Federal Practitioner

Perimenopausal women are using prescription sleep medications for long periods of time despite no evidence of efficacy, a new study shows.

“While there are good data from [randomized, controlled trials] that these medications improve sleep disturbances in the short term,” few studies have examined whether they provide long-term benefits, stated the authors of the paper, which was published in BMJ Open.

“The current observational study does not support use of sleep medications over the long term, as there were no self-reported differences at 1 or 2 years of follow-up comparing sleep medication users with nonusers,” author Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital, Boston, and colleagues wrote.

Women included in the analysis were drawn from the Study of Women’s Health Across the Nation (SWAN), an ongoing multicenter, longitudinal study examining women during the menopausal transition. The average age of the women included in the cohort was 49.5 years and approximately half were White. All women reported a sleep disturbance on at least 3 nights per week during a 2-week interval. At follow up, women were asked to use a Likert scale to rate three aspects of sleep: difficulty initiating sleep, frequent awakening, and waking up early. On the scale, 1 represented having no difficulties on any nights, 3 represented having difficulties 1-2 nights per week, and 5 represented having difficulty 5-7 nights per week.

Women already using prescription sleep medication at their baseline visit were excluded from the study. Medications used included benzodiazepines, selective BZD receptor agonists, and other hypnotics.

Over the 21 years of follow-up in the SWAN study (1995-2016), Dr. Solomon and colleagues identified 238 women using sleep medication and these were compared with a cohort of 447 propensity score–matched non–sleep medication uses. Overall, the 685 women included were similar in characteristics to each other as well as to the other potentially eligible women not included in the analysis.
 

Sleep disturbance patterns compared

At baseline, sleep disturbance patterns were similar between the two groups. Among medication users, the mean score for difficulty initiating sleep was 2.7 (95% confidence interval, 2.5-2.9), waking frequently 3.8 (95% CI, 3.6-3.9), and waking early 2.9 (95% CI, 2.7-3.1). Among the nonusers, the baseline scores were 2.6 (95% CI, 2.5-2.7), 3.7 (95% CI, 3.6-3.8), and 2.7 (95% CI, 2.5-2.8), respectively. After 1 year, there was no statistically significant difference in scores between the two groups. The average ratings for medication users were 2.6 (95% CI, 2.3-2.8) for difficulty initiating sleep, 3.8 (95% CI, 3.6-4.0) for waking frequently, and 2.8 (95% CI, 2.6-3.0) for waking early.

Average ratings among nonusers were 2.3 (95% CI, 2.2-2.4), 3.5 (95% CI, 3.3-3.6), and 2.5 (95% CI, 2.3-2.6), respectively.

After 2 years, there were still no statistically significant reductions in sleep disturbances among those taking prescription sleep medications, compared with those not taking medication.

The researchers noted that approximately half of the women in this cohort were current or past tobacco users and that 20% were moderate to heavy alcohol users.
 

More work-up, not more medication, needed

The study authors acknowledged the limitations of an observational study and noted that, since participants only reported medication use and sleep disturbances at annual visits, they did not know whether patients’ medication use was intermittent or of any interim outcomes. Additionally, the authors pointed out that those classified as “nonusers” may have been using over-the-counter medication.

“Investigations should look at detailed-use patterns, on a daily or weekly basis, with frequent outcomes data,” Dr. Solomon said in an interview. “While our data shed new light on chronic use, we only had data collected on an annual basis; daily or weekly data would provide more granular information.”

Regarding clinician prescribing practices, Dr. Solomon said, “short-term, intermittent use can be helpful, but use these agents sparingly” and “educate patients that chronic regular use of medications for sleep is not associated with improvement in sleep disturbances.”

Commenting on the study, Andrea Matsumura, MD, a sleep specialist at the Oregon Clinic in Portland, echoed this sentiment: “When someone says they are having trouble sleeping this is the tip of the iceberg and it warrants an evaluation to determine if someone has a breathing disorder, a circadian disorder, a life situation, or a type of insomnia that is driving the sleeplessness.”

“I think this study supports what we all should know,” Dr. Matsumura concluded. “Sleep aids are not meant to be used long term” and should not be used for longer than 2 weeks without further work-up.

Funding for this study was provided through a grant from the National Institutes of Health. Dr. Solomon has received salary support from research grants to Brigham and Women’s Hospital for unrelated work from AbbVie, Amgen, Corrona, Genentech and Pfizer. The other authors and Dr. Matsumura have reported no relevant financial relationships.

Perimenopausal women are using prescription sleep medications for long periods of time despite no evidence of efficacy, a new study shows.

“While there are good data from [randomized, controlled trials] that these medications improve sleep disturbances in the short term,” few studies have examined whether they provide long-term benefits, stated the authors of the paper, which was published in BMJ Open.

“The current observational study does not support use of sleep medications over the long term, as there were no self-reported differences at 1 or 2 years of follow-up comparing sleep medication users with nonusers,” author Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital, Boston, and colleagues wrote.

Women included in the analysis were drawn from the Study of Women’s Health Across the Nation (SWAN), an ongoing multicenter, longitudinal study examining women during the menopausal transition. The average age of the women included in the cohort was 49.5 years and approximately half were White. All women reported a sleep disturbance on at least 3 nights per week during a 2-week interval. At follow up, women were asked to use a Likert scale to rate three aspects of sleep: difficulty initiating sleep, frequent awakening, and waking up early. On the scale, 1 represented having no difficulties on any nights, 3 represented having difficulties 1-2 nights per week, and 5 represented having difficulty 5-7 nights per week.

Women already using prescription sleep medication at their baseline visit were excluded from the study. Medications used included benzodiazepines, selective BZD receptor agonists, and other hypnotics.

Over the 21 years of follow-up in the SWAN study (1995-2016), Dr. Solomon and colleagues identified 238 women using sleep medication and these were compared with a cohort of 447 propensity score–matched non–sleep medication uses. Overall, the 685 women included were similar in characteristics to each other as well as to the other potentially eligible women not included in the analysis.
 

Sleep disturbance patterns compared

At baseline, sleep disturbance patterns were similar between the two groups. Among medication users, the mean score for difficulty initiating sleep was 2.7 (95% confidence interval, 2.5-2.9), waking frequently 3.8 (95% CI, 3.6-3.9), and waking early 2.9 (95% CI, 2.7-3.1). Among the nonusers, the baseline scores were 2.6 (95% CI, 2.5-2.7), 3.7 (95% CI, 3.6-3.8), and 2.7 (95% CI, 2.5-2.8), respectively. After 1 year, there was no statistically significant difference in scores between the two groups. The average ratings for medication users were 2.6 (95% CI, 2.3-2.8) for difficulty initiating sleep, 3.8 (95% CI, 3.6-4.0) for waking frequently, and 2.8 (95% CI, 2.6-3.0) for waking early.

Average ratings among nonusers were 2.3 (95% CI, 2.2-2.4), 3.5 (95% CI, 3.3-3.6), and 2.5 (95% CI, 2.3-2.6), respectively.

After 2 years, there were still no statistically significant reductions in sleep disturbances among those taking prescription sleep medications, compared with those not taking medication.

The researchers noted that approximately half of the women in this cohort were current or past tobacco users and that 20% were moderate to heavy alcohol users.
 

More work-up, not more medication, needed

The study authors acknowledged the limitations of an observational study and noted that, since participants only reported medication use and sleep disturbances at annual visits, they did not know whether patients’ medication use was intermittent or of any interim outcomes. Additionally, the authors pointed out that those classified as “nonusers” may have been using over-the-counter medication.

“Investigations should look at detailed-use patterns, on a daily or weekly basis, with frequent outcomes data,” Dr. Solomon said in an interview. “While our data shed new light on chronic use, we only had data collected on an annual basis; daily or weekly data would provide more granular information.”

Regarding clinician prescribing practices, Dr. Solomon said, “short-term, intermittent use can be helpful, but use these agents sparingly” and “educate patients that chronic regular use of medications for sleep is not associated with improvement in sleep disturbances.”

Commenting on the study, Andrea Matsumura, MD, a sleep specialist at the Oregon Clinic in Portland, echoed this sentiment: “When someone says they are having trouble sleeping this is the tip of the iceberg and it warrants an evaluation to determine if someone has a breathing disorder, a circadian disorder, a life situation, or a type of insomnia that is driving the sleeplessness.”

“I think this study supports what we all should know,” Dr. Matsumura concluded. “Sleep aids are not meant to be used long term” and should not be used for longer than 2 weeks without further work-up.

Funding for this study was provided through a grant from the National Institutes of Health. Dr. Solomon has received salary support from research grants to Brigham and Women’s Hospital for unrelated work from AbbVie, Amgen, Corrona, Genentech and Pfizer. The other authors and Dr. Matsumura have reported no relevant financial relationships.

Perimenopausal women are using prescription sleep medications for long periods of time despite no evidence of efficacy, a new study shows.

“While there are good data from [randomized, controlled trials] that these medications improve sleep disturbances in the short term,” few studies have examined whether they provide long-term benefits, stated the authors of the paper, which was published in BMJ Open.

“The current observational study does not support use of sleep medications over the long term, as there were no self-reported differences at 1 or 2 years of follow-up comparing sleep medication users with nonusers,” author Daniel H. Solomon, MD, MPH, from Brigham and Women’s Hospital, Boston, and colleagues wrote.

Women included in the analysis were drawn from the Study of Women’s Health Across the Nation (SWAN), an ongoing multicenter, longitudinal study examining women during the menopausal transition. The average age of the women included in the cohort was 49.5 years and approximately half were White. All women reported a sleep disturbance on at least 3 nights per week during a 2-week interval. At follow up, women were asked to use a Likert scale to rate three aspects of sleep: difficulty initiating sleep, frequent awakening, and waking up early. On the scale, 1 represented having no difficulties on any nights, 3 represented having difficulties 1-2 nights per week, and 5 represented having difficulty 5-7 nights per week.

Women already using prescription sleep medication at their baseline visit were excluded from the study. Medications used included benzodiazepines, selective BZD receptor agonists, and other hypnotics.

Over the 21 years of follow-up in the SWAN study (1995-2016), Dr. Solomon and colleagues identified 238 women using sleep medication and these were compared with a cohort of 447 propensity score–matched non–sleep medication uses. Overall, the 685 women included were similar in characteristics to each other as well as to the other potentially eligible women not included in the analysis.
 

Sleep disturbance patterns compared

At baseline, sleep disturbance patterns were similar between the two groups. Among medication users, the mean score for difficulty initiating sleep was 2.7 (95% confidence interval, 2.5-2.9), waking frequently 3.8 (95% CI, 3.6-3.9), and waking early 2.9 (95% CI, 2.7-3.1). Among the nonusers, the baseline scores were 2.6 (95% CI, 2.5-2.7), 3.7 (95% CI, 3.6-3.8), and 2.7 (95% CI, 2.5-2.8), respectively. After 1 year, there was no statistically significant difference in scores between the two groups. The average ratings for medication users were 2.6 (95% CI, 2.3-2.8) for difficulty initiating sleep, 3.8 (95% CI, 3.6-4.0) for waking frequently, and 2.8 (95% CI, 2.6-3.0) for waking early.

Average ratings among nonusers were 2.3 (95% CI, 2.2-2.4), 3.5 (95% CI, 3.3-3.6), and 2.5 (95% CI, 2.3-2.6), respectively.

After 2 years, there were still no statistically significant reductions in sleep disturbances among those taking prescription sleep medications, compared with those not taking medication.

The researchers noted that approximately half of the women in this cohort were current or past tobacco users and that 20% were moderate to heavy alcohol users.
 

More work-up, not more medication, needed

The study authors acknowledged the limitations of an observational study and noted that, since participants only reported medication use and sleep disturbances at annual visits, they did not know whether patients’ medication use was intermittent or of any interim outcomes. Additionally, the authors pointed out that those classified as “nonusers” may have been using over-the-counter medication.

“Investigations should look at detailed-use patterns, on a daily or weekly basis, with frequent outcomes data,” Dr. Solomon said in an interview. “While our data shed new light on chronic use, we only had data collected on an annual basis; daily or weekly data would provide more granular information.”

Regarding clinician prescribing practices, Dr. Solomon said, “short-term, intermittent use can be helpful, but use these agents sparingly” and “educate patients that chronic regular use of medications for sleep is not associated with improvement in sleep disturbances.”

Commenting on the study, Andrea Matsumura, MD, a sleep specialist at the Oregon Clinic in Portland, echoed this sentiment: “When someone says they are having trouble sleeping this is the tip of the iceberg and it warrants an evaluation to determine if someone has a breathing disorder, a circadian disorder, a life situation, or a type of insomnia that is driving the sleeplessness.”

“I think this study supports what we all should know,” Dr. Matsumura concluded. “Sleep aids are not meant to be used long term” and should not be used for longer than 2 weeks without further work-up.

Funding for this study was provided through a grant from the National Institutes of Health. Dr. Solomon has received salary support from research grants to Brigham and Women’s Hospital for unrelated work from AbbVie, Amgen, Corrona, Genentech and Pfizer. The other authors and Dr. Matsumura have reported no relevant financial relationships.

The use of e-cigarettes is linked to a higher frequency of self-reported wheezing and shortness of breath in adolescents and young adults, according to an online survey. The association was present even after controlling for cigarette and cannabis use.

Previous studies of adolescents and young adults have shown associations between e-cigarette use and wheeze, shortness of breath, and asthma. The Youth Risk Behavior Surveillance (YRBS) survey by the Centers for Disease Control and Prevention and other health agencies, conducted from 2015 to 2017, found that 63.5% of youth who used e-cigarettes also used some combination of cigarettes and cannabis. Combined use was associated with a 55%-65% increased odds of self-reported asthma.

The Population Assessment of Tobacco and Health (PATH) study, which was published in October 2020, had similar findings, though it did not find an association between e-cigarette use alone and wheezing.

“The findings from the current study highlight that we need to keep asking young people about respiratory symptoms, couse of other tobacco products, as well as cannabis use. As more products, including cannabis and various e-cigarette devices, enter the market, assessing respiratory health will be important both where adolescents and young adults receive their health care and in research,” Alayna Tackett, PhD, said in an interview. Dr. Tackett presented the study at the American Thoracic Society’s virtual international conference. She is an assistant professor of preventive medicine at the University of Southern California, Los Angeles.

“I found [the study] very interesting because it seems to be identifying a physiologic response to these e-cigarettes,” said Christopher Pascoe, MD, who was asked to comment. “And they were so young [age 14-21 years]. The fact that these symptoms of wheezing and shortness of breath are coming from people who are this young suggests that there may be chronic problems showing up later with continued use of these devices.”

Dr. Pascoe is an assistant professor of physiology and pathophysiology at the University of Manitoba, Winnipeg, where he also works with the Children’s Hospital Research Institute of Manitoba. His own research examines lung tissue harvested from pneumothorax surgeries in smokers and e-cigarette users to identify markers of inflammation.

He called the research a “good start” at unraveling the impacts of e-cigarettes and smoking, since some people use both products. “The fact that there was still a twofold increase in odds for wheezing, shortness of breath among people who use these e-cigarettes, but weren’t using cannabis and weren’t using cigarettes. I think it’s novel, and it suggests that there is an effect [of e-cigarettes alone].”

The study is based on a self-reported data, which is a significant limitation, especially considering that asthma is often overreported. “Self-report can be fraught with things, but I think it’s an interesting starting point for trying to recruit people who are just e-cigarette users and following them up further,” said Dr. Pascoe.

The researchers surveyed 2,931 individuals aged 14-21 years between Aug. 6 and Aug.30, 2020, with an average age of 18.9 years. Of the respondents, 80% were women and girls, and 75% were White. The high percentage of women and girls was unusual. Dr. Tackett provided no explanation for the atypical demographic but noted that the current study used convenience sampling.

The survey asked about use of e-cigarettes, cigarettes, and cannabis in the past 30 days, as well as asthma diagnosis and respiratory symptoms over the same period. The methodology employed survey management company Lucid, which recruited, collected data from, and provided compensation to participants.

A total of 24% of participants reported asthma, 13% reported wheeze, and 20% reported shortness of breath. Among 1,414 respondents who reported e-cigarette use in the past 30 days, 15% also said they had used cigarettes, and 37% said they had used cannabis.

After controlling for age, birth sex, and race/ethnicity, compared with self-reported never e-cigarette users, there was an association between past 30-day e-cigarette use and self-reported asthma (odds ratio, 1.4; 95% CI, 1.1-1.7), wheeze (OR, 3.1; 95% CI, 2.3-4.2), and shortness of breath (OR, 2.9; 95% CI, 2.3-3.6). After the researchers controlled for past 30-day cigarette cannabis use, the association with asthma was no longer statistically significant (OR, 1.11; 95% CI, 0.87-1.41), but the association with wheeze (OR, 2.3; 95% CI, 1.6-3.0) and shortness of breath (OR, 2.1; 95% CI, 1.6-2.8) remained.

Dr. Tackett noted that wheeze and shortness of breath are only two indicators of respiratory health, and more research needs to be done. Her team is conducting follow-up studies using objective measurement tools such as home-based spirometry in adolescents and young adults who exclusively use e-cigarettes and who have never used e-cigarettes.

“We need to better understand the complex relationships between use of these products and whether multiple product use is associated with worse respiratory outcomes,” said Dr. Tackett.

Dr. Pascoe and Dr. Tackett disclosed no relevant financial relationships.

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

The use of e-cigarettes is linked to a higher frequency of self-reported wheezing and shortness of breath in adolescents and young adults, according to an online survey. The association was present even after controlling for cigarette and cannabis use.

Previous studies of adolescents and young adults have shown associations between e-cigarette use and wheeze, shortness of breath, and asthma. The Youth Risk Behavior Surveillance (YRBS) survey by the Centers for Disease Control and Prevention and other health agencies, conducted from 2015 to 2017, found that 63.5% of youth who used e-cigarettes also used some combination of cigarettes and cannabis. Combined use was associated with a 55%-65% increased odds of self-reported asthma.

The Population Assessment of Tobacco and Health (PATH) study, which was published in October 2020, had similar findings, though it did not find an association between e-cigarette use alone and wheezing.

“The findings from the current study highlight that we need to keep asking young people about respiratory symptoms, couse of other tobacco products, as well as cannabis use. As more products, including cannabis and various e-cigarette devices, enter the market, assessing respiratory health will be important both where adolescents and young adults receive their health care and in research,” Alayna Tackett, PhD, said in an interview. Dr. Tackett presented the study at the American Thoracic Society’s virtual international conference. She is an assistant professor of preventive medicine at the University of Southern California, Los Angeles.

“I found [the study] very interesting because it seems to be identifying a physiologic response to these e-cigarettes,” said Christopher Pascoe, MD, who was asked to comment. “And they were so young [age 14-21 years]. The fact that these symptoms of wheezing and shortness of breath are coming from people who are this young suggests that there may be chronic problems showing up later with continued use of these devices.”

Dr. Pascoe is an assistant professor of physiology and pathophysiology at the University of Manitoba, Winnipeg, where he also works with the Children’s Hospital Research Institute of Manitoba. His own research examines lung tissue harvested from pneumothorax surgeries in smokers and e-cigarette users to identify markers of inflammation.

He called the research a “good start” at unraveling the impacts of e-cigarettes and smoking, since some people use both products. “The fact that there was still a twofold increase in odds for wheezing, shortness of breath among people who use these e-cigarettes, but weren’t using cannabis and weren’t using cigarettes. I think it’s novel, and it suggests that there is an effect [of e-cigarettes alone].”

The study is based on a self-reported data, which is a significant limitation, especially considering that asthma is often overreported. “Self-report can be fraught with things, but I think it’s an interesting starting point for trying to recruit people who are just e-cigarette users and following them up further,” said Dr. Pascoe.

The researchers surveyed 2,931 individuals aged 14-21 years between Aug. 6 and Aug.30, 2020, with an average age of 18.9 years. Of the respondents, 80% were women and girls, and 75% were White. The high percentage of women and girls was unusual. Dr. Tackett provided no explanation for the atypical demographic but noted that the current study used convenience sampling.

The survey asked about use of e-cigarettes, cigarettes, and cannabis in the past 30 days, as well as asthma diagnosis and respiratory symptoms over the same period. The methodology employed survey management company Lucid, which recruited, collected data from, and provided compensation to participants.

A total of 24% of participants reported asthma, 13% reported wheeze, and 20% reported shortness of breath. Among 1,414 respondents who reported e-cigarette use in the past 30 days, 15% also said they had used cigarettes, and 37% said they had used cannabis.

After controlling for age, birth sex, and race/ethnicity, compared with self-reported never e-cigarette users, there was an association between past 30-day e-cigarette use and self-reported asthma (odds ratio, 1.4; 95% CI, 1.1-1.7), wheeze (OR, 3.1; 95% CI, 2.3-4.2), and shortness of breath (OR, 2.9; 95% CI, 2.3-3.6). After the researchers controlled for past 30-day cigarette cannabis use, the association with asthma was no longer statistically significant (OR, 1.11; 95% CI, 0.87-1.41), but the association with wheeze (OR, 2.3; 95% CI, 1.6-3.0) and shortness of breath (OR, 2.1; 95% CI, 1.6-2.8) remained.

Dr. Tackett noted that wheeze and shortness of breath are only two indicators of respiratory health, and more research needs to be done. Her team is conducting follow-up studies using objective measurement tools such as home-based spirometry in adolescents and young adults who exclusively use e-cigarettes and who have never used e-cigarettes.

“We need to better understand the complex relationships between use of these products and whether multiple product use is associated with worse respiratory outcomes,” said Dr. Tackett.

Dr. Pascoe and Dr. Tackett disclosed no relevant financial relationships.

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

The use of e-cigarettes is linked to a higher frequency of self-reported wheezing and shortness of breath in adolescents and young adults, according to an online survey. The association was present even after controlling for cigarette and cannabis use.

Previous studies of adolescents and young adults have shown associations between e-cigarette use and wheeze, shortness of breath, and asthma. The Youth Risk Behavior Surveillance (YRBS) survey by the Centers for Disease Control and Prevention and other health agencies, conducted from 2015 to 2017, found that 63.5% of youth who used e-cigarettes also used some combination of cigarettes and cannabis. Combined use was associated with a 55%-65% increased odds of self-reported asthma.

The Population Assessment of Tobacco and Health (PATH) study, which was published in October 2020, had similar findings, though it did not find an association between e-cigarette use alone and wheezing.

“The findings from the current study highlight that we need to keep asking young people about respiratory symptoms, couse of other tobacco products, as well as cannabis use. As more products, including cannabis and various e-cigarette devices, enter the market, assessing respiratory health will be important both where adolescents and young adults receive their health care and in research,” Alayna Tackett, PhD, said in an interview. Dr. Tackett presented the study at the American Thoracic Society’s virtual international conference. She is an assistant professor of preventive medicine at the University of Southern California, Los Angeles.

“I found [the study] very interesting because it seems to be identifying a physiologic response to these e-cigarettes,” said Christopher Pascoe, MD, who was asked to comment. “And they were so young [age 14-21 years]. The fact that these symptoms of wheezing and shortness of breath are coming from people who are this young suggests that there may be chronic problems showing up later with continued use of these devices.”

Dr. Pascoe is an assistant professor of physiology and pathophysiology at the University of Manitoba, Winnipeg, where he also works with the Children’s Hospital Research Institute of Manitoba. His own research examines lung tissue harvested from pneumothorax surgeries in smokers and e-cigarette users to identify markers of inflammation.

He called the research a “good start” at unraveling the impacts of e-cigarettes and smoking, since some people use both products. “The fact that there was still a twofold increase in odds for wheezing, shortness of breath among people who use these e-cigarettes, but weren’t using cannabis and weren’t using cigarettes. I think it’s novel, and it suggests that there is an effect [of e-cigarettes alone].”

The study is based on a self-reported data, which is a significant limitation, especially considering that asthma is often overreported. “Self-report can be fraught with things, but I think it’s an interesting starting point for trying to recruit people who are just e-cigarette users and following them up further,” said Dr. Pascoe.

The researchers surveyed 2,931 individuals aged 14-21 years between Aug. 6 and Aug.30, 2020, with an average age of 18.9 years. Of the respondents, 80% were women and girls, and 75% were White. The high percentage of women and girls was unusual. Dr. Tackett provided no explanation for the atypical demographic but noted that the current study used convenience sampling.

The survey asked about use of e-cigarettes, cigarettes, and cannabis in the past 30 days, as well as asthma diagnosis and respiratory symptoms over the same period. The methodology employed survey management company Lucid, which recruited, collected data from, and provided compensation to participants.

A total of 24% of participants reported asthma, 13% reported wheeze, and 20% reported shortness of breath. Among 1,414 respondents who reported e-cigarette use in the past 30 days, 15% also said they had used cigarettes, and 37% said they had used cannabis.

After controlling for age, birth sex, and race/ethnicity, compared with self-reported never e-cigarette users, there was an association between past 30-day e-cigarette use and self-reported asthma (odds ratio, 1.4; 95% CI, 1.1-1.7), wheeze (OR, 3.1; 95% CI, 2.3-4.2), and shortness of breath (OR, 2.9; 95% CI, 2.3-3.6). After the researchers controlled for past 30-day cigarette cannabis use, the association with asthma was no longer statistically significant (OR, 1.11; 95% CI, 0.87-1.41), but the association with wheeze (OR, 2.3; 95% CI, 1.6-3.0) and shortness of breath (OR, 2.1; 95% CI, 1.6-2.8) remained.

Dr. Tackett noted that wheeze and shortness of breath are only two indicators of respiratory health, and more research needs to be done. Her team is conducting follow-up studies using objective measurement tools such as home-based spirometry in adolescents and young adults who exclusively use e-cigarettes and who have never used e-cigarettes.

“We need to better understand the complex relationships between use of these products and whether multiple product use is associated with worse respiratory outcomes,” said Dr. Tackett.

Dr. Pascoe and Dr. Tackett disclosed no relevant financial relationships.

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

A rare, life-threatening anemia now has a new treatment option. The Food and Drug Administration announced the approval of pegcetacoplan (Empaveli) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). Pegcetacoplan is the first PNH treatment that binds to complement protein C3, according to the FDA announcement. Complement protein C3 is a key component of host immunity and defense.

Special concern

Because of the risk of severe side effects, the drug is available only through a restricted program under a risk evaluation and mitigation strategy (REMS). Serious infections can occur in patients taking pegcetacoplan that can become life-threatening or fatal if not treated early. According to the FDA, REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication, and only a few drugs require a REMS.

The most common other side effects are injection site reactions, diarrhea, abdominal pain, and fatigue.

Pegcetacoplan was approved based upon a study of 80 patients with PNH and anemia who had been taking eculizumab, a previously approved treatment. During 16 weeks of treatment, patients in the pegcetacoplan group had an average increase in their hemoglobin of 2.4 g/dL, while patients in the eculizumab group had an average decrease in their hemoglobin of 1.5 g/dL.
 

About the disease

PNH is caused by gene mutations that affect red blood cells, causing them to be defective and susceptible to destruction by a patient’s own immune system. Red blood cells in people with these mutations are defective and can be destroyed by the immune system, causing anemia.

Other symptoms include blood clots and destruction of bone marrow. The disease affects 1-1.5 people per million, with diagnosis typically occurring around ages 35-40, and a median survival of only 10 years after diagnosis, according to the FDA.

[email protected]

A rare, life-threatening anemia now has a new treatment option. The Food and Drug Administration announced the approval of pegcetacoplan (Empaveli) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). Pegcetacoplan is the first PNH treatment that binds to complement protein C3, according to the FDA announcement. Complement protein C3 is a key component of host immunity and defense.

Special concern

Because of the risk of severe side effects, the drug is available only through a restricted program under a risk evaluation and mitigation strategy (REMS). Serious infections can occur in patients taking pegcetacoplan that can become life-threatening or fatal if not treated early. According to the FDA, REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication, and only a few drugs require a REMS.

The most common other side effects are injection site reactions, diarrhea, abdominal pain, and fatigue.

Pegcetacoplan was approved based upon a study of 80 patients with PNH and anemia who had been taking eculizumab, a previously approved treatment. During 16 weeks of treatment, patients in the pegcetacoplan group had an average increase in their hemoglobin of 2.4 g/dL, while patients in the eculizumab group had an average decrease in their hemoglobin of 1.5 g/dL.
 

About the disease

PNH is caused by gene mutations that affect red blood cells, causing them to be defective and susceptible to destruction by a patient’s own immune system. Red blood cells in people with these mutations are defective and can be destroyed by the immune system, causing anemia.

Other symptoms include blood clots and destruction of bone marrow. The disease affects 1-1.5 people per million, with diagnosis typically occurring around ages 35-40, and a median survival of only 10 years after diagnosis, according to the FDA.

[email protected]

A rare, life-threatening anemia now has a new treatment option. The Food and Drug Administration announced the approval of pegcetacoplan (Empaveli) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). Pegcetacoplan is the first PNH treatment that binds to complement protein C3, according to the FDA announcement. Complement protein C3 is a key component of host immunity and defense.

Special concern

Because of the risk of severe side effects, the drug is available only through a restricted program under a risk evaluation and mitigation strategy (REMS). Serious infections can occur in patients taking pegcetacoplan that can become life-threatening or fatal if not treated early. According to the FDA, REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication, and only a few drugs require a REMS.

The most common other side effects are injection site reactions, diarrhea, abdominal pain, and fatigue.

Pegcetacoplan was approved based upon a study of 80 patients with PNH and anemia who had been taking eculizumab, a previously approved treatment. During 16 weeks of treatment, patients in the pegcetacoplan group had an average increase in their hemoglobin of 2.4 g/dL, while patients in the eculizumab group had an average decrease in their hemoglobin of 1.5 g/dL.
 

About the disease

PNH is caused by gene mutations that affect red blood cells, causing them to be defective and susceptible to destruction by a patient’s own immune system. Red blood cells in people with these mutations are defective and can be destroyed by the immune system, causing anemia.

Other symptoms include blood clots and destruction of bone marrow. The disease affects 1-1.5 people per million, with diagnosis typically occurring around ages 35-40, and a median survival of only 10 years after diagnosis, according to the FDA.

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Treatment with transcranial magnetic stimulation (TMS) has a robust effect for patients with major depressive disorder (MDD), results from a large registry study show.

From patient self-reports and clinician assessments, investigators found that TMS was “surprisingly effective” and “an eye-opener” for these patients, lead investigator Harold A. Sackeim, PhD, professor of clinical psychology in psychiatry and radiology, Columbia University, New York, told this news organization.

“In a presumably treatment-resistant population, the efficacy compared favorably with virtually all pharmacologic treatments” tested in the studies, said Dr. Sackeim.

He noted that the registry from which the data were obtained “is the largest for any treatment of depression, period.” These positive results suggest TMS should be considered a first-line treatment for MDD, he added.

The study was presented at the virtual American Psychiatric Association 2021 Annual Meeting and was previously published in the Journal of Affective Disorders.
 

Real-world study

Results of randomized clinical trials have shown that TMS is effective for episodes of MDD. However, the investigators note that there is a need to characterize and identify patient- and treatment-related clinical outcomes.

The study included 5,010 adult patients who had received a primary diagnosis of MDD and were treated at 103 practices in the United States. Participants completed the nine-item Patient Health Questionnaire (PHQ-9) at baseline and at least one other time following a TMS treatment.

The average baseline PHQ-9 score was 19.8, indicating moderate to severe symptoms. This was also reflected in a smaller sample that included Clinical Global Impressions–Severity (CGI-S) ratings by clinicians, mostly psychiatrists.

About two-thirds of the study population were women. The average age was about 50 years. Participants typically received about 30 TMS sessions over 7 to 8 weeks.

TMS targets tissue in the dorsolateral prefrontal cortex. The standard protocol involves administering “fast” or high-frequency (10-Hz) stimulation on the left side. Sometimes, slow-frequency stimulation on the right side is added. About 57% of patients were treated on the left side, and 43% were treated on both sides. Each session involved delivery of about 3,000 pulses.

In the analysis of patient self-reports (PHQ-9), the response rate, which was defined as resolution of 50% or more of symptoms, was from 58% to 69%. The remission rate, defined as becoming asymptomatic or having minimal symptoms, ranged from 28% to 36%.

Results were about 5% higher in the “completer” sample, which included 3,814 patients who received at least 20 treatments and who completed a PHQ-9 assessment at the end the treatment course.

The number of completers in the analysis was “massive,” said Dr. Sackeim. It’s “ten times larger than in any previous TMS study; all randomized trials have a couple of hundred subjects at most, so this is whopping.”

The results provide “a full snapshot” of TMS in the “real-world” community instead of in the “highly controlled” environment of most studies, he added.
 

Gender differences

The analysis that included CGI-S clinician measures yielded higher outcome estimates – 79% to 83% for the response rate, and 47% to 63% for the remission rate.

Women tended to have better clinical outcomes. “It appears to me that around age 50 is where you see the difference,” said Dr. Sackeim. “Among women, it looks like the older they get, the better the outcome, whereas men are not showing that type of positive aging effect.”

This difference might be due to hormonal changes associated with menopause and the fact that older men with depression may have had a stroke or brain lesion. Dr. Sackeim said he plans to look more closely at outcomes of women in comparison with men.

The finding of a significant positive effect on aging contrasts with earlier research suggesting that age was a negative predictor. This, said Dr. Sackeim, illustrates how rapidly the TMS field is evolving.

He noted that researchers are now personalizing the procedure by determining the optimal target for individual patients. Other investigators are testing different protocols.

In the current study, results tended to be better for those who received 4,000 or more pulses, said Dr. Sackeim. “There was an indication of a dose response effect in terms of how many pulses per session,” he said.

The authors note that the study’s PDQ-9 response and remission rates indicate that clinical outcomes are comparable to those of the seven antidepressants studied in Level 2 of the large Sequenced Treatment Alternatives to Relieve Depression (STAR-D) trial.

Initial data for relapse in the study population are “encouraging,” said Dr. Sackeim. “You don’t see the rapid relapse that you do when you discontinue some treatments, for example with ECT [electroconvulsive therapy].”

The “slower onset of action” over the course of several sessions “may induce longer benefit,” he added.
 

Expanded use warranted?

The intervention proved very safe. Side effects, including headaches, were minimal, and there were “virtually no cognitive effects,” said Dr. Sackeim.

Dr. Sackeim believes TMS, as it has evolved, “is an outstanding option for treatment-resistant depression, and it has a very bright future” and should not be reserved for patients with established treatment-resistant depression (TRD), which is the current U.S. Food and Drug Administration indication.

“Restricting it to TRD in my mind is probably a mistake. Why shouldn’t the patient who is just starting on their course of treatment for depression have this as a nonpharmacological option?” he said.

Limitations of the study included its open-label design and the fact that only patients’ age, gender, outcome scores, and TMS treatment parameters were recorded in the registry. Other clinical characteristics, including medication use, were unknown.

However, it’s presumed that most patients had TRD, because insurance reimbursement for TMS typically requires an extensive history of failed antidepressant treatment.

Commenting on the study for an interview, Mark George, MD, professor, and Layton McCurdy, endowed chair in psychiatry, the Medical University of South Carolina, Charleston, called the remission and response rates “remarkable.”

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

Treatment with transcranial magnetic stimulation (TMS) has a robust effect for patients with major depressive disorder (MDD), results from a large registry study show.

From patient self-reports and clinician assessments, investigators found that TMS was “surprisingly effective” and “an eye-opener” for these patients, lead investigator Harold A. Sackeim, PhD, professor of clinical psychology in psychiatry and radiology, Columbia University, New York, told this news organization.

“In a presumably treatment-resistant population, the efficacy compared favorably with virtually all pharmacologic treatments” tested in the studies, said Dr. Sackeim.

He noted that the registry from which the data were obtained “is the largest for any treatment of depression, period.” These positive results suggest TMS should be considered a first-line treatment for MDD, he added.

The study was presented at the virtual American Psychiatric Association 2021 Annual Meeting and was previously published in the Journal of Affective Disorders.
 

Real-world study

Results of randomized clinical trials have shown that TMS is effective for episodes of MDD. However, the investigators note that there is a need to characterize and identify patient- and treatment-related clinical outcomes.

The study included 5,010 adult patients who had received a primary diagnosis of MDD and were treated at 103 practices in the United States. Participants completed the nine-item Patient Health Questionnaire (PHQ-9) at baseline and at least one other time following a TMS treatment.

The average baseline PHQ-9 score was 19.8, indicating moderate to severe symptoms. This was also reflected in a smaller sample that included Clinical Global Impressions–Severity (CGI-S) ratings by clinicians, mostly psychiatrists.

About two-thirds of the study population were women. The average age was about 50 years. Participants typically received about 30 TMS sessions over 7 to 8 weeks.

TMS targets tissue in the dorsolateral prefrontal cortex. The standard protocol involves administering “fast” or high-frequency (10-Hz) stimulation on the left side. Sometimes, slow-frequency stimulation on the right side is added. About 57% of patients were treated on the left side, and 43% were treated on both sides. Each session involved delivery of about 3,000 pulses.

In the analysis of patient self-reports (PHQ-9), the response rate, which was defined as resolution of 50% or more of symptoms, was from 58% to 69%. The remission rate, defined as becoming asymptomatic or having minimal symptoms, ranged from 28% to 36%.

Results were about 5% higher in the “completer” sample, which included 3,814 patients who received at least 20 treatments and who completed a PHQ-9 assessment at the end the treatment course.

The number of completers in the analysis was “massive,” said Dr. Sackeim. It’s “ten times larger than in any previous TMS study; all randomized trials have a couple of hundred subjects at most, so this is whopping.”

The results provide “a full snapshot” of TMS in the “real-world” community instead of in the “highly controlled” environment of most studies, he added.
 

Gender differences

The analysis that included CGI-S clinician measures yielded higher outcome estimates – 79% to 83% for the response rate, and 47% to 63% for the remission rate.

Women tended to have better clinical outcomes. “It appears to me that around age 50 is where you see the difference,” said Dr. Sackeim. “Among women, it looks like the older they get, the better the outcome, whereas men are not showing that type of positive aging effect.”

This difference might be due to hormonal changes associated with menopause and the fact that older men with depression may have had a stroke or brain lesion. Dr. Sackeim said he plans to look more closely at outcomes of women in comparison with men.

The finding of a significant positive effect on aging contrasts with earlier research suggesting that age was a negative predictor. This, said Dr. Sackeim, illustrates how rapidly the TMS field is evolving.

He noted that researchers are now personalizing the procedure by determining the optimal target for individual patients. Other investigators are testing different protocols.

In the current study, results tended to be better for those who received 4,000 or more pulses, said Dr. Sackeim. “There was an indication of a dose response effect in terms of how many pulses per session,” he said.

The authors note that the study’s PDQ-9 response and remission rates indicate that clinical outcomes are comparable to those of the seven antidepressants studied in Level 2 of the large Sequenced Treatment Alternatives to Relieve Depression (STAR-D) trial.

Initial data for relapse in the study population are “encouraging,” said Dr. Sackeim. “You don’t see the rapid relapse that you do when you discontinue some treatments, for example with ECT [electroconvulsive therapy].”

The “slower onset of action” over the course of several sessions “may induce longer benefit,” he added.
 

Expanded use warranted?

The intervention proved very safe. Side effects, including headaches, were minimal, and there were “virtually no cognitive effects,” said Dr. Sackeim.

Dr. Sackeim believes TMS, as it has evolved, “is an outstanding option for treatment-resistant depression, and it has a very bright future” and should not be reserved for patients with established treatment-resistant depression (TRD), which is the current U.S. Food and Drug Administration indication.

“Restricting it to TRD in my mind is probably a mistake. Why shouldn’t the patient who is just starting on their course of treatment for depression have this as a nonpharmacological option?” he said.

Limitations of the study included its open-label design and the fact that only patients’ age, gender, outcome scores, and TMS treatment parameters were recorded in the registry. Other clinical characteristics, including medication use, were unknown.

However, it’s presumed that most patients had TRD, because insurance reimbursement for TMS typically requires an extensive history of failed antidepressant treatment.

Commenting on the study for an interview, Mark George, MD, professor, and Layton McCurdy, endowed chair in psychiatry, the Medical University of South Carolina, Charleston, called the remission and response rates “remarkable.”

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

Treatment with transcranial magnetic stimulation (TMS) has a robust effect for patients with major depressive disorder (MDD), results from a large registry study show.

From patient self-reports and clinician assessments, investigators found that TMS was “surprisingly effective” and “an eye-opener” for these patients, lead investigator Harold A. Sackeim, PhD, professor of clinical psychology in psychiatry and radiology, Columbia University, New York, told this news organization.

“In a presumably treatment-resistant population, the efficacy compared favorably with virtually all pharmacologic treatments” tested in the studies, said Dr. Sackeim.

He noted that the registry from which the data were obtained “is the largest for any treatment of depression, period.” These positive results suggest TMS should be considered a first-line treatment for MDD, he added.

The study was presented at the virtual American Psychiatric Association 2021 Annual Meeting and was previously published in the Journal of Affective Disorders.
 

Real-world study

Results of randomized clinical trials have shown that TMS is effective for episodes of MDD. However, the investigators note that there is a need to characterize and identify patient- and treatment-related clinical outcomes.

The study included 5,010 adult patients who had received a primary diagnosis of MDD and were treated at 103 practices in the United States. Participants completed the nine-item Patient Health Questionnaire (PHQ-9) at baseline and at least one other time following a TMS treatment.

The average baseline PHQ-9 score was 19.8, indicating moderate to severe symptoms. This was also reflected in a smaller sample that included Clinical Global Impressions–Severity (CGI-S) ratings by clinicians, mostly psychiatrists.

About two-thirds of the study population were women. The average age was about 50 years. Participants typically received about 30 TMS sessions over 7 to 8 weeks.

TMS targets tissue in the dorsolateral prefrontal cortex. The standard protocol involves administering “fast” or high-frequency (10-Hz) stimulation on the left side. Sometimes, slow-frequency stimulation on the right side is added. About 57% of patients were treated on the left side, and 43% were treated on both sides. Each session involved delivery of about 3,000 pulses.

In the analysis of patient self-reports (PHQ-9), the response rate, which was defined as resolution of 50% or more of symptoms, was from 58% to 69%. The remission rate, defined as becoming asymptomatic or having minimal symptoms, ranged from 28% to 36%.

Results were about 5% higher in the “completer” sample, which included 3,814 patients who received at least 20 treatments and who completed a PHQ-9 assessment at the end the treatment course.

The number of completers in the analysis was “massive,” said Dr. Sackeim. It’s “ten times larger than in any previous TMS study; all randomized trials have a couple of hundred subjects at most, so this is whopping.”

The results provide “a full snapshot” of TMS in the “real-world” community instead of in the “highly controlled” environment of most studies, he added.
 

Gender differences

The analysis that included CGI-S clinician measures yielded higher outcome estimates – 79% to 83% for the response rate, and 47% to 63% for the remission rate.

Women tended to have better clinical outcomes. “It appears to me that around age 50 is where you see the difference,” said Dr. Sackeim. “Among women, it looks like the older they get, the better the outcome, whereas men are not showing that type of positive aging effect.”

This difference might be due to hormonal changes associated with menopause and the fact that older men with depression may have had a stroke or brain lesion. Dr. Sackeim said he plans to look more closely at outcomes of women in comparison with men.

The finding of a significant positive effect on aging contrasts with earlier research suggesting that age was a negative predictor. This, said Dr. Sackeim, illustrates how rapidly the TMS field is evolving.

He noted that researchers are now personalizing the procedure by determining the optimal target for individual patients. Other investigators are testing different protocols.

In the current study, results tended to be better for those who received 4,000 or more pulses, said Dr. Sackeim. “There was an indication of a dose response effect in terms of how many pulses per session,” he said.

The authors note that the study’s PDQ-9 response and remission rates indicate that clinical outcomes are comparable to those of the seven antidepressants studied in Level 2 of the large Sequenced Treatment Alternatives to Relieve Depression (STAR-D) trial.

Initial data for relapse in the study population are “encouraging,” said Dr. Sackeim. “You don’t see the rapid relapse that you do when you discontinue some treatments, for example with ECT [electroconvulsive therapy].”

The “slower onset of action” over the course of several sessions “may induce longer benefit,” he added.
 

Expanded use warranted?

The intervention proved very safe. Side effects, including headaches, were minimal, and there were “virtually no cognitive effects,” said Dr. Sackeim.

Dr. Sackeim believes TMS, as it has evolved, “is an outstanding option for treatment-resistant depression, and it has a very bright future” and should not be reserved for patients with established treatment-resistant depression (TRD), which is the current U.S. Food and Drug Administration indication.

“Restricting it to TRD in my mind is probably a mistake. Why shouldn’t the patient who is just starting on their course of treatment for depression have this as a nonpharmacological option?” he said.

Limitations of the study included its open-label design and the fact that only patients’ age, gender, outcome scores, and TMS treatment parameters were recorded in the registry. Other clinical characteristics, including medication use, were unknown.

However, it’s presumed that most patients had TRD, because insurance reimbursement for TMS typically requires an extensive history of failed antidepressant treatment.

Commenting on the study for an interview, Mark George, MD, professor, and Layton McCurdy, endowed chair in psychiatry, the Medical University of South Carolina, Charleston, called the remission and response rates “remarkable.”

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

The next study explored ways to identify patients who have HCC using PIVKA-II (prothrombin induced by vitamin K deficiency/antagonist – II), a promising marker that may be more sensitive/specific than AFP in identifying patients with liver cancer. Feng et al. used enzyme-linked immunosorbent assay (ELISA) to measure serum PIVKA-II levels in 168 patients with HCC, 150 patients with benign liver disease, and 153 healthy controls. Patients with HCC had significantly higher median PIVKA-II levels (181.50 mAu/mL), compared with atients with noncancerous liver disease (28.6 mAU/mL) or healthy controls 21.82 mAU/mL), with p<0.0001. In addition, PIVKA-II was more sensitive (83.9% vs 64.3%) and more specific (91.5% vs 84.7%) than AFP in identifying patients with HCC. When PIVKA-II and AFP were combined, sensitivity (81.95%) and specificity (89.3%) were increased more, suggesting that this combination of markers may be most useful in clinical practice to identify patients who have HCC.

Finally, in patients whose HCC was treated with orthotopic liver transplantation, acute organ rejection was found to be linked to HCC recurrence. Gul-Klein et al. identified 252 patients who underwent liver transplantation for HCC between 2001 and 2015, 91 of whom had confirmed acute rejection, and 47 of whom had recurrent HCC (the median time to HCC recurrence was 20 months). HCC recurrence was identified in 28.6% of patients with acute rejection, and in 13% of patients without acute rejection (p=0.002). Acute rejection within 20 months of liver transplantation was identified as a significant risk factor for HCC recurrence in multivariate analysis (hazard ratio of 2.91). The authors suggested that more intensive monitoring for HCC recurrence may be appropriate for patients who have evidence of acute rejection.

The next study explored ways to identify patients who have HCC using PIVKA-II (prothrombin induced by vitamin K deficiency/antagonist – II), a promising marker that may be more sensitive/specific than AFP in identifying patients with liver cancer. Feng et al. used enzyme-linked immunosorbent assay (ELISA) to measure serum PIVKA-II levels in 168 patients with HCC, 150 patients with benign liver disease, and 153 healthy controls. Patients with HCC had significantly higher median PIVKA-II levels (181.50 mAu/mL), compared with atients with noncancerous liver disease (28.6 mAU/mL) or healthy controls 21.82 mAU/mL), with p<0.0001. In addition, PIVKA-II was more sensitive (83.9% vs 64.3%) and more specific (91.5% vs 84.7%) than AFP in identifying patients with HCC. When PIVKA-II and AFP were combined, sensitivity (81.95%) and specificity (89.3%) were increased more, suggesting that this combination of markers may be most useful in clinical practice to identify patients who have HCC.

Finally, in patients whose HCC was treated with orthotopic liver transplantation, acute organ rejection was found to be linked to HCC recurrence. Gul-Klein et al. identified 252 patients who underwent liver transplantation for HCC between 2001 and 2015, 91 of whom had confirmed acute rejection, and 47 of whom had recurrent HCC (the median time to HCC recurrence was 20 months). HCC recurrence was identified in 28.6% of patients with acute rejection, and in 13% of patients without acute rejection (p=0.002). Acute rejection within 20 months of liver transplantation was identified as a significant risk factor for HCC recurrence in multivariate analysis (hazard ratio of 2.91). The authors suggested that more intensive monitoring for HCC recurrence may be appropriate for patients who have evidence of acute rejection.

The next study explored ways to identify patients who have HCC using PIVKA-II (prothrombin induced by vitamin K deficiency/antagonist – II), a promising marker that may be more sensitive/specific than AFP in identifying patients with liver cancer. Feng et al. used enzyme-linked immunosorbent assay (ELISA) to measure serum PIVKA-II levels in 168 patients with HCC, 150 patients with benign liver disease, and 153 healthy controls. Patients with HCC had significantly higher median PIVKA-II levels (181.50 mAu/mL), compared with atients with noncancerous liver disease (28.6 mAU/mL) or healthy controls 21.82 mAU/mL), with p<0.0001. In addition, PIVKA-II was more sensitive (83.9% vs 64.3%) and more specific (91.5% vs 84.7%) than AFP in identifying patients with HCC. When PIVKA-II and AFP were combined, sensitivity (81.95%) and specificity (89.3%) were increased more, suggesting that this combination of markers may be most useful in clinical practice to identify patients who have HCC.

Finally, in patients whose HCC was treated with orthotopic liver transplantation, acute organ rejection was found to be linked to HCC recurrence. Gul-Klein et al. identified 252 patients who underwent liver transplantation for HCC between 2001 and 2015, 91 of whom had confirmed acute rejection, and 47 of whom had recurrent HCC (the median time to HCC recurrence was 20 months). HCC recurrence was identified in 28.6% of patients with acute rejection, and in 13% of patients without acute rejection (p=0.002). Acute rejection within 20 months of liver transplantation was identified as a significant risk factor for HCC recurrence in multivariate analysis (hazard ratio of 2.91). The authors suggested that more intensive monitoring for HCC recurrence may be appropriate for patients who have evidence of acute rejection.

Medications typically used to treat opioid use disorder (OUD) may* also be effective for the growing public health problem of kratom addiction, new research shows.

Results of a comprehensive literature review and an expert survey suggest buprenorphine, naltrexone, and methadone may be effective for patients seeking help for kratom addiction, and if further research confirms these findings, the indication for OUD medications could potentially be expanded to include moderate-to-severe kratom addiction, study investigator Saeed Ahmed, MD, medical director of West Ridge Center at Rutland Regional Medical Center, Rutland, Vermont, said in an interview.

Dr. Ahmed, who practices general psychiatry and addiction psychiatry, presented the findings at the virtual American Psychiatric Association 2021 Annual Meeting.
 

Emerging public health problem

Kratom can be ingested in pill or capsule form or as an extract. Its leaves can be chewed or dried and powdered to make a tea. It can also be incorporated into topical creams, balms, or tinctures.

Products containing the substance are “readily available and legal for sale in many states and cities in the U.S.,” said Dr. Ahmed, adding that it can be purchased online or at local smoke shops and is increasingly used by individuals to self-treat a variety of conditions including pain, anxiety, and mood conditions and as an opioid substitute.

As reported by this news organization, a 2018 analysis conducted by the U.S. Food and Drug Administration showed kratom is, in fact, an opioid, a finding that garnered significant push-back from the American Kratom Association.

Kratom addiction is an “emerging public health problem,” said Dr. Ahmed, adding that in recent years the number of calls to poison control centers across the country has increased 52-fold – from one per month to two per day. He believes misinformation through social media has helped fuel its use.

Kratom use, the investigators note, can lead to muscle pain, weight loss, insomnia, hallucinations and, in some cases (particularly when combined with synthetic opioids or benzodiazepines), it can lead to respiratory depression, seizures, coma, and death.

In addition, the investigators note that to date, there are no guidelines on its management.

To investigate, the researchers conducted a systematic literature search for cases pertaining to maintenance treatment for kratom dependence. They also tapped into case reports and scientific posters from reliable online sources and conference proceedings. In addition, they conducted a survey of members from the American Society of Addiction Medicine (ASAM).

The researchers found 14 reports of long-term management of kratom addiction, half of which did not involve an OUD. It’s important to exclude OUDs to avoid possible confounding.

In most cases, buprenorphine was used, but in a few cases naltrexone or methadone were prescribed. All cases had a favorable outcome. Dr. Ahmed noted that buprenorphine maintenance doses appear to be lower than those required to effectively treat OUD.

With a response rate of 11.5% (82 respondents) the ASAM survey results showed 82.6% of respondents (n = 57) had experience managing KUD, including 27.5% (n = 19) who had kratom addiction only. Of these, 89.5% (n = 17-19), used buprenorphine to manage KUD and of these, 6 combined it with talk therapy.

Dr. Ahmed cautioned that the included cases varied significantly in terms of relevant data, including kratom dose and route of administration, toxicology screening used to monitor abstinence, and duration of maintenance follow-up.

Despite these limitations, the review and survey underscore the importance of including moderate to severe kratom dependence as an indication for current OUD medications, the researchers note.

Including kratom addiction as an indication for these medications is important, especially for patients who are heavily addicted, to meet DSM-5 diagnostic criteria for moderate or severe SUD, they add.

In addition, the researchers recommend that clinicians consider referring patients with moderate to severe kratom dependence for counseling or enrollment in 12-step addiction treatment programs.

A separate diagnosis?

Dr. Ahmed said he would like to see kratom dependence included in the DSM-5 as a separate entity because it is a botanical with properties similar to, but different from, traditional opioids.

“This will not only help to better inform clinicians about a diagnostic criteria encompassing problematic use and facilitate screening, but it will also pave the way for treatments to be explored for this diagnosable condition,” he said. Dr. Ahmed pointed to a review published in the Wisconsin Medical Journal earlier this year that explored potential treatments for kratom dependence.

Commenting on the study for an interview, Petros Levounis, MD, professor and chair, department of psychiatry, and associate dean for professional development, Rutgers New Jersey Medical School, Newark, said the authors “have done a great job reviewing the literature and asking experts” about kratom addiction treatment.

“The punchline of their study is that kratom behaves very much like an opioid and is treated like an opioid.”

Dr. Levounis noted that kratom dependence is so new that experts don’t know much about it. However, he added, emerging evidence suggests that kratom “should be considered an opioid more than anything else,” but specified that he does not believe it warrants its own diagnosis.

He noted that individual opioids don’t have their own diagnostic category and that opioid use disorder is an umbrella term that covers all of these drugs.

Dr. Ahmed and Dr. Levounis have disclosed no relevant financial relationships.

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

*Updated 5/18/2021

Medications typically used to treat opioid use disorder (OUD) may* also be effective for the growing public health problem of kratom addiction, new research shows.

Results of a comprehensive literature review and an expert survey suggest buprenorphine, naltrexone, and methadone may be effective for patients seeking help for kratom addiction, and if further research confirms these findings, the indication for OUD medications could potentially be expanded to include moderate-to-severe kratom addiction, study investigator Saeed Ahmed, MD, medical director of West Ridge Center at Rutland Regional Medical Center, Rutland, Vermont, said in an interview.

Dr. Ahmed, who practices general psychiatry and addiction psychiatry, presented the findings at the virtual American Psychiatric Association 2021 Annual Meeting.
 

Emerging public health problem

Kratom can be ingested in pill or capsule form or as an extract. Its leaves can be chewed or dried and powdered to make a tea. It can also be incorporated into topical creams, balms, or tinctures.

Products containing the substance are “readily available and legal for sale in many states and cities in the U.S.,” said Dr. Ahmed, adding that it can be purchased online or at local smoke shops and is increasingly used by individuals to self-treat a variety of conditions including pain, anxiety, and mood conditions and as an opioid substitute.

As reported by this news organization, a 2018 analysis conducted by the U.S. Food and Drug Administration showed kratom is, in fact, an opioid, a finding that garnered significant push-back from the American Kratom Association.

Kratom addiction is an “emerging public health problem,” said Dr. Ahmed, adding that in recent years the number of calls to poison control centers across the country has increased 52-fold – from one per month to two per day. He believes misinformation through social media has helped fuel its use.

Kratom use, the investigators note, can lead to muscle pain, weight loss, insomnia, hallucinations and, in some cases (particularly when combined with synthetic opioids or benzodiazepines), it can lead to respiratory depression, seizures, coma, and death.

In addition, the investigators note that to date, there are no guidelines on its management.

To investigate, the researchers conducted a systematic literature search for cases pertaining to maintenance treatment for kratom dependence. They also tapped into case reports and scientific posters from reliable online sources and conference proceedings. In addition, they conducted a survey of members from the American Society of Addiction Medicine (ASAM).

The researchers found 14 reports of long-term management of kratom addiction, half of which did not involve an OUD. It’s important to exclude OUDs to avoid possible confounding.

In most cases, buprenorphine was used, but in a few cases naltrexone or methadone were prescribed. All cases had a favorable outcome. Dr. Ahmed noted that buprenorphine maintenance doses appear to be lower than those required to effectively treat OUD.

With a response rate of 11.5% (82 respondents) the ASAM survey results showed 82.6% of respondents (n = 57) had experience managing KUD, including 27.5% (n = 19) who had kratom addiction only. Of these, 89.5% (n = 17-19), used buprenorphine to manage KUD and of these, 6 combined it with talk therapy.

Dr. Ahmed cautioned that the included cases varied significantly in terms of relevant data, including kratom dose and route of administration, toxicology screening used to monitor abstinence, and duration of maintenance follow-up.

Despite these limitations, the review and survey underscore the importance of including moderate to severe kratom dependence as an indication for current OUD medications, the researchers note.

Including kratom addiction as an indication for these medications is important, especially for patients who are heavily addicted, to meet DSM-5 diagnostic criteria for moderate or severe SUD, they add.

In addition, the researchers recommend that clinicians consider referring patients with moderate to severe kratom dependence for counseling or enrollment in 12-step addiction treatment programs.

A separate diagnosis?

Dr. Ahmed said he would like to see kratom dependence included in the DSM-5 as a separate entity because it is a botanical with properties similar to, but different from, traditional opioids.

“This will not only help to better inform clinicians about a diagnostic criteria encompassing problematic use and facilitate screening, but it will also pave the way for treatments to be explored for this diagnosable condition,” he said. Dr. Ahmed pointed to a review published in the Wisconsin Medical Journal earlier this year that explored potential treatments for kratom dependence.

Commenting on the study for an interview, Petros Levounis, MD, professor and chair, department of psychiatry, and associate dean for professional development, Rutgers New Jersey Medical School, Newark, said the authors “have done a great job reviewing the literature and asking experts” about kratom addiction treatment.

“The punchline of their study is that kratom behaves very much like an opioid and is treated like an opioid.”

Dr. Levounis noted that kratom dependence is so new that experts don’t know much about it. However, he added, emerging evidence suggests that kratom “should be considered an opioid more than anything else,” but specified that he does not believe it warrants its own diagnosis.

He noted that individual opioids don’t have their own diagnostic category and that opioid use disorder is an umbrella term that covers all of these drugs.

Dr. Ahmed and Dr. Levounis have disclosed no relevant financial relationships.

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

*Updated 5/18/2021

Medications typically used to treat opioid use disorder (OUD) may* also be effective for the growing public health problem of kratom addiction, new research shows.

Results of a comprehensive literature review and an expert survey suggest buprenorphine, naltrexone, and methadone may be effective for patients seeking help for kratom addiction, and if further research confirms these findings, the indication for OUD medications could potentially be expanded to include moderate-to-severe kratom addiction, study investigator Saeed Ahmed, MD, medical director of West Ridge Center at Rutland Regional Medical Center, Rutland, Vermont, said in an interview.

Dr. Ahmed, who practices general psychiatry and addiction psychiatry, presented the findings at the virtual American Psychiatric Association 2021 Annual Meeting.
 

Emerging public health problem

Kratom can be ingested in pill or capsule form or as an extract. Its leaves can be chewed or dried and powdered to make a tea. It can also be incorporated into topical creams, balms, or tinctures.

Products containing the substance are “readily available and legal for sale in many states and cities in the U.S.,” said Dr. Ahmed, adding that it can be purchased online or at local smoke shops and is increasingly used by individuals to self-treat a variety of conditions including pain, anxiety, and mood conditions and as an opioid substitute.

As reported by this news organization, a 2018 analysis conducted by the U.S. Food and Drug Administration showed kratom is, in fact, an opioid, a finding that garnered significant push-back from the American Kratom Association.

Kratom addiction is an “emerging public health problem,” said Dr. Ahmed, adding that in recent years the number of calls to poison control centers across the country has increased 52-fold – from one per month to two per day. He believes misinformation through social media has helped fuel its use.

Kratom use, the investigators note, can lead to muscle pain, weight loss, insomnia, hallucinations and, in some cases (particularly when combined with synthetic opioids or benzodiazepines), it can lead to respiratory depression, seizures, coma, and death.

In addition, the investigators note that to date, there are no guidelines on its management.

To investigate, the researchers conducted a systematic literature search for cases pertaining to maintenance treatment for kratom dependence. They also tapped into case reports and scientific posters from reliable online sources and conference proceedings. In addition, they conducted a survey of members from the American Society of Addiction Medicine (ASAM).

The researchers found 14 reports of long-term management of kratom addiction, half of which did not involve an OUD. It’s important to exclude OUDs to avoid possible confounding.

In most cases, buprenorphine was used, but in a few cases naltrexone or methadone were prescribed. All cases had a favorable outcome. Dr. Ahmed noted that buprenorphine maintenance doses appear to be lower than those required to effectively treat OUD.

With a response rate of 11.5% (82 respondents) the ASAM survey results showed 82.6% of respondents (n = 57) had experience managing KUD, including 27.5% (n = 19) who had kratom addiction only. Of these, 89.5% (n = 17-19), used buprenorphine to manage KUD and of these, 6 combined it with talk therapy.

Dr. Ahmed cautioned that the included cases varied significantly in terms of relevant data, including kratom dose and route of administration, toxicology screening used to monitor abstinence, and duration of maintenance follow-up.

Despite these limitations, the review and survey underscore the importance of including moderate to severe kratom dependence as an indication for current OUD medications, the researchers note.

Including kratom addiction as an indication for these medications is important, especially for patients who are heavily addicted, to meet DSM-5 diagnostic criteria for moderate or severe SUD, they add.

In addition, the researchers recommend that clinicians consider referring patients with moderate to severe kratom dependence for counseling or enrollment in 12-step addiction treatment programs.

A separate diagnosis?

Dr. Ahmed said he would like to see kratom dependence included in the DSM-5 as a separate entity because it is a botanical with properties similar to, but different from, traditional opioids.

“This will not only help to better inform clinicians about a diagnostic criteria encompassing problematic use and facilitate screening, but it will also pave the way for treatments to be explored for this diagnosable condition,” he said. Dr. Ahmed pointed to a review published in the Wisconsin Medical Journal earlier this year that explored potential treatments for kratom dependence.

Commenting on the study for an interview, Petros Levounis, MD, professor and chair, department of psychiatry, and associate dean for professional development, Rutgers New Jersey Medical School, Newark, said the authors “have done a great job reviewing the literature and asking experts” about kratom addiction treatment.

“The punchline of their study is that kratom behaves very much like an opioid and is treated like an opioid.”

Dr. Levounis noted that kratom dependence is so new that experts don’t know much about it. However, he added, emerging evidence suggests that kratom “should be considered an opioid more than anything else,” but specified that he does not believe it warrants its own diagnosis.

He noted that individual opioids don’t have their own diagnostic category and that opioid use disorder is an umbrella term that covers all of these drugs.

Dr. Ahmed and Dr. Levounis have disclosed no relevant financial relationships.

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

*Updated 5/18/2021

A majority of Mohs surgeons have adopted telemedicine during the COVID-19 pandemic, a new survey finds, but only half expressed interest in making it a permanent part of their practices.

A variety of factors combine to make it “very difficult for surgeons to make long-term plans for implementing telemedicine in their practices,” said Mario Maruthur, MD, who presented the findings at the annual meeting of the American College of Mohs Surgery. “Telemedicine likely has a role in Mohs practices, particularly with postop follow-up visits. However, postpandemic reimbursement and regulatory issues need to be formally laid out before Mohs surgeons are able to incorporate it into their permanent work flow.”

Dr. Maruthur, a Mohs surgery and dermatologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York, and colleagues sent a survey to ACMS members in September and October 2020. “We saw first-hand in our surgical practice that telemedicine quickly became an important tool when the pandemic surged in the spring of 2020,” he said. Considering that surgical practices are highly dependent on in-person visits, the impetus for this study was to assess to what degree Mohs practices from across the spectrum, including academic and private practices, embraced telemedicine during the pandemic, and “what these surgical practices used telemedicine for, how it was received by their patients, which telemedicine platforms were most often utilized, and lastly, what are their plans if any for incorporating telemedicine into their surgical practices after the pandemic subsides.”

The researchers received responses from 115 surgeons representing all regions of the country (40% Northeast, 21% South, 21% Midwest, and 18% West). Half practiced in urban areas (37%) and large cities (13%), and 40% were in an academic setting versus 36% in a single-specialty private practice.

More than 70% of the respondents said their case load fell by at least 75% during the initial surge of the pandemic; 80% turned to telemedicine, compared with just 23% who relied on the technology prior to the pandemic. The most commonly used telemedicine technologies were FaceTime, Zoom, Doximity, and Epic.

Mohs surgeons reported most commonly using telemedicine for postsurgery management (77% of the total 115 responses). “Telemedicine is a great fit for this category of visits as they allow the surgeon to view the surgical site and answer any questions they patient may have,” Dr. Maruthur said. “If the surgeon does suspect a postop infection or other concern based on a patient’s signs or symptoms, they can easily schedule the patient for an in-person assessment. We suspect that postop follow-up visits may be the best candidate for long-term use of telemedicine in Mohs surgery practices.”

Surgeons also reported using telemedicine for “spot checks” (61%) and surgical consultations (59%).

However, Dr. Maruther noted that preoperative assessments and spot checks can be difficult to perform using telemedicine. “The quality of the video image is not always great, patients can have a difficult time pointing the camera at the right spot and at the right distance. Even appreciating the actual size of the lesion are all difficult over a video encounter. And there is a lot of information gleaned from in-person physical examination, such as whether the lesion is fixed to a deeper structure and whether there are any nearby scars or other suspicious lesions.”

Nearly three-quarters of the surgeons using the technology said most or all patients were receptive to telemedicine.

However, the surgeons reported multiple barriers to the use of telemedicine: Limitations when compared with physical exams (88%), fitting it into the work flow (58%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).

In an interview, Sumaira Z. Aasi, MD, director of Mohs and dermatologic surgery, Stanford University, agreed that there are many obstacles to routine use of telemedicine by Mohs surgeons. “As surgeons, we rely on the physical and tactile exam to get a sense of the size and extent of the cancer and characteristics such as the laxity of the surrounding tissue whether the tumor is fixed,” she said. “It is very difficult to access this on a telemedicine visit.”

In addition, she said, “many of our patients are in the elderly population, and some may not be comfortable using this technology. Also, it’s not a work flow that we are comfortable or familiar with. And I think that the technology has to improve to allow for better resolution of images as we ‘examine’ patients through a telemedicine visit.”

She added that “another con is there is a reliance on having the patient point out lesions of concern. Many cancers are picked by a careful in-person examination by a qualified physician/dermatologist/Mohs surgeon when the lesion is quite small or subtle and not even noticed by the patient themselves. This approach invariably leads to earlier biopsies and earlier treatments that can prevent morbidity and save health care money.”

On the other hand, she said, telemedicine “may save patients some time and money in terms of the effort and cost of transportation to come in for simpler postoperative medical visits that are often short in their very nature, such as postop check-ups.”

Most of the surgeons surveyed (69%) said telemedicine probably or definitely deserves a place in the practice Mohs surgery, but only 50% said they’d like to or would definitely pursue giving telemedicine a role in their practices once the pandemic is over.

“At the start of the pandemic, many regulations in areas such as HIPAA were eased, and reimbursements were increased, which allowed telemedicine to be quickly adopted,” Dr. Maruther said. “The government and payers have yet to decide which regulations and reimbursements will be in place after the pandemic. That makes it very difficult for surgeons to make long-term plans for implementing telemedicine in their practices.”

Dr. Aasi predicted that telemedicine will become more appealing to patients and physicians as it its technology and usability improves. More familiarity with its use will also be helpful, she said, and surgeons will be more receptive as it’s incorporated into efficient daily work flow.

The study was funded in part by the National Institutes of Health.

A majority of Mohs surgeons have adopted telemedicine during the COVID-19 pandemic, a new survey finds, but only half expressed interest in making it a permanent part of their practices.

A variety of factors combine to make it “very difficult for surgeons to make long-term plans for implementing telemedicine in their practices,” said Mario Maruthur, MD, who presented the findings at the annual meeting of the American College of Mohs Surgery. “Telemedicine likely has a role in Mohs practices, particularly with postop follow-up visits. However, postpandemic reimbursement and regulatory issues need to be formally laid out before Mohs surgeons are able to incorporate it into their permanent work flow.”

Dr. Maruthur, a Mohs surgery and dermatologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York, and colleagues sent a survey to ACMS members in September and October 2020. “We saw first-hand in our surgical practice that telemedicine quickly became an important tool when the pandemic surged in the spring of 2020,” he said. Considering that surgical practices are highly dependent on in-person visits, the impetus for this study was to assess to what degree Mohs practices from across the spectrum, including academic and private practices, embraced telemedicine during the pandemic, and “what these surgical practices used telemedicine for, how it was received by their patients, which telemedicine platforms were most often utilized, and lastly, what are their plans if any for incorporating telemedicine into their surgical practices after the pandemic subsides.”

The researchers received responses from 115 surgeons representing all regions of the country (40% Northeast, 21% South, 21% Midwest, and 18% West). Half practiced in urban areas (37%) and large cities (13%), and 40% were in an academic setting versus 36% in a single-specialty private practice.

More than 70% of the respondents said their case load fell by at least 75% during the initial surge of the pandemic; 80% turned to telemedicine, compared with just 23% who relied on the technology prior to the pandemic. The most commonly used telemedicine technologies were FaceTime, Zoom, Doximity, and Epic.

Mohs surgeons reported most commonly using telemedicine for postsurgery management (77% of the total 115 responses). “Telemedicine is a great fit for this category of visits as they allow the surgeon to view the surgical site and answer any questions they patient may have,” Dr. Maruthur said. “If the surgeon does suspect a postop infection or other concern based on a patient’s signs or symptoms, they can easily schedule the patient for an in-person assessment. We suspect that postop follow-up visits may be the best candidate for long-term use of telemedicine in Mohs surgery practices.”

Surgeons also reported using telemedicine for “spot checks” (61%) and surgical consultations (59%).

However, Dr. Maruther noted that preoperative assessments and spot checks can be difficult to perform using telemedicine. “The quality of the video image is not always great, patients can have a difficult time pointing the camera at the right spot and at the right distance. Even appreciating the actual size of the lesion are all difficult over a video encounter. And there is a lot of information gleaned from in-person physical examination, such as whether the lesion is fixed to a deeper structure and whether there are any nearby scars or other suspicious lesions.”

Nearly three-quarters of the surgeons using the technology said most or all patients were receptive to telemedicine.

However, the surgeons reported multiple barriers to the use of telemedicine: Limitations when compared with physical exams (88%), fitting it into the work flow (58%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).

In an interview, Sumaira Z. Aasi, MD, director of Mohs and dermatologic surgery, Stanford University, agreed that there are many obstacles to routine use of telemedicine by Mohs surgeons. “As surgeons, we rely on the physical and tactile exam to get a sense of the size and extent of the cancer and characteristics such as the laxity of the surrounding tissue whether the tumor is fixed,” she said. “It is very difficult to access this on a telemedicine visit.”

In addition, she said, “many of our patients are in the elderly population, and some may not be comfortable using this technology. Also, it’s not a work flow that we are comfortable or familiar with. And I think that the technology has to improve to allow for better resolution of images as we ‘examine’ patients through a telemedicine visit.”

She added that “another con is there is a reliance on having the patient point out lesions of concern. Many cancers are picked by a careful in-person examination by a qualified physician/dermatologist/Mohs surgeon when the lesion is quite small or subtle and not even noticed by the patient themselves. This approach invariably leads to earlier biopsies and earlier treatments that can prevent morbidity and save health care money.”

On the other hand, she said, telemedicine “may save patients some time and money in terms of the effort and cost of transportation to come in for simpler postoperative medical visits that are often short in their very nature, such as postop check-ups.”

Most of the surgeons surveyed (69%) said telemedicine probably or definitely deserves a place in the practice Mohs surgery, but only 50% said they’d like to or would definitely pursue giving telemedicine a role in their practices once the pandemic is over.

“At the start of the pandemic, many regulations in areas such as HIPAA were eased, and reimbursements were increased, which allowed telemedicine to be quickly adopted,” Dr. Maruther said. “The government and payers have yet to decide which regulations and reimbursements will be in place after the pandemic. That makes it very difficult for surgeons to make long-term plans for implementing telemedicine in their practices.”

Dr. Aasi predicted that telemedicine will become more appealing to patients and physicians as it its technology and usability improves. More familiarity with its use will also be helpful, she said, and surgeons will be more receptive as it’s incorporated into efficient daily work flow.

The study was funded in part by the National Institutes of Health.

A majority of Mohs surgeons have adopted telemedicine during the COVID-19 pandemic, a new survey finds, but only half expressed interest in making it a permanent part of their practices.

A variety of factors combine to make it “very difficult for surgeons to make long-term plans for implementing telemedicine in their practices,” said Mario Maruthur, MD, who presented the findings at the annual meeting of the American College of Mohs Surgery. “Telemedicine likely has a role in Mohs practices, particularly with postop follow-up visits. However, postpandemic reimbursement and regulatory issues need to be formally laid out before Mohs surgeons are able to incorporate it into their permanent work flow.”

Dr. Maruthur, a Mohs surgery and dermatologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York, and colleagues sent a survey to ACMS members in September and October 2020. “We saw first-hand in our surgical practice that telemedicine quickly became an important tool when the pandemic surged in the spring of 2020,” he said. Considering that surgical practices are highly dependent on in-person visits, the impetus for this study was to assess to what degree Mohs practices from across the spectrum, including academic and private practices, embraced telemedicine during the pandemic, and “what these surgical practices used telemedicine for, how it was received by their patients, which telemedicine platforms were most often utilized, and lastly, what are their plans if any for incorporating telemedicine into their surgical practices after the pandemic subsides.”

The researchers received responses from 115 surgeons representing all regions of the country (40% Northeast, 21% South, 21% Midwest, and 18% West). Half practiced in urban areas (37%) and large cities (13%), and 40% were in an academic setting versus 36% in a single-specialty private practice.

More than 70% of the respondents said their case load fell by at least 75% during the initial surge of the pandemic; 80% turned to telemedicine, compared with just 23% who relied on the technology prior to the pandemic. The most commonly used telemedicine technologies were FaceTime, Zoom, Doximity, and Epic.

Mohs surgeons reported most commonly using telemedicine for postsurgery management (77% of the total 115 responses). “Telemedicine is a great fit for this category of visits as they allow the surgeon to view the surgical site and answer any questions they patient may have,” Dr. Maruthur said. “If the surgeon does suspect a postop infection or other concern based on a patient’s signs or symptoms, they can easily schedule the patient for an in-person assessment. We suspect that postop follow-up visits may be the best candidate for long-term use of telemedicine in Mohs surgery practices.”

Surgeons also reported using telemedicine for “spot checks” (61%) and surgical consultations (59%).

However, Dr. Maruther noted that preoperative assessments and spot checks can be difficult to perform using telemedicine. “The quality of the video image is not always great, patients can have a difficult time pointing the camera at the right spot and at the right distance. Even appreciating the actual size of the lesion are all difficult over a video encounter. And there is a lot of information gleaned from in-person physical examination, such as whether the lesion is fixed to a deeper structure and whether there are any nearby scars or other suspicious lesions.”

Nearly three-quarters of the surgeons using the technology said most or all patients were receptive to telemedicine.

However, the surgeons reported multiple barriers to the use of telemedicine: Limitations when compared with physical exams (88%), fitting it into the work flow (58%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).

In an interview, Sumaira Z. Aasi, MD, director of Mohs and dermatologic surgery, Stanford University, agreed that there are many obstacles to routine use of telemedicine by Mohs surgeons. “As surgeons, we rely on the physical and tactile exam to get a sense of the size and extent of the cancer and characteristics such as the laxity of the surrounding tissue whether the tumor is fixed,” she said. “It is very difficult to access this on a telemedicine visit.”

In addition, she said, “many of our patients are in the elderly population, and some may not be comfortable using this technology. Also, it’s not a work flow that we are comfortable or familiar with. And I think that the technology has to improve to allow for better resolution of images as we ‘examine’ patients through a telemedicine visit.”

She added that “another con is there is a reliance on having the patient point out lesions of concern. Many cancers are picked by a careful in-person examination by a qualified physician/dermatologist/Mohs surgeon when the lesion is quite small or subtle and not even noticed by the patient themselves. This approach invariably leads to earlier biopsies and earlier treatments that can prevent morbidity and save health care money.”

On the other hand, she said, telemedicine “may save patients some time and money in terms of the effort and cost of transportation to come in for simpler postoperative medical visits that are often short in their very nature, such as postop check-ups.”

Most of the surgeons surveyed (69%) said telemedicine probably or definitely deserves a place in the practice Mohs surgery, but only 50% said they’d like to or would definitely pursue giving telemedicine a role in their practices once the pandemic is over.

“At the start of the pandemic, many regulations in areas such as HIPAA were eased, and reimbursements were increased, which allowed telemedicine to be quickly adopted,” Dr. Maruther said. “The government and payers have yet to decide which regulations and reimbursements will be in place after the pandemic. That makes it very difficult for surgeons to make long-term plans for implementing telemedicine in their practices.”

Dr. Aasi predicted that telemedicine will become more appealing to patients and physicians as it its technology and usability improves. More familiarity with its use will also be helpful, she said, and surgeons will be more receptive as it’s incorporated into efficient daily work flow.

The study was funded in part by the National Institutes of Health.

Patients with chronic lymphocytic leukemia (CLL) have increased risk for severe COVID-19 disease as well as mortality.

South_agency/Getty Images

Such patients are likely to have compromised immune systems, making them respond poorly to vaccines, as has been seen in studies involving pneumococcal, hepatitis B, and influenza A and B vaccination. 

In order to determine if vaccination against COVID-19 disease will be effective among these patients, researchers performed a study to determine the efficacy of a single COVID-19 vaccine in patients with CLL. They found that the response rate of patients with CLL to vaccination was significantly lower than that of healthy controls, according to the study published in Blood Advances.

Study details

The study (NCT04746092) assessed the humoral immune responses to BNT162b2 mRNA COVID-19 (Pfizer) vaccination in adult patients with CLL and compared responses with those obtained in age-matched healthy controls. Patients received two vaccine doses, 21 days apart, and antibody titers were measured 2-3 weeks after administration of the second dose, according to Yair Herishanu, MD, of the Tel-Aviv Sourasky Medical Center, Tel Aviv University, and colleagues.

Troubling results

The researchers found an antibody-mediated response to the BNT162b2 mRNA COVID-19 vaccine in only 66 of 167 (39.5%) of all patients with CLL. The response rate of 52 of these responding patients with CLL to the vaccine was significantly lower than that occurring in 52 age- and sex-matched healthy controls (52% vs. 100%, respectively; adjusted odds ratio, 0.010; 95% confidence interval, 0.001-0.162; P < .001). 

Among the patients with CLL, the response rate was highest in those who obtained clinical remission after treatment (79.2%), followed by 55.2% in treatment-naive patients, and it was only 16% in patients under treatment at the time of vaccination. 

In patients treated with either BTK inhibitors or venetoclax with and without anti-CD20 antibody, response rates were low (16.0% and 13.6%, respectively). In particular, none of the patients exposed to anti-CD20 antibodies less than 12 months prior to vaccination responded, according to the researchers.

Multivariate analysis showed that the independent predictors of a vaccine response were age (65 years or younger; odds ratio, 3.17; P = .025), sex (women; OR, 3.66; P = .006), lack of active therapy (including treatment naive and previously treated patients; OR 6.59; P < .001), IgG levels 550 mg/dL or greater (OR, 3.70; P = .037), and IgM levels 40mg/dL or greater (OR, 2.92; P = .017). 

Within a median follow-up period of 75 days since the first vaccine dose, none of the CLL patients developed COVID-19 infection, the researchers reported.

“Vaccinated patients with CLL should continue to adhere to masking, social distancing, and vaccination of their close contacts should be strongly recommended. Serological tests after the second injection of the COVID-19 vaccine can provide valuable information to the individual patient and perhaps, may be integrated in future clinical decisions,” the researchers concluded.

The study was sponsored by the Tel-Aviv Sourasky Medical Center. The authors reported that they had no conflicts of interest. 

[email protected] 

Patients with chronic lymphocytic leukemia (CLL) have increased risk for severe COVID-19 disease as well as mortality.

South_agency/Getty Images

Such patients are likely to have compromised immune systems, making them respond poorly to vaccines, as has been seen in studies involving pneumococcal, hepatitis B, and influenza A and B vaccination. 

In order to determine if vaccination against COVID-19 disease will be effective among these patients, researchers performed a study to determine the efficacy of a single COVID-19 vaccine in patients with CLL. They found that the response rate of patients with CLL to vaccination was significantly lower than that of healthy controls, according to the study published in Blood Advances.

Study details

The study (NCT04746092) assessed the humoral immune responses to BNT162b2 mRNA COVID-19 (Pfizer) vaccination in adult patients with CLL and compared responses with those obtained in age-matched healthy controls. Patients received two vaccine doses, 21 days apart, and antibody titers were measured 2-3 weeks after administration of the second dose, according to Yair Herishanu, MD, of the Tel-Aviv Sourasky Medical Center, Tel Aviv University, and colleagues.

Troubling results

The researchers found an antibody-mediated response to the BNT162b2 mRNA COVID-19 vaccine in only 66 of 167 (39.5%) of all patients with CLL. The response rate of 52 of these responding patients with CLL to the vaccine was significantly lower than that occurring in 52 age- and sex-matched healthy controls (52% vs. 100%, respectively; adjusted odds ratio, 0.010; 95% confidence interval, 0.001-0.162; P < .001). 

Among the patients with CLL, the response rate was highest in those who obtained clinical remission after treatment (79.2%), followed by 55.2% in treatment-naive patients, and it was only 16% in patients under treatment at the time of vaccination. 

In patients treated with either BTK inhibitors or venetoclax with and without anti-CD20 antibody, response rates were low (16.0% and 13.6%, respectively). In particular, none of the patients exposed to anti-CD20 antibodies less than 12 months prior to vaccination responded, according to the researchers.

Multivariate analysis showed that the independent predictors of a vaccine response were age (65 years or younger; odds ratio, 3.17; P = .025), sex (women; OR, 3.66; P = .006), lack of active therapy (including treatment naive and previously treated patients; OR 6.59; P < .001), IgG levels 550 mg/dL or greater (OR, 3.70; P = .037), and IgM levels 40mg/dL or greater (OR, 2.92; P = .017). 

Within a median follow-up period of 75 days since the first vaccine dose, none of the CLL patients developed COVID-19 infection, the researchers reported.

“Vaccinated patients with CLL should continue to adhere to masking, social distancing, and vaccination of their close contacts should be strongly recommended. Serological tests after the second injection of the COVID-19 vaccine can provide valuable information to the individual patient and perhaps, may be integrated in future clinical decisions,” the researchers concluded.

The study was sponsored by the Tel-Aviv Sourasky Medical Center. The authors reported that they had no conflicts of interest. 

[email protected] 

Patients with chronic lymphocytic leukemia (CLL) have increased risk for severe COVID-19 disease as well as mortality.

South_agency/Getty Images

Such patients are likely to have compromised immune systems, making them respond poorly to vaccines, as has been seen in studies involving pneumococcal, hepatitis B, and influenza A and B vaccination. 

In order to determine if vaccination against COVID-19 disease will be effective among these patients, researchers performed a study to determine the efficacy of a single COVID-19 vaccine in patients with CLL. They found that the response rate of patients with CLL to vaccination was significantly lower than that of healthy controls, according to the study published in Blood Advances.

Study details

The study (NCT04746092) assessed the humoral immune responses to BNT162b2 mRNA COVID-19 (Pfizer) vaccination in adult patients with CLL and compared responses with those obtained in age-matched healthy controls. Patients received two vaccine doses, 21 days apart, and antibody titers were measured 2-3 weeks after administration of the second dose, according to Yair Herishanu, MD, of the Tel-Aviv Sourasky Medical Center, Tel Aviv University, and colleagues.

Troubling results

The researchers found an antibody-mediated response to the BNT162b2 mRNA COVID-19 vaccine in only 66 of 167 (39.5%) of all patients with CLL. The response rate of 52 of these responding patients with CLL to the vaccine was significantly lower than that occurring in 52 age- and sex-matched healthy controls (52% vs. 100%, respectively; adjusted odds ratio, 0.010; 95% confidence interval, 0.001-0.162; P < .001). 

Among the patients with CLL, the response rate was highest in those who obtained clinical remission after treatment (79.2%), followed by 55.2% in treatment-naive patients, and it was only 16% in patients under treatment at the time of vaccination. 

In patients treated with either BTK inhibitors or venetoclax with and without anti-CD20 antibody, response rates were low (16.0% and 13.6%, respectively). In particular, none of the patients exposed to anti-CD20 antibodies less than 12 months prior to vaccination responded, according to the researchers.

Multivariate analysis showed that the independent predictors of a vaccine response were age (65 years or younger; odds ratio, 3.17; P = .025), sex (women; OR, 3.66; P = .006), lack of active therapy (including treatment naive and previously treated patients; OR 6.59; P < .001), IgG levels 550 mg/dL or greater (OR, 3.70; P = .037), and IgM levels 40mg/dL or greater (OR, 2.92; P = .017). 

Within a median follow-up period of 75 days since the first vaccine dose, none of the CLL patients developed COVID-19 infection, the researchers reported.

“Vaccinated patients with CLL should continue to adhere to masking, social distancing, and vaccination of their close contacts should be strongly recommended. Serological tests after the second injection of the COVID-19 vaccine can provide valuable information to the individual patient and perhaps, may be integrated in future clinical decisions,” the researchers concluded.

The study was sponsored by the Tel-Aviv Sourasky Medical Center. The authors reported that they had no conflicts of interest. 

[email protected] 

Race and socioeconomic status can hinder and delay patient access to migraine treatment and result in poorer outcomes, according to a study published in the April issue of Headache. People of African descent and Latinx ethnicity tend to fare worse than other people of color and their White counterparts.

“It should be shocking to neurologists and other clinicians who care for migraine patients how few are able to successfully traverse the barriers to achieve an accurate diagnosis and proper, evidence-based, acute and preventative treatment,” commented Peter McAllister, MD, medical director at the New England Institute for Neurology and Headache and chief medical officer for clinical research at Ki Clinical Research in Stamford, Conn. Dr. McAllister was not involved in this study.
 

Assessing barriers to care

Researchers designed the study with the primary objective of estimating the number of patients with migraines with unmet clinical needs and who were impacted by four preidentified barriers to care. To evaluate their objective, researchers conducted a longitudinal, Internet-based survey known as the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. They collected data over 1 year examining a cohort of patients that mimicked the diverse demographics of the U.S. population. Researchers conducted longitudinal assessments every 3 months for 15 months, incorporating cross-sectional analyses that surveyed health care use, family burden, and comorbidities or endophenotypes.

Eligible enrollees were 18 years of age or older.

Researchers identified four barriers that hindered patient outcomes, and they served as the primary outcomes of the studies. They were:

• Health care provider consultations. Investigators used study participants’ responses to the following question during their interactions with their health care providers to help evaluate the quality of their consultation experience: “What type of doctor is currently managing your headaches?” Researchers included data from patients whose practitioners fit the description of those they deemed best suited to address ongoing headache challenges. These medical professionals included general practitioners, family physicians, internal medicine doctors, nurse practitioners, physician assistants, neurologists, pain specialists, headache specialists, and obstetrician-gynecologists.
• Diagnosis. Carefully evaluating patients’ responses to a series of questions helped researchers gauge the accuracy of diagnosis. Questions included: “Have you ever been diagnosed by a doctor or other health professional with any of the following types of headaches?” Respondents were also given a list of options that provided additional context around their headaches and were encouraged to select all appropriate responses. The list included a fictional response option of “citrene headache” to determine incorrect responses. For this study, researchers deemed it necessary to recognize a chronic migraine diagnosis to ensure that patients received appropriate treatment.
• Minimally appropriate pharmacologic treatment. Researchers used the following question to determine whether patients’ chronic migraine and episodic migraine were being managed with the least amount of pharmacological treatment necessary. “Which of these medications (if any) are you currently using (or typically keep on hand) to treat your headaches when you have them?” Researchers defined “minimally appropriate acute pharmacologic treatment” as the use of any prescription nonsteroidal anti-inflammatory drug (NSAID), triptan, ergotamine derivative, or isometheptene.
• Avoidance of medication overuse. The study authors pointed out the sometimes nebulous process of characterizing the appropriate use of preventative medication in patients with episodic migraines as “not straightforward” for some patients because not all patients require preventive treatment. Study participants were required to report having received any form of preventative therapy, defined as pharmacological therapies approved by guidelines and supported by data. Such therapies included various antiseizure medication, antidepressants (for example, doxepin, venlafaxine, duloxetine, amitriptyline, imipramine, nortriptyline, and desvenlafaxine), antihypertensives, and toxin injections. Treatments such as behavioral and neuromodulatory therapies were excluded from the list.

According to lead author Dawn C. Buse, PhD, of the department of neurology at Albert Einstein College of Medicine, New York, acute medication overuse provides an important modifiable target for intervention and recommends that clinicians use the opportunity to optimize migraine care by reducing the patients’ reliance on acute therapies. Taking such initiatives to decrease medication overuse is especially important in communities of color, who are more likely to overuse medications for migraines.

Patients with higher income levels were more likely to overcome each barrier. People of African, African American, or multiracial descent were more prone to overuse of medications to manage their migraines.

Of the 489,537 respondents invited to participate in the CaMEO study, 16,879 qualified for inclusion. Slightly more than half of the respondents (n = 9,184 [54.7%]) had a migraine-related disability (MIDAS) score of 6 or greater – an indicator of disability that is least mild in nature. Most patients who had episodic migraines or chronic migraines (86.2%) had some form of health insurance coverage (n = 9.184; 84.1%; P = .048). Of those patients who were insured, 7,930 patients experienced episodic migraine (86.3%) and the remainder had chronic migraine (n = 1,254; 13.7%). Higher-income patients were more likely to traverse barriers to care. While patients of African descent had higher consultation rates, they also had higher rates of acute medication overuse.

Patients with chronic migraine were more likely to be older than patients with episodic migraine (41.0 vs. 39.6 years; P = .0001) and female (83.0% vs. 79.0%; P = .001), and White (84.5% vs. 79.1%; P < .001). Similarly, patients with chronic migraine were more likely to have a higher mean body mass index (29.8 kg/m² vs. 28.9 kg/m²; P < .001) and lower rates of full- or part-time employment (56.8% vs. 67.1%; P < .001), and were less likely to have a 4-year degree (64.8 vs. 55.6; P < .001) and annual household incomes below $75,000 (72.6% vs. 64.6%; P < .001). Approximately three-quarters of the patients with episodic migraine (75.7%; 1655/2187) and one-third of patients with chronic migraine (32.8%; 168/512) received accurate diagnoses.

The data uncovered an association with acute medication overuse. Among current consulters who had received an accurate diagnosis and minimally adequate treatment, medication overuse rates were highest among those reporting two or more races (53%) and Blacks and African Americans (45%) and lowest among Whites (33%) and those categorized as “other” race (32%). Ethnic and cultural differences in headache literacy may contribute to differences in medication overuse. 
 

Strategies to improve outcomes

Both Dr. Buse and Dr. McAllister see the value advocacy and education offer in helping to improve outcomes in marginalized communities and other groups negatively impacted by various barriers.

“Patient advocacy and outreach are key here, especially in those traditionally underrepresented in the migraine space, such as men, people of color, blue-collar workers, etc.,” Dr. McAllister noted.

Dr. Buse emphasized the importance of education for patients and health care professionals alike. “A large percentage of people who meet criteria for migraine in the U.S. do not seek care or possibly even know that they have migraines,” Dr. Buse said. “This finding underscores the importance of public health education about migraine as well as well as providing migraine support, education, and resources to health care professionals on the front lines.”

Other strategies recommended by Dr, Buse to ease the impact of barriers include encouraging patient discussion, setting up time for follow-up appointments and education, referring patients for neurological and other specialty consults when warranted, reviewing essential lifestyle habits for migraine management, and creating personalized, mutually agreed-upon treatment plans.

Dr. Buse has received support and honoraria from AbbVie, Amgen, Avanir, Biohaven, Eli Lilly, and Promius.

Race and socioeconomic status can hinder and delay patient access to migraine treatment and result in poorer outcomes, according to a study published in the April issue of Headache. People of African descent and Latinx ethnicity tend to fare worse than other people of color and their White counterparts.

“It should be shocking to neurologists and other clinicians who care for migraine patients how few are able to successfully traverse the barriers to achieve an accurate diagnosis and proper, evidence-based, acute and preventative treatment,” commented Peter McAllister, MD, medical director at the New England Institute for Neurology and Headache and chief medical officer for clinical research at Ki Clinical Research in Stamford, Conn. Dr. McAllister was not involved in this study.
 

Assessing barriers to care

Researchers designed the study with the primary objective of estimating the number of patients with migraines with unmet clinical needs and who were impacted by four preidentified barriers to care. To evaluate their objective, researchers conducted a longitudinal, Internet-based survey known as the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. They collected data over 1 year examining a cohort of patients that mimicked the diverse demographics of the U.S. population. Researchers conducted longitudinal assessments every 3 months for 15 months, incorporating cross-sectional analyses that surveyed health care use, family burden, and comorbidities or endophenotypes.

Eligible enrollees were 18 years of age or older.

Researchers identified four barriers that hindered patient outcomes, and they served as the primary outcomes of the studies. They were:

• Health care provider consultations. Investigators used study participants’ responses to the following question during their interactions with their health care providers to help evaluate the quality of their consultation experience: “What type of doctor is currently managing your headaches?” Researchers included data from patients whose practitioners fit the description of those they deemed best suited to address ongoing headache challenges. These medical professionals included general practitioners, family physicians, internal medicine doctors, nurse practitioners, physician assistants, neurologists, pain specialists, headache specialists, and obstetrician-gynecologists.
• Diagnosis. Carefully evaluating patients’ responses to a series of questions helped researchers gauge the accuracy of diagnosis. Questions included: “Have you ever been diagnosed by a doctor or other health professional with any of the following types of headaches?” Respondents were also given a list of options that provided additional context around their headaches and were encouraged to select all appropriate responses. The list included a fictional response option of “citrene headache” to determine incorrect responses. For this study, researchers deemed it necessary to recognize a chronic migraine diagnosis to ensure that patients received appropriate treatment.
• Minimally appropriate pharmacologic treatment. Researchers used the following question to determine whether patients’ chronic migraine and episodic migraine were being managed with the least amount of pharmacological treatment necessary. “Which of these medications (if any) are you currently using (or typically keep on hand) to treat your headaches when you have them?” Researchers defined “minimally appropriate acute pharmacologic treatment” as the use of any prescription nonsteroidal anti-inflammatory drug (NSAID), triptan, ergotamine derivative, or isometheptene.
• Avoidance of medication overuse. The study authors pointed out the sometimes nebulous process of characterizing the appropriate use of preventative medication in patients with episodic migraines as “not straightforward” for some patients because not all patients require preventive treatment. Study participants were required to report having received any form of preventative therapy, defined as pharmacological therapies approved by guidelines and supported by data. Such therapies included various antiseizure medication, antidepressants (for example, doxepin, venlafaxine, duloxetine, amitriptyline, imipramine, nortriptyline, and desvenlafaxine), antihypertensives, and toxin injections. Treatments such as behavioral and neuromodulatory therapies were excluded from the list.

According to lead author Dawn C. Buse, PhD, of the department of neurology at Albert Einstein College of Medicine, New York, acute medication overuse provides an important modifiable target for intervention and recommends that clinicians use the opportunity to optimize migraine care by reducing the patients’ reliance on acute therapies. Taking such initiatives to decrease medication overuse is especially important in communities of color, who are more likely to overuse medications for migraines.

Patients with higher income levels were more likely to overcome each barrier. People of African, African American, or multiracial descent were more prone to overuse of medications to manage their migraines.

Of the 489,537 respondents invited to participate in the CaMEO study, 16,879 qualified for inclusion. Slightly more than half of the respondents (n = 9,184 [54.7%]) had a migraine-related disability (MIDAS) score of 6 or greater – an indicator of disability that is least mild in nature. Most patients who had episodic migraines or chronic migraines (86.2%) had some form of health insurance coverage (n = 9.184; 84.1%; P = .048). Of those patients who were insured, 7,930 patients experienced episodic migraine (86.3%) and the remainder had chronic migraine (n = 1,254; 13.7%). Higher-income patients were more likely to traverse barriers to care. While patients of African descent had higher consultation rates, they also had higher rates of acute medication overuse.

Patients with chronic migraine were more likely to be older than patients with episodic migraine (41.0 vs. 39.6 years; P = .0001) and female (83.0% vs. 79.0%; P = .001), and White (84.5% vs. 79.1%; P < .001). Similarly, patients with chronic migraine were more likely to have a higher mean body mass index (29.8 kg/m² vs. 28.9 kg/m²; P < .001) and lower rates of full- or part-time employment (56.8% vs. 67.1%; P < .001), and were less likely to have a 4-year degree (64.8 vs. 55.6; P < .001) and annual household incomes below $75,000 (72.6% vs. 64.6%; P < .001). Approximately three-quarters of the patients with episodic migraine (75.7%; 1655/2187) and one-third of patients with chronic migraine (32.8%; 168/512) received accurate diagnoses.

The data uncovered an association with acute medication overuse. Among current consulters who had received an accurate diagnosis and minimally adequate treatment, medication overuse rates were highest among those reporting two or more races (53%) and Blacks and African Americans (45%) and lowest among Whites (33%) and those categorized as “other” race (32%). Ethnic and cultural differences in headache literacy may contribute to differences in medication overuse. 
 

Strategies to improve outcomes

Both Dr. Buse and Dr. McAllister see the value advocacy and education offer in helping to improve outcomes in marginalized communities and other groups negatively impacted by various barriers.

“Patient advocacy and outreach are key here, especially in those traditionally underrepresented in the migraine space, such as men, people of color, blue-collar workers, etc.,” Dr. McAllister noted.

Dr. Buse emphasized the importance of education for patients and health care professionals alike. “A large percentage of people who meet criteria for migraine in the U.S. do not seek care or possibly even know that they have migraines,” Dr. Buse said. “This finding underscores the importance of public health education about migraine as well as well as providing migraine support, education, and resources to health care professionals on the front lines.”

Other strategies recommended by Dr, Buse to ease the impact of barriers include encouraging patient discussion, setting up time for follow-up appointments and education, referring patients for neurological and other specialty consults when warranted, reviewing essential lifestyle habits for migraine management, and creating personalized, mutually agreed-upon treatment plans.

Dr. Buse has received support and honoraria from AbbVie, Amgen, Avanir, Biohaven, Eli Lilly, and Promius.

Race and socioeconomic status can hinder and delay patient access to migraine treatment and result in poorer outcomes, according to a study published in the April issue of Headache. People of African descent and Latinx ethnicity tend to fare worse than other people of color and their White counterparts.

“It should be shocking to neurologists and other clinicians who care for migraine patients how few are able to successfully traverse the barriers to achieve an accurate diagnosis and proper, evidence-based, acute and preventative treatment,” commented Peter McAllister, MD, medical director at the New England Institute for Neurology and Headache and chief medical officer for clinical research at Ki Clinical Research in Stamford, Conn. Dr. McAllister was not involved in this study.
 

Assessing barriers to care

Researchers designed the study with the primary objective of estimating the number of patients with migraines with unmet clinical needs and who were impacted by four preidentified barriers to care. To evaluate their objective, researchers conducted a longitudinal, Internet-based survey known as the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. They collected data over 1 year examining a cohort of patients that mimicked the diverse demographics of the U.S. population. Researchers conducted longitudinal assessments every 3 months for 15 months, incorporating cross-sectional analyses that surveyed health care use, family burden, and comorbidities or endophenotypes.

Eligible enrollees were 18 years of age or older.

Researchers identified four barriers that hindered patient outcomes, and they served as the primary outcomes of the studies. They were:

• Health care provider consultations. Investigators used study participants’ responses to the following question during their interactions with their health care providers to help evaluate the quality of their consultation experience: “What type of doctor is currently managing your headaches?” Researchers included data from patients whose practitioners fit the description of those they deemed best suited to address ongoing headache challenges. These medical professionals included general practitioners, family physicians, internal medicine doctors, nurse practitioners, physician assistants, neurologists, pain specialists, headache specialists, and obstetrician-gynecologists.
• Diagnosis. Carefully evaluating patients’ responses to a series of questions helped researchers gauge the accuracy of diagnosis. Questions included: “Have you ever been diagnosed by a doctor or other health professional with any of the following types of headaches?” Respondents were also given a list of options that provided additional context around their headaches and were encouraged to select all appropriate responses. The list included a fictional response option of “citrene headache” to determine incorrect responses. For this study, researchers deemed it necessary to recognize a chronic migraine diagnosis to ensure that patients received appropriate treatment.
• Minimally appropriate pharmacologic treatment. Researchers used the following question to determine whether patients’ chronic migraine and episodic migraine were being managed with the least amount of pharmacological treatment necessary. “Which of these medications (if any) are you currently using (or typically keep on hand) to treat your headaches when you have them?” Researchers defined “minimally appropriate acute pharmacologic treatment” as the use of any prescription nonsteroidal anti-inflammatory drug (NSAID), triptan, ergotamine derivative, or isometheptene.
• Avoidance of medication overuse. The study authors pointed out the sometimes nebulous process of characterizing the appropriate use of preventative medication in patients with episodic migraines as “not straightforward” for some patients because not all patients require preventive treatment. Study participants were required to report having received any form of preventative therapy, defined as pharmacological therapies approved by guidelines and supported by data. Such therapies included various antiseizure medication, antidepressants (for example, doxepin, venlafaxine, duloxetine, amitriptyline, imipramine, nortriptyline, and desvenlafaxine), antihypertensives, and toxin injections. Treatments such as behavioral and neuromodulatory therapies were excluded from the list.

According to lead author Dawn C. Buse, PhD, of the department of neurology at Albert Einstein College of Medicine, New York, acute medication overuse provides an important modifiable target for intervention and recommends that clinicians use the opportunity to optimize migraine care by reducing the patients’ reliance on acute therapies. Taking such initiatives to decrease medication overuse is especially important in communities of color, who are more likely to overuse medications for migraines.

Patients with higher income levels were more likely to overcome each barrier. People of African, African American, or multiracial descent were more prone to overuse of medications to manage their migraines.

Of the 489,537 respondents invited to participate in the CaMEO study, 16,879 qualified for inclusion. Slightly more than half of the respondents (n = 9,184 [54.7%]) had a migraine-related disability (MIDAS) score of 6 or greater – an indicator of disability that is least mild in nature. Most patients who had episodic migraines or chronic migraines (86.2%) had some form of health insurance coverage (n = 9.184; 84.1%; P = .048). Of those patients who were insured, 7,930 patients experienced episodic migraine (86.3%) and the remainder had chronic migraine (n = 1,254; 13.7%). Higher-income patients were more likely to traverse barriers to care. While patients of African descent had higher consultation rates, they also had higher rates of acute medication overuse.

Patients with chronic migraine were more likely to be older than patients with episodic migraine (41.0 vs. 39.6 years; P = .0001) and female (83.0% vs. 79.0%; P = .001), and White (84.5% vs. 79.1%; P < .001). Similarly, patients with chronic migraine were more likely to have a higher mean body mass index (29.8 kg/m² vs. 28.9 kg/m²; P < .001) and lower rates of full- or part-time employment (56.8% vs. 67.1%; P < .001), and were less likely to have a 4-year degree (64.8 vs. 55.6; P < .001) and annual household incomes below $75,000 (72.6% vs. 64.6%; P < .001). Approximately three-quarters of the patients with episodic migraine (75.7%; 1655/2187) and one-third of patients with chronic migraine (32.8%; 168/512) received accurate diagnoses.

The data uncovered an association with acute medication overuse. Among current consulters who had received an accurate diagnosis and minimally adequate treatment, medication overuse rates were highest among those reporting two or more races (53%) and Blacks and African Americans (45%) and lowest among Whites (33%) and those categorized as “other” race (32%). Ethnic and cultural differences in headache literacy may contribute to differences in medication overuse. 
 

Strategies to improve outcomes

Both Dr. Buse and Dr. McAllister see the value advocacy and education offer in helping to improve outcomes in marginalized communities and other groups negatively impacted by various barriers.

“Patient advocacy and outreach are key here, especially in those traditionally underrepresented in the migraine space, such as men, people of color, blue-collar workers, etc.,” Dr. McAllister noted.

Dr. Buse emphasized the importance of education for patients and health care professionals alike. “A large percentage of people who meet criteria for migraine in the U.S. do not seek care or possibly even know that they have migraines,” Dr. Buse said. “This finding underscores the importance of public health education about migraine as well as well as providing migraine support, education, and resources to health care professionals on the front lines.”

Other strategies recommended by Dr, Buse to ease the impact of barriers include encouraging patient discussion, setting up time for follow-up appointments and education, referring patients for neurological and other specialty consults when warranted, reviewing essential lifestyle habits for migraine management, and creating personalized, mutually agreed-upon treatment plans.

Dr. Buse has received support and honoraria from AbbVie, Amgen, Avanir, Biohaven, Eli Lilly, and Promius.

We have no way of precisely knowing how many lives might have been saved, and how much grief and loneliness spared and economic ruin contained during COVID-19 if we had risen to its myriad challenges in a timely fashion. However, I feel we can safely say that the United States deserves to be graded with an “F” for its management of the pandemic.

To render this grade, we need only to read the countless verified reports of how critically needed public health measures were not taken soon enough, or sufficiently, to substantially mitigate human and societal suffering.

This began with the failure to protect doctors, nurses, and technicians, who did not have the personal protective equipment needed to prevent infection and spare risk to their loved ones. It soon extended to the country’s failure to adequately protect all its citizens and residents. COVID-19 then rained its grievous consequences disproportionately upon people of color, those living in poverty, and those with housing and food insecurity – those already greatly foreclosed from opportunities to exit from their circumstances.

We all have heard, “Fool me once, shame on you; fool me twice, shame on me.”

Bear witness, colleagues and friends: It will be our shared shame if we too continue to fail in our response to COVID-19. But failure need not happen because protecting ourselves and our country is a solvable problem; complex and demanding for sure, but solvable.
 

To battle trauma, we must first define it

The sine qua non of a disaster is its psychic and social trauma. I asked Maureen Sayres Van Niel, MD, chair of the American Psychiatric Association’s Minority and Underrepresented Caucus and a former steering committee member of the U.S. Preventive Services Task Force, to define trauma. She said, “It is [the product of] a catastrophic, unexpected event over which we have little control, with grave consequences to the lives and psychological functioning of those individuals and groups affected.”

The COVID-19 pandemic is a massively amplified traumatic event because of the virulence and contagious properties of the virus and its variants; the absence of end date on the horizon; its effect as a proverbial ax that disproportionately falls on the majority of the populace experiencing racial and social inequities; and the ironic yet necessary imperative to distance ourselves from those we care about and who care about us.

Four interdependent factors drive the magnitude of the traumatic impact of a disaster: the degree of exposure to the life-threatening event; the duration and threat of recurrence; an individual’s preexisting (natural and human-made) trauma and mental and addictive disorders; and the adequacy of family and fundamental resources such as housing, food, safety, and access to health care (the social dimensions of health and mental health). These factors underline the “who,” “what,” “where,” and “how” of what should have been (and continue to be) an effective public health response to the COVID-19 pandemic.

Yet existing categories that we have used to predict risk for trauma no longer hold. The gravity, prevalence, and persistence of COVID-19’s horrors erase any differences among victims, witnesses, and bystanders. Dr Sayres Van Niel asserts that we have a “collective, national trauma.” In April, the Kaiser Family Foundation’s Vaccine Monitor reported that 24% of U.S. adults had a close friend or family member who died of COVID-19. That’s 82 million Americans! Our country has eclipsed individual victimization and trauma because we are all in its maw.
 

Vital lessons from the past

In a previous column, I described my role as New York City’s mental health commissioner after 9/11 and the many lessons we learned during that multiyear process. Our work served as a template for other disasters to follow, such as Hurricane Sandy. Its value to COVID-19 is equally apparent.

We learned that those most at risk of developing symptomatic, functionally impairing mental illness had prior traumatic experiences (for example, from childhood abuse or neglect, violence, war, and forced displacement from their native land) and/or a preexisting mental or substance use disorder.

Once these individuals and communities were identified, we could prioritize their treatment and care. Doing so required mobilizing both inner and external (social) resources, which can be used before disaster strikes or in its wake.

For individuals, adaptive resources include developing any of a number of mind-body activities (for example, meditation, mindfulness, slow breathing, and yoga); sufficient but not necessarily excessive levels of exercise (as has been said, if exercise were a pill, it would be the most potent of medicines); nourishing diets; sleep, nature’s restorative state; and perhaps most important, attachment and human connection to people who care about you and whom you care about and trust.

One unexpected, yet now consistent, predictor of resilience in the wake of disaster is faith. This does not necessarily mean holding or following an institutional religion or belonging to house of worship (though, of course, that melds and augments faith with community). For a great many, myself included, there is spirituality, the belief in a greater power, which need not be a God yet instills a sense of the vastness, universality, and continuity of life.

For communities, adaptive resources include safe homes and neighborhoods; diminishing housing and food insecurity; education, including pre-K; employment, with a livable wage; ridding human interactions of the endless, so-called microaggressions (which are not micro at all, because they accrue) of race, ethnic, class, and age discrimination and injustice; and ready access to quality and affordable health care, now more than ever for the rising tide of mental and substance use disorders that COVID-19 has unleashed.

Every gain we make to ablate racism, social injustice, discrimination, and widely and deeply spread resource and opportunity inequities means more cohesion among the members of our collective tribe. Greater cohesion, a love for thy neighbor, and equity (in action, not polemics) will fuel the resilience we will need to withstand more of COVID-19’s ongoing trauma; that of other, inescapable disasters and losses; and the wear and tear of everyday life. The rewards of equity are priceless and include the dignity that derives from fairness and justice – given and received.
 

An unprecedented disaster requires a bold response

My, what a list. But to me, the encompassing nature of what’s needed means that we can make differences anywhere, everywhere, and in countless and continuous ways.

The measure of any society is in how it cares for those who are foreclosed, through no fault of their own, from what we all want: a life safe from violence, secure in housing and food, with loving relationships and the pride that comes of making contributions, each in our own, wonderfully unique way.

Where will we all be in a year, 2, or 3 from now? Prepared, or not? Emotionally inoculated, or not? Better equipped, or not? As divided, or more cohesive?

Well, I imagine that depends on each and every one of us.

Lloyd I. Sederer, MD, is a psychiatrist, public health doctor, and writer. He is an adjunct professor at the Columbia University School of Public Health, director of Columbia Psychiatry Media, chief medical officer of Bongo Media, and chair of the advisory board of Get Help. He has been chief medical officer of McLean Hospital, a Harvard teaching hospital; mental health commissioner of New York City (in the Bloomberg administration); and chief medical officer of the New York State Office of Mental Health, the nation’s largest state mental health agency.

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

We have no way of precisely knowing how many lives might have been saved, and how much grief and loneliness spared and economic ruin contained during COVID-19 if we had risen to its myriad challenges in a timely fashion. However, I feel we can safely say that the United States deserves to be graded with an “F” for its management of the pandemic.

To render this grade, we need only to read the countless verified reports of how critically needed public health measures were not taken soon enough, or sufficiently, to substantially mitigate human and societal suffering.

This began with the failure to protect doctors, nurses, and technicians, who did not have the personal protective equipment needed to prevent infection and spare risk to their loved ones. It soon extended to the country’s failure to adequately protect all its citizens and residents. COVID-19 then rained its grievous consequences disproportionately upon people of color, those living in poverty, and those with housing and food insecurity – those already greatly foreclosed from opportunities to exit from their circumstances.

We all have heard, “Fool me once, shame on you; fool me twice, shame on me.”

Bear witness, colleagues and friends: It will be our shared shame if we too continue to fail in our response to COVID-19. But failure need not happen because protecting ourselves and our country is a solvable problem; complex and demanding for sure, but solvable.
 

To battle trauma, we must first define it

The sine qua non of a disaster is its psychic and social trauma. I asked Maureen Sayres Van Niel, MD, chair of the American Psychiatric Association’s Minority and Underrepresented Caucus and a former steering committee member of the U.S. Preventive Services Task Force, to define trauma. She said, “It is [the product of] a catastrophic, unexpected event over which we have little control, with grave consequences to the lives and psychological functioning of those individuals and groups affected.”

The COVID-19 pandemic is a massively amplified traumatic event because of the virulence and contagious properties of the virus and its variants; the absence of end date on the horizon; its effect as a proverbial ax that disproportionately falls on the majority of the populace experiencing racial and social inequities; and the ironic yet necessary imperative to distance ourselves from those we care about and who care about us.

Four interdependent factors drive the magnitude of the traumatic impact of a disaster: the degree of exposure to the life-threatening event; the duration and threat of recurrence; an individual’s preexisting (natural and human-made) trauma and mental and addictive disorders; and the adequacy of family and fundamental resources such as housing, food, safety, and access to health care (the social dimensions of health and mental health). These factors underline the “who,” “what,” “where,” and “how” of what should have been (and continue to be) an effective public health response to the COVID-19 pandemic.

Yet existing categories that we have used to predict risk for trauma no longer hold. The gravity, prevalence, and persistence of COVID-19’s horrors erase any differences among victims, witnesses, and bystanders. Dr Sayres Van Niel asserts that we have a “collective, national trauma.” In April, the Kaiser Family Foundation’s Vaccine Monitor reported that 24% of U.S. adults had a close friend or family member who died of COVID-19. That’s 82 million Americans! Our country has eclipsed individual victimization and trauma because we are all in its maw.
 

Vital lessons from the past

In a previous column, I described my role as New York City’s mental health commissioner after 9/11 and the many lessons we learned during that multiyear process. Our work served as a template for other disasters to follow, such as Hurricane Sandy. Its value to COVID-19 is equally apparent.

We learned that those most at risk of developing symptomatic, functionally impairing mental illness had prior traumatic experiences (for example, from childhood abuse or neglect, violence, war, and forced displacement from their native land) and/or a preexisting mental or substance use disorder.

Once these individuals and communities were identified, we could prioritize their treatment and care. Doing so required mobilizing both inner and external (social) resources, which can be used before disaster strikes or in its wake.

For individuals, adaptive resources include developing any of a number of mind-body activities (for example, meditation, mindfulness, slow breathing, and yoga); sufficient but not necessarily excessive levels of exercise (as has been said, if exercise were a pill, it would be the most potent of medicines); nourishing diets; sleep, nature’s restorative state; and perhaps most important, attachment and human connection to people who care about you and whom you care about and trust.

One unexpected, yet now consistent, predictor of resilience in the wake of disaster is faith. This does not necessarily mean holding or following an institutional religion or belonging to house of worship (though, of course, that melds and augments faith with community). For a great many, myself included, there is spirituality, the belief in a greater power, which need not be a God yet instills a sense of the vastness, universality, and continuity of life.

For communities, adaptive resources include safe homes and neighborhoods; diminishing housing and food insecurity; education, including pre-K; employment, with a livable wage; ridding human interactions of the endless, so-called microaggressions (which are not micro at all, because they accrue) of race, ethnic, class, and age discrimination and injustice; and ready access to quality and affordable health care, now more than ever for the rising tide of mental and substance use disorders that COVID-19 has unleashed.

Every gain we make to ablate racism, social injustice, discrimination, and widely and deeply spread resource and opportunity inequities means more cohesion among the members of our collective tribe. Greater cohesion, a love for thy neighbor, and equity (in action, not polemics) will fuel the resilience we will need to withstand more of COVID-19’s ongoing trauma; that of other, inescapable disasters and losses; and the wear and tear of everyday life. The rewards of equity are priceless and include the dignity that derives from fairness and justice – given and received.
 

An unprecedented disaster requires a bold response

My, what a list. But to me, the encompassing nature of what’s needed means that we can make differences anywhere, everywhere, and in countless and continuous ways.

The measure of any society is in how it cares for those who are foreclosed, through no fault of their own, from what we all want: a life safe from violence, secure in housing and food, with loving relationships and the pride that comes of making contributions, each in our own, wonderfully unique way.

Where will we all be in a year, 2, or 3 from now? Prepared, or not? Emotionally inoculated, or not? Better equipped, or not? As divided, or more cohesive?

Well, I imagine that depends on each and every one of us.

Lloyd I. Sederer, MD, is a psychiatrist, public health doctor, and writer. He is an adjunct professor at the Columbia University School of Public Health, director of Columbia Psychiatry Media, chief medical officer of Bongo Media, and chair of the advisory board of Get Help. He has been chief medical officer of McLean Hospital, a Harvard teaching hospital; mental health commissioner of New York City (in the Bloomberg administration); and chief medical officer of the New York State Office of Mental Health, the nation’s largest state mental health agency.

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

We have no way of precisely knowing how many lives might have been saved, and how much grief and loneliness spared and economic ruin contained during COVID-19 if we had risen to its myriad challenges in a timely fashion. However, I feel we can safely say that the United States deserves to be graded with an “F” for its management of the pandemic.

To render this grade, we need only to read the countless verified reports of how critically needed public health measures were not taken soon enough, or sufficiently, to substantially mitigate human and societal suffering.

This began with the failure to protect doctors, nurses, and technicians, who did not have the personal protective equipment needed to prevent infection and spare risk to their loved ones. It soon extended to the country’s failure to adequately protect all its citizens and residents. COVID-19 then rained its grievous consequences disproportionately upon people of color, those living in poverty, and those with housing and food insecurity – those already greatly foreclosed from opportunities to exit from their circumstances.

We all have heard, “Fool me once, shame on you; fool me twice, shame on me.”

Bear witness, colleagues and friends: It will be our shared shame if we too continue to fail in our response to COVID-19. But failure need not happen because protecting ourselves and our country is a solvable problem; complex and demanding for sure, but solvable.
 

To battle trauma, we must first define it

The sine qua non of a disaster is its psychic and social trauma. I asked Maureen Sayres Van Niel, MD, chair of the American Psychiatric Association’s Minority and Underrepresented Caucus and a former steering committee member of the U.S. Preventive Services Task Force, to define trauma. She said, “It is [the product of] a catastrophic, unexpected event over which we have little control, with grave consequences to the lives and psychological functioning of those individuals and groups affected.”

The COVID-19 pandemic is a massively amplified traumatic event because of the virulence and contagious properties of the virus and its variants; the absence of end date on the horizon; its effect as a proverbial ax that disproportionately falls on the majority of the populace experiencing racial and social inequities; and the ironic yet necessary imperative to distance ourselves from those we care about and who care about us.

Four interdependent factors drive the magnitude of the traumatic impact of a disaster: the degree of exposure to the life-threatening event; the duration and threat of recurrence; an individual’s preexisting (natural and human-made) trauma and mental and addictive disorders; and the adequacy of family and fundamental resources such as housing, food, safety, and access to health care (the social dimensions of health and mental health). These factors underline the “who,” “what,” “where,” and “how” of what should have been (and continue to be) an effective public health response to the COVID-19 pandemic.

Yet existing categories that we have used to predict risk for trauma no longer hold. The gravity, prevalence, and persistence of COVID-19’s horrors erase any differences among victims, witnesses, and bystanders. Dr Sayres Van Niel asserts that we have a “collective, national trauma.” In April, the Kaiser Family Foundation’s Vaccine Monitor reported that 24% of U.S. adults had a close friend or family member who died of COVID-19. That’s 82 million Americans! Our country has eclipsed individual victimization and trauma because we are all in its maw.