoscopy provides better protection from interval lesions than low-quality exams with no polyps detected at that index exam,” he said in an oral abstract presentation at the annual meeting of the American College of Gastroenterology.

“These data support the importance of high-quality index exams in the prevention of interval colorectal cancer, and support the 10-year interval for normal exams,” Dr. Anderson added.

He recommended that endoscopists focus on the quality of their exams by using adequate scope withdrawal time – 8-10 minutes – to ensure optimal adenoma detection, and by ensuring the use of optimal bowel preparation in their practices.

Registry study

Dr. Anderson and colleagues studied how the quality of index colonoscopies could affect the risk of advanced outcomes in low-risk patients at the 10-year or later follow-up. They used records from the New Hampshire Colonoscopy Registry, which includes data from 2004 to the present on more than 250,000 exams performed by more than 150 endoscopists in more than 30 Granite State practices.

The investigators also looked at data on patients with less than 5 years of follow-up, and those with follow-up from 5 to less than 10 years.

The study sample included patients with no adenoma or significant serrated polyps on their index exams who had at least one follow-up exam 12 months or more after the index exams. Patients with inflammatory bowel disease or familial colon cancer syndromes were excluded.

They defined a high-quality colonoscopy as an exam complete to cecum, with adequate bowel preparation, and performed by an endoscopist with an adenoma detection rate of 25 or higher.

The adenoma detection rate is calculated as the number of screening colonoscopies with at least one adenoma divided by the total number of screening colonoscopies.

The definition of advanced outcomes included advanced adenomas, colorectal cancer, and/or large serrated polyps (1 cm or greater).

Of the 14,011 patients in the sample, 2,283 had a follow-up exam at 10 years. The absolute risk for advanced outcomes among patients who had a high quality index exam was 4.0% vs. 6.7% for those with lower quality exams.

Among patients with low-quality index exams – but not patients with high quality exams – there was a statistically significant increase in the absolute risk for advanced outcomes at all time periods, from 5.1% in the less than 5-year follow-up group, to 6.7% in the 10-years or more follow-up group.

Patients with initial high-quality exams also had a lower risk for postcolonoscopy colorectal cancer, compared with patients who had low-quality index exams: 0.4% vs. 0.8%. This difference translated into an adjusted hazard ratio for colorectal cancer after a high-quality exam of 0.53.
 

It’s getting better all the time

In an interview, Daniel J. Pambianco, MD, FACG from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that Dr. Anderson and colleagues highlighted the importance of the quality of the bowel prep and the quality of the examination itself.

He noted that the use of devices such as colonoscopy caps can help further improve adenoma detection rates and pointed to up-and-coming developments such as the use of artificial intelligence algorithms to aid human endoscopists.

Dr. Pambianco comoderated the session where the data were presented.

The investigators did not report a study funding source. Dr. Anderson and Dr. Pambianco reported having no relevant financial disclosures.

CHARLOTTE, N.C.– Performing high-quality index colonoscopies may pay off later in your patients’ reduced risk for advanced neoplasia, investigators report.

A study of registry data on more than 2,200 patients who had an index colonoscopy showing no evidence of neoplasia found that, on repeat colonoscopy 10 years later, the absolute risk for advanced neoplasia outcomes was lower for those with a high-quality index exam, compared with those who had a lesser-quality index colonoscopy.

Neil Osterweil/MDedge News

The adjusted odds ratio for patients who underwent high-quality index exams was 0.59%, reported Joseph Anderson, MD, from the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“These data demonstrate that high-quality index colonoscopy provides better protection from interval lesions than low-quality exams with no polyps detected at that index exam,” he said in an oral abstract presentation at the annual meeting of the American College of Gastroenterology.

“These data support the importance of high-quality index exams in the prevention of interval colorectal cancer, and support the 10-year interval for normal exams,” Dr. Anderson added.

He recommended that endoscopists focus on the quality of their exams by using adequate scope withdrawal time – 8-10 minutes – to ensure optimal adenoma detection, and by ensuring the use of optimal bowel preparation in their practices.

Registry study

Dr. Anderson and colleagues studied how the quality of index colonoscopies could affect the risk of advanced outcomes in low-risk patients at the 10-year or later follow-up. They used records from the New Hampshire Colonoscopy Registry, which includes data from 2004 to the present on more than 250,000 exams performed by more than 150 endoscopists in more than 30 Granite State practices.

The investigators also looked at data on patients with less than 5 years of follow-up, and those with follow-up from 5 to less than 10 years.

The study sample included patients with no adenoma or significant serrated polyps on their index exams who had at least one follow-up exam 12 months or more after the index exams. Patients with inflammatory bowel disease or familial colon cancer syndromes were excluded.

They defined a high-quality colonoscopy as an exam complete to cecum, with adequate bowel preparation, and performed by an endoscopist with an adenoma detection rate of 25 or higher.

The adenoma detection rate is calculated as the number of screening colonoscopies with at least one adenoma divided by the total number of screening colonoscopies.

The definition of advanced outcomes included advanced adenomas, colorectal cancer, and/or large serrated polyps (1 cm or greater).

Of the 14,011 patients in the sample, 2,283 had a follow-up exam at 10 years. The absolute risk for advanced outcomes among patients who had a high quality index exam was 4.0% vs. 6.7% for those with lower quality exams.

Among patients with low-quality index exams – but not patients with high quality exams – there was a statistically significant increase in the absolute risk for advanced outcomes at all time periods, from 5.1% in the less than 5-year follow-up group, to 6.7% in the 10-years or more follow-up group.

Patients with initial high-quality exams also had a lower risk for postcolonoscopy colorectal cancer, compared with patients who had low-quality index exams: 0.4% vs. 0.8%. This difference translated into an adjusted hazard ratio for colorectal cancer after a high-quality exam of 0.53.
 

It’s getting better all the time

In an interview, Daniel J. Pambianco, MD, FACG from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that Dr. Anderson and colleagues highlighted the importance of the quality of the bowel prep and the quality of the examination itself.

He noted that the use of devices such as colonoscopy caps can help further improve adenoma detection rates and pointed to up-and-coming developments such as the use of artificial intelligence algorithms to aid human endoscopists.

Dr. Pambianco comoderated the session where the data were presented.

The investigators did not report a study funding source. Dr. Anderson and Dr. Pambianco reported having no relevant financial disclosures.