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In Lecanemab Alzheimer Extension Study, Placebo Roll-Over Group Does Not Catch Up
DENVER — , according to a first report of 6-month OLE data.
Due to the steady disease progression observed after the switch of placebo to active therapy, the message of these data is that “early initiation of lecanemab is important,” according to Michael Irizarry, MD, the senior vice president of clinical research at Eisai Ltd, which markets lecanemab.
The 6-month OLE data along with data from a tau PET substudy were presented by Dr. Irizarry at the 2024 annual meeting of the American Academy of Neurology.
From the start of the OLE through the 6-month follow-up, the downward trajectory of cognitive function, as measured with the Clinical Dementia Rating – Sum of Boxes (CDR-SB), has been parallel for the lecanemab-start and switch arms. As a result, the degree of separation between active and placebo groups over the course of the OLE has remained unchanged from the end of the randomized trial.
This does not rule out any benefit in the switch arm, according to Dr. Irizarry. Although there was no discernible change in the trajectory of decline among placebo patients after they were switched to lecanemab, Dr. Irizarry postulated that this might overlook the greater likely decline over time with no treatment.
“There was no placebo group in the OLE to compare with those on active treatment,” he pointed out. He then juxtaposed data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). Over the same 6-month timeframe, these data show a hypothetical separation of the curves if no treatment had been received.
The 6-month OLE data provide a preliminary look at outcomes in a planned 4-year follow-up. At the end of the randomized CLARITY trial, the mean decline from the baseline CDR-SB score of 3.2, was 1.21 in the lecanemab group, translating into a 38% decline, and 1.66 in the placebo group, translating into about a 50% decline. Over the 6 months of OLE, there has been a further mean CDR-SB reduction of approximately 0.6 in both arms, suggesting a further 18% decline from baseline.
Additional Data
In the pivotal CLARITY trial, which was published a few months prior to regulatory approval early last year, 1785 patients were randomized to 10 mg/kg lecanemab or placebo infused every 2 weeks. At the end of 18 months, the superiority of lecanemab for the primary endpoint of adverse change in CDR-SB was highly significant (P < .001) as were the differences in key secondary endpoints, such as Alzheimer’s Disease Composite Score (P < .001).
Of those who participated in CLARITY, 1385 patients entered the OLE. Placebo patients were switched to lecanemab which is being maintained in all patients on the trial schedule of 10 mg/kg administered by intravenous infusion every 2 weeks.
In addition to the overall OLE 6-month data, which has not raised any new safety signals, Dr. Irizarry provided a new look at the PET TAU substudy with a focus on patients who entered the study with a low relative tau burden. Of the three classifications, which also included medium and high tau, as measured with positron-emission tomography (PET), the low tau group represented 41.2% of the 342 tau PET substudy participants. With only 2.9% entering the study with a high tau burden, almost all the others fell in the medium stratification.
Due to the potential for a lower therapeutic response, “patients with low Tau are often excluded from trials,” Dr. Irizarry said. But the sizable proportion of low tau patients has permitted an assessment of relative response with lecanemab, which turned out to be substantial.
“Consistent rates of clinical stability or improvements were observed regardless of baseline tau levels with the highest rates of improvements observed for the low tau group after 24 months of follow-up,” Dr. Irizarry reported.
In previously reported results from the tau PET substudy, lecanemab was shown to slow tau spread at least numerically in every section of the brain evaluated, including the frontal, cingulate, parietal, and whole cortical gray matter areas. The reductions reached significance for the medial temporal (P = .0024), meta temporal (P = .012), and temporal (P = .16) portions.
When most recently evaluated in the OLE, the CDR-SB score declined 38% less among those treated with lecanemab than those treated with placebo in the subgroup enrolled in the tau PET substudy.
Relative to those with intermediate or high tau, patients in the low tau had an even greater reduction in cognitive decline than those with higher tau burdens. Although Dr. Irizarry cautioned that greater baseline CDR-SB scores exaggerated the treatment effect in the low tau group, the message is that “a lecanemab treatment effect is seen even when baseline tau levels are low.”
Now, with the recent market withdrawal of aducanumab, another anti-amyloid monoclonal antibody that was previously approved for Alzheimer’s disease, lecanemab is the only therapy currently available for the goal of changing disease progression, not just modifying symptoms.
Looking Long Term
Both sets of data provide important messages for clinicians, according to Marcelo Matiello, MD, a physician investigator at Mass General Hospital and associate professor of neurology at Harvard Medical School, Boston.
“Clinicians are really looking for more data because this remains a relatively new drug,” he said. Both sets of findings presented by Dr. Irizarry “look good but the follow-up is still short, so I think everyone is still looking closely at long-term safety and efficacy.”
The need for continuous indefinite therapy is one concern that Dr. Matiello expressed. As moderator of the session in which these data were presented, Dr. Matiello specifically asked Dr. Irizarry if there are plans to explore whether periods without treatment might be a means to reduce the cost and burden of frequent infusions while preserving cognitive gains.
In response, Dr. Irizarry said that earlier studies showed rapid progression when lecanemab was stopped. On this basis, he thinks therapy must be maintained, but he did say that there are plans to look at less frequent dosing, such as once per month. He also said that a subcutaneous formulation in development might also reduce the burden of prolonged treatment.
Dr. Irizarry is an employee of Eisai Ltd., which manufacturers lecanemab. Dr. Matiello reports no potential conflicts of interest.
DENVER — , according to a first report of 6-month OLE data.
Due to the steady disease progression observed after the switch of placebo to active therapy, the message of these data is that “early initiation of lecanemab is important,” according to Michael Irizarry, MD, the senior vice president of clinical research at Eisai Ltd, which markets lecanemab.
The 6-month OLE data along with data from a tau PET substudy were presented by Dr. Irizarry at the 2024 annual meeting of the American Academy of Neurology.
From the start of the OLE through the 6-month follow-up, the downward trajectory of cognitive function, as measured with the Clinical Dementia Rating – Sum of Boxes (CDR-SB), has been parallel for the lecanemab-start and switch arms. As a result, the degree of separation between active and placebo groups over the course of the OLE has remained unchanged from the end of the randomized trial.
This does not rule out any benefit in the switch arm, according to Dr. Irizarry. Although there was no discernible change in the trajectory of decline among placebo patients after they were switched to lecanemab, Dr. Irizarry postulated that this might overlook the greater likely decline over time with no treatment.
“There was no placebo group in the OLE to compare with those on active treatment,” he pointed out. He then juxtaposed data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). Over the same 6-month timeframe, these data show a hypothetical separation of the curves if no treatment had been received.
The 6-month OLE data provide a preliminary look at outcomes in a planned 4-year follow-up. At the end of the randomized CLARITY trial, the mean decline from the baseline CDR-SB score of 3.2, was 1.21 in the lecanemab group, translating into a 38% decline, and 1.66 in the placebo group, translating into about a 50% decline. Over the 6 months of OLE, there has been a further mean CDR-SB reduction of approximately 0.6 in both arms, suggesting a further 18% decline from baseline.
Additional Data
In the pivotal CLARITY trial, which was published a few months prior to regulatory approval early last year, 1785 patients were randomized to 10 mg/kg lecanemab or placebo infused every 2 weeks. At the end of 18 months, the superiority of lecanemab for the primary endpoint of adverse change in CDR-SB was highly significant (P < .001) as were the differences in key secondary endpoints, such as Alzheimer’s Disease Composite Score (P < .001).
Of those who participated in CLARITY, 1385 patients entered the OLE. Placebo patients were switched to lecanemab which is being maintained in all patients on the trial schedule of 10 mg/kg administered by intravenous infusion every 2 weeks.
In addition to the overall OLE 6-month data, which has not raised any new safety signals, Dr. Irizarry provided a new look at the PET TAU substudy with a focus on patients who entered the study with a low relative tau burden. Of the three classifications, which also included medium and high tau, as measured with positron-emission tomography (PET), the low tau group represented 41.2% of the 342 tau PET substudy participants. With only 2.9% entering the study with a high tau burden, almost all the others fell in the medium stratification.
Due to the potential for a lower therapeutic response, “patients with low Tau are often excluded from trials,” Dr. Irizarry said. But the sizable proportion of low tau patients has permitted an assessment of relative response with lecanemab, which turned out to be substantial.
“Consistent rates of clinical stability or improvements were observed regardless of baseline tau levels with the highest rates of improvements observed for the low tau group after 24 months of follow-up,” Dr. Irizarry reported.
In previously reported results from the tau PET substudy, lecanemab was shown to slow tau spread at least numerically in every section of the brain evaluated, including the frontal, cingulate, parietal, and whole cortical gray matter areas. The reductions reached significance for the medial temporal (P = .0024), meta temporal (P = .012), and temporal (P = .16) portions.
When most recently evaluated in the OLE, the CDR-SB score declined 38% less among those treated with lecanemab than those treated with placebo in the subgroup enrolled in the tau PET substudy.
Relative to those with intermediate or high tau, patients in the low tau had an even greater reduction in cognitive decline than those with higher tau burdens. Although Dr. Irizarry cautioned that greater baseline CDR-SB scores exaggerated the treatment effect in the low tau group, the message is that “a lecanemab treatment effect is seen even when baseline tau levels are low.”
Now, with the recent market withdrawal of aducanumab, another anti-amyloid monoclonal antibody that was previously approved for Alzheimer’s disease, lecanemab is the only therapy currently available for the goal of changing disease progression, not just modifying symptoms.
Looking Long Term
Both sets of data provide important messages for clinicians, according to Marcelo Matiello, MD, a physician investigator at Mass General Hospital and associate professor of neurology at Harvard Medical School, Boston.
“Clinicians are really looking for more data because this remains a relatively new drug,” he said. Both sets of findings presented by Dr. Irizarry “look good but the follow-up is still short, so I think everyone is still looking closely at long-term safety and efficacy.”
The need for continuous indefinite therapy is one concern that Dr. Matiello expressed. As moderator of the session in which these data were presented, Dr. Matiello specifically asked Dr. Irizarry if there are plans to explore whether periods without treatment might be a means to reduce the cost and burden of frequent infusions while preserving cognitive gains.
In response, Dr. Irizarry said that earlier studies showed rapid progression when lecanemab was stopped. On this basis, he thinks therapy must be maintained, but he did say that there are plans to look at less frequent dosing, such as once per month. He also said that a subcutaneous formulation in development might also reduce the burden of prolonged treatment.
Dr. Irizarry is an employee of Eisai Ltd., which manufacturers lecanemab. Dr. Matiello reports no potential conflicts of interest.
DENVER — , according to a first report of 6-month OLE data.
Due to the steady disease progression observed after the switch of placebo to active therapy, the message of these data is that “early initiation of lecanemab is important,” according to Michael Irizarry, MD, the senior vice president of clinical research at Eisai Ltd, which markets lecanemab.
The 6-month OLE data along with data from a tau PET substudy were presented by Dr. Irizarry at the 2024 annual meeting of the American Academy of Neurology.
From the start of the OLE through the 6-month follow-up, the downward trajectory of cognitive function, as measured with the Clinical Dementia Rating – Sum of Boxes (CDR-SB), has been parallel for the lecanemab-start and switch arms. As a result, the degree of separation between active and placebo groups over the course of the OLE has remained unchanged from the end of the randomized trial.
This does not rule out any benefit in the switch arm, according to Dr. Irizarry. Although there was no discernible change in the trajectory of decline among placebo patients after they were switched to lecanemab, Dr. Irizarry postulated that this might overlook the greater likely decline over time with no treatment.
“There was no placebo group in the OLE to compare with those on active treatment,” he pointed out. He then juxtaposed data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). Over the same 6-month timeframe, these data show a hypothetical separation of the curves if no treatment had been received.
The 6-month OLE data provide a preliminary look at outcomes in a planned 4-year follow-up. At the end of the randomized CLARITY trial, the mean decline from the baseline CDR-SB score of 3.2, was 1.21 in the lecanemab group, translating into a 38% decline, and 1.66 in the placebo group, translating into about a 50% decline. Over the 6 months of OLE, there has been a further mean CDR-SB reduction of approximately 0.6 in both arms, suggesting a further 18% decline from baseline.
Additional Data
In the pivotal CLARITY trial, which was published a few months prior to regulatory approval early last year, 1785 patients were randomized to 10 mg/kg lecanemab or placebo infused every 2 weeks. At the end of 18 months, the superiority of lecanemab for the primary endpoint of adverse change in CDR-SB was highly significant (P < .001) as were the differences in key secondary endpoints, such as Alzheimer’s Disease Composite Score (P < .001).
Of those who participated in CLARITY, 1385 patients entered the OLE. Placebo patients were switched to lecanemab which is being maintained in all patients on the trial schedule of 10 mg/kg administered by intravenous infusion every 2 weeks.
In addition to the overall OLE 6-month data, which has not raised any new safety signals, Dr. Irizarry provided a new look at the PET TAU substudy with a focus on patients who entered the study with a low relative tau burden. Of the three classifications, which also included medium and high tau, as measured with positron-emission tomography (PET), the low tau group represented 41.2% of the 342 tau PET substudy participants. With only 2.9% entering the study with a high tau burden, almost all the others fell in the medium stratification.
Due to the potential for a lower therapeutic response, “patients with low Tau are often excluded from trials,” Dr. Irizarry said. But the sizable proportion of low tau patients has permitted an assessment of relative response with lecanemab, which turned out to be substantial.
“Consistent rates of clinical stability or improvements were observed regardless of baseline tau levels with the highest rates of improvements observed for the low tau group after 24 months of follow-up,” Dr. Irizarry reported.
In previously reported results from the tau PET substudy, lecanemab was shown to slow tau spread at least numerically in every section of the brain evaluated, including the frontal, cingulate, parietal, and whole cortical gray matter areas. The reductions reached significance for the medial temporal (P = .0024), meta temporal (P = .012), and temporal (P = .16) portions.
When most recently evaluated in the OLE, the CDR-SB score declined 38% less among those treated with lecanemab than those treated with placebo in the subgroup enrolled in the tau PET substudy.
Relative to those with intermediate or high tau, patients in the low tau had an even greater reduction in cognitive decline than those with higher tau burdens. Although Dr. Irizarry cautioned that greater baseline CDR-SB scores exaggerated the treatment effect in the low tau group, the message is that “a lecanemab treatment effect is seen even when baseline tau levels are low.”
Now, with the recent market withdrawal of aducanumab, another anti-amyloid monoclonal antibody that was previously approved for Alzheimer’s disease, lecanemab is the only therapy currently available for the goal of changing disease progression, not just modifying symptoms.
Looking Long Term
Both sets of data provide important messages for clinicians, according to Marcelo Matiello, MD, a physician investigator at Mass General Hospital and associate professor of neurology at Harvard Medical School, Boston.
“Clinicians are really looking for more data because this remains a relatively new drug,” he said. Both sets of findings presented by Dr. Irizarry “look good but the follow-up is still short, so I think everyone is still looking closely at long-term safety and efficacy.”
The need for continuous indefinite therapy is one concern that Dr. Matiello expressed. As moderator of the session in which these data were presented, Dr. Matiello specifically asked Dr. Irizarry if there are plans to explore whether periods without treatment might be a means to reduce the cost and burden of frequent infusions while preserving cognitive gains.
In response, Dr. Irizarry said that earlier studies showed rapid progression when lecanemab was stopped. On this basis, he thinks therapy must be maintained, but he did say that there are plans to look at less frequent dosing, such as once per month. He also said that a subcutaneous formulation in development might also reduce the burden of prolonged treatment.
Dr. Irizarry is an employee of Eisai Ltd., which manufacturers lecanemab. Dr. Matiello reports no potential conflicts of interest.
FROM AAN 2024
Survey Finds Mental Health Issues Increased After Cosmetic Procedure Complications
BALTIMORE — of patients with dermatology-related complications.
The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.
“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
Rise in Mental Health Issues
The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results.
Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.
“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”
Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”
The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).
The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).
Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.
“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
Take-Home Lesson
The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”
She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”
She said she hopes her findings lead to more research in the future.
Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”
She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.
The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”
Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.
A version of this article appeared on Medscape.com.
BALTIMORE — of patients with dermatology-related complications.
The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.
“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
Rise in Mental Health Issues
The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results.
Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.
“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”
Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”
The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).
The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).
Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.
“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
Take-Home Lesson
The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”
She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”
She said she hopes her findings lead to more research in the future.
Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”
She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.
The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”
Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.
A version of this article appeared on Medscape.com.
BALTIMORE — of patients with dermatology-related complications.
The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.
“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
Rise in Mental Health Issues
The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results.
Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.
“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”
Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”
The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).
The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).
Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.
“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
Take-Home Lesson
The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”
She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”
She said she hopes her findings lead to more research in the future.
Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”
She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.
The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”
Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.
A version of this article appeared on Medscape.com.
FROM ASLMS 2024
Cannabis Constituent May Be Key to Easing THC-Induced Anxiety
, new data from a small study suggested.
Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.
Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.
“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.
“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.
The study was published online in Drug and Alcohol Dependence.
Entourage Theory
Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.
Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.
Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.
“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.
Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.
All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.
Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.
Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.
Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
First Evidence
There were no significant differences in outcomes between the D-limonene alone and placebo groups.
Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.
A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).
In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).
Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).
In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.
On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).
As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.
There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.
The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).
“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.
Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
Significant Impact
Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.
The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.
“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.
Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”
In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”
This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
A version of this article appeared on Medscape.com.
, new data from a small study suggested.
Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.
Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.
“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.
“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.
The study was published online in Drug and Alcohol Dependence.
Entourage Theory
Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.
Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.
Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.
“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.
Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.
All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.
Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.
Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.
Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
First Evidence
There were no significant differences in outcomes between the D-limonene alone and placebo groups.
Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.
A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).
In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).
Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).
In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.
On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).
As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.
There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.
The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).
“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.
Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
Significant Impact
Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.
The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.
“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.
Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”
In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”
This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
A version of this article appeared on Medscape.com.
, new data from a small study suggested.
Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.
Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.
“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.
“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.
The study was published online in Drug and Alcohol Dependence.
Entourage Theory
Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.
Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.
Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.
“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.
Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.
All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.
Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.
Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.
Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
First Evidence
There were no significant differences in outcomes between the D-limonene alone and placebo groups.
Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.
A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).
In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).
Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).
In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.
On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).
As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.
There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.
The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).
“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.
Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
Significant Impact
Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.
The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.
“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.
Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”
In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”
This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
A version of this article appeared on Medscape.com.
From Drug and Alcohol Dependence
‘Difficult Patient’: Stigmatizing Words and Medical Error
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Association Calls For Increased Oversight in Response to Reports of Possibly Counterfeit Botulinum Toxin
, including medical spas.
In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.
The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.
Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.
Key Takeaways
All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.
“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.
However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.
A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”
Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
Additional Guidance, Actions Needed
As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.
D. Sodha had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
, including medical spas.
In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.
The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.
Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.
Key Takeaways
All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.
“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.
However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.
A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”
Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
Additional Guidance, Actions Needed
As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.
D. Sodha had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
, including medical spas.
In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.
The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.
Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.
Key Takeaways
All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.
“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.
However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.
A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”
Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
Additional Guidance, Actions Needed
As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.
D. Sodha had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Recently Immunized Febrile Infants Have Low Infection Risk
TOPLINE:
METHODOLOGY:
- Researchers evaluated 508 infants aged 6-12 weeks who presented with a fever of 38 °C or greater at two US military academic emergency departments (EDs) over a span of 4 years.
- The infants were categorized as “recently immunized” if they had received immunizations within 72 hours before ED presentation and “not recently immunized” if they had not. Among the 508 infants, 114 were immunized recently.
- The primary outcome was the prevalence of a serious bacterial infection (SBI), categorized into IBI and non-IBI on the basis of culture and radiography findings.
TAKEAWAY:
- The prevalence of SBI was 3.5% in the recently immunized febrile infants and 13.7% in not recently immunized febrile infants.
- Among the recently immunized infants, the prevalence of SBI was lower in those immunized within the first 24 hours than those immunized more than 24 hours before ED presentation (2% vs 14.3%, respectively).
- Almost all identified SBI cases were of urinary tract infection (UTI), with the only non-UTI case being pneumonia in an infant who exhibited respiratory symptoms within 24 hours of receiving immunization.
IN PRACTICE:
Physicians should discuss the possibilities of a less invasive approach for evaluating recently immunized febrile infants. The study findings support the general recommendation to obtain a urinalysis for all recently immunized infants over 60 days presenting with fever, including those presenting less than 24 hours post immunization.
SOURCE:
This study, led by Kyla Casey, MD, Department of Emergency Medicine, Naval Medical Center San Diego, was published online in The American Journal of Emergency Medicine.
LIMITATIONS:
The small sample size and retrospective design might have resulted in an overestimation of outcomes like IBIs within 24 hours after immunization. As the study was conducted in a specific clinical setting with febrile infants from military medical centers, the findings may have limited generalizability. Moreover, the inclusion of premature infants without age correction for prematurity could have impacted the prevalence of IBIs. Factors like missing vaccination history, healthcare referral patterns, and immunization practices in the military system may have introduced bias.
DISCLOSURE:
This research did not receive any specific grant from funding agencies in the public, commercial, or not for profit sectors. The authors had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers evaluated 508 infants aged 6-12 weeks who presented with a fever of 38 °C or greater at two US military academic emergency departments (EDs) over a span of 4 years.
- The infants were categorized as “recently immunized” if they had received immunizations within 72 hours before ED presentation and “not recently immunized” if they had not. Among the 508 infants, 114 were immunized recently.
- The primary outcome was the prevalence of a serious bacterial infection (SBI), categorized into IBI and non-IBI on the basis of culture and radiography findings.
TAKEAWAY:
- The prevalence of SBI was 3.5% in the recently immunized febrile infants and 13.7% in not recently immunized febrile infants.
- Among the recently immunized infants, the prevalence of SBI was lower in those immunized within the first 24 hours than those immunized more than 24 hours before ED presentation (2% vs 14.3%, respectively).
- Almost all identified SBI cases were of urinary tract infection (UTI), with the only non-UTI case being pneumonia in an infant who exhibited respiratory symptoms within 24 hours of receiving immunization.
IN PRACTICE:
Physicians should discuss the possibilities of a less invasive approach for evaluating recently immunized febrile infants. The study findings support the general recommendation to obtain a urinalysis for all recently immunized infants over 60 days presenting with fever, including those presenting less than 24 hours post immunization.
SOURCE:
This study, led by Kyla Casey, MD, Department of Emergency Medicine, Naval Medical Center San Diego, was published online in The American Journal of Emergency Medicine.
LIMITATIONS:
The small sample size and retrospective design might have resulted in an overestimation of outcomes like IBIs within 24 hours after immunization. As the study was conducted in a specific clinical setting with febrile infants from military medical centers, the findings may have limited generalizability. Moreover, the inclusion of premature infants without age correction for prematurity could have impacted the prevalence of IBIs. Factors like missing vaccination history, healthcare referral patterns, and immunization practices in the military system may have introduced bias.
DISCLOSURE:
This research did not receive any specific grant from funding agencies in the public, commercial, or not for profit sectors. The authors had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers evaluated 508 infants aged 6-12 weeks who presented with a fever of 38 °C or greater at two US military academic emergency departments (EDs) over a span of 4 years.
- The infants were categorized as “recently immunized” if they had received immunizations within 72 hours before ED presentation and “not recently immunized” if they had not. Among the 508 infants, 114 were immunized recently.
- The primary outcome was the prevalence of a serious bacterial infection (SBI), categorized into IBI and non-IBI on the basis of culture and radiography findings.
TAKEAWAY:
- The prevalence of SBI was 3.5% in the recently immunized febrile infants and 13.7% in not recently immunized febrile infants.
- Among the recently immunized infants, the prevalence of SBI was lower in those immunized within the first 24 hours than those immunized more than 24 hours before ED presentation (2% vs 14.3%, respectively).
- Almost all identified SBI cases were of urinary tract infection (UTI), with the only non-UTI case being pneumonia in an infant who exhibited respiratory symptoms within 24 hours of receiving immunization.
IN PRACTICE:
Physicians should discuss the possibilities of a less invasive approach for evaluating recently immunized febrile infants. The study findings support the general recommendation to obtain a urinalysis for all recently immunized infants over 60 days presenting with fever, including those presenting less than 24 hours post immunization.
SOURCE:
This study, led by Kyla Casey, MD, Department of Emergency Medicine, Naval Medical Center San Diego, was published online in The American Journal of Emergency Medicine.
LIMITATIONS:
The small sample size and retrospective design might have resulted in an overestimation of outcomes like IBIs within 24 hours after immunization. As the study was conducted in a specific clinical setting with febrile infants from military medical centers, the findings may have limited generalizability. Moreover, the inclusion of premature infants without age correction for prematurity could have impacted the prevalence of IBIs. Factors like missing vaccination history, healthcare referral patterns, and immunization practices in the military system may have introduced bias.
DISCLOSURE:
This research did not receive any specific grant from funding agencies in the public, commercial, or not for profit sectors. The authors had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
Internists blame bureaucracy as top cause of burnout
Reported burnout among internal medicine physicians decreased over the past year based on data from Medscape’s annual survey of burnout and depression among physicians in the United States.
Approximately 80% of male internists and 85% of female internists said that their feelings of burnout and/or depression were driven by their jobs all or most of the time. The job-related stress and burnout come home with them — 76% of respondents overall said that burnout had negatively affected their personal relationships.
Too many bureaucratic tasks such as charting and paperwork were by far the top contributor to burnout, reported by 70% of respondents, with insufficient compensation and lack of respect from employers, colleagues, and staff as relatively distant second and third contributors (40% and 37%, respectively).
In addition, nearly half of the physicians said that their burnout was severe enough that they might leave medicine.
To help manage burnout, more internists reported positive coping strategies such as exercise (51%), talking with friends and family (47%), spending time alone (41%), and sleeping (40%), compared to less healthy strategies such as eating junk food, drinking alcohol, and using nicotine or cannabis products.
When asked what workplace measures would help with burnout, no one strategy rose to the top, but the top three were increased compensation (49%), additional support staff (48%), and more flexible work schedules (45%).
Notably, 62% of internists reported depression they defined as colloquial (feeling down or sad) and 27% described their depression as clinical. However, only 9% said they had sought professional help for depression, and 15% said they had sought help for burnout.
Staying in Practice Despite Burnout
The percentage of physicians across specialties who report depression and burnout worsened during the COVID-19 pandemic, said Noel Deep, MD, an internal medicine physician in group practice in Antigo, Wisconsin, in an interview.
Since the pandemic, newer stressors have replaced the pandemic-related stressors, and increasing bureaucratic burdens and paperwork continue to cause more physicians to report burnout, he said.
“If not assessed and addressed, this will lead to attrition in the physician workforce leading to increased burden on other physicians and impact patient access to healthcare,” he added.
The survey findings reflect Dr. Deep’s observations. “When talking to physicians across specialties, I have heard universally from many physicians about their experiences and ongoing struggles with potential burnout and mood-related issues,” he said. “While many of them feel that they are getting to the point of burnout, most of them also stoically continue to provide care to patients because they feel an obligation to them,” he said.
This feeling of obligation to patients is why less than one third of the physicians who consider retiring or leaving medicine because of burnout actually do, he said.
As for measures to reduce burnout, “I personally feel that increasing the compensation will not lead to decreased burnout,” Dr. Deep said. Although more money may provide temporary satisfaction, it will not yield long-term improvement in burnout, he said. “Based on personal experiences and my interactions with physicians, providing them more autonomy and control over their practices ... would contribute to decreasing the burnout,” Dr. Deep emphasized.
What Is to Be Done?
“I would favor having physician leaders in healthcare organizations take the time to talk to physicians [and] provide mentoring programs when new physicians are recruited, with ongoing discussions at operations and governance meetings about physician health and wellness,” Dr. Deep said. Providing frequent updates to physicians about wellness resources and encouraging them to seek out help anonymously through Employee Assistance Programs and other counseling services would be beneficial, he added.
“I would also consider peer mentoring when possible. Employers, healthcare organizations, and other key stakeholders should continue to work toward decreasing the stigma of depression and burnout,” Dr. Deep said.
Employers can help physicians manage and reduce burnout and depression by engaging with them, listening to their concerns, and trying to address them, said Dr. Deep. These actions will increase physicians’ trust in their administrations and promote a positive and healthy work environment, he said. “This will lead to reduced attrition in the workforce, retention of experienced physicians and support staff, and lead to increased patient satisfaction as well.”
The data come from Medscape’s annual report on Physician Burnout & Depression, which included 9226 practicing physicians in the United States across more than 29 specialties.
Dr. Deep had no financial conflicts to disclose; he serves on the Editorial Advisory Board of Internal Medicine News.
Reported burnout among internal medicine physicians decreased over the past year based on data from Medscape’s annual survey of burnout and depression among physicians in the United States.
Approximately 80% of male internists and 85% of female internists said that their feelings of burnout and/or depression were driven by their jobs all or most of the time. The job-related stress and burnout come home with them — 76% of respondents overall said that burnout had negatively affected their personal relationships.
Too many bureaucratic tasks such as charting and paperwork were by far the top contributor to burnout, reported by 70% of respondents, with insufficient compensation and lack of respect from employers, colleagues, and staff as relatively distant second and third contributors (40% and 37%, respectively).
In addition, nearly half of the physicians said that their burnout was severe enough that they might leave medicine.
To help manage burnout, more internists reported positive coping strategies such as exercise (51%), talking with friends and family (47%), spending time alone (41%), and sleeping (40%), compared to less healthy strategies such as eating junk food, drinking alcohol, and using nicotine or cannabis products.
When asked what workplace measures would help with burnout, no one strategy rose to the top, but the top three were increased compensation (49%), additional support staff (48%), and more flexible work schedules (45%).
Notably, 62% of internists reported depression they defined as colloquial (feeling down or sad) and 27% described their depression as clinical. However, only 9% said they had sought professional help for depression, and 15% said they had sought help for burnout.
Staying in Practice Despite Burnout
The percentage of physicians across specialties who report depression and burnout worsened during the COVID-19 pandemic, said Noel Deep, MD, an internal medicine physician in group practice in Antigo, Wisconsin, in an interview.
Since the pandemic, newer stressors have replaced the pandemic-related stressors, and increasing bureaucratic burdens and paperwork continue to cause more physicians to report burnout, he said.
“If not assessed and addressed, this will lead to attrition in the physician workforce leading to increased burden on other physicians and impact patient access to healthcare,” he added.
The survey findings reflect Dr. Deep’s observations. “When talking to physicians across specialties, I have heard universally from many physicians about their experiences and ongoing struggles with potential burnout and mood-related issues,” he said. “While many of them feel that they are getting to the point of burnout, most of them also stoically continue to provide care to patients because they feel an obligation to them,” he said.
This feeling of obligation to patients is why less than one third of the physicians who consider retiring or leaving medicine because of burnout actually do, he said.
As for measures to reduce burnout, “I personally feel that increasing the compensation will not lead to decreased burnout,” Dr. Deep said. Although more money may provide temporary satisfaction, it will not yield long-term improvement in burnout, he said. “Based on personal experiences and my interactions with physicians, providing them more autonomy and control over their practices ... would contribute to decreasing the burnout,” Dr. Deep emphasized.
What Is to Be Done?
“I would favor having physician leaders in healthcare organizations take the time to talk to physicians [and] provide mentoring programs when new physicians are recruited, with ongoing discussions at operations and governance meetings about physician health and wellness,” Dr. Deep said. Providing frequent updates to physicians about wellness resources and encouraging them to seek out help anonymously through Employee Assistance Programs and other counseling services would be beneficial, he added.
“I would also consider peer mentoring when possible. Employers, healthcare organizations, and other key stakeholders should continue to work toward decreasing the stigma of depression and burnout,” Dr. Deep said.
Employers can help physicians manage and reduce burnout and depression by engaging with them, listening to their concerns, and trying to address them, said Dr. Deep. These actions will increase physicians’ trust in their administrations and promote a positive and healthy work environment, he said. “This will lead to reduced attrition in the workforce, retention of experienced physicians and support staff, and lead to increased patient satisfaction as well.”
The data come from Medscape’s annual report on Physician Burnout & Depression, which included 9226 practicing physicians in the United States across more than 29 specialties.
Dr. Deep had no financial conflicts to disclose; he serves on the Editorial Advisory Board of Internal Medicine News.
Reported burnout among internal medicine physicians decreased over the past year based on data from Medscape’s annual survey of burnout and depression among physicians in the United States.
Approximately 80% of male internists and 85% of female internists said that their feelings of burnout and/or depression were driven by their jobs all or most of the time. The job-related stress and burnout come home with them — 76% of respondents overall said that burnout had negatively affected their personal relationships.
Too many bureaucratic tasks such as charting and paperwork were by far the top contributor to burnout, reported by 70% of respondents, with insufficient compensation and lack of respect from employers, colleagues, and staff as relatively distant second and third contributors (40% and 37%, respectively).
In addition, nearly half of the physicians said that their burnout was severe enough that they might leave medicine.
To help manage burnout, more internists reported positive coping strategies such as exercise (51%), talking with friends and family (47%), spending time alone (41%), and sleeping (40%), compared to less healthy strategies such as eating junk food, drinking alcohol, and using nicotine or cannabis products.
When asked what workplace measures would help with burnout, no one strategy rose to the top, but the top three were increased compensation (49%), additional support staff (48%), and more flexible work schedules (45%).
Notably, 62% of internists reported depression they defined as colloquial (feeling down or sad) and 27% described their depression as clinical. However, only 9% said they had sought professional help for depression, and 15% said they had sought help for burnout.
Staying in Practice Despite Burnout
The percentage of physicians across specialties who report depression and burnout worsened during the COVID-19 pandemic, said Noel Deep, MD, an internal medicine physician in group practice in Antigo, Wisconsin, in an interview.
Since the pandemic, newer stressors have replaced the pandemic-related stressors, and increasing bureaucratic burdens and paperwork continue to cause more physicians to report burnout, he said.
“If not assessed and addressed, this will lead to attrition in the physician workforce leading to increased burden on other physicians and impact patient access to healthcare,” he added.
The survey findings reflect Dr. Deep’s observations. “When talking to physicians across specialties, I have heard universally from many physicians about their experiences and ongoing struggles with potential burnout and mood-related issues,” he said. “While many of them feel that they are getting to the point of burnout, most of them also stoically continue to provide care to patients because they feel an obligation to them,” he said.
This feeling of obligation to patients is why less than one third of the physicians who consider retiring or leaving medicine because of burnout actually do, he said.
As for measures to reduce burnout, “I personally feel that increasing the compensation will not lead to decreased burnout,” Dr. Deep said. Although more money may provide temporary satisfaction, it will not yield long-term improvement in burnout, he said. “Based on personal experiences and my interactions with physicians, providing them more autonomy and control over their practices ... would contribute to decreasing the burnout,” Dr. Deep emphasized.
What Is to Be Done?
“I would favor having physician leaders in healthcare organizations take the time to talk to physicians [and] provide mentoring programs when new physicians are recruited, with ongoing discussions at operations and governance meetings about physician health and wellness,” Dr. Deep said. Providing frequent updates to physicians about wellness resources and encouraging them to seek out help anonymously through Employee Assistance Programs and other counseling services would be beneficial, he added.
“I would also consider peer mentoring when possible. Employers, healthcare organizations, and other key stakeholders should continue to work toward decreasing the stigma of depression and burnout,” Dr. Deep said.
Employers can help physicians manage and reduce burnout and depression by engaging with them, listening to their concerns, and trying to address them, said Dr. Deep. These actions will increase physicians’ trust in their administrations and promote a positive and healthy work environment, he said. “This will lead to reduced attrition in the workforce, retention of experienced physicians and support staff, and lead to increased patient satisfaction as well.”
The data come from Medscape’s annual report on Physician Burnout & Depression, which included 9226 practicing physicians in the United States across more than 29 specialties.
Dr. Deep had no financial conflicts to disclose; he serves on the Editorial Advisory Board of Internal Medicine News.
Sugar Substitutes Satisfy Appetite, Blunt Insulin Response
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
Children With ASD May Have Earlier Onset of Suicidal Thoughts, Behaviors
, according to a research letter in JAMA Pediatrics.
Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket. Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.
People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.
Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.
They found the following reported lifetime STB incidence:
- 392 (40.5%) reported wanting to die
- 187 (19.3%) reported wanting to end their own lives
- 72 (7.4%) reported having a suicide plan
Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.
Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
Disturbing Findings
“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.
The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.
Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
Thoughts Come at a ‘Shockingly Young Age’
Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”
The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.
Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.
This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.
“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
Current Screening Recommendations
Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.
This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.
Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.
“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.
Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.
Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”
Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.
, according to a research letter in JAMA Pediatrics.
Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket. Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.
People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.
Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.
They found the following reported lifetime STB incidence:
- 392 (40.5%) reported wanting to die
- 187 (19.3%) reported wanting to end their own lives
- 72 (7.4%) reported having a suicide plan
Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.
Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
Disturbing Findings
“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.
The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.
Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
Thoughts Come at a ‘Shockingly Young Age’
Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”
The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.
Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.
This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.
“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
Current Screening Recommendations
Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.
This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.
Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.
“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.
Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.
Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”
Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.
, according to a research letter in JAMA Pediatrics.
Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket. Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.
People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.
Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.
They found the following reported lifetime STB incidence:
- 392 (40.5%) reported wanting to die
- 187 (19.3%) reported wanting to end their own lives
- 72 (7.4%) reported having a suicide plan
Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.
Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
Disturbing Findings
“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.
The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.
Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
Thoughts Come at a ‘Shockingly Young Age’
Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”
The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.
Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.
This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.
“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
Current Screening Recommendations
Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.
This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.
Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.
“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.
Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.
Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”
Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.
FROM JAMA PEDIATRICS
The Rise of Positive Psychiatry (and How Pediatrics Can Join the Effort)
Psychiatry, like all medical disciplines, changes over time. For many decades, psychiatrists were primarily psychotherapists. As medications slowly became available, these became a second tool for treatment — so much so that by the 21st century many, if not most, psychiatrists saw themselves primarily as psychopharmacologists and diagnosticians who were skilled at identifying various forms of mental illness and using medications in the hopes of inducing a clinically meaningful “response” in symptoms. While still belonging to the umbrella category of a mental health professional, more and more psychiatrists trained and practiced as mental illness professionals.
Slowly, however, there have been stirrings within the field by many who have found the identity of the psychiatrist as a “prescriber” to be too narrow, and the current “med check” model of treatment too confining. This change was partly inspired by our colleagues in clinical psychology who were challenged in the 1990s by then American Psychological Association President Martin Seligman, PhD, to develop knowledge and expertise not only in alleviating mental suffering but also in promoting true mental well-being, a construct that still was often vaguely defined. One framework of well-being that was advanced at the time was the PERMA model, representing the five well-being dimensions of Positive emotions, Engagement, Relationships, Meaning, and Accomplishment.1
While there have always been those in psychiatry who have advocated for a broad emphasis that incorporates the full spectrum of mental health, there has been a surge of interest in the past 10-15 years, urging a focus on well-being and the tools that can help a person achieve it. This trend has variably been referred to as positive psychiatry, lifestyle psychiatry, and other terms.2 As one might expect, child and adolescent psychiatry has been particularly fertile ground for such principles, and models such as the Vermont Family Based Approach have expanded the concept beyond the individual to the family and even community.3
It is important to note here that embracing the concept of well-being in treatment does not in any way require one to abandon the idea that genetic or environmental factors can lead to negative outcomes in brain development, nor does it mandate that one leaves behind important treatment modalities such as traditional psychotherapy and medication treatment. Further, this approach should not be confused with some “wellness” activities that offer quick fixes and lack scientific rigor. Positive psychiatry does, however, offer a third pathway to advance positive emotional behavioral growth, namely through health promotion activities ranging from exercise to good nutrition to positive parenting in ways that have been shown to benefit both those who are already doing fairly well as well as those who are actively struggling with significant psychiatric disorders.4
Primary care clinicians already have extensive familiarity talking about these kinds of health promoting activities with families. That said, it’s been my observation from many years of doing consultations and reviewing notes that these conversations happen almost exclusively during well-check visits and can get forgotten when a child presents with emotional behavioral challenges.
So how can the primary care clinician who is interested in more fully incorporating the burgeoning science on well-being work these principles into routine practice? Here are three suggestions.
Ask Some New Questions
It’s difficult to treat things that aren’t assessed. To best incorporate true mental health within one’s work with families, it can be very helpful to expand the regular questions one asks to include those that address some of the PERMA and health promotion areas described above. Some examples could include the following:
- Hopes. What would a perfect life look like for you when you’re older?
- Connection. Is there anything that you just love doing, so much so that time sometimes just seems to go away?
- Strengths. What are you good at? What good things would your friends say about you?
- Parenting. What are you most proud of as a parent, and where are your biggest challenges?
- Nutrition. What does a typical school day breakfast look like for you?
- Screens. Do you have any restrictions related to what you do on screens?
- Sleep. Tell me about your typical bedtime routine.
Add Some New Interventions
Counseling and medications can be powerful ways to bring improvement in a child’s life, but thinking about health promotion opens up a whole new avenue for intervention. This domain includes areas like physical activity, nutrition, sleep practices, parenting, participation in music and the arts, practicing kindness towards others, and mindfulness, among others.
For someone newly diagnosed with ADHD, for example, consider expanding your treatment plan to include not only medications but also specific guidance to exercise more, limit screen usage, practice good bedtime routines, eat a real breakfast, and reduce the helicopter parenting. Monitor these areas over time.
Another example relates to common sleep problems. Before making that melatonin recommendation, ask yourself if you understand what is happening in that child’s environment at night. Are they allowed to play video games until 2 a.m.? Are they taking naps during the day because they have nothing to do? Are they downing caffeinated drinks with dinner? Does the child get zero physical activity outside of the PE class? Maybe you still will need the melatonin, but perhaps other areas need to be addressed first.
Find Some New Colleagues
While it can be challenging sometimes to find anyone in mental health who sees new patients, there is value is finding out the approach and methodology that psychiatric clinicians and therapists apply in their practice. Working collaboratively with those who value a well-being orientation and who can work productively with the whole family to increase health promotion can yield benefits for a patient’s long-term physical and mental health.
The renewed interest and attention on well-being and health promotion activities that can optimize brain growth are a welcome and overdue development in mental health treatment. Pediatricians and other primary care clinicians can be a critical part of this growing initiative by gaining knowledge about youth well-being, applying this knowledge in day-to-day practice, and working collaboratively with those who share a similar perspective.
Dr. Rettew is a child & adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Oregon. He is on the psychiatry faculty at Oregon Health & Science University. You can follow him on Facebook and X @PediPsych. His latest book is Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.
References
1. Seligman, MEP. Flourish: a visionary new understanding of happiness and well-being. New York: Simon & Schuster; 2011.
2. Jeste DV, Palmer BW. (Eds.). Positive psychiatry: a clinical handbook. Washington DC: American Psychiatric Publishing; 2015. doi: 10.1176/appi.books.9781615370818.
3. Hudziak J, Ivanova MY. The Vermont family based approach: Family based health promotion, illness prevention, and intervention. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78. doi: 10.1016/j.chc.2015.11.002.
4. Rettew DC. Incorporating positive psychiatry with children and adolescents. Current Psychiatry. 2022 November;21(11):12-16,45. doi: 10.12788/cp.0303.
Psychiatry, like all medical disciplines, changes over time. For many decades, psychiatrists were primarily psychotherapists. As medications slowly became available, these became a second tool for treatment — so much so that by the 21st century many, if not most, psychiatrists saw themselves primarily as psychopharmacologists and diagnosticians who were skilled at identifying various forms of mental illness and using medications in the hopes of inducing a clinically meaningful “response” in symptoms. While still belonging to the umbrella category of a mental health professional, more and more psychiatrists trained and practiced as mental illness professionals.
Slowly, however, there have been stirrings within the field by many who have found the identity of the psychiatrist as a “prescriber” to be too narrow, and the current “med check” model of treatment too confining. This change was partly inspired by our colleagues in clinical psychology who were challenged in the 1990s by then American Psychological Association President Martin Seligman, PhD, to develop knowledge and expertise not only in alleviating mental suffering but also in promoting true mental well-being, a construct that still was often vaguely defined. One framework of well-being that was advanced at the time was the PERMA model, representing the five well-being dimensions of Positive emotions, Engagement, Relationships, Meaning, and Accomplishment.1
While there have always been those in psychiatry who have advocated for a broad emphasis that incorporates the full spectrum of mental health, there has been a surge of interest in the past 10-15 years, urging a focus on well-being and the tools that can help a person achieve it. This trend has variably been referred to as positive psychiatry, lifestyle psychiatry, and other terms.2 As one might expect, child and adolescent psychiatry has been particularly fertile ground for such principles, and models such as the Vermont Family Based Approach have expanded the concept beyond the individual to the family and even community.3
It is important to note here that embracing the concept of well-being in treatment does not in any way require one to abandon the idea that genetic or environmental factors can lead to negative outcomes in brain development, nor does it mandate that one leaves behind important treatment modalities such as traditional psychotherapy and medication treatment. Further, this approach should not be confused with some “wellness” activities that offer quick fixes and lack scientific rigor. Positive psychiatry does, however, offer a third pathway to advance positive emotional behavioral growth, namely through health promotion activities ranging from exercise to good nutrition to positive parenting in ways that have been shown to benefit both those who are already doing fairly well as well as those who are actively struggling with significant psychiatric disorders.4
Primary care clinicians already have extensive familiarity talking about these kinds of health promoting activities with families. That said, it’s been my observation from many years of doing consultations and reviewing notes that these conversations happen almost exclusively during well-check visits and can get forgotten when a child presents with emotional behavioral challenges.
So how can the primary care clinician who is interested in more fully incorporating the burgeoning science on well-being work these principles into routine practice? Here are three suggestions.
Ask Some New Questions
It’s difficult to treat things that aren’t assessed. To best incorporate true mental health within one’s work with families, it can be very helpful to expand the regular questions one asks to include those that address some of the PERMA and health promotion areas described above. Some examples could include the following:
- Hopes. What would a perfect life look like for you when you’re older?
- Connection. Is there anything that you just love doing, so much so that time sometimes just seems to go away?
- Strengths. What are you good at? What good things would your friends say about you?
- Parenting. What are you most proud of as a parent, and where are your biggest challenges?
- Nutrition. What does a typical school day breakfast look like for you?
- Screens. Do you have any restrictions related to what you do on screens?
- Sleep. Tell me about your typical bedtime routine.
Add Some New Interventions
Counseling and medications can be powerful ways to bring improvement in a child’s life, but thinking about health promotion opens up a whole new avenue for intervention. This domain includes areas like physical activity, nutrition, sleep practices, parenting, participation in music and the arts, practicing kindness towards others, and mindfulness, among others.
For someone newly diagnosed with ADHD, for example, consider expanding your treatment plan to include not only medications but also specific guidance to exercise more, limit screen usage, practice good bedtime routines, eat a real breakfast, and reduce the helicopter parenting. Monitor these areas over time.
Another example relates to common sleep problems. Before making that melatonin recommendation, ask yourself if you understand what is happening in that child’s environment at night. Are they allowed to play video games until 2 a.m.? Are they taking naps during the day because they have nothing to do? Are they downing caffeinated drinks with dinner? Does the child get zero physical activity outside of the PE class? Maybe you still will need the melatonin, but perhaps other areas need to be addressed first.
Find Some New Colleagues
While it can be challenging sometimes to find anyone in mental health who sees new patients, there is value is finding out the approach and methodology that psychiatric clinicians and therapists apply in their practice. Working collaboratively with those who value a well-being orientation and who can work productively with the whole family to increase health promotion can yield benefits for a patient’s long-term physical and mental health.
The renewed interest and attention on well-being and health promotion activities that can optimize brain growth are a welcome and overdue development in mental health treatment. Pediatricians and other primary care clinicians can be a critical part of this growing initiative by gaining knowledge about youth well-being, applying this knowledge in day-to-day practice, and working collaboratively with those who share a similar perspective.
Dr. Rettew is a child & adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Oregon. He is on the psychiatry faculty at Oregon Health & Science University. You can follow him on Facebook and X @PediPsych. His latest book is Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.
References
1. Seligman, MEP. Flourish: a visionary new understanding of happiness and well-being. New York: Simon & Schuster; 2011.
2. Jeste DV, Palmer BW. (Eds.). Positive psychiatry: a clinical handbook. Washington DC: American Psychiatric Publishing; 2015. doi: 10.1176/appi.books.9781615370818.
3. Hudziak J, Ivanova MY. The Vermont family based approach: Family based health promotion, illness prevention, and intervention. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78. doi: 10.1016/j.chc.2015.11.002.
4. Rettew DC. Incorporating positive psychiatry with children and adolescents. Current Psychiatry. 2022 November;21(11):12-16,45. doi: 10.12788/cp.0303.
Psychiatry, like all medical disciplines, changes over time. For many decades, psychiatrists were primarily psychotherapists. As medications slowly became available, these became a second tool for treatment — so much so that by the 21st century many, if not most, psychiatrists saw themselves primarily as psychopharmacologists and diagnosticians who were skilled at identifying various forms of mental illness and using medications in the hopes of inducing a clinically meaningful “response” in symptoms. While still belonging to the umbrella category of a mental health professional, more and more psychiatrists trained and practiced as mental illness professionals.
Slowly, however, there have been stirrings within the field by many who have found the identity of the psychiatrist as a “prescriber” to be too narrow, and the current “med check” model of treatment too confining. This change was partly inspired by our colleagues in clinical psychology who were challenged in the 1990s by then American Psychological Association President Martin Seligman, PhD, to develop knowledge and expertise not only in alleviating mental suffering but also in promoting true mental well-being, a construct that still was often vaguely defined. One framework of well-being that was advanced at the time was the PERMA model, representing the five well-being dimensions of Positive emotions, Engagement, Relationships, Meaning, and Accomplishment.1
While there have always been those in psychiatry who have advocated for a broad emphasis that incorporates the full spectrum of mental health, there has been a surge of interest in the past 10-15 years, urging a focus on well-being and the tools that can help a person achieve it. This trend has variably been referred to as positive psychiatry, lifestyle psychiatry, and other terms.2 As one might expect, child and adolescent psychiatry has been particularly fertile ground for such principles, and models such as the Vermont Family Based Approach have expanded the concept beyond the individual to the family and even community.3
It is important to note here that embracing the concept of well-being in treatment does not in any way require one to abandon the idea that genetic or environmental factors can lead to negative outcomes in brain development, nor does it mandate that one leaves behind important treatment modalities such as traditional psychotherapy and medication treatment. Further, this approach should not be confused with some “wellness” activities that offer quick fixes and lack scientific rigor. Positive psychiatry does, however, offer a third pathway to advance positive emotional behavioral growth, namely through health promotion activities ranging from exercise to good nutrition to positive parenting in ways that have been shown to benefit both those who are already doing fairly well as well as those who are actively struggling with significant psychiatric disorders.4
Primary care clinicians already have extensive familiarity talking about these kinds of health promoting activities with families. That said, it’s been my observation from many years of doing consultations and reviewing notes that these conversations happen almost exclusively during well-check visits and can get forgotten when a child presents with emotional behavioral challenges.
So how can the primary care clinician who is interested in more fully incorporating the burgeoning science on well-being work these principles into routine practice? Here are three suggestions.
Ask Some New Questions
It’s difficult to treat things that aren’t assessed. To best incorporate true mental health within one’s work with families, it can be very helpful to expand the regular questions one asks to include those that address some of the PERMA and health promotion areas described above. Some examples could include the following:
- Hopes. What would a perfect life look like for you when you’re older?
- Connection. Is there anything that you just love doing, so much so that time sometimes just seems to go away?
- Strengths. What are you good at? What good things would your friends say about you?
- Parenting. What are you most proud of as a parent, and where are your biggest challenges?
- Nutrition. What does a typical school day breakfast look like for you?
- Screens. Do you have any restrictions related to what you do on screens?
- Sleep. Tell me about your typical bedtime routine.
Add Some New Interventions
Counseling and medications can be powerful ways to bring improvement in a child’s life, but thinking about health promotion opens up a whole new avenue for intervention. This domain includes areas like physical activity, nutrition, sleep practices, parenting, participation in music and the arts, practicing kindness towards others, and mindfulness, among others.
For someone newly diagnosed with ADHD, for example, consider expanding your treatment plan to include not only medications but also specific guidance to exercise more, limit screen usage, practice good bedtime routines, eat a real breakfast, and reduce the helicopter parenting. Monitor these areas over time.
Another example relates to common sleep problems. Before making that melatonin recommendation, ask yourself if you understand what is happening in that child’s environment at night. Are they allowed to play video games until 2 a.m.? Are they taking naps during the day because they have nothing to do? Are they downing caffeinated drinks with dinner? Does the child get zero physical activity outside of the PE class? Maybe you still will need the melatonin, but perhaps other areas need to be addressed first.
Find Some New Colleagues
While it can be challenging sometimes to find anyone in mental health who sees new patients, there is value is finding out the approach and methodology that psychiatric clinicians and therapists apply in their practice. Working collaboratively with those who value a well-being orientation and who can work productively with the whole family to increase health promotion can yield benefits for a patient’s long-term physical and mental health.
The renewed interest and attention on well-being and health promotion activities that can optimize brain growth are a welcome and overdue development in mental health treatment. Pediatricians and other primary care clinicians can be a critical part of this growing initiative by gaining knowledge about youth well-being, applying this knowledge in day-to-day practice, and working collaboratively with those who share a similar perspective.
Dr. Rettew is a child & adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Oregon. He is on the psychiatry faculty at Oregon Health & Science University. You can follow him on Facebook and X @PediPsych. His latest book is Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.
References
1. Seligman, MEP. Flourish: a visionary new understanding of happiness and well-being. New York: Simon & Schuster; 2011.
2. Jeste DV, Palmer BW. (Eds.). Positive psychiatry: a clinical handbook. Washington DC: American Psychiatric Publishing; 2015. doi: 10.1176/appi.books.9781615370818.
3. Hudziak J, Ivanova MY. The Vermont family based approach: Family based health promotion, illness prevention, and intervention. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78. doi: 10.1016/j.chc.2015.11.002.
4. Rettew DC. Incorporating positive psychiatry with children and adolescents. Current Psychiatry. 2022 November;21(11):12-16,45. doi: 10.12788/cp.0303.