Conference Coverage

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

In a pilot study, intravenous gentamicin improved wound closure and quality of life while dampening disease activity in patients with recessive dystrophic epidermolysis bullosa attributable to nonsense mutations, Michelle Hao said at the virtual annual meeting of the American Academy of Dermatology.

Serial skin biopsies and immunofluorescent staining demonstrated the mechanism of benefit: The aminoglycoside promoted creation of new full-length functional collagen fibrils at the dermal-epidermal junction in affected patients, added Ms. Hao, a medical student at the University of Southern California, Los Angeles.

“Glycoside-mediated nonsense suppression therapy may provide a novel, low cost, and readily available treatment for RDEB [recessive dystrophic epidermolysis bullosa] patients harboring nonsense mutations,” she declared.

RDEB is a rare, incurable, life-threatening genetic skin disease which manifests as severe skin fragility and widespread blistering. The disease is caused by mutations in a gene coding for collagen type VII alpha 1 (COL7A1), the building block for the anchoring fibrils responsible for dermal-epidermal adherence. Roughly 30% of COL7A1 mutations are nonsense mutations, which result in truncated, nonfunctional collagen type VII.

Ms. Hao and her senior coinvestigators have previously shown that aminoglycoside antibiotics can override nonsense mutations to produce full-length, functioning protein. Indeed, they demonstrated that topical gentamicin in particular induces formation of new collagen type VII and improves wound closure in RDEB patients with nonsense mutations. However, RDEB skin lesions are so widespread that topical therapy becomes impractical. This was the impetus for the phase 1/2 clinical trial of IV gentamicin.

The open-label study included four patients with RDEB with nonsense mutations. All participants received IV gentamicin at 7.5 mg/kg/day for 2 weeks. Two of the four patients then got additional twice-weekly infusions at the same dose for another 3 months. Skin biopsies were obtained from two prospectively monitored open erosive wound sites and two intact skin sites at baseline and 1 and 3 months after treatment.

The primary endpoint was evidence of new collagen type VII at the dermal-epidermal junction post treatment. At baseline, patients averaged only 2% of the amount present in normal skin. One month post treatment, all four patients showed significant gains in expression of functioning collagen type VII, with levels 30%-130% of what’s present in normal skin. This effect proved durable 3 months post treatment.

At the same visits when biopsies were obtained, participants were assessed regarding wound closure, disease activity as measured using the validated Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), and quality of life as reflected in Skindex-16 scores. All four patients showed improved wound closure at 1 and 3 months post treatment at the monitored sites, as well as better EBDASI and Skindex-16 Symptoms and Skindex-16 Emotion scores, Ms. Hao continued.

Safety assessments revealed no evidence of oto- or nephrotoxicity in the gentamicin-treated patients. And no one developed autoantibodies to collagen type VII in skin or sera in response to the aminoglycoside-induced creation of new collagen type VII.

Ms. Hao said preliminary analysis of the study data suggests that the more convenient schedule of twice-weekly IV gentamicin was as effective with regard to wound closure as daily infusion therapy.

She reported having no financial conflicts regarding the study, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the EB Research Partnership, and the EB Research Foundation.

bjancin@mdedge.com
 

In a pilot study, intravenous gentamicin improved wound closure and quality of life while dampening disease activity in patients with recessive dystrophic epidermolysis bullosa attributable to nonsense mutations, Michelle Hao said at the virtual annual meeting of the American Academy of Dermatology.

Serial skin biopsies and immunofluorescent staining demonstrated the mechanism of benefit: The aminoglycoside promoted creation of new full-length functional collagen fibrils at the dermal-epidermal junction in affected patients, added Ms. Hao, a medical student at the University of Southern California, Los Angeles.

“Glycoside-mediated nonsense suppression therapy may provide a novel, low cost, and readily available treatment for RDEB [recessive dystrophic epidermolysis bullosa] patients harboring nonsense mutations,” she declared.

RDEB is a rare, incurable, life-threatening genetic skin disease which manifests as severe skin fragility and widespread blistering. The disease is caused by mutations in a gene coding for collagen type VII alpha 1 (COL7A1), the building block for the anchoring fibrils responsible for dermal-epidermal adherence. Roughly 30% of COL7A1 mutations are nonsense mutations, which result in truncated, nonfunctional collagen type VII.

Ms. Hao and her senior coinvestigators have previously shown that aminoglycoside antibiotics can override nonsense mutations to produce full-length, functioning protein. Indeed, they demonstrated that topical gentamicin in particular induces formation of new collagen type VII and improves wound closure in RDEB patients with nonsense mutations. However, RDEB skin lesions are so widespread that topical therapy becomes impractical. This was the impetus for the phase 1/2 clinical trial of IV gentamicin.

The open-label study included four patients with RDEB with nonsense mutations. All participants received IV gentamicin at 7.5 mg/kg/day for 2 weeks. Two of the four patients then got additional twice-weekly infusions at the same dose for another 3 months. Skin biopsies were obtained from two prospectively monitored open erosive wound sites and two intact skin sites at baseline and 1 and 3 months after treatment.

The primary endpoint was evidence of new collagen type VII at the dermal-epidermal junction post treatment. At baseline, patients averaged only 2% of the amount present in normal skin. One month post treatment, all four patients showed significant gains in expression of functioning collagen type VII, with levels 30%-130% of what’s present in normal skin. This effect proved durable 3 months post treatment.

At the same visits when biopsies were obtained, participants were assessed regarding wound closure, disease activity as measured using the validated Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), and quality of life as reflected in Skindex-16 scores. All four patients showed improved wound closure at 1 and 3 months post treatment at the monitored sites, as well as better EBDASI and Skindex-16 Symptoms and Skindex-16 Emotion scores, Ms. Hao continued.

Safety assessments revealed no evidence of oto- or nephrotoxicity in the gentamicin-treated patients. And no one developed autoantibodies to collagen type VII in skin or sera in response to the aminoglycoside-induced creation of new collagen type VII.

Ms. Hao said preliminary analysis of the study data suggests that the more convenient schedule of twice-weekly IV gentamicin was as effective with regard to wound closure as daily infusion therapy.

She reported having no financial conflicts regarding the study, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the EB Research Partnership, and the EB Research Foundation.

bjancin@mdedge.com
 

In a pilot study, intravenous gentamicin improved wound closure and quality of life while dampening disease activity in patients with recessive dystrophic epidermolysis bullosa attributable to nonsense mutations, Michelle Hao said at the virtual annual meeting of the American Academy of Dermatology.

Serial skin biopsies and immunofluorescent staining demonstrated the mechanism of benefit: The aminoglycoside promoted creation of new full-length functional collagen fibrils at the dermal-epidermal junction in affected patients, added Ms. Hao, a medical student at the University of Southern California, Los Angeles.

“Glycoside-mediated nonsense suppression therapy may provide a novel, low cost, and readily available treatment for RDEB [recessive dystrophic epidermolysis bullosa] patients harboring nonsense mutations,” she declared.

RDEB is a rare, incurable, life-threatening genetic skin disease which manifests as severe skin fragility and widespread blistering. The disease is caused by mutations in a gene coding for collagen type VII alpha 1 (COL7A1), the building block for the anchoring fibrils responsible for dermal-epidermal adherence. Roughly 30% of COL7A1 mutations are nonsense mutations, which result in truncated, nonfunctional collagen type VII.

Ms. Hao and her senior coinvestigators have previously shown that aminoglycoside antibiotics can override nonsense mutations to produce full-length, functioning protein. Indeed, they demonstrated that topical gentamicin in particular induces formation of new collagen type VII and improves wound closure in RDEB patients with nonsense mutations. However, RDEB skin lesions are so widespread that topical therapy becomes impractical. This was the impetus for the phase 1/2 clinical trial of IV gentamicin.

The open-label study included four patients with RDEB with nonsense mutations. All participants received IV gentamicin at 7.5 mg/kg/day for 2 weeks. Two of the four patients then got additional twice-weekly infusions at the same dose for another 3 months. Skin biopsies were obtained from two prospectively monitored open erosive wound sites and two intact skin sites at baseline and 1 and 3 months after treatment.

The primary endpoint was evidence of new collagen type VII at the dermal-epidermal junction post treatment. At baseline, patients averaged only 2% of the amount present in normal skin. One month post treatment, all four patients showed significant gains in expression of functioning collagen type VII, with levels 30%-130% of what’s present in normal skin. This effect proved durable 3 months post treatment.

At the same visits when biopsies were obtained, participants were assessed regarding wound closure, disease activity as measured using the validated Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI), and quality of life as reflected in Skindex-16 scores. All four patients showed improved wound closure at 1 and 3 months post treatment at the monitored sites, as well as better EBDASI and Skindex-16 Symptoms and Skindex-16 Emotion scores, Ms. Hao continued.

Safety assessments revealed no evidence of oto- or nephrotoxicity in the gentamicin-treated patients. And no one developed autoantibodies to collagen type VII in skin or sera in response to the aminoglycoside-induced creation of new collagen type VII.

Ms. Hao said preliminary analysis of the study data suggests that the more convenient schedule of twice-weekly IV gentamicin was as effective with regard to wound closure as daily infusion therapy.

She reported having no financial conflicts regarding the study, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the EB Research Partnership, and the EB Research Foundation.

bjancin@mdedge.com
 

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

An uneven distribution of board-certified pediatric dermatologists exists in the United States, which has resulted in children with unmet dermatologic needs in many densely populated areas. In fact, nine states do not have a single pediatric dermatologist.

The findings come from a cross-sectional analysis of national data presented by Sepideh Ashrafzadeh at the virtual annual meeting of the Society for Pediatric Dermatology.

“Nearly 82% of pediatricians report that their patients have difficulty accessing pediatric dermatologists [and] over 25% of pediatric dermatologists have a wait time of greater than 10 weeks for new patient appointments,” Ms. Ashrafzadeh, a student at Harvard Medical School, Boston, and associates wrote in their poster abstract. “While the shortage of pediatric dermatologists is well documented, little is known about the distribution of pediatric dermatologists across the U.S., which in turn affects families’ travel time and access to pediatric dermatologists. Defining the specific regions with greatest need for pediatric dermatology can help shape recruitment efforts and initiatives to increase access to pediatric dermatologists in areas with the greatest need.”

For the current study, the researchers drew from the SPD Directory in March 2020 to identify all U.S. board-certified pediatric dermatologists. They used the 2020 American Board of Pediatrics Directory and the 2020 Centers for Medicaid & Medicare Physician Compare Database to identify pediatric generalists, which were defined as pediatricians and family medicine physicians. They used the 2018 American Community Survey, published by the U.S. Census Bureau, to obtain the number of children ages 0-17 years in each county and state.

Next, Ms. Ashrafzadeh and colleagues tabulated the number of children, pediatric dermatologists, and pediatric generalists in each county and state, and calculated ratios of pediatric dermatologists and generalists to number of children. The Gini index, a standardized scale where 0 signifies equal distribution and 1 signifies complete maldistribution, was calculated for pediatric dermatologists and generalists relative to the population of children at the state level.

Of the 317 pediatric dermatologists included in the analysis, 243 (77%) were female, 194 (61%) worked in an academic center, and 311 (98%) worked in a metropolitan county. A pediatric dermatologist was present in 41 of 50 states (82%) and in 142 of 3,228 counties (4%). There was not a single pediatric dermatologist in 73 out of 158 counties (46%) with over 100,000 children, 19 out of 66 counties (29%) with over 200,000 children, and 4 out of 13 counties (31%) with over 500,000 children. Nine states had no pediatric dermatologists: Delaware, Idaho, Maine, Mississippi, Montana, Nevada, North Dakota, South Dakota, and Wyoming. States with the greatest density of pediatric dermatologists (range, 10.1-15.2 pediatric dermatologists per 1,000,000 children) were Wisconsin, Massachusetts, Rhode Island, and New Hampshire. The Gini index for the distribution of pediatric dermatologists relative to the population of children was 0.488, compared with 0.132 for that of pediatric generalists.

“To address the unmet pediatric dermatology need, educators and policymakers can create initiatives to recruit pediatric dermatologists and expand access to telehealth pediatric dermatology services in these high priority states and counties,” the researchers wrote in their abstract. “Future studies need to be done quantifying travel distances to pediatric dermatologists across the US as travel distances can further identify areas that are in great need of pediatric dermatologists.”

They acknowledged certain limitations of the study, including the fact that they may have missed board-certified pediatric dermatologists who are not listed in the SPD Directory. Ms. Ashrafzadeh and colleagues reported having no financial disclosures.

dbrunk@mdedge.com

An uneven distribution of board-certified pediatric dermatologists exists in the United States, which has resulted in children with unmet dermatologic needs in many densely populated areas. In fact, nine states do not have a single pediatric dermatologist.

The findings come from a cross-sectional analysis of national data presented by Sepideh Ashrafzadeh at the virtual annual meeting of the Society for Pediatric Dermatology.

“Nearly 82% of pediatricians report that their patients have difficulty accessing pediatric dermatologists [and] over 25% of pediatric dermatologists have a wait time of greater than 10 weeks for new patient appointments,” Ms. Ashrafzadeh, a student at Harvard Medical School, Boston, and associates wrote in their poster abstract. “While the shortage of pediatric dermatologists is well documented, little is known about the distribution of pediatric dermatologists across the U.S., which in turn affects families’ travel time and access to pediatric dermatologists. Defining the specific regions with greatest need for pediatric dermatology can help shape recruitment efforts and initiatives to increase access to pediatric dermatologists in areas with the greatest need.”

For the current study, the researchers drew from the SPD Directory in March 2020 to identify all U.S. board-certified pediatric dermatologists. They used the 2020 American Board of Pediatrics Directory and the 2020 Centers for Medicaid & Medicare Physician Compare Database to identify pediatric generalists, which were defined as pediatricians and family medicine physicians. They used the 2018 American Community Survey, published by the U.S. Census Bureau, to obtain the number of children ages 0-17 years in each county and state.

Next, Ms. Ashrafzadeh and colleagues tabulated the number of children, pediatric dermatologists, and pediatric generalists in each county and state, and calculated ratios of pediatric dermatologists and generalists to number of children. The Gini index, a standardized scale where 0 signifies equal distribution and 1 signifies complete maldistribution, was calculated for pediatric dermatologists and generalists relative to the population of children at the state level.

Of the 317 pediatric dermatologists included in the analysis, 243 (77%) were female, 194 (61%) worked in an academic center, and 311 (98%) worked in a metropolitan county. A pediatric dermatologist was present in 41 of 50 states (82%) and in 142 of 3,228 counties (4%). There was not a single pediatric dermatologist in 73 out of 158 counties (46%) with over 100,000 children, 19 out of 66 counties (29%) with over 200,000 children, and 4 out of 13 counties (31%) with over 500,000 children. Nine states had no pediatric dermatologists: Delaware, Idaho, Maine, Mississippi, Montana, Nevada, North Dakota, South Dakota, and Wyoming. States with the greatest density of pediatric dermatologists (range, 10.1-15.2 pediatric dermatologists per 1,000,000 children) were Wisconsin, Massachusetts, Rhode Island, and New Hampshire. The Gini index for the distribution of pediatric dermatologists relative to the population of children was 0.488, compared with 0.132 for that of pediatric generalists.

“To address the unmet pediatric dermatology need, educators and policymakers can create initiatives to recruit pediatric dermatologists and expand access to telehealth pediatric dermatology services in these high priority states and counties,” the researchers wrote in their abstract. “Future studies need to be done quantifying travel distances to pediatric dermatologists across the US as travel distances can further identify areas that are in great need of pediatric dermatologists.”

They acknowledged certain limitations of the study, including the fact that they may have missed board-certified pediatric dermatologists who are not listed in the SPD Directory. Ms. Ashrafzadeh and colleagues reported having no financial disclosures.

dbrunk@mdedge.com

An uneven distribution of board-certified pediatric dermatologists exists in the United States, which has resulted in children with unmet dermatologic needs in many densely populated areas. In fact, nine states do not have a single pediatric dermatologist.

The findings come from a cross-sectional analysis of national data presented by Sepideh Ashrafzadeh at the virtual annual meeting of the Society for Pediatric Dermatology.

“Nearly 82% of pediatricians report that their patients have difficulty accessing pediatric dermatologists [and] over 25% of pediatric dermatologists have a wait time of greater than 10 weeks for new patient appointments,” Ms. Ashrafzadeh, a student at Harvard Medical School, Boston, and associates wrote in their poster abstract. “While the shortage of pediatric dermatologists is well documented, little is known about the distribution of pediatric dermatologists across the U.S., which in turn affects families’ travel time and access to pediatric dermatologists. Defining the specific regions with greatest need for pediatric dermatology can help shape recruitment efforts and initiatives to increase access to pediatric dermatologists in areas with the greatest need.”

For the current study, the researchers drew from the SPD Directory in March 2020 to identify all U.S. board-certified pediatric dermatologists. They used the 2020 American Board of Pediatrics Directory and the 2020 Centers for Medicaid & Medicare Physician Compare Database to identify pediatric generalists, which were defined as pediatricians and family medicine physicians. They used the 2018 American Community Survey, published by the U.S. Census Bureau, to obtain the number of children ages 0-17 years in each county and state.

Next, Ms. Ashrafzadeh and colleagues tabulated the number of children, pediatric dermatologists, and pediatric generalists in each county and state, and calculated ratios of pediatric dermatologists and generalists to number of children. The Gini index, a standardized scale where 0 signifies equal distribution and 1 signifies complete maldistribution, was calculated for pediatric dermatologists and generalists relative to the population of children at the state level.

Of the 317 pediatric dermatologists included in the analysis, 243 (77%) were female, 194 (61%) worked in an academic center, and 311 (98%) worked in a metropolitan county. A pediatric dermatologist was present in 41 of 50 states (82%) and in 142 of 3,228 counties (4%). There was not a single pediatric dermatologist in 73 out of 158 counties (46%) with over 100,000 children, 19 out of 66 counties (29%) with over 200,000 children, and 4 out of 13 counties (31%) with over 500,000 children. Nine states had no pediatric dermatologists: Delaware, Idaho, Maine, Mississippi, Montana, Nevada, North Dakota, South Dakota, and Wyoming. States with the greatest density of pediatric dermatologists (range, 10.1-15.2 pediatric dermatologists per 1,000,000 children) were Wisconsin, Massachusetts, Rhode Island, and New Hampshire. The Gini index for the distribution of pediatric dermatologists relative to the population of children was 0.488, compared with 0.132 for that of pediatric generalists.

“To address the unmet pediatric dermatology need, educators and policymakers can create initiatives to recruit pediatric dermatologists and expand access to telehealth pediatric dermatology services in these high priority states and counties,” the researchers wrote in their abstract. “Future studies need to be done quantifying travel distances to pediatric dermatologists across the US as travel distances can further identify areas that are in great need of pediatric dermatologists.”

They acknowledged certain limitations of the study, including the fact that they may have missed board-certified pediatric dermatologists who are not listed in the SPD Directory. Ms. Ashrafzadeh and colleagues reported having no financial disclosures.

dbrunk@mdedge.com

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

For patients with psychotic depression, response to treatment, remission rates, and cognitive improvement are better following electroconvulsive therapy (ECT) than for patients with nonpsychotic depression, results from a new study suggest.

However, findings from another study suggest that at least some of these differences may be because psychotic patients are referred for ECT earlier in the disease course.

Both studies were presented at the European Psychiatric Association 2020 Congress, which was held online this year because of the COVID-19 pandemic.
 

Limited, old evidence

The first study was led by Christopher Yi Wen Chan, MD, Institute of Mental Health, Singapore. The investigators stated that they have “often observed” superior remission rates with ECT in psychotic versus nonpsychotic depression. However, the evidence base is “limited and mostly more than 10 years old.”

They conducted a retrospective case-control study that included 160 patients – 50 with psychotic depression, and 110 with nonpsychotic depression. All patients had a primary diagnosis of unipolar major depressive disorder and underwent ECT at a tertiary psychiatric institute between January 2016 and January 2018.

Baseline characteristics of the two groups were similar, although patients with psychosis were more likely to have had an involuntary hospital admission and to have had higher baseline scores on the Montreal Cognitive Assessment (MoCA) and Clinical Global Impression–Severity scale (CGI-S) than nonpsychotic patients.

Response rates to ECT were significantly higher for the patients with psychotic depression than for those with nonpsychotic depression (79% vs. 51%; P = .009), as were remission rates (71% vs. 36%; P = .001).

Both groups showed significant improvement following ECT in Montgomery-Åsberg Depression Rating Scale, CGI, and quality-of-life scores.

However, only the participants with psychotic depression showed a significant improvement in MoCA total score (P = .038), as well as on attention (P = .024), language (P = .008), and orientation (P = .021) subdomains.
 

Psychotic depression markers?

For the second study, a team led by Aida De Arriba Arnau, MD, Centro de Investigación Biomédica en Red de Salud Mental, Barcelona, Spain, retrospectively analyzed 66 patients with depression who had received ECT. Of these, 26 had psychotic depression, and 40 had nonpsychotic depression.

Response rates were again higher in patients with psychotic vs nonpsychotic depression (92.3% vs. 85.0%). A similar number of sessions was needed to achieve a response.

Improvements in Hamilton Depression Rating Scale scores were significant between the two groups from the start of treatment, although the difference became nonsignificant at week 6.

Arriba Arnau said that there were some notable differences between patients with psychotic depression and those with nonpsychotic depression. For example, the former had “poor functionality, shorter episode duration, and less pharmacological resistance before receiving ECT,” she said.

“So we hypothesized that they might be referred more promptly to ECT treatment,” she added.

The psychotic depression group was significantly older than the group with nonpsychotic depression, at an average of 67.81 years vs 58.96 years.

They also “showed more illness severity and cognitive disturbances at baseline and ... required less anesthetic doses and higher initial stimulus intensity,» Arriba Arnau noted.

“All these features could be the markers of psychotic depression as an entity,” she said. However, the potential impact of age on these differences should be “further studied.”

She added that other aspects, such as age at onset and number of previous episodes, were similar between the groups.
 

Confirmatory data

Commenting on the findings for Medscape Medical News, Georgios Petrides, MD, associate professor of psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, East Garden City, New York, noted that differences in response to ECT between patients with psychotic depression and those with nonpsychotic depression are “well known.”

However, “it’s actually good to present more data that confirm what people are doing in clinical practice,” said Petrides, who was not involved with the research.

Petrides noted that some guidelines recommend ECT as first-line treatment for psychotic depression.

“For nonpsychotic depression, we’d try medications, psychotherapy, and everything else first,” he said. He noted that the current results are “a good replication of what is known so far.”

As to why ECT should be more effective for patients with psychotic depression, he said, “A lot of people think that the biology of psychotic depression is different from the biology of nonpsychotic depression.”

Many things that ECT “corrects” are disturbed in psychotic depression, including cortisol homeostasis, which is thought to be affected via the hypothalamic-pituitary-adrenal axis, Petrides added.

That ECT is more effective in psychotic depression is an “indirect point of evidence” to support that theory.

One aspect that has traditionally dogged the use of ECT has been the stigma that surrounds the procedure, Petrides noted. That’s “always an issue, but it’s getting less and less over time,” he said.

He added that ECT is extremely safe and that it is associated with the “lowest mortality for any procedure performed under general anesthesia,” which helps to reduce the stigma around it, he noted.

The study authors and Petrides have reported no relevant financial relationships.

This article first appeared on Medscape.com.

For patients with psychotic depression, response to treatment, remission rates, and cognitive improvement are better following electroconvulsive therapy (ECT) than for patients with nonpsychotic depression, results from a new study suggest.

However, findings from another study suggest that at least some of these differences may be because psychotic patients are referred for ECT earlier in the disease course.

Both studies were presented at the European Psychiatric Association 2020 Congress, which was held online this year because of the COVID-19 pandemic.
 

Limited, old evidence

The first study was led by Christopher Yi Wen Chan, MD, Institute of Mental Health, Singapore. The investigators stated that they have “often observed” superior remission rates with ECT in psychotic versus nonpsychotic depression. However, the evidence base is “limited and mostly more than 10 years old.”

They conducted a retrospective case-control study that included 160 patients – 50 with psychotic depression, and 110 with nonpsychotic depression. All patients had a primary diagnosis of unipolar major depressive disorder and underwent ECT at a tertiary psychiatric institute between January 2016 and January 2018.

Baseline characteristics of the two groups were similar, although patients with psychosis were more likely to have had an involuntary hospital admission and to have had higher baseline scores on the Montreal Cognitive Assessment (MoCA) and Clinical Global Impression–Severity scale (CGI-S) than nonpsychotic patients.

Response rates to ECT were significantly higher for the patients with psychotic depression than for those with nonpsychotic depression (79% vs. 51%; P = .009), as were remission rates (71% vs. 36%; P = .001).

Both groups showed significant improvement following ECT in Montgomery-Åsberg Depression Rating Scale, CGI, and quality-of-life scores.

However, only the participants with psychotic depression showed a significant improvement in MoCA total score (P = .038), as well as on attention (P = .024), language (P = .008), and orientation (P = .021) subdomains.
 

Psychotic depression markers?

For the second study, a team led by Aida De Arriba Arnau, MD, Centro de Investigación Biomédica en Red de Salud Mental, Barcelona, Spain, retrospectively analyzed 66 patients with depression who had received ECT. Of these, 26 had psychotic depression, and 40 had nonpsychotic depression.

Response rates were again higher in patients with psychotic vs nonpsychotic depression (92.3% vs. 85.0%). A similar number of sessions was needed to achieve a response.

Improvements in Hamilton Depression Rating Scale scores were significant between the two groups from the start of treatment, although the difference became nonsignificant at week 6.

Arriba Arnau said that there were some notable differences between patients with psychotic depression and those with nonpsychotic depression. For example, the former had “poor functionality, shorter episode duration, and less pharmacological resistance before receiving ECT,” she said.

“So we hypothesized that they might be referred more promptly to ECT treatment,” she added.

The psychotic depression group was significantly older than the group with nonpsychotic depression, at an average of 67.81 years vs 58.96 years.

They also “showed more illness severity and cognitive disturbances at baseline and ... required less anesthetic doses and higher initial stimulus intensity,» Arriba Arnau noted.

“All these features could be the markers of psychotic depression as an entity,” she said. However, the potential impact of age on these differences should be “further studied.”

She added that other aspects, such as age at onset and number of previous episodes, were similar between the groups.
 

Confirmatory data

Commenting on the findings for Medscape Medical News, Georgios Petrides, MD, associate professor of psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, East Garden City, New York, noted that differences in response to ECT between patients with psychotic depression and those with nonpsychotic depression are “well known.”

However, “it’s actually good to present more data that confirm what people are doing in clinical practice,” said Petrides, who was not involved with the research.

Petrides noted that some guidelines recommend ECT as first-line treatment for psychotic depression.

“For nonpsychotic depression, we’d try medications, psychotherapy, and everything else first,” he said. He noted that the current results are “a good replication of what is known so far.”

As to why ECT should be more effective for patients with psychotic depression, he said, “A lot of people think that the biology of psychotic depression is different from the biology of nonpsychotic depression.”

Many things that ECT “corrects” are disturbed in psychotic depression, including cortisol homeostasis, which is thought to be affected via the hypothalamic-pituitary-adrenal axis, Petrides added.

That ECT is more effective in psychotic depression is an “indirect point of evidence” to support that theory.

One aspect that has traditionally dogged the use of ECT has been the stigma that surrounds the procedure, Petrides noted. That’s “always an issue, but it’s getting less and less over time,” he said.

He added that ECT is extremely safe and that it is associated with the “lowest mortality for any procedure performed under general anesthesia,” which helps to reduce the stigma around it, he noted.

The study authors and Petrides have reported no relevant financial relationships.

This article first appeared on Medscape.com.

For patients with psychotic depression, response to treatment, remission rates, and cognitive improvement are better following electroconvulsive therapy (ECT) than for patients with nonpsychotic depression, results from a new study suggest.

However, findings from another study suggest that at least some of these differences may be because psychotic patients are referred for ECT earlier in the disease course.

Both studies were presented at the European Psychiatric Association 2020 Congress, which was held online this year because of the COVID-19 pandemic.
 

Limited, old evidence

The first study was led by Christopher Yi Wen Chan, MD, Institute of Mental Health, Singapore. The investigators stated that they have “often observed” superior remission rates with ECT in psychotic versus nonpsychotic depression. However, the evidence base is “limited and mostly more than 10 years old.”

They conducted a retrospective case-control study that included 160 patients – 50 with psychotic depression, and 110 with nonpsychotic depression. All patients had a primary diagnosis of unipolar major depressive disorder and underwent ECT at a tertiary psychiatric institute between January 2016 and January 2018.

Baseline characteristics of the two groups were similar, although patients with psychosis were more likely to have had an involuntary hospital admission and to have had higher baseline scores on the Montreal Cognitive Assessment (MoCA) and Clinical Global Impression–Severity scale (CGI-S) than nonpsychotic patients.

Response rates to ECT were significantly higher for the patients with psychotic depression than for those with nonpsychotic depression (79% vs. 51%; P = .009), as were remission rates (71% vs. 36%; P = .001).

Both groups showed significant improvement following ECT in Montgomery-Åsberg Depression Rating Scale, CGI, and quality-of-life scores.

However, only the participants with psychotic depression showed a significant improvement in MoCA total score (P = .038), as well as on attention (P = .024), language (P = .008), and orientation (P = .021) subdomains.
 

Psychotic depression markers?

For the second study, a team led by Aida De Arriba Arnau, MD, Centro de Investigación Biomédica en Red de Salud Mental, Barcelona, Spain, retrospectively analyzed 66 patients with depression who had received ECT. Of these, 26 had psychotic depression, and 40 had nonpsychotic depression.

Response rates were again higher in patients with psychotic vs nonpsychotic depression (92.3% vs. 85.0%). A similar number of sessions was needed to achieve a response.

Improvements in Hamilton Depression Rating Scale scores were significant between the two groups from the start of treatment, although the difference became nonsignificant at week 6.

Arriba Arnau said that there were some notable differences between patients with psychotic depression and those with nonpsychotic depression. For example, the former had “poor functionality, shorter episode duration, and less pharmacological resistance before receiving ECT,” she said.

“So we hypothesized that they might be referred more promptly to ECT treatment,” she added.

The psychotic depression group was significantly older than the group with nonpsychotic depression, at an average of 67.81 years vs 58.96 years.

They also “showed more illness severity and cognitive disturbances at baseline and ... required less anesthetic doses and higher initial stimulus intensity,» Arriba Arnau noted.

“All these features could be the markers of psychotic depression as an entity,” she said. However, the potential impact of age on these differences should be “further studied.”

She added that other aspects, such as age at onset and number of previous episodes, were similar between the groups.
 

Confirmatory data

Commenting on the findings for Medscape Medical News, Georgios Petrides, MD, associate professor of psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, East Garden City, New York, noted that differences in response to ECT between patients with psychotic depression and those with nonpsychotic depression are “well known.”

However, “it’s actually good to present more data that confirm what people are doing in clinical practice,” said Petrides, who was not involved with the research.

Petrides noted that some guidelines recommend ECT as first-line treatment for psychotic depression.

“For nonpsychotic depression, we’d try medications, psychotherapy, and everything else first,” he said. He noted that the current results are “a good replication of what is known so far.”

As to why ECT should be more effective for patients with psychotic depression, he said, “A lot of people think that the biology of psychotic depression is different from the biology of nonpsychotic depression.”

Many things that ECT “corrects” are disturbed in psychotic depression, including cortisol homeostasis, which is thought to be affected via the hypothalamic-pituitary-adrenal axis, Petrides added.

That ECT is more effective in psychotic depression is an “indirect point of evidence” to support that theory.

One aspect that has traditionally dogged the use of ECT has been the stigma that surrounds the procedure, Petrides noted. That’s “always an issue, but it’s getting less and less over time,” he said.

He added that ECT is extremely safe and that it is associated with the “lowest mortality for any procedure performed under general anesthesia,” which helps to reduce the stigma around it, he noted.

The study authors and Petrides have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Prostate-specific membrane antigen (PSMA) PET/CT was 27% more accurate than conventional imaging for detecting metastases and staging men prior to curative-intent therapy for high-risk prostate cancer in the phase 3 ProPSMA study.

The accuracy was 92% for PSMA PET/CT and 65% for CT and bone scintigraphy (P < .001), according to data reported at the virtual annual congress of the European Association of Urology and published in The Lancet.

In addition, PSMA PET/CT had greater effects on treatment. First-line imaging led to treatment changes in 28% of the PSMA PET/CT group and 15% of the CT/bone scan group. Second-line imaging led to treatment changes in 27% and 5% of patients, respectively.

“My strong view is that this is practice-changing data,” said study investigator Michael Hofman, MBBS, of the Peter MacCallum Cancer Centre in Melbourne.

Highly relevant secondary outcomes were included in the study, Dr. Hofman said, and results were all in favor of PSMA PET/CT over conventional imaging.

PSMA PET/CT was associated with a lower rate of equivocal or uncertain findings (7% vs. 23%), and half the radiation dose was needed with PSMA PET/CT (8 mSv vs. 19 mSv). Furthermore, PSMA PET/CT was more accurate when used after CT/bone scan than when CT/bone scan was used after PSMA PET/CT (19% vs. 2%).

“PSMA PET/CT has emerged as a potential new gold standard for imaging prostate cancer,” Dr. Hofman said. The images it can produce were “striking” compared to conventional CT, he added. Pelvic and abdominal metastases that are barely visible on CT were “lighting up very brightly” on PSMA PET/CT, he said.

The study also showed that PSMA PET/CT was superior to CT/bone scans for picking up metastases throughout the body. The detection rate was 91% and 59%, respectively, for pelvic nodal metastases and 95% and 74%, respectively, for distant metastases.
 

Study details

ProPSMA is a multicenter, phase 3 trial directly comparing PSMA PET/CT and the standard of imaging. Of 339 men assessed for inclusion across 10 centers in Australia, 302 were randomized. They had a median age of 69 years. All patients had high-risk prostate cancer, which was defined as a prostate-specific antigen level of 20 ng/mL, Gleason Grade Group 3-5, or clinical stage T3 or higher. They were all about to undergo either surgery or radiotherapy with the intention of curing their prostate cancer.

PSMA PET/CT was performed using the gallium-68-labelled PSMA-11 tracer, but the results would likely be no different if another tracer were used, Dr. Hofman said in the discussion following his talk.

Of the three available tracers, there were minor differences, mostly in how they were excreted. However, “they’re all extremely good. I’m not sure anyone’s ever going to undertake a head-to-head study comparing them,” Dr. Hofman said.

“Whichever one you can access, at the cheapest cost, I think, is going to be the best one in your center,” he added. “That really does vary geographically, but I really don’t think one is better or worse than the other.”
 

Praise and criticism

The latest European guidelines acknowledge that PSMA PET/CT is more sensitive for detecting lymph node and bone metastases than the classical workup of abdominopelvic CT and bone scintigraphy, according to invited discussant Matthias Heck, PD Dr. med, of the Technical University of Munich in Germany.

“Molecular imaging using PSMA PET/CT facilitates the detection of small lymph node metastasis, with the size of a few millimeters,” Dr. Heck said.

Although he commended the ProPSMA investigators, Dr. Heck had one criticism of the study design that may have resulted in over-sensitivity of PSMA PET/CT.

“As a urologist, I want to address as a discussion point the low number of histopathologic validation in the ProPSMA study,” he said. “Pelvic lymph node sampling was performed only in 66% of patients treated with radical prostatectomy for high-risk prostate cancer. Hard criteria to define the presence of metastasis were only used in 23% of patients with metastases. Therefore, it is possible that the sensitivity was overestimated by using mainly soft criteria.”

The sensitivity of PSMA PET/CT was 85%, while that of CT/bone scan was 38%. The respective specificities were 98% and 91%.

“What I like most about this study is that, when we perform a PSMA PET/CT, you see the whole body; you don’t see only pelvic lymph nodes,” Dr. Heck said. Since it was not possible to validate distant metastasis by histopathology, he added, this imaging method could clearly help determine the best treatment.

“If we have distant metastasis in the bones or in the lymph nodes outside of the pelvis, it’s clearly unnecessary to direct this patient to undergo local treatment, and we need to think about other treatments,” Dr. Heck said. “Therefore, I think it’s a very important question that is being raised by this study, and we all need to look at the whole body of the patient and not focus only on the pelvic lymph nodes.”

The study was funded by the Prostate Cancer Foundation of Australia. Dr. Hofman said he has no relevant conflicts of interest. Dr. Heck disclosed relationships with Astellas, Janssen, Ipsen, Amgen, Bayer, Heise, Merck, Sanofi, and Takeda.

SOURCES: Hofman M et al. Lancet. March 22, doi: https://doi.org/10.1016/S0140-6736(20)30314-7.

Prostate-specific membrane antigen (PSMA) PET/CT was 27% more accurate than conventional imaging for detecting metastases and staging men prior to curative-intent therapy for high-risk prostate cancer in the phase 3 ProPSMA study.

The accuracy was 92% for PSMA PET/CT and 65% for CT and bone scintigraphy (P < .001), according to data reported at the virtual annual congress of the European Association of Urology and published in The Lancet.

In addition, PSMA PET/CT had greater effects on treatment. First-line imaging led to treatment changes in 28% of the PSMA PET/CT group and 15% of the CT/bone scan group. Second-line imaging led to treatment changes in 27% and 5% of patients, respectively.

“My strong view is that this is practice-changing data,” said study investigator Michael Hofman, MBBS, of the Peter MacCallum Cancer Centre in Melbourne.

Highly relevant secondary outcomes were included in the study, Dr. Hofman said, and results were all in favor of PSMA PET/CT over conventional imaging.

PSMA PET/CT was associated with a lower rate of equivocal or uncertain findings (7% vs. 23%), and half the radiation dose was needed with PSMA PET/CT (8 mSv vs. 19 mSv). Furthermore, PSMA PET/CT was more accurate when used after CT/bone scan than when CT/bone scan was used after PSMA PET/CT (19% vs. 2%).

“PSMA PET/CT has emerged as a potential new gold standard for imaging prostate cancer,” Dr. Hofman said. The images it can produce were “striking” compared to conventional CT, he added. Pelvic and abdominal metastases that are barely visible on CT were “lighting up very brightly” on PSMA PET/CT, he said.

The study also showed that PSMA PET/CT was superior to CT/bone scans for picking up metastases throughout the body. The detection rate was 91% and 59%, respectively, for pelvic nodal metastases and 95% and 74%, respectively, for distant metastases.
 

Study details

ProPSMA is a multicenter, phase 3 trial directly comparing PSMA PET/CT and the standard of imaging. Of 339 men assessed for inclusion across 10 centers in Australia, 302 were randomized. They had a median age of 69 years. All patients had high-risk prostate cancer, which was defined as a prostate-specific antigen level of 20 ng/mL, Gleason Grade Group 3-5, or clinical stage T3 or higher. They were all about to undergo either surgery or radiotherapy with the intention of curing their prostate cancer.

PSMA PET/CT was performed using the gallium-68-labelled PSMA-11 tracer, but the results would likely be no different if another tracer were used, Dr. Hofman said in the discussion following his talk.

Of the three available tracers, there were minor differences, mostly in how they were excreted. However, “they’re all extremely good. I’m not sure anyone’s ever going to undertake a head-to-head study comparing them,” Dr. Hofman said.

“Whichever one you can access, at the cheapest cost, I think, is going to be the best one in your center,” he added. “That really does vary geographically, but I really don’t think one is better or worse than the other.”
 

Praise and criticism

The latest European guidelines acknowledge that PSMA PET/CT is more sensitive for detecting lymph node and bone metastases than the classical workup of abdominopelvic CT and bone scintigraphy, according to invited discussant Matthias Heck, PD Dr. med, of the Technical University of Munich in Germany.

“Molecular imaging using PSMA PET/CT facilitates the detection of small lymph node metastasis, with the size of a few millimeters,” Dr. Heck said.

Although he commended the ProPSMA investigators, Dr. Heck had one criticism of the study design that may have resulted in over-sensitivity of PSMA PET/CT.

“As a urologist, I want to address as a discussion point the low number of histopathologic validation in the ProPSMA study,” he said. “Pelvic lymph node sampling was performed only in 66% of patients treated with radical prostatectomy for high-risk prostate cancer. Hard criteria to define the presence of metastasis were only used in 23% of patients with metastases. Therefore, it is possible that the sensitivity was overestimated by using mainly soft criteria.”

The sensitivity of PSMA PET/CT was 85%, while that of CT/bone scan was 38%. The respective specificities were 98% and 91%.

“What I like most about this study is that, when we perform a PSMA PET/CT, you see the whole body; you don’t see only pelvic lymph nodes,” Dr. Heck said. Since it was not possible to validate distant metastasis by histopathology, he added, this imaging method could clearly help determine the best treatment.

“If we have distant metastasis in the bones or in the lymph nodes outside of the pelvis, it’s clearly unnecessary to direct this patient to undergo local treatment, and we need to think about other treatments,” Dr. Heck said. “Therefore, I think it’s a very important question that is being raised by this study, and we all need to look at the whole body of the patient and not focus only on the pelvic lymph nodes.”

The study was funded by the Prostate Cancer Foundation of Australia. Dr. Hofman said he has no relevant conflicts of interest. Dr. Heck disclosed relationships with Astellas, Janssen, Ipsen, Amgen, Bayer, Heise, Merck, Sanofi, and Takeda.

SOURCES: Hofman M et al. Lancet. March 22, doi: https://doi.org/10.1016/S0140-6736(20)30314-7.

Prostate-specific membrane antigen (PSMA) PET/CT was 27% more accurate than conventional imaging for detecting metastases and staging men prior to curative-intent therapy for high-risk prostate cancer in the phase 3 ProPSMA study.

The accuracy was 92% for PSMA PET/CT and 65% for CT and bone scintigraphy (P < .001), according to data reported at the virtual annual congress of the European Association of Urology and published in The Lancet.

In addition, PSMA PET/CT had greater effects on treatment. First-line imaging led to treatment changes in 28% of the PSMA PET/CT group and 15% of the CT/bone scan group. Second-line imaging led to treatment changes in 27% and 5% of patients, respectively.

“My strong view is that this is practice-changing data,” said study investigator Michael Hofman, MBBS, of the Peter MacCallum Cancer Centre in Melbourne.

Highly relevant secondary outcomes were included in the study, Dr. Hofman said, and results were all in favor of PSMA PET/CT over conventional imaging.

PSMA PET/CT was associated with a lower rate of equivocal or uncertain findings (7% vs. 23%), and half the radiation dose was needed with PSMA PET/CT (8 mSv vs. 19 mSv). Furthermore, PSMA PET/CT was more accurate when used after CT/bone scan than when CT/bone scan was used after PSMA PET/CT (19% vs. 2%).

“PSMA PET/CT has emerged as a potential new gold standard for imaging prostate cancer,” Dr. Hofman said. The images it can produce were “striking” compared to conventional CT, he added. Pelvic and abdominal metastases that are barely visible on CT were “lighting up very brightly” on PSMA PET/CT, he said.

The study also showed that PSMA PET/CT was superior to CT/bone scans for picking up metastases throughout the body. The detection rate was 91% and 59%, respectively, for pelvic nodal metastases and 95% and 74%, respectively, for distant metastases.
 

Study details

ProPSMA is a multicenter, phase 3 trial directly comparing PSMA PET/CT and the standard of imaging. Of 339 men assessed for inclusion across 10 centers in Australia, 302 were randomized. They had a median age of 69 years. All patients had high-risk prostate cancer, which was defined as a prostate-specific antigen level of 20 ng/mL, Gleason Grade Group 3-5, or clinical stage T3 or higher. They were all about to undergo either surgery or radiotherapy with the intention of curing their prostate cancer.

PSMA PET/CT was performed using the gallium-68-labelled PSMA-11 tracer, but the results would likely be no different if another tracer were used, Dr. Hofman said in the discussion following his talk.

Of the three available tracers, there were minor differences, mostly in how they were excreted. However, “they’re all extremely good. I’m not sure anyone’s ever going to undertake a head-to-head study comparing them,” Dr. Hofman said.

“Whichever one you can access, at the cheapest cost, I think, is going to be the best one in your center,” he added. “That really does vary geographically, but I really don’t think one is better or worse than the other.”
 

Praise and criticism

The latest European guidelines acknowledge that PSMA PET/CT is more sensitive for detecting lymph node and bone metastases than the classical workup of abdominopelvic CT and bone scintigraphy, according to invited discussant Matthias Heck, PD Dr. med, of the Technical University of Munich in Germany.

“Molecular imaging using PSMA PET/CT facilitates the detection of small lymph node metastasis, with the size of a few millimeters,” Dr. Heck said.

Although he commended the ProPSMA investigators, Dr. Heck had one criticism of the study design that may have resulted in over-sensitivity of PSMA PET/CT.

“As a urologist, I want to address as a discussion point the low number of histopathologic validation in the ProPSMA study,” he said. “Pelvic lymph node sampling was performed only in 66% of patients treated with radical prostatectomy for high-risk prostate cancer. Hard criteria to define the presence of metastasis were only used in 23% of patients with metastases. Therefore, it is possible that the sensitivity was overestimated by using mainly soft criteria.”

The sensitivity of PSMA PET/CT was 85%, while that of CT/bone scan was 38%. The respective specificities were 98% and 91%.

“What I like most about this study is that, when we perform a PSMA PET/CT, you see the whole body; you don’t see only pelvic lymph nodes,” Dr. Heck said. Since it was not possible to validate distant metastasis by histopathology, he added, this imaging method could clearly help determine the best treatment.

“If we have distant metastasis in the bones or in the lymph nodes outside of the pelvis, it’s clearly unnecessary to direct this patient to undergo local treatment, and we need to think about other treatments,” Dr. Heck said. “Therefore, I think it’s a very important question that is being raised by this study, and we all need to look at the whole body of the patient and not focus only on the pelvic lymph nodes.”

The study was funded by the Prostate Cancer Foundation of Australia. Dr. Hofman said he has no relevant conflicts of interest. Dr. Heck disclosed relationships with Astellas, Janssen, Ipsen, Amgen, Bayer, Heise, Merck, Sanofi, and Takeda.

SOURCES: Hofman M et al. Lancet. March 22, doi: https://doi.org/10.1016/S0140-6736(20)30314-7.

The use of topical corticosteroids does not significantly increase fracture risk in young children diagnosed with atopic dermatitis, results from a large population-based study suggest.

LucaLorenzelli/Thinkstock

“Little has been published about the risk of fracture in children with atopic dermatitis on topical corticosteroids specifically,” one of the study authors, Reese L. Imhof, said in an interview following the virtual annual meeting of the Society for Pediatric Dermatology. “There are concerns, particularly among parents, regarding potential bone side effects through possible corticosteroid percutaneous absorption. Fears related to topical corticosteroid use likely stem from the fact that prolonged systemic corticosteroid use is associated with an increased risk of bone fractures.”

In an effort to determine the fracture risk in children who were diagnosed with atopic dermatitis (AD) prior to age 4 years and received topical corticosteroid treatment, Mr. Imhof, from Mayo Medical School, Rochester, Minn., and his associates used the Rochester Epidemiology Project records-linkage system to identify patients in Olmstead County, Minn., who received their first AD diagnosis prior to age 4 years between Jan. 1, 2004, through Dec. 31, 2017. Those who received topical corticosteroids listed in National Drug File-Reference Terminology class 8952 (anti-inflammatory, topical) or 8954 (anti-infective/anti-inflammatory combinations, topical) between Jan. 1, 2004, and Dec. 31, 2018 were included in the analysis and were followed to identify new bone fractures, excluding pathological fractures in neoplastic disease and skull or facial bone fractures.

The researchers conducted two analyses of the data. For the primary statistical analysis, they evaluated topical corticosteroid exposure as a binary time-dependent covariate in a Cox proportional hazard model using age as the time scale, with patients entering the risk set at the age of the first clinic visit rather than the age of their first AD diagnosis. Next, the researchers performed a landmark analysis as a sensitivity analysis. For this, each patient’s fourth birthday was defined as the starting point, since all included patients were diagnosed with AD prior to age 4 years.

Of the 7,505 patients first identified with AD, 3,542 were included in the primary analysis and 2,499 were included in the landmark analysis. In the primary analysis, 2,384 patients (67%) received a topical prescription for a topical corticosteroid prior to age 4 years, and an additional 190 (5%) received their first prescription after age 4 years. The researchers observed that 451 patients (13%) had a fracture after AD diagnosis at a median age of 7.4 years. The median age at last follow-up for the remaining 3,091 patients was 6.6 years. Evaluated as a time-dependent covariate, the use of a topical corticosteroid was associated with a nonsignificant 17% increased risk of fracture (hazard ratio, 1.17; P = .16).

In the landmark analysis, 1,722 patients (69%) were prescribed a topical corticosteroid prior to age 4 years. Of these patients, 333 (13%) had their first fracture after AD diagnosis, at a median age of 8.7 years. The median age at last follow-up for the remaining patients was 9.3 years. The researchers observed that, starting at 4 years of age, there was no association between topical corticosteroid use and risk of fracture (HR, 1.00; P = 1.00).

“Our findings suggest that topical corticosteroids do not significantly increase fracture risk in this pediatric population with atopic dermatitis,” Mr. Imhof said. “Dermatologists can use the results of this study to reassure parents of infants and young children, as most patients in our study received their first topical corticosteroid prescription prior to age 4.”

He acknowledged certain limitations of the study, such as its retrospective design and study population, which was predominantly white and resided in the upper Midwest. “Also, our study examined prescription data with the assumption made that topical corticosteroids were used as prescribed,” he said. “An additional limitation is that we evaluated ever versus never exposure to topical corticosteroids rather than cumulative duration of use and/or potency.”

Mr. Imhof and his colleagues reported having no financial disclosures.

dbrunk@mdedge.com

The use of topical corticosteroids does not significantly increase fracture risk in young children diagnosed with atopic dermatitis, results from a large population-based study suggest.

LucaLorenzelli/Thinkstock

“Little has been published about the risk of fracture in children with atopic dermatitis on topical corticosteroids specifically,” one of the study authors, Reese L. Imhof, said in an interview following the virtual annual meeting of the Society for Pediatric Dermatology. “There are concerns, particularly among parents, regarding potential bone side effects through possible corticosteroid percutaneous absorption. Fears related to topical corticosteroid use likely stem from the fact that prolonged systemic corticosteroid use is associated with an increased risk of bone fractures.”

In an effort to determine the fracture risk in children who were diagnosed with atopic dermatitis (AD) prior to age 4 years and received topical corticosteroid treatment, Mr. Imhof, from Mayo Medical School, Rochester, Minn., and his associates used the Rochester Epidemiology Project records-linkage system to identify patients in Olmstead County, Minn., who received their first AD diagnosis prior to age 4 years between Jan. 1, 2004, through Dec. 31, 2017. Those who received topical corticosteroids listed in National Drug File-Reference Terminology class 8952 (anti-inflammatory, topical) or 8954 (anti-infective/anti-inflammatory combinations, topical) between Jan. 1, 2004, and Dec. 31, 2018 were included in the analysis and were followed to identify new bone fractures, excluding pathological fractures in neoplastic disease and skull or facial bone fractures.

The researchers conducted two analyses of the data. For the primary statistical analysis, they evaluated topical corticosteroid exposure as a binary time-dependent covariate in a Cox proportional hazard model using age as the time scale, with patients entering the risk set at the age of the first clinic visit rather than the age of their first AD diagnosis. Next, the researchers performed a landmark analysis as a sensitivity analysis. For this, each patient’s fourth birthday was defined as the starting point, since all included patients were diagnosed with AD prior to age 4 years.

Of the 7,505 patients first identified with AD, 3,542 were included in the primary analysis and 2,499 were included in the landmark analysis. In the primary analysis, 2,384 patients (67%) received a topical prescription for a topical corticosteroid prior to age 4 years, and an additional 190 (5%) received their first prescription after age 4 years. The researchers observed that 451 patients (13%) had a fracture after AD diagnosis at a median age of 7.4 years. The median age at last follow-up for the remaining 3,091 patients was 6.6 years. Evaluated as a time-dependent covariate, the use of a topical corticosteroid was associated with a nonsignificant 17% increased risk of fracture (hazard ratio, 1.17; P = .16).

In the landmark analysis, 1,722 patients (69%) were prescribed a topical corticosteroid prior to age 4 years. Of these patients, 333 (13%) had their first fracture after AD diagnosis, at a median age of 8.7 years. The median age at last follow-up for the remaining patients was 9.3 years. The researchers observed that, starting at 4 years of age, there was no association between topical corticosteroid use and risk of fracture (HR, 1.00; P = 1.00).

“Our findings suggest that topical corticosteroids do not significantly increase fracture risk in this pediatric population with atopic dermatitis,” Mr. Imhof said. “Dermatologists can use the results of this study to reassure parents of infants and young children, as most patients in our study received their first topical corticosteroid prescription prior to age 4.”

He acknowledged certain limitations of the study, such as its retrospective design and study population, which was predominantly white and resided in the upper Midwest. “Also, our study examined prescription data with the assumption made that topical corticosteroids were used as prescribed,” he said. “An additional limitation is that we evaluated ever versus never exposure to topical corticosteroids rather than cumulative duration of use and/or potency.”

Mr. Imhof and his colleagues reported having no financial disclosures.

dbrunk@mdedge.com

The use of topical corticosteroids does not significantly increase fracture risk in young children diagnosed with atopic dermatitis, results from a large population-based study suggest.

LucaLorenzelli/Thinkstock

“Little has been published about the risk of fracture in children with atopic dermatitis on topical corticosteroids specifically,” one of the study authors, Reese L. Imhof, said in an interview following the virtual annual meeting of the Society for Pediatric Dermatology. “There are concerns, particularly among parents, regarding potential bone side effects through possible corticosteroid percutaneous absorption. Fears related to topical corticosteroid use likely stem from the fact that prolonged systemic corticosteroid use is associated with an increased risk of bone fractures.”

In an effort to determine the fracture risk in children who were diagnosed with atopic dermatitis (AD) prior to age 4 years and received topical corticosteroid treatment, Mr. Imhof, from Mayo Medical School, Rochester, Minn., and his associates used the Rochester Epidemiology Project records-linkage system to identify patients in Olmstead County, Minn., who received their first AD diagnosis prior to age 4 years between Jan. 1, 2004, through Dec. 31, 2017. Those who received topical corticosteroids listed in National Drug File-Reference Terminology class 8952 (anti-inflammatory, topical) or 8954 (anti-infective/anti-inflammatory combinations, topical) between Jan. 1, 2004, and Dec. 31, 2018 were included in the analysis and were followed to identify new bone fractures, excluding pathological fractures in neoplastic disease and skull or facial bone fractures.

The researchers conducted two analyses of the data. For the primary statistical analysis, they evaluated topical corticosteroid exposure as a binary time-dependent covariate in a Cox proportional hazard model using age as the time scale, with patients entering the risk set at the age of the first clinic visit rather than the age of their first AD diagnosis. Next, the researchers performed a landmark analysis as a sensitivity analysis. For this, each patient’s fourth birthday was defined as the starting point, since all included patients were diagnosed with AD prior to age 4 years.

Of the 7,505 patients first identified with AD, 3,542 were included in the primary analysis and 2,499 were included in the landmark analysis. In the primary analysis, 2,384 patients (67%) received a topical prescription for a topical corticosteroid prior to age 4 years, and an additional 190 (5%) received their first prescription after age 4 years. The researchers observed that 451 patients (13%) had a fracture after AD diagnosis at a median age of 7.4 years. The median age at last follow-up for the remaining 3,091 patients was 6.6 years. Evaluated as a time-dependent covariate, the use of a topical corticosteroid was associated with a nonsignificant 17% increased risk of fracture (hazard ratio, 1.17; P = .16).

In the landmark analysis, 1,722 patients (69%) were prescribed a topical corticosteroid prior to age 4 years. Of these patients, 333 (13%) had their first fracture after AD diagnosis, at a median age of 8.7 years. The median age at last follow-up for the remaining patients was 9.3 years. The researchers observed that, starting at 4 years of age, there was no association between topical corticosteroid use and risk of fracture (HR, 1.00; P = 1.00).

“Our findings suggest that topical corticosteroids do not significantly increase fracture risk in this pediatric population with atopic dermatitis,” Mr. Imhof said. “Dermatologists can use the results of this study to reassure parents of infants and young children, as most patients in our study received their first topical corticosteroid prescription prior to age 4.”

He acknowledged certain limitations of the study, such as its retrospective design and study population, which was predominantly white and resided in the upper Midwest. “Also, our study examined prescription data with the assumption made that topical corticosteroids were used as prescribed,” he said. “An additional limitation is that we evaluated ever versus never exposure to topical corticosteroids rather than cumulative duration of use and/or potency.”

Mr. Imhof and his colleagues reported having no financial disclosures.

dbrunk@mdedge.com

Patients with psoriatic disease are known to be at increased risk of heart failure. A new cohort study suggests that part of the risk may be attributable to the disease itself, not just traditional cardiovascular risk factors like obesity and metabolic abnormalities that are common comorbidities in psoriatic disease. There may also be differences in the risk profiles of patients with ischemic and nonischemic heart failure.

Courtesy Dr. Sahil Koppikar

Previous studies have shown that heart failure risk in patients with psoriatic arthritis is 32% higher than in the general population, and with psoriasis, it is 22%-53% higher. However, those studies were based on administrative databases with no clinical information to back up the accuracy of diagnoses, Sahil Koppikar, MD, from the University of Toronto, said during a presentation of the research at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The finding that psoriatic disease inflammation may be a direct risk factor for heart failure might be good news for patients. “By controlling inflammation, we may be able to reduce the risk of heart failure in these patients,” Dr. Koppikar said.

During a question and answer session, discussant Deepak Jadon, MBChB, PhD, director of the rheumatology research unit and lead for psoriatic arthritis at Addenbrooke’s Hospital, Cambridge (England), noted that patients with conditions like lupus and systemic sclerosis may undergo regular echocardiograms, chest CTs, or other surveillance, and asked if Dr. Koppikar could recommend a framework for similar surveillance in psoriatic arthritis.

“With the current data we have, I don’t know if we can make recommendations. What we learned from our study is that patients that have elevated inflammatory disease, with elevated inflammatory markers for a prolonged period of time, were at higher risk than [if they had elevated markers only] just before the event. So poorly controlled patients might be something you should be more aware of, and maybe get cardiology involved. But I don’t think it’s something we should be doing right now for all patients,” Dr. Koppikar said.

The researchers analyzed data from a psoriasis cohort at the University of Toronto that began in 2006. Every 6-12 months, they were assessed by a rheumatologist and underwent imaging assessment and laboratory tests. The primary outcome of the study was the first heart failure event, which the researchers identified by linking the cohort database with provincial hospitalization and mortality databases. They verified all events by examining medical records. They also assessed the association between heart failure and disease activity over time rather than just before the event.

The analysis included 1,994 patients. A total of 64 new heart failure events occurred during a mean follow-up of 11.3 years (2.85 per 1,000 person-years), including 38 ischemic and 26 nonischemic events. A multivariate analysis found that heart failure was associated with adjusted mean (AM) tender joint count (hazard ratio, 1.51; P = .02), AM swollen joint count (HR, 1.82; P = .04), AM erythrocyte sedimentation rate (HR, 1.26; P = .009), AM C-reactive protein (HR, 1.27; P = .001), Health Assessment Questionnaire (HR, 1.95; P = .001), and minimum disease activity state (HR, 0.40; P = .04). The multivariate analysis was adjusted for sex, hypertension, diabetes mellitus, body mass index, ischemic heart disease, lipids, and smoking status.

When the researchers separated the analysis into ischemic and nonischemic heart failure, some interesting associations popped out. Nonischemic heart failure was associated with AM tender joint count (HR, 1.83; P = .004), but ischemic heart failure was not. Other factors associated with nonischemic but not ischemic heart failure included AM swollen joint count (HR, 3.56; P = .0003), damaged joint count (HR, 1.29; P = .04), and pain score (HR, 1.22; P = .047). Minimum disease activity had the opposite result: It was associated with only ischemic heart failure (HR, 0.40; P = .04).

The study cohort more closely resembles a rheumatology cohort than a dermatology cohort, and it suggests that patients with psoriatic arthritis have different cardiovascular comorbidities than those with pure psoriasis, according to Diamant Thaçi, MD, PhD, professor and chairman of the department of dermatology at the University of Lübeck (Germany). “It shows how it important it is to look for comorbidity in the rheumatologic setting,” Dr. Thaçi said in an interview.

The study was supported by the Arthritis Society. Dr. Koppikar and Dr. Thaçi have no relevant financial disclosures.

SOURCE: Koppikar S et al. GRAPPA 2020 Virtual Annual Meeting.

Patients with psoriatic disease are known to be at increased risk of heart failure. A new cohort study suggests that part of the risk may be attributable to the disease itself, not just traditional cardiovascular risk factors like obesity and metabolic abnormalities that are common comorbidities in psoriatic disease. There may also be differences in the risk profiles of patients with ischemic and nonischemic heart failure.

Courtesy Dr. Sahil Koppikar

Previous studies have shown that heart failure risk in patients with psoriatic arthritis is 32% higher than in the general population, and with psoriasis, it is 22%-53% higher. However, those studies were based on administrative databases with no clinical information to back up the accuracy of diagnoses, Sahil Koppikar, MD, from the University of Toronto, said during a presentation of the research at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The finding that psoriatic disease inflammation may be a direct risk factor for heart failure might be good news for patients. “By controlling inflammation, we may be able to reduce the risk of heart failure in these patients,” Dr. Koppikar said.

During a question and answer session, discussant Deepak Jadon, MBChB, PhD, director of the rheumatology research unit and lead for psoriatic arthritis at Addenbrooke’s Hospital, Cambridge (England), noted that patients with conditions like lupus and systemic sclerosis may undergo regular echocardiograms, chest CTs, or other surveillance, and asked if Dr. Koppikar could recommend a framework for similar surveillance in psoriatic arthritis.

“With the current data we have, I don’t know if we can make recommendations. What we learned from our study is that patients that have elevated inflammatory disease, with elevated inflammatory markers for a prolonged period of time, were at higher risk than [if they had elevated markers only] just before the event. So poorly controlled patients might be something you should be more aware of, and maybe get cardiology involved. But I don’t think it’s something we should be doing right now for all patients,” Dr. Koppikar said.

The researchers analyzed data from a psoriasis cohort at the University of Toronto that began in 2006. Every 6-12 months, they were assessed by a rheumatologist and underwent imaging assessment and laboratory tests. The primary outcome of the study was the first heart failure event, which the researchers identified by linking the cohort database with provincial hospitalization and mortality databases. They verified all events by examining medical records. They also assessed the association between heart failure and disease activity over time rather than just before the event.

The analysis included 1,994 patients. A total of 64 new heart failure events occurred during a mean follow-up of 11.3 years (2.85 per 1,000 person-years), including 38 ischemic and 26 nonischemic events. A multivariate analysis found that heart failure was associated with adjusted mean (AM) tender joint count (hazard ratio, 1.51; P = .02), AM swollen joint count (HR, 1.82; P = .04), AM erythrocyte sedimentation rate (HR, 1.26; P = .009), AM C-reactive protein (HR, 1.27; P = .001), Health Assessment Questionnaire (HR, 1.95; P = .001), and minimum disease activity state (HR, 0.40; P = .04). The multivariate analysis was adjusted for sex, hypertension, diabetes mellitus, body mass index, ischemic heart disease, lipids, and smoking status.

When the researchers separated the analysis into ischemic and nonischemic heart failure, some interesting associations popped out. Nonischemic heart failure was associated with AM tender joint count (HR, 1.83; P = .004), but ischemic heart failure was not. Other factors associated with nonischemic but not ischemic heart failure included AM swollen joint count (HR, 3.56; P = .0003), damaged joint count (HR, 1.29; P = .04), and pain score (HR, 1.22; P = .047). Minimum disease activity had the opposite result: It was associated with only ischemic heart failure (HR, 0.40; P = .04).

The study cohort more closely resembles a rheumatology cohort than a dermatology cohort, and it suggests that patients with psoriatic arthritis have different cardiovascular comorbidities than those with pure psoriasis, according to Diamant Thaçi, MD, PhD, professor and chairman of the department of dermatology at the University of Lübeck (Germany). “It shows how it important it is to look for comorbidity in the rheumatologic setting,” Dr. Thaçi said in an interview.

The study was supported by the Arthritis Society. Dr. Koppikar and Dr. Thaçi have no relevant financial disclosures.

SOURCE: Koppikar S et al. GRAPPA 2020 Virtual Annual Meeting.

Patients with psoriatic disease are known to be at increased risk of heart failure. A new cohort study suggests that part of the risk may be attributable to the disease itself, not just traditional cardiovascular risk factors like obesity and metabolic abnormalities that are common comorbidities in psoriatic disease. There may also be differences in the risk profiles of patients with ischemic and nonischemic heart failure.

Courtesy Dr. Sahil Koppikar

Previous studies have shown that heart failure risk in patients with psoriatic arthritis is 32% higher than in the general population, and with psoriasis, it is 22%-53% higher. However, those studies were based on administrative databases with no clinical information to back up the accuracy of diagnoses, Sahil Koppikar, MD, from the University of Toronto, said during a presentation of the research at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The finding that psoriatic disease inflammation may be a direct risk factor for heart failure might be good news for patients. “By controlling inflammation, we may be able to reduce the risk of heart failure in these patients,” Dr. Koppikar said.

During a question and answer session, discussant Deepak Jadon, MBChB, PhD, director of the rheumatology research unit and lead for psoriatic arthritis at Addenbrooke’s Hospital, Cambridge (England), noted that patients with conditions like lupus and systemic sclerosis may undergo regular echocardiograms, chest CTs, or other surveillance, and asked if Dr. Koppikar could recommend a framework for similar surveillance in psoriatic arthritis.

“With the current data we have, I don’t know if we can make recommendations. What we learned from our study is that patients that have elevated inflammatory disease, with elevated inflammatory markers for a prolonged period of time, were at higher risk than [if they had elevated markers only] just before the event. So poorly controlled patients might be something you should be more aware of, and maybe get cardiology involved. But I don’t think it’s something we should be doing right now for all patients,” Dr. Koppikar said.

The researchers analyzed data from a psoriasis cohort at the University of Toronto that began in 2006. Every 6-12 months, they were assessed by a rheumatologist and underwent imaging assessment and laboratory tests. The primary outcome of the study was the first heart failure event, which the researchers identified by linking the cohort database with provincial hospitalization and mortality databases. They verified all events by examining medical records. They also assessed the association between heart failure and disease activity over time rather than just before the event.

The analysis included 1,994 patients. A total of 64 new heart failure events occurred during a mean follow-up of 11.3 years (2.85 per 1,000 person-years), including 38 ischemic and 26 nonischemic events. A multivariate analysis found that heart failure was associated with adjusted mean (AM) tender joint count (hazard ratio, 1.51; P = .02), AM swollen joint count (HR, 1.82; P = .04), AM erythrocyte sedimentation rate (HR, 1.26; P = .009), AM C-reactive protein (HR, 1.27; P = .001), Health Assessment Questionnaire (HR, 1.95; P = .001), and minimum disease activity state (HR, 0.40; P = .04). The multivariate analysis was adjusted for sex, hypertension, diabetes mellitus, body mass index, ischemic heart disease, lipids, and smoking status.

When the researchers separated the analysis into ischemic and nonischemic heart failure, some interesting associations popped out. Nonischemic heart failure was associated with AM tender joint count (HR, 1.83; P = .004), but ischemic heart failure was not. Other factors associated with nonischemic but not ischemic heart failure included AM swollen joint count (HR, 3.56; P = .0003), damaged joint count (HR, 1.29; P = .04), and pain score (HR, 1.22; P = .047). Minimum disease activity had the opposite result: It was associated with only ischemic heart failure (HR, 0.40; P = .04).

The study cohort more closely resembles a rheumatology cohort than a dermatology cohort, and it suggests that patients with psoriatic arthritis have different cardiovascular comorbidities than those with pure psoriasis, according to Diamant Thaçi, MD, PhD, professor and chairman of the department of dermatology at the University of Lübeck (Germany). “It shows how it important it is to look for comorbidity in the rheumatologic setting,” Dr. Thaçi said in an interview.

The study was supported by the Arthritis Society. Dr. Koppikar and Dr. Thaçi have no relevant financial disclosures.

SOURCE: Koppikar S et al. GRAPPA 2020 Virtual Annual Meeting.