Federal Practitioner

All women, regardless of their risk profile, should consider prophylactic removal of the fallopian tubes at the same time as other pelvic surgery once they are finished having children, the Ovarian Cancer Research Alliance has advised.

The recommendation, announced Feb. 1, replaces the decades-old focus on symptom awareness and early detection and follows “sobering and deeply disappointing” results from a large U.K. study published 2 years ago, the organization said.

That was the UK Collaborative Trial of Ovarian Cancer Screening published in The Lancet in 2021, which followed more than 200,000 women for a median 16 years. It showed that screening average-risk women with a CA-125 blood test and ultrasound does not reduce deaths from the disease, as reported at the time by this news organization.

“We all hoped that the trial would show that early detection was effective in changing mortality rates. When the results came out, it was very hard to accept,” Audra Moran, OCRA president and CEO, said in an interview.

“We have an obligation to let people know that symptom awareness and early detection will not save lives” but considering opportunistic salpingectomy “absolutely will,” said Ms. Moran. Hence the renewed call for women to consider having their fallopian tubes removed.  

What sounds new about this call is that the group is directing fallopian tube removal to all women “who are undergoing pelvic surgeries for benign conditions,” irrespective of what perceived risk they have of developing ovarian cancer (for example, based on family history).

But this advice has been in place for years for women who are known to be at higher risk for the disease.

For instance, women at high risk for ovarian cancer based on Hereditary Breast and Ovarian Cancer Syndrome (HBOC) have long been recommended to undergo surgery to remove ovaries and fallopian tubes (risk-reducing bilateral salpingo-oophorectomy or RRBSO) once there is no longer a desire for pregnancy.

Approached for comment about the new messaging, Stephanie V. Blank, MD, president of the Society of Gynecologic Oncology, says that the new recommendation – that all women who are finished childbearing consider opportunistic salpingectomy at the time of other pelvic surgery for benign conditions – is “not aggressive.”

“It’s reasonable and makes sense,” Dr. Blank said in an interview.

And she pointed out that it’s actually not “new”; it is, however, getting “new attention” based on the disappointing U.K. screening study, said Dr. Blank, director of gynecologic oncology for the Mount Sinai Health System in New York and professor of gynecologic oncology at Icahn School of Medicine at Mount Sinai.

She noted that the procedure of opportunistic salpingectomy has been endorsed by SGO since 2013 and by the American College of Obstetricians and Gynecologists since 2015.

There is increasing evidence that most high-grade serous ovarian cancers arise from cells in the fallopian tubes, William Dahut, MD, chief scientific officer for the American Cancer Society, told this news organization.

“Indirect evidence suggests a fairly strong degree of risk reduction associated with opportunistic salpingectomy for the most prevalent type of ovarian cancer (serous), and some risk reduction of epithelial ovarian cancer. At this time, these discussions seem warranted,” Dr. Dahut said.

At this point, however, the fact that leading organizations advise “consideration” means that the evidence base has “not been judged to be sufficiently strong (in terms of what we can say about benefits and harms) to advise a direct recommendation for opportunistic salpingectomy,” Dr. Dahut added.

There is no current recommendation to have fallopian tubes removed as a stand-alone procedure, he pointed out. However, he commented that “the occasion of scheduled gynecologic surgery presents an opportunity to possibly reduce the risk of ovarian cancer without known adverse effects in women who have completed childbearing. Having the discussion seems to be justified by the current evidence,” Dr. Dahut said.

Deanna Gerber, MD, a gynecologic oncologist at NYU Langone Perlmutter Cancer Center-Long Island, agrees. “In women who are scheduled to have a gynecologic or pelvic procedure, clinicians should discuss the possibility of removing the fallopian tubes at that time. A salpingectomy is a relatively low-risk procedure and adds little time to the surgery,” Dr. Gerber said in an interview.

“Women should understand that there is still ongoing research on this topic, but this low-risk procedure may reduce their risk of developing an ovarian or fallopian tube cancer,” Dr. Gerber said.

OCRA also encourages all women (or anyone born with ovaries) to know their risk for ovarian cancer. To that end, the organization has launched a pilot program offering free, at-home genetic testing kits to people with a personal or family history of breast, ovarian, uterine, or colorectal cancer.

Ms. Moran, Dr. Blank, Dr. Dahut, and Dr. Gerber report no relevant financial relationships.

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

All women, regardless of their risk profile, should consider prophylactic removal of the fallopian tubes at the same time as other pelvic surgery once they are finished having children, the Ovarian Cancer Research Alliance has advised.

The recommendation, announced Feb. 1, replaces the decades-old focus on symptom awareness and early detection and follows “sobering and deeply disappointing” results from a large U.K. study published 2 years ago, the organization said.

That was the UK Collaborative Trial of Ovarian Cancer Screening published in The Lancet in 2021, which followed more than 200,000 women for a median 16 years. It showed that screening average-risk women with a CA-125 blood test and ultrasound does not reduce deaths from the disease, as reported at the time by this news organization.

“We all hoped that the trial would show that early detection was effective in changing mortality rates. When the results came out, it was very hard to accept,” Audra Moran, OCRA president and CEO, said in an interview.

“We have an obligation to let people know that symptom awareness and early detection will not save lives” but considering opportunistic salpingectomy “absolutely will,” said Ms. Moran. Hence the renewed call for women to consider having their fallopian tubes removed.  

What sounds new about this call is that the group is directing fallopian tube removal to all women “who are undergoing pelvic surgeries for benign conditions,” irrespective of what perceived risk they have of developing ovarian cancer (for example, based on family history).

But this advice has been in place for years for women who are known to be at higher risk for the disease.

For instance, women at high risk for ovarian cancer based on Hereditary Breast and Ovarian Cancer Syndrome (HBOC) have long been recommended to undergo surgery to remove ovaries and fallopian tubes (risk-reducing bilateral salpingo-oophorectomy or RRBSO) once there is no longer a desire for pregnancy.

Approached for comment about the new messaging, Stephanie V. Blank, MD, president of the Society of Gynecologic Oncology, says that the new recommendation – that all women who are finished childbearing consider opportunistic salpingectomy at the time of other pelvic surgery for benign conditions – is “not aggressive.”

“It’s reasonable and makes sense,” Dr. Blank said in an interview.

And she pointed out that it’s actually not “new”; it is, however, getting “new attention” based on the disappointing U.K. screening study, said Dr. Blank, director of gynecologic oncology for the Mount Sinai Health System in New York and professor of gynecologic oncology at Icahn School of Medicine at Mount Sinai.

She noted that the procedure of opportunistic salpingectomy has been endorsed by SGO since 2013 and by the American College of Obstetricians and Gynecologists since 2015.

There is increasing evidence that most high-grade serous ovarian cancers arise from cells in the fallopian tubes, William Dahut, MD, chief scientific officer for the American Cancer Society, told this news organization.

“Indirect evidence suggests a fairly strong degree of risk reduction associated with opportunistic salpingectomy for the most prevalent type of ovarian cancer (serous), and some risk reduction of epithelial ovarian cancer. At this time, these discussions seem warranted,” Dr. Dahut said.

At this point, however, the fact that leading organizations advise “consideration” means that the evidence base has “not been judged to be sufficiently strong (in terms of what we can say about benefits and harms) to advise a direct recommendation for opportunistic salpingectomy,” Dr. Dahut added.

There is no current recommendation to have fallopian tubes removed as a stand-alone procedure, he pointed out. However, he commented that “the occasion of scheduled gynecologic surgery presents an opportunity to possibly reduce the risk of ovarian cancer without known adverse effects in women who have completed childbearing. Having the discussion seems to be justified by the current evidence,” Dr. Dahut said.

Deanna Gerber, MD, a gynecologic oncologist at NYU Langone Perlmutter Cancer Center-Long Island, agrees. “In women who are scheduled to have a gynecologic or pelvic procedure, clinicians should discuss the possibility of removing the fallopian tubes at that time. A salpingectomy is a relatively low-risk procedure and adds little time to the surgery,” Dr. Gerber said in an interview.

“Women should understand that there is still ongoing research on this topic, but this low-risk procedure may reduce their risk of developing an ovarian or fallopian tube cancer,” Dr. Gerber said.

OCRA also encourages all women (or anyone born with ovaries) to know their risk for ovarian cancer. To that end, the organization has launched a pilot program offering free, at-home genetic testing kits to people with a personal or family history of breast, ovarian, uterine, or colorectal cancer.

Ms. Moran, Dr. Blank, Dr. Dahut, and Dr. Gerber report no relevant financial relationships.

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

All women, regardless of their risk profile, should consider prophylactic removal of the fallopian tubes at the same time as other pelvic surgery once they are finished having children, the Ovarian Cancer Research Alliance has advised.

The recommendation, announced Feb. 1, replaces the decades-old focus on symptom awareness and early detection and follows “sobering and deeply disappointing” results from a large U.K. study published 2 years ago, the organization said.

That was the UK Collaborative Trial of Ovarian Cancer Screening published in The Lancet in 2021, which followed more than 200,000 women for a median 16 years. It showed that screening average-risk women with a CA-125 blood test and ultrasound does not reduce deaths from the disease, as reported at the time by this news organization.

“We all hoped that the trial would show that early detection was effective in changing mortality rates. When the results came out, it was very hard to accept,” Audra Moran, OCRA president and CEO, said in an interview.

“We have an obligation to let people know that symptom awareness and early detection will not save lives” but considering opportunistic salpingectomy “absolutely will,” said Ms. Moran. Hence the renewed call for women to consider having their fallopian tubes removed.  

What sounds new about this call is that the group is directing fallopian tube removal to all women “who are undergoing pelvic surgeries for benign conditions,” irrespective of what perceived risk they have of developing ovarian cancer (for example, based on family history).

But this advice has been in place for years for women who are known to be at higher risk for the disease.

For instance, women at high risk for ovarian cancer based on Hereditary Breast and Ovarian Cancer Syndrome (HBOC) have long been recommended to undergo surgery to remove ovaries and fallopian tubes (risk-reducing bilateral salpingo-oophorectomy or RRBSO) once there is no longer a desire for pregnancy.

Approached for comment about the new messaging, Stephanie V. Blank, MD, president of the Society of Gynecologic Oncology, says that the new recommendation – that all women who are finished childbearing consider opportunistic salpingectomy at the time of other pelvic surgery for benign conditions – is “not aggressive.”

“It’s reasonable and makes sense,” Dr. Blank said in an interview.

And she pointed out that it’s actually not “new”; it is, however, getting “new attention” based on the disappointing U.K. screening study, said Dr. Blank, director of gynecologic oncology for the Mount Sinai Health System in New York and professor of gynecologic oncology at Icahn School of Medicine at Mount Sinai.

She noted that the procedure of opportunistic salpingectomy has been endorsed by SGO since 2013 and by the American College of Obstetricians and Gynecologists since 2015.

There is increasing evidence that most high-grade serous ovarian cancers arise from cells in the fallopian tubes, William Dahut, MD, chief scientific officer for the American Cancer Society, told this news organization.

“Indirect evidence suggests a fairly strong degree of risk reduction associated with opportunistic salpingectomy for the most prevalent type of ovarian cancer (serous), and some risk reduction of epithelial ovarian cancer. At this time, these discussions seem warranted,” Dr. Dahut said.

At this point, however, the fact that leading organizations advise “consideration” means that the evidence base has “not been judged to be sufficiently strong (in terms of what we can say about benefits and harms) to advise a direct recommendation for opportunistic salpingectomy,” Dr. Dahut added.

There is no current recommendation to have fallopian tubes removed as a stand-alone procedure, he pointed out. However, he commented that “the occasion of scheduled gynecologic surgery presents an opportunity to possibly reduce the risk of ovarian cancer without known adverse effects in women who have completed childbearing. Having the discussion seems to be justified by the current evidence,” Dr. Dahut said.

Deanna Gerber, MD, a gynecologic oncologist at NYU Langone Perlmutter Cancer Center-Long Island, agrees. “In women who are scheduled to have a gynecologic or pelvic procedure, clinicians should discuss the possibility of removing the fallopian tubes at that time. A salpingectomy is a relatively low-risk procedure and adds little time to the surgery,” Dr. Gerber said in an interview.

“Women should understand that there is still ongoing research on this topic, but this low-risk procedure may reduce their risk of developing an ovarian or fallopian tube cancer,” Dr. Gerber said.

OCRA also encourages all women (or anyone born with ovaries) to know their risk for ovarian cancer. To that end, the organization has launched a pilot program offering free, at-home genetic testing kits to people with a personal or family history of breast, ovarian, uterine, or colorectal cancer.

Ms. Moran, Dr. Blank, Dr. Dahut, and Dr. Gerber report no relevant financial relationships.

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

Gout-associated genetic factors increase the risk of gout by nearly two and a half times among people with a close family history of the disease. The risk is approximately three times higher among people with a family history of gout who are also heavy drinkers; for people with a family history of gout who are also overweight, the risk is four times higher, according to a large population-based study from South Korea.

The increased familial risk of gout (hazard ratio, 2.42) dropped only slightly after adjustment for lifestyle and biological risk factors (HR, 2.29), suggesting that genes are the key drivers for the risk of gout among first-degree relatives.

Robert Kirk/iStock/Getty Images Plus

Risk was highest among individuals with an affected brother (HR, 3.00), followed by father (HR, 2.33), sister (HR, 1.97), and mother (HR, 1.68).

“Although the familial aggregation of gout [where a first-degree relative has the disease] is influenced by both genetic and lifestyle/biological factors, our findings suggest that a genetic predisposition is the predominant driver of familial aggregation,” first author Kyoung-Hoon Kim, PhD, from Health Insurance Review and Assessment Service, Wonju-si, South Korea, and colleagues wrote in Arthritis Care and Research.

However, lifestyle is still important, as suggested by comparisons with members of the general population who do not have a family history of gout or a high body mass index (BMI). The risk increased for persons with a family history of gout who were also overweight (HR, 4.39), and it increased further for people with obesity (HR, 6.62), suggesting a dose-response interaction, the authors wrote.

When family history was combined with heavy alcohol consumption, the risk rose (HR, 2.95) in comparison with the general population who had neither risk factor.

The study fills a gap in evidence on “familial risk of gout as opposed to hereditary risk of gout, which has long been recognized,” the researchers wrote.

In addition, the findings suggest the possibility of a dose-dependent gene-environment interaction, “as the combination of both a family history of gout and either high BMI or heavy alcohol consumption was associated with a markedly increased risk of disease, which was even further elevated among obese individuals.”

Abhishek Abhishek, MD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust, reflected on the minimal attenuation after adjustment for lifestyle and demographic factors. “This suggests that most of the familial impact is, in fact, genetic rather than due to shared environmental factors and is an important finding.”

He said in an interview that the findings also confirmed the synergistic effect of genetic and lifestyle factors in causing gout. “Lifestyle factors such as alcohol excess and obesity should be addressed more aggressively in those with a first-degree relative with gout.

“Although not directly evaluated in this study, aggressive management of excess weight and high alcohol consumption may prevent the onset of gout or improve its outcomes in those who already have this condition,” he added.
 

Study of over 5 million individuals with familial aggregation of gout

The researchers drew on data from the government-operated mandatory insurance service that provides for South Korea’s entire population of over 50 million people (the National Health Insurance database), as well as the National Health Screening Program database. Information on familial relationships and risk factor data were identified for 5,524,403 individuals from 2002 to 2018 who had a blood-related first-degree relative.

Familial risk was calculated by comparing the risk of individuals with and those without affected first-degree relatives. Interactions between family history and obesity or alcohol consumption were assessed using a scale that measured gout risk due to interaction of two factors.

Initially, adjustments to familial risk were made with respect to age and sex. Subsequently, possible risk factors included smoking, BMI, hypertension, and hyperglycemia.

Alcohol consumption levels were noted and categorized as nondrinker, moderate drinker, or heavy drinker, with different consumption levels for men and women. For men, heavy drinking was defined as having at least two drinks per week and at least five drinks on any day; for women, heavy drinking was defined as having at least two drinks per week and at least four drinks on any day.

Overweight and obesity were determined on the basis of BMI, using standard categories: overweight was defined as BMI of 25 to less than 30 kg/m2, and obesity was defined as BMI of 30 or higher.

Dr. Kim and coauthors noted that both high BMI and heavy drinking were associated with an increased risk of gout, regardless of whether there was a family history of the disease, and that the findings suggest “a dose-dependent interactive relationship in which genetic factors and obesity potentiate each other rather than operating independently.”

People who are both overweight and have a family history of disease had a combined risk of gout that was significantly higher than the sum of their individual risk factors (HR, 4.39 vs. 3.43). This risk was accentuated among people with obesity (HR, 6.62 vs. 4.74) and was more pronounced in men than in women.

In other risk analyses in which familial and nonfamilial gout risk groups were compared, the risk associated with obesity was higher in the familial, compared with the nonfamilial group (HR, 5.50 vs. 5.36).

Bruce Rothschild, MD, a rheumatologist with Indiana University Health, Muncie, and research associate at Carnegie Museum of Natural History, Pittsburgh, shared his thoughts on the study in an interview and noted some limitations. “The findings of this study do not conflict with what is generally believed, but there are several issues that complicate interpretation,” he began. “The first is how gout is diagnosed. Since crystal presence confirmation is rare in clinical practice, and by assumption of the database used, diagnosis is based on fulfillment of a certain number of criteria, one of which is hyperuricemia – this is not actual confirmation of diagnosis.”

He pointed out that the incidence of gout depends on who received treatment, and the study excluded those who were not receiving treatment and those who were not prescribed allopurinol or febuxostat. “Single parents were also excluded, and this may also have affected results.

“Overweight and obesity were not adjusted for age, and the interpretation is age dependent,” he added. “It really comes down to the way gout is diagnosed, and this is a worldwide problem because the diagnosis has been so dumbed down that we don’t really know what is claimed as gout.”

Dr. Kim and coauthors disclosed no relevant financial relationships. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadilla Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Rothschild disclosed no relevant financial relationships.

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

Gout-associated genetic factors increase the risk of gout by nearly two and a half times among people with a close family history of the disease. The risk is approximately three times higher among people with a family history of gout who are also heavy drinkers; for people with a family history of gout who are also overweight, the risk is four times higher, according to a large population-based study from South Korea.

The increased familial risk of gout (hazard ratio, 2.42) dropped only slightly after adjustment for lifestyle and biological risk factors (HR, 2.29), suggesting that genes are the key drivers for the risk of gout among first-degree relatives.

Robert Kirk/iStock/Getty Images Plus

Risk was highest among individuals with an affected brother (HR, 3.00), followed by father (HR, 2.33), sister (HR, 1.97), and mother (HR, 1.68).

“Although the familial aggregation of gout [where a first-degree relative has the disease] is influenced by both genetic and lifestyle/biological factors, our findings suggest that a genetic predisposition is the predominant driver of familial aggregation,” first author Kyoung-Hoon Kim, PhD, from Health Insurance Review and Assessment Service, Wonju-si, South Korea, and colleagues wrote in Arthritis Care and Research.

However, lifestyle is still important, as suggested by comparisons with members of the general population who do not have a family history of gout or a high body mass index (BMI). The risk increased for persons with a family history of gout who were also overweight (HR, 4.39), and it increased further for people with obesity (HR, 6.62), suggesting a dose-response interaction, the authors wrote.

When family history was combined with heavy alcohol consumption, the risk rose (HR, 2.95) in comparison with the general population who had neither risk factor.

The study fills a gap in evidence on “familial risk of gout as opposed to hereditary risk of gout, which has long been recognized,” the researchers wrote.

In addition, the findings suggest the possibility of a dose-dependent gene-environment interaction, “as the combination of both a family history of gout and either high BMI or heavy alcohol consumption was associated with a markedly increased risk of disease, which was even further elevated among obese individuals.”

Abhishek Abhishek, MD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust, reflected on the minimal attenuation after adjustment for lifestyle and demographic factors. “This suggests that most of the familial impact is, in fact, genetic rather than due to shared environmental factors and is an important finding.”

He said in an interview that the findings also confirmed the synergistic effect of genetic and lifestyle factors in causing gout. “Lifestyle factors such as alcohol excess and obesity should be addressed more aggressively in those with a first-degree relative with gout.

“Although not directly evaluated in this study, aggressive management of excess weight and high alcohol consumption may prevent the onset of gout or improve its outcomes in those who already have this condition,” he added.
 

Study of over 5 million individuals with familial aggregation of gout

The researchers drew on data from the government-operated mandatory insurance service that provides for South Korea’s entire population of over 50 million people (the National Health Insurance database), as well as the National Health Screening Program database. Information on familial relationships and risk factor data were identified for 5,524,403 individuals from 2002 to 2018 who had a blood-related first-degree relative.

Familial risk was calculated by comparing the risk of individuals with and those without affected first-degree relatives. Interactions between family history and obesity or alcohol consumption were assessed using a scale that measured gout risk due to interaction of two factors.

Initially, adjustments to familial risk were made with respect to age and sex. Subsequently, possible risk factors included smoking, BMI, hypertension, and hyperglycemia.

Alcohol consumption levels were noted and categorized as nondrinker, moderate drinker, or heavy drinker, with different consumption levels for men and women. For men, heavy drinking was defined as having at least two drinks per week and at least five drinks on any day; for women, heavy drinking was defined as having at least two drinks per week and at least four drinks on any day.

Overweight and obesity were determined on the basis of BMI, using standard categories: overweight was defined as BMI of 25 to less than 30 kg/m2, and obesity was defined as BMI of 30 or higher.

Dr. Kim and coauthors noted that both high BMI and heavy drinking were associated with an increased risk of gout, regardless of whether there was a family history of the disease, and that the findings suggest “a dose-dependent interactive relationship in which genetic factors and obesity potentiate each other rather than operating independently.”

People who are both overweight and have a family history of disease had a combined risk of gout that was significantly higher than the sum of their individual risk factors (HR, 4.39 vs. 3.43). This risk was accentuated among people with obesity (HR, 6.62 vs. 4.74) and was more pronounced in men than in women.

In other risk analyses in which familial and nonfamilial gout risk groups were compared, the risk associated with obesity was higher in the familial, compared with the nonfamilial group (HR, 5.50 vs. 5.36).

Bruce Rothschild, MD, a rheumatologist with Indiana University Health, Muncie, and research associate at Carnegie Museum of Natural History, Pittsburgh, shared his thoughts on the study in an interview and noted some limitations. “The findings of this study do not conflict with what is generally believed, but there are several issues that complicate interpretation,” he began. “The first is how gout is diagnosed. Since crystal presence confirmation is rare in clinical practice, and by assumption of the database used, diagnosis is based on fulfillment of a certain number of criteria, one of which is hyperuricemia – this is not actual confirmation of diagnosis.”

He pointed out that the incidence of gout depends on who received treatment, and the study excluded those who were not receiving treatment and those who were not prescribed allopurinol or febuxostat. “Single parents were also excluded, and this may also have affected results.

“Overweight and obesity were not adjusted for age, and the interpretation is age dependent,” he added. “It really comes down to the way gout is diagnosed, and this is a worldwide problem because the diagnosis has been so dumbed down that we don’t really know what is claimed as gout.”

Dr. Kim and coauthors disclosed no relevant financial relationships. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadilla Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Rothschild disclosed no relevant financial relationships.

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

Gout-associated genetic factors increase the risk of gout by nearly two and a half times among people with a close family history of the disease. The risk is approximately three times higher among people with a family history of gout who are also heavy drinkers; for people with a family history of gout who are also overweight, the risk is four times higher, according to a large population-based study from South Korea.

The increased familial risk of gout (hazard ratio, 2.42) dropped only slightly after adjustment for lifestyle and biological risk factors (HR, 2.29), suggesting that genes are the key drivers for the risk of gout among first-degree relatives.

Robert Kirk/iStock/Getty Images Plus

Risk was highest among individuals with an affected brother (HR, 3.00), followed by father (HR, 2.33), sister (HR, 1.97), and mother (HR, 1.68).

“Although the familial aggregation of gout [where a first-degree relative has the disease] is influenced by both genetic and lifestyle/biological factors, our findings suggest that a genetic predisposition is the predominant driver of familial aggregation,” first author Kyoung-Hoon Kim, PhD, from Health Insurance Review and Assessment Service, Wonju-si, South Korea, and colleagues wrote in Arthritis Care and Research.

However, lifestyle is still important, as suggested by comparisons with members of the general population who do not have a family history of gout or a high body mass index (BMI). The risk increased for persons with a family history of gout who were also overweight (HR, 4.39), and it increased further for people with obesity (HR, 6.62), suggesting a dose-response interaction, the authors wrote.

When family history was combined with heavy alcohol consumption, the risk rose (HR, 2.95) in comparison with the general population who had neither risk factor.

The study fills a gap in evidence on “familial risk of gout as opposed to hereditary risk of gout, which has long been recognized,” the researchers wrote.

In addition, the findings suggest the possibility of a dose-dependent gene-environment interaction, “as the combination of both a family history of gout and either high BMI or heavy alcohol consumption was associated with a markedly increased risk of disease, which was even further elevated among obese individuals.”

Abhishek Abhishek, MD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust, reflected on the minimal attenuation after adjustment for lifestyle and demographic factors. “This suggests that most of the familial impact is, in fact, genetic rather than due to shared environmental factors and is an important finding.”

He said in an interview that the findings also confirmed the synergistic effect of genetic and lifestyle factors in causing gout. “Lifestyle factors such as alcohol excess and obesity should be addressed more aggressively in those with a first-degree relative with gout.

“Although not directly evaluated in this study, aggressive management of excess weight and high alcohol consumption may prevent the onset of gout or improve its outcomes in those who already have this condition,” he added.
 

Study of over 5 million individuals with familial aggregation of gout

The researchers drew on data from the government-operated mandatory insurance service that provides for South Korea’s entire population of over 50 million people (the National Health Insurance database), as well as the National Health Screening Program database. Information on familial relationships and risk factor data were identified for 5,524,403 individuals from 2002 to 2018 who had a blood-related first-degree relative.

Familial risk was calculated by comparing the risk of individuals with and those without affected first-degree relatives. Interactions between family history and obesity or alcohol consumption were assessed using a scale that measured gout risk due to interaction of two factors.

Initially, adjustments to familial risk were made with respect to age and sex. Subsequently, possible risk factors included smoking, BMI, hypertension, and hyperglycemia.

Alcohol consumption levels were noted and categorized as nondrinker, moderate drinker, or heavy drinker, with different consumption levels for men and women. For men, heavy drinking was defined as having at least two drinks per week and at least five drinks on any day; for women, heavy drinking was defined as having at least two drinks per week and at least four drinks on any day.

Overweight and obesity were determined on the basis of BMI, using standard categories: overweight was defined as BMI of 25 to less than 30 kg/m2, and obesity was defined as BMI of 30 or higher.

Dr. Kim and coauthors noted that both high BMI and heavy drinking were associated with an increased risk of gout, regardless of whether there was a family history of the disease, and that the findings suggest “a dose-dependent interactive relationship in which genetic factors and obesity potentiate each other rather than operating independently.”

People who are both overweight and have a family history of disease had a combined risk of gout that was significantly higher than the sum of their individual risk factors (HR, 4.39 vs. 3.43). This risk was accentuated among people with obesity (HR, 6.62 vs. 4.74) and was more pronounced in men than in women.

In other risk analyses in which familial and nonfamilial gout risk groups were compared, the risk associated with obesity was higher in the familial, compared with the nonfamilial group (HR, 5.50 vs. 5.36).

Bruce Rothschild, MD, a rheumatologist with Indiana University Health, Muncie, and research associate at Carnegie Museum of Natural History, Pittsburgh, shared his thoughts on the study in an interview and noted some limitations. “The findings of this study do not conflict with what is generally believed, but there are several issues that complicate interpretation,” he began. “The first is how gout is diagnosed. Since crystal presence confirmation is rare in clinical practice, and by assumption of the database used, diagnosis is based on fulfillment of a certain number of criteria, one of which is hyperuricemia – this is not actual confirmation of diagnosis.”

He pointed out that the incidence of gout depends on who received treatment, and the study excluded those who were not receiving treatment and those who were not prescribed allopurinol or febuxostat. “Single parents were also excluded, and this may also have affected results.

“Overweight and obesity were not adjusted for age, and the interpretation is age dependent,” he added. “It really comes down to the way gout is diagnosed, and this is a worldwide problem because the diagnosis has been so dumbed down that we don’t really know what is claimed as gout.”

Dr. Kim and coauthors disclosed no relevant financial relationships. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadilla Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Rothschild disclosed no relevant financial relationships.

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

San Diego – Despite advances in dermoscopy and other techniques for diagnosing cutaneous melanoma, histology remains the gold standard.

“I don’t think that’s going to change in the short term,” Travis W. Blalock, MD, director of dermatologic surgery, Mohs micrographic surgery, and cutaneous oncology at Emory University, Atlanta, said at the annual Cutaneous Malignancy Update. “But I do think we can supplement that with other modalities that will improve the clinical examination and help dermatopathologists as they assess and evaluate these lesions,” he said, adding: “The reality is, histopathology, while it may be the gold standard, is not necessarily a consistently reproducible evaluation. That raises the question: What can we do better?”

Christoph Burgstedt/Science Photo Library/Getty Images

According to Dr. Blalock, the future may include more routine use of noninvasive genetic molecular assays to assist with the diagnostics challenges linked to the visual image and pattern recognition approach of detecting cutaneous melanoma. For example, a two-gene classification method based on LINC00518 and preferentially expressed antigen in melanoma (PRAME) gene expression was evaluated and validated in 555 pigmented lesions obtained noninvasively via adhesive patch biopsy.

“Today, you can pick up a kit from your local pharmacy that can tell you a bit about broad genetic susceptibilities,” he said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. He predicted that using adhesive patch biopsies to assess suspicious melanocytic lesions “is likely the wave of the future.” This may increase patient understanding “as to the types of risks they have, the different lesions they have, and minimize invasive disease, but it also will pose different challenges for us when it comes to deploying patient-centered health care. For example, in a patient with multiple different lesions, how are you going to keep track of them all?”

Dermoscopy

In Dr. Blalock’s clinical opinion, dermoscopy improves the sensitivity of human visual detection of melanoma and may allow detection before a lesion displays classical features described with the “ABCDE rule.” However, the learning curve for dermoscopy is steep, he added, and whether the technique should be considered a first-line tool or as a supplement to other methods of examining cutaneous lesions remains a matter of debate.

“Dermoscopy is our version of the stethoscope,” he said. “We need to figure out when we’re going to use it. Should we be using it all of the time or only some of the time? Based on the clinical setting, maybe it’s a personal choice, but this can be a helpful skill and art in your practice if you’re willing to take the time to learn.”

In 2007, the International Dermoscopy Society (IDS) established a proposal for the standardization and recommended criteria necessary to effectively convey dermoscopic findings to consulting physicians and colleagues. The document includes 10 points categorized as either recommended or optional for a standardized dermoscopy report.

“The first step is to assess the lesion to determine whether or not it’s melanocytic in the first place,” said Dr. Blalock. “There are many different features – the mile-high [global features] evaluation of the lesions – then more specific local features that may clue you in to specific diagnoses,” he noted. “Once we get past that first step of determining that a lesion is melanocytic, it’s not enough to stop there, because we don’t want to biopsy every single lesion that’s melanocytic,” so there is a need to determine which ones require intervention, which is where dermoscopy “gets trickier and a little more challenging.”

According to the IDS, a standard dermoscopy report should include the patient’s age, relevant history pertaining to the lesion, pertinent personal and family history (recommended); clinical description of the lesion (recommended); the two-step method of dermoscopy differentiating melanocytic from nonmelanocytic tumors (recommended); and the use of standardized terms to describe structures as defined by the Dermoscopy Consensus Report published in 2003.

For new terms, the document states, “it would be helpful” for the physician to provide a working definition (recommended); the dermoscopic algorithm used should be mentioned (optional); information on the imaging equipment and magnification (recommended); clinical and dermoscopic images of the tumor (recommended); a diagnosis or differential diagnosis (recommended); decision concerning management (recommended), and specific comments for the pathologist when excision and histopathologic examination are recommended (optional).

The 2007 IDS document also includes a proposed seven-point checklist to differentiate between benign and melanocytic lesions on dermoscopy. Three major criteria are worth two points each: The presence of an atypical pigment network, gray-blue areas (commonly known as the veil), and an atypical vascular pattern. Four minor criteria are worth one point each: Irregular streaks, irregular dots/globules, irregular pigmentation, and regression structures. A minimum total score of 3 is required to establish a diagnosis of melanoma.

Another diagnostic technique, digital mole mapping, involves the use of photography to detect new or changing lesions. Dr. Blalock described this approach as rife with limitations, including variations in quality, challenges of storing and maintaining records, cost, time required to evaluate them, and determining which patients are appropriate candidates.

Other techniques being evaluated include computer algorithms to help dermatologists determine the diagnosis of melanoma from dermoscopic images, electrical impedance spectroscopy for noninvasive evaluation of atypical pigmented lesions, and ultrasound for staging of cutaneous malignant tumors.

Ultimately, “I think we’ll have multiple tools in our belt,” Dr. Blalock said, adding, “How do we pull them out at the right time to improve the lives of our patients? Are we going to use ultrasound? Dermoscopy? Integrate them with some of the genetic findings?”

Dr. Blalock disclosed that he has served as a principal investigator for Castle Biosciences.

San Diego – Despite advances in dermoscopy and other techniques for diagnosing cutaneous melanoma, histology remains the gold standard.

“I don’t think that’s going to change in the short term,” Travis W. Blalock, MD, director of dermatologic surgery, Mohs micrographic surgery, and cutaneous oncology at Emory University, Atlanta, said at the annual Cutaneous Malignancy Update. “But I do think we can supplement that with other modalities that will improve the clinical examination and help dermatopathologists as they assess and evaluate these lesions,” he said, adding: “The reality is, histopathology, while it may be the gold standard, is not necessarily a consistently reproducible evaluation. That raises the question: What can we do better?”

Christoph Burgstedt/Science Photo Library/Getty Images

According to Dr. Blalock, the future may include more routine use of noninvasive genetic molecular assays to assist with the diagnostics challenges linked to the visual image and pattern recognition approach of detecting cutaneous melanoma. For example, a two-gene classification method based on LINC00518 and preferentially expressed antigen in melanoma (PRAME) gene expression was evaluated and validated in 555 pigmented lesions obtained noninvasively via adhesive patch biopsy.

“Today, you can pick up a kit from your local pharmacy that can tell you a bit about broad genetic susceptibilities,” he said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. He predicted that using adhesive patch biopsies to assess suspicious melanocytic lesions “is likely the wave of the future.” This may increase patient understanding “as to the types of risks they have, the different lesions they have, and minimize invasive disease, but it also will pose different challenges for us when it comes to deploying patient-centered health care. For example, in a patient with multiple different lesions, how are you going to keep track of them all?”

Dermoscopy

In Dr. Blalock’s clinical opinion, dermoscopy improves the sensitivity of human visual detection of melanoma and may allow detection before a lesion displays classical features described with the “ABCDE rule.” However, the learning curve for dermoscopy is steep, he added, and whether the technique should be considered a first-line tool or as a supplement to other methods of examining cutaneous lesions remains a matter of debate.

“Dermoscopy is our version of the stethoscope,” he said. “We need to figure out when we’re going to use it. Should we be using it all of the time or only some of the time? Based on the clinical setting, maybe it’s a personal choice, but this can be a helpful skill and art in your practice if you’re willing to take the time to learn.”

In 2007, the International Dermoscopy Society (IDS) established a proposal for the standardization and recommended criteria necessary to effectively convey dermoscopic findings to consulting physicians and colleagues. The document includes 10 points categorized as either recommended or optional for a standardized dermoscopy report.

“The first step is to assess the lesion to determine whether or not it’s melanocytic in the first place,” said Dr. Blalock. “There are many different features – the mile-high [global features] evaluation of the lesions – then more specific local features that may clue you in to specific diagnoses,” he noted. “Once we get past that first step of determining that a lesion is melanocytic, it’s not enough to stop there, because we don’t want to biopsy every single lesion that’s melanocytic,” so there is a need to determine which ones require intervention, which is where dermoscopy “gets trickier and a little more challenging.”

According to the IDS, a standard dermoscopy report should include the patient’s age, relevant history pertaining to the lesion, pertinent personal and family history (recommended); clinical description of the lesion (recommended); the two-step method of dermoscopy differentiating melanocytic from nonmelanocytic tumors (recommended); and the use of standardized terms to describe structures as defined by the Dermoscopy Consensus Report published in 2003.

For new terms, the document states, “it would be helpful” for the physician to provide a working definition (recommended); the dermoscopic algorithm used should be mentioned (optional); information on the imaging equipment and magnification (recommended); clinical and dermoscopic images of the tumor (recommended); a diagnosis or differential diagnosis (recommended); decision concerning management (recommended), and specific comments for the pathologist when excision and histopathologic examination are recommended (optional).

The 2007 IDS document also includes a proposed seven-point checklist to differentiate between benign and melanocytic lesions on dermoscopy. Three major criteria are worth two points each: The presence of an atypical pigment network, gray-blue areas (commonly known as the veil), and an atypical vascular pattern. Four minor criteria are worth one point each: Irregular streaks, irregular dots/globules, irregular pigmentation, and regression structures. A minimum total score of 3 is required to establish a diagnosis of melanoma.

Another diagnostic technique, digital mole mapping, involves the use of photography to detect new or changing lesions. Dr. Blalock described this approach as rife with limitations, including variations in quality, challenges of storing and maintaining records, cost, time required to evaluate them, and determining which patients are appropriate candidates.

Other techniques being evaluated include computer algorithms to help dermatologists determine the diagnosis of melanoma from dermoscopic images, electrical impedance spectroscopy for noninvasive evaluation of atypical pigmented lesions, and ultrasound for staging of cutaneous malignant tumors.

Ultimately, “I think we’ll have multiple tools in our belt,” Dr. Blalock said, adding, “How do we pull them out at the right time to improve the lives of our patients? Are we going to use ultrasound? Dermoscopy? Integrate them with some of the genetic findings?”

Dr. Blalock disclosed that he has served as a principal investigator for Castle Biosciences.

San Diego – Despite advances in dermoscopy and other techniques for diagnosing cutaneous melanoma, histology remains the gold standard.

“I don’t think that’s going to change in the short term,” Travis W. Blalock, MD, director of dermatologic surgery, Mohs micrographic surgery, and cutaneous oncology at Emory University, Atlanta, said at the annual Cutaneous Malignancy Update. “But I do think we can supplement that with other modalities that will improve the clinical examination and help dermatopathologists as they assess and evaluate these lesions,” he said, adding: “The reality is, histopathology, while it may be the gold standard, is not necessarily a consistently reproducible evaluation. That raises the question: What can we do better?”

Christoph Burgstedt/Science Photo Library/Getty Images

According to Dr. Blalock, the future may include more routine use of noninvasive genetic molecular assays to assist with the diagnostics challenges linked to the visual image and pattern recognition approach of detecting cutaneous melanoma. For example, a two-gene classification method based on LINC00518 and preferentially expressed antigen in melanoma (PRAME) gene expression was evaluated and validated in 555 pigmented lesions obtained noninvasively via adhesive patch biopsy.

“Today, you can pick up a kit from your local pharmacy that can tell you a bit about broad genetic susceptibilities,” he said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. He predicted that using adhesive patch biopsies to assess suspicious melanocytic lesions “is likely the wave of the future.” This may increase patient understanding “as to the types of risks they have, the different lesions they have, and minimize invasive disease, but it also will pose different challenges for us when it comes to deploying patient-centered health care. For example, in a patient with multiple different lesions, how are you going to keep track of them all?”

Dermoscopy

In Dr. Blalock’s clinical opinion, dermoscopy improves the sensitivity of human visual detection of melanoma and may allow detection before a lesion displays classical features described with the “ABCDE rule.” However, the learning curve for dermoscopy is steep, he added, and whether the technique should be considered a first-line tool or as a supplement to other methods of examining cutaneous lesions remains a matter of debate.

“Dermoscopy is our version of the stethoscope,” he said. “We need to figure out when we’re going to use it. Should we be using it all of the time or only some of the time? Based on the clinical setting, maybe it’s a personal choice, but this can be a helpful skill and art in your practice if you’re willing to take the time to learn.”

In 2007, the International Dermoscopy Society (IDS) established a proposal for the standardization and recommended criteria necessary to effectively convey dermoscopic findings to consulting physicians and colleagues. The document includes 10 points categorized as either recommended or optional for a standardized dermoscopy report.

“The first step is to assess the lesion to determine whether or not it’s melanocytic in the first place,” said Dr. Blalock. “There are many different features – the mile-high [global features] evaluation of the lesions – then more specific local features that may clue you in to specific diagnoses,” he noted. “Once we get past that first step of determining that a lesion is melanocytic, it’s not enough to stop there, because we don’t want to biopsy every single lesion that’s melanocytic,” so there is a need to determine which ones require intervention, which is where dermoscopy “gets trickier and a little more challenging.”

According to the IDS, a standard dermoscopy report should include the patient’s age, relevant history pertaining to the lesion, pertinent personal and family history (recommended); clinical description of the lesion (recommended); the two-step method of dermoscopy differentiating melanocytic from nonmelanocytic tumors (recommended); and the use of standardized terms to describe structures as defined by the Dermoscopy Consensus Report published in 2003.

For new terms, the document states, “it would be helpful” for the physician to provide a working definition (recommended); the dermoscopic algorithm used should be mentioned (optional); information on the imaging equipment and magnification (recommended); clinical and dermoscopic images of the tumor (recommended); a diagnosis or differential diagnosis (recommended); decision concerning management (recommended), and specific comments for the pathologist when excision and histopathologic examination are recommended (optional).

The 2007 IDS document also includes a proposed seven-point checklist to differentiate between benign and melanocytic lesions on dermoscopy. Three major criteria are worth two points each: The presence of an atypical pigment network, gray-blue areas (commonly known as the veil), and an atypical vascular pattern. Four minor criteria are worth one point each: Irregular streaks, irregular dots/globules, irregular pigmentation, and regression structures. A minimum total score of 3 is required to establish a diagnosis of melanoma.

Another diagnostic technique, digital mole mapping, involves the use of photography to detect new or changing lesions. Dr. Blalock described this approach as rife with limitations, including variations in quality, challenges of storing and maintaining records, cost, time required to evaluate them, and determining which patients are appropriate candidates.

Other techniques being evaluated include computer algorithms to help dermatologists determine the diagnosis of melanoma from dermoscopic images, electrical impedance spectroscopy for noninvasive evaluation of atypical pigmented lesions, and ultrasound for staging of cutaneous malignant tumors.

Ultimately, “I think we’ll have multiple tools in our belt,” Dr. Blalock said, adding, “How do we pull them out at the right time to improve the lives of our patients? Are we going to use ultrasound? Dermoscopy? Integrate them with some of the genetic findings?”

Dr. Blalock disclosed that he has served as a principal investigator for Castle Biosciences.

Measures enacted in the early days of the COVID-19 pandemic to increase access to buprenorphine did not lead to an increase in the proportion of overdose deaths involving the drug, new research suggests.

Researchers say the data add weight to the argument for permanently adopting the pandemic-era prescribing regulations for buprenorphine, a treatment for opioid use disorder.

“We saw no evidence that increased availability of buprenorphine through the loosening of rules around prescribing and dispensing of buprenorphine during the pandemic increased overdose deaths,” investigator Wilson Compton, MD, deputy director of the National Institute on Drug Abuse, told this news organization.

“This is reassuring that, even when we opened up the doors to easier access to buprenorphine, we didn’t see that most serious consequence,” Dr. Compton said.

The findings were published online in JAMA Network Open .
 

Cause and effect

Federal agencies relaxed prescribing regulations for buprenorphine in March 2020 to make it easier for clinicians to prescribe the drug via telemedicine and for patients to take the medication at home.

The number of buprenorphine prescriptions has increased since that change, with more than 1 million people receiving the medication in 2021 from retail pharmacies in the United States.

However, questions remained about whether increased access would lead to an increase in buprenorphine-involved overdose.

Researchers with NIDA and the Centers for Disease Control and Prevention analyzed data from the State Unintentional Drug Overdose Reporting System, a CDC database that combines medical examiner and coroner reports and postmortem toxicology testing.

The study included information about overdose deaths from July 2019 to June 2021 in 46 states and the District of Columbia.

Between July 2019 and June 2021, there were 1,955 buprenorphine-involved overdose deaths, which accounted for 2.2% of all drug overdose deaths and 2.6% of opioid-involved overdose deaths.

However, researchers went beyond overall numbers and evaluated details from coroner’s and medical examiner reports, something they had not done before.

“For the first time we looked at the characteristics of decedents from buprenorphine because this has not been studied in this type of detail with a near-national sample,” Dr. Compton said.

“That allowed us to look at patterns of use of other substances as well as the circumstances that are recorded at the death scene that are in the data set,” he added.
 

Important insights

Reports from nearly all buprenorphine-involved deaths included the presence of at least one other drug, compared with opioid overdose deaths that typically involved only one drug.

“This is consistent with the pharmacology of buprenorphine being a partial agonist, so it may not be as fatal all by itself as some of the other opioids,” Dr. Compton said.

Deaths involving buprenorphine were less likely to include illicitly manufactured fentanyls, and other prescription medications were more often found on the scene, such as antidepressants.

Compared with opioid decedents, buprenorphine decedents were more likely to be women, age 35-44, White, and receiving treatment for mental health conditions, including for substance use disorder (SUD).

These kinds of characteristics provide important insights about potential ways to improve safety and clinical outcomes, Dr. Compton noted.

“When we see things like a little higher rate of SUD treatment and this evidence of other prescription drugs on the scene, and some higher rates of antidepressants in these decedents than I might have expected, I’m very curious about their use of other medical services outside of substance use treatment, because that might be a place where some interventions could be implemented,” he said.

A similar study showed pandemic-era policy changes that allowed methadone to be taken at home was followed by a decrease in methadone-related overdose deaths.

The new findings are consistent with those results, Dr. Compton said.
 

‘Chipping away’ at stigma

Commenting on the study, O. Trent Hall, DO, assistant professor of addiction medicine, Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, said that, although he welcomed the findings, they aren’t unexpected.

“Buprenorphine is well established as a safe and effective medication for opioid use disorder and as a physician who routinely cares for patients in the hospital after opioid overdose, I am not at all surprised by these results,” said Dr. Hall, who was not involved with the research.

“When my patients leave the hospital with a buprenorphine prescription, they are much less likely to return with another overdose or serious opioid-related medical problem,” he added.

U.S. drug overdose deaths topped 100,000 for the first time in 2021, and most were opioid-related. Although the latest data from the CDC shows drug overdose deaths have been declining slowly since early 2022, the numbers remain high.

Buprenorphine is one of only two drugs known to reduce the risk of opioid overdose. While prescriptions have increased since 2020, the medication remains underutilized, despite its known effectiveness in treating opioid use disorder.

Dr. Hall noted that research such as the new study could help increase buprenorphine’s use.

“Studies like this one chip away at the stigma that has been misapplied to buprenorphine,” he said. “I hope this article will encourage more providers to offer buprenorphine to patients with opioid use disorder.”

The study was funded internally by NIDA and the CDC. Dr. Compton reported owning stock in General Electric, 3M, and Pfizer outside the submitted work. Dr. Hall has disclosed no relevant financial relationships.

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

Measures enacted in the early days of the COVID-19 pandemic to increase access to buprenorphine did not lead to an increase in the proportion of overdose deaths involving the drug, new research suggests.

Researchers say the data add weight to the argument for permanently adopting the pandemic-era prescribing regulations for buprenorphine, a treatment for opioid use disorder.

“We saw no evidence that increased availability of buprenorphine through the loosening of rules around prescribing and dispensing of buprenorphine during the pandemic increased overdose deaths,” investigator Wilson Compton, MD, deputy director of the National Institute on Drug Abuse, told this news organization.

“This is reassuring that, even when we opened up the doors to easier access to buprenorphine, we didn’t see that most serious consequence,” Dr. Compton said.

The findings were published online in JAMA Network Open .
 

Cause and effect

Federal agencies relaxed prescribing regulations for buprenorphine in March 2020 to make it easier for clinicians to prescribe the drug via telemedicine and for patients to take the medication at home.

The number of buprenorphine prescriptions has increased since that change, with more than 1 million people receiving the medication in 2021 from retail pharmacies in the United States.

However, questions remained about whether increased access would lead to an increase in buprenorphine-involved overdose.

Researchers with NIDA and the Centers for Disease Control and Prevention analyzed data from the State Unintentional Drug Overdose Reporting System, a CDC database that combines medical examiner and coroner reports and postmortem toxicology testing.

The study included information about overdose deaths from July 2019 to June 2021 in 46 states and the District of Columbia.

Between July 2019 and June 2021, there were 1,955 buprenorphine-involved overdose deaths, which accounted for 2.2% of all drug overdose deaths and 2.6% of opioid-involved overdose deaths.

However, researchers went beyond overall numbers and evaluated details from coroner’s and medical examiner reports, something they had not done before.

“For the first time we looked at the characteristics of decedents from buprenorphine because this has not been studied in this type of detail with a near-national sample,” Dr. Compton said.

“That allowed us to look at patterns of use of other substances as well as the circumstances that are recorded at the death scene that are in the data set,” he added.
 

Important insights

Reports from nearly all buprenorphine-involved deaths included the presence of at least one other drug, compared with opioid overdose deaths that typically involved only one drug.

“This is consistent with the pharmacology of buprenorphine being a partial agonist, so it may not be as fatal all by itself as some of the other opioids,” Dr. Compton said.

Deaths involving buprenorphine were less likely to include illicitly manufactured fentanyls, and other prescription medications were more often found on the scene, such as antidepressants.

Compared with opioid decedents, buprenorphine decedents were more likely to be women, age 35-44, White, and receiving treatment for mental health conditions, including for substance use disorder (SUD).

These kinds of characteristics provide important insights about potential ways to improve safety and clinical outcomes, Dr. Compton noted.

“When we see things like a little higher rate of SUD treatment and this evidence of other prescription drugs on the scene, and some higher rates of antidepressants in these decedents than I might have expected, I’m very curious about their use of other medical services outside of substance use treatment, because that might be a place where some interventions could be implemented,” he said.

A similar study showed pandemic-era policy changes that allowed methadone to be taken at home was followed by a decrease in methadone-related overdose deaths.

The new findings are consistent with those results, Dr. Compton said.
 

‘Chipping away’ at stigma

Commenting on the study, O. Trent Hall, DO, assistant professor of addiction medicine, Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, said that, although he welcomed the findings, they aren’t unexpected.

“Buprenorphine is well established as a safe and effective medication for opioid use disorder and as a physician who routinely cares for patients in the hospital after opioid overdose, I am not at all surprised by these results,” said Dr. Hall, who was not involved with the research.

“When my patients leave the hospital with a buprenorphine prescription, they are much less likely to return with another overdose or serious opioid-related medical problem,” he added.

U.S. drug overdose deaths topped 100,000 for the first time in 2021, and most were opioid-related. Although the latest data from the CDC shows drug overdose deaths have been declining slowly since early 2022, the numbers remain high.

Buprenorphine is one of only two drugs known to reduce the risk of opioid overdose. While prescriptions have increased since 2020, the medication remains underutilized, despite its known effectiveness in treating opioid use disorder.

Dr. Hall noted that research such as the new study could help increase buprenorphine’s use.

“Studies like this one chip away at the stigma that has been misapplied to buprenorphine,” he said. “I hope this article will encourage more providers to offer buprenorphine to patients with opioid use disorder.”

The study was funded internally by NIDA and the CDC. Dr. Compton reported owning stock in General Electric, 3M, and Pfizer outside the submitted work. Dr. Hall has disclosed no relevant financial relationships.

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

Measures enacted in the early days of the COVID-19 pandemic to increase access to buprenorphine did not lead to an increase in the proportion of overdose deaths involving the drug, new research suggests.

Researchers say the data add weight to the argument for permanently adopting the pandemic-era prescribing regulations for buprenorphine, a treatment for opioid use disorder.

“We saw no evidence that increased availability of buprenorphine through the loosening of rules around prescribing and dispensing of buprenorphine during the pandemic increased overdose deaths,” investigator Wilson Compton, MD, deputy director of the National Institute on Drug Abuse, told this news organization.

“This is reassuring that, even when we opened up the doors to easier access to buprenorphine, we didn’t see that most serious consequence,” Dr. Compton said.

The findings were published online in JAMA Network Open .
 

Cause and effect

Federal agencies relaxed prescribing regulations for buprenorphine in March 2020 to make it easier for clinicians to prescribe the drug via telemedicine and for patients to take the medication at home.

The number of buprenorphine prescriptions has increased since that change, with more than 1 million people receiving the medication in 2021 from retail pharmacies in the United States.

However, questions remained about whether increased access would lead to an increase in buprenorphine-involved overdose.

Researchers with NIDA and the Centers for Disease Control and Prevention analyzed data from the State Unintentional Drug Overdose Reporting System, a CDC database that combines medical examiner and coroner reports and postmortem toxicology testing.

The study included information about overdose deaths from July 2019 to June 2021 in 46 states and the District of Columbia.

Between July 2019 and June 2021, there were 1,955 buprenorphine-involved overdose deaths, which accounted for 2.2% of all drug overdose deaths and 2.6% of opioid-involved overdose deaths.

However, researchers went beyond overall numbers and evaluated details from coroner’s and medical examiner reports, something they had not done before.

“For the first time we looked at the characteristics of decedents from buprenorphine because this has not been studied in this type of detail with a near-national sample,” Dr. Compton said.

“That allowed us to look at patterns of use of other substances as well as the circumstances that are recorded at the death scene that are in the data set,” he added.
 

Important insights

Reports from nearly all buprenorphine-involved deaths included the presence of at least one other drug, compared with opioid overdose deaths that typically involved only one drug.

“This is consistent with the pharmacology of buprenorphine being a partial agonist, so it may not be as fatal all by itself as some of the other opioids,” Dr. Compton said.

Deaths involving buprenorphine were less likely to include illicitly manufactured fentanyls, and other prescription medications were more often found on the scene, such as antidepressants.

Compared with opioid decedents, buprenorphine decedents were more likely to be women, age 35-44, White, and receiving treatment for mental health conditions, including for substance use disorder (SUD).

These kinds of characteristics provide important insights about potential ways to improve safety and clinical outcomes, Dr. Compton noted.

“When we see things like a little higher rate of SUD treatment and this evidence of other prescription drugs on the scene, and some higher rates of antidepressants in these decedents than I might have expected, I’m very curious about their use of other medical services outside of substance use treatment, because that might be a place where some interventions could be implemented,” he said.

A similar study showed pandemic-era policy changes that allowed methadone to be taken at home was followed by a decrease in methadone-related overdose deaths.

The new findings are consistent with those results, Dr. Compton said.
 

‘Chipping away’ at stigma

Commenting on the study, O. Trent Hall, DO, assistant professor of addiction medicine, Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, said that, although he welcomed the findings, they aren’t unexpected.

“Buprenorphine is well established as a safe and effective medication for opioid use disorder and as a physician who routinely cares for patients in the hospital after opioid overdose, I am not at all surprised by these results,” said Dr. Hall, who was not involved with the research.

“When my patients leave the hospital with a buprenorphine prescription, they are much less likely to return with another overdose or serious opioid-related medical problem,” he added.

U.S. drug overdose deaths topped 100,000 for the first time in 2021, and most were opioid-related. Although the latest data from the CDC shows drug overdose deaths have been declining slowly since early 2022, the numbers remain high.

Buprenorphine is one of only two drugs known to reduce the risk of opioid overdose. While prescriptions have increased since 2020, the medication remains underutilized, despite its known effectiveness in treating opioid use disorder.

Dr. Hall noted that research such as the new study could help increase buprenorphine’s use.

“Studies like this one chip away at the stigma that has been misapplied to buprenorphine,” he said. “I hope this article will encourage more providers to offer buprenorphine to patients with opioid use disorder.”

The study was funded internally by NIDA and the CDC. Dr. Compton reported owning stock in General Electric, 3M, and Pfizer outside the submitted work. Dr. Hall has disclosed no relevant financial relationships.

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

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

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

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

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

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

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

Physician recommendations for surveillance colonoscopies in older adults with prior adenomas vary based on several factors, including patient age, health, adenoma risk, and physician specialty, according to a national survey.

In general, physicians were more likely to recommend surveillance for patients at a younger age, with better health, and with prior high-risk adenomas. Additionally, a large proportion of physicians reported uncertainty about whether the benefits of continued surveillance outweighed the risk of harm in older adults.

“There are no existing surveillance colonoscopy guidelines that integrate patient age, health, and adenoma risk, and physicians report significant decisional uncertainty,” Nancy Schoenborn, MD, MHS, associate professor of medicine at Johns Hopkins University, Baltimore, and colleagues wrote.

“Developing the evidence base to evaluate the risks and benefits of surveillance colonoscopy in older adults and decisional support tools that help physicians and patients incorporate available data and weigh risks and benefits are needed to address current gaps in care for older adults with prior adenomas,” the authors wrote.

The study was published online in the American Journal of Gastroenterology.
 

Surveying physicians

National guidelines recommend surveillance colonoscopy after adenoma removal at more frequent intervals than screening colonoscopy because of a higher risk of colorectal cancer among patients with adenomas. The high quality of screening colonoscopies coupled with an aging population means that many older adults have a history of adenomas and continue to undergo surveillance colonoscopies, the authors wrote.

The benefit-harm balance becomes uncertain as potential harms from the procedure increase with age. However, there is no clear guidance on when to stop surveillance in older adults following adenoma detection, they wrote.

Dr. Schoenborn and colleagues conducted a national cross-sectional survey of 1,800 primary care physicians and 600 gastroenterologists between April and November 2021. The primary care group included internal medicine, family medicine, general practice, and geriatric medicine physicians.

The research team asked whether physicians would recommend surveillance colonoscopy in a series of 12 vignettes that varied by patient age (75 or 85), patient health (good, medium, or poor), and prior adenoma risk (low or high).

Good health was described as well-controlled hypertension and living independently, whereas moderate health was described as moderate heart failure and has difficulty walking, and poor health was described as severe chronic obstructive pulmonary disease on oxygenand requires help with self-care.

For prior adenomas, high risk involved five tubular adenomas, one of which was 15 mm, and low risk involved two tubular adenomas, both of which were less than 10 mm. The survey also noted that the recommended surveillance intervals were 3 years in the high-risk scenario and 7 years in the low-risk scenario.

Researchers mailed 2,400 surveys and received 1,040 responses. They included 874 in the analysis because the physician respondents provided care to patients ages 65 and older and spent time seeing patients in clinic. Decisions about surveillance colonoscopies for adenomas in the absence of symptoms almost always occur in the outpatient setting, rather than acute or urgent care, the authors wrote.
 

Large variations found

Overall, physicians were less likely to recommend surveillance colonoscopies if the patient was older, had poor health, and had lower-risk adenomas. Patient age and health had larger effects on decision-making than adenoma risk, with health status having the largest effect.

About 20.6% of physicians recommended surveillance if the patient was 85, compared with 49.8% if the patient was 75. In addition, 7.1% of physicians recommended surveillance if the patient was in poor health, compared with 28.8% for those in moderate health, and 67.7% for patients in good health.

If the prior adenoma was low risk, 29.7% of physicians recommended surveillance, compared with 41.6% if the prior adenoma was high risk.

In general, family medicine and general practice physicians were most likely to recommend surveillance, at 40%, and gastroenterologists were least likely to recommend surveillance, at 30.9%. Patient age and health had larger effects among gastroenterologists than among primary care physicians, and adenoma risk had similar effects between the two groups.

“The importance of patient age and health status found in our study mirrors study results on physician decision-making regarding screening colonoscopies in older adults and makes intuitive sense,” the authors wrote. “Whether the priorities reflected in our findings are supported by evidence is not clear, and our results highlight important knowledge gaps in the field that warrant future research.”
 

Physician uncertainty

Additional guidance would be helpful, the authors wrote. In the survey, about 52.3% of primary care physicians and 35.4% of gastroenterologists reported uncertainty about the benefit–harm balance of surveillance in older adults.

“Current guidelines on surveillance colonoscopies are solely based on prior adenoma characteristics,” the authors wrote. “Guidelines need to incorporate guidance that considers patient age and health status, as well as adenoma risk, and explicitly considers when surveillance should stop in older adults.”

In addition, most physicians in the survey – 85.9% of primary care physicians and 77% of gastroenterologists – said they would find a decision support tool helpful. At the same time, 32.8% of primary care physicians and 71.5% of gastroenterologists perceived it as the gastroenterologist’s role to decide about surveillance colonoscopies.

“Developing patient-facing materials, communication tools for clinicians, and tools to support shared decision-making about surveillance colonoscopies that engage both physicians and patients are all important next steps,” the authors wrote. “To our knowledge, there is no existing patient decision aid about surveillance colonoscopies; developing such a tool may be valuable.”

The study was supported by Dr. Schoenborn’s career development award from the National Institute on Aging. The authors reported no conflicts of interest.

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

Physician recommendations for surveillance colonoscopies in older adults with prior adenomas vary based on several factors, including patient age, health, adenoma risk, and physician specialty, according to a national survey.

In general, physicians were more likely to recommend surveillance for patients at a younger age, with better health, and with prior high-risk adenomas. Additionally, a large proportion of physicians reported uncertainty about whether the benefits of continued surveillance outweighed the risk of harm in older adults.

“There are no existing surveillance colonoscopy guidelines that integrate patient age, health, and adenoma risk, and physicians report significant decisional uncertainty,” Nancy Schoenborn, MD, MHS, associate professor of medicine at Johns Hopkins University, Baltimore, and colleagues wrote.

“Developing the evidence base to evaluate the risks and benefits of surveillance colonoscopy in older adults and decisional support tools that help physicians and patients incorporate available data and weigh risks and benefits are needed to address current gaps in care for older adults with prior adenomas,” the authors wrote.

The study was published online in the American Journal of Gastroenterology.
 

Surveying physicians

National guidelines recommend surveillance colonoscopy after adenoma removal at more frequent intervals than screening colonoscopy because of a higher risk of colorectal cancer among patients with adenomas. The high quality of screening colonoscopies coupled with an aging population means that many older adults have a history of adenomas and continue to undergo surveillance colonoscopies, the authors wrote.

The benefit-harm balance becomes uncertain as potential harms from the procedure increase with age. However, there is no clear guidance on when to stop surveillance in older adults following adenoma detection, they wrote.

Dr. Schoenborn and colleagues conducted a national cross-sectional survey of 1,800 primary care physicians and 600 gastroenterologists between April and November 2021. The primary care group included internal medicine, family medicine, general practice, and geriatric medicine physicians.

The research team asked whether physicians would recommend surveillance colonoscopy in a series of 12 vignettes that varied by patient age (75 or 85), patient health (good, medium, or poor), and prior adenoma risk (low or high).

Good health was described as well-controlled hypertension and living independently, whereas moderate health was described as moderate heart failure and has difficulty walking, and poor health was described as severe chronic obstructive pulmonary disease on oxygenand requires help with self-care.

For prior adenomas, high risk involved five tubular adenomas, one of which was 15 mm, and low risk involved two tubular adenomas, both of which were less than 10 mm. The survey also noted that the recommended surveillance intervals were 3 years in the high-risk scenario and 7 years in the low-risk scenario.

Researchers mailed 2,400 surveys and received 1,040 responses. They included 874 in the analysis because the physician respondents provided care to patients ages 65 and older and spent time seeing patients in clinic. Decisions about surveillance colonoscopies for adenomas in the absence of symptoms almost always occur in the outpatient setting, rather than acute or urgent care, the authors wrote.
 

Large variations found

Overall, physicians were less likely to recommend surveillance colonoscopies if the patient was older, had poor health, and had lower-risk adenomas. Patient age and health had larger effects on decision-making than adenoma risk, with health status having the largest effect.

About 20.6% of physicians recommended surveillance if the patient was 85, compared with 49.8% if the patient was 75. In addition, 7.1% of physicians recommended surveillance if the patient was in poor health, compared with 28.8% for those in moderate health, and 67.7% for patients in good health.

If the prior adenoma was low risk, 29.7% of physicians recommended surveillance, compared with 41.6% if the prior adenoma was high risk.

In general, family medicine and general practice physicians were most likely to recommend surveillance, at 40%, and gastroenterologists were least likely to recommend surveillance, at 30.9%. Patient age and health had larger effects among gastroenterologists than among primary care physicians, and adenoma risk had similar effects between the two groups.

“The importance of patient age and health status found in our study mirrors study results on physician decision-making regarding screening colonoscopies in older adults and makes intuitive sense,” the authors wrote. “Whether the priorities reflected in our findings are supported by evidence is not clear, and our results highlight important knowledge gaps in the field that warrant future research.”
 

Physician uncertainty

Additional guidance would be helpful, the authors wrote. In the survey, about 52.3% of primary care physicians and 35.4% of gastroenterologists reported uncertainty about the benefit–harm balance of surveillance in older adults.

“Current guidelines on surveillance colonoscopies are solely based on prior adenoma characteristics,” the authors wrote. “Guidelines need to incorporate guidance that considers patient age and health status, as well as adenoma risk, and explicitly considers when surveillance should stop in older adults.”

In addition, most physicians in the survey – 85.9% of primary care physicians and 77% of gastroenterologists – said they would find a decision support tool helpful. At the same time, 32.8% of primary care physicians and 71.5% of gastroenterologists perceived it as the gastroenterologist’s role to decide about surveillance colonoscopies.

“Developing patient-facing materials, communication tools for clinicians, and tools to support shared decision-making about surveillance colonoscopies that engage both physicians and patients are all important next steps,” the authors wrote. “To our knowledge, there is no existing patient decision aid about surveillance colonoscopies; developing such a tool may be valuable.”

The study was supported by Dr. Schoenborn’s career development award from the National Institute on Aging. The authors reported no conflicts of interest.

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

Physician recommendations for surveillance colonoscopies in older adults with prior adenomas vary based on several factors, including patient age, health, adenoma risk, and physician specialty, according to a national survey.

In general, physicians were more likely to recommend surveillance for patients at a younger age, with better health, and with prior high-risk adenomas. Additionally, a large proportion of physicians reported uncertainty about whether the benefits of continued surveillance outweighed the risk of harm in older adults.

“There are no existing surveillance colonoscopy guidelines that integrate patient age, health, and adenoma risk, and physicians report significant decisional uncertainty,” Nancy Schoenborn, MD, MHS, associate professor of medicine at Johns Hopkins University, Baltimore, and colleagues wrote.

“Developing the evidence base to evaluate the risks and benefits of surveillance colonoscopy in older adults and decisional support tools that help physicians and patients incorporate available data and weigh risks and benefits are needed to address current gaps in care for older adults with prior adenomas,” the authors wrote.

The study was published online in the American Journal of Gastroenterology.
 

Surveying physicians

National guidelines recommend surveillance colonoscopy after adenoma removal at more frequent intervals than screening colonoscopy because of a higher risk of colorectal cancer among patients with adenomas. The high quality of screening colonoscopies coupled with an aging population means that many older adults have a history of adenomas and continue to undergo surveillance colonoscopies, the authors wrote.

The benefit-harm balance becomes uncertain as potential harms from the procedure increase with age. However, there is no clear guidance on when to stop surveillance in older adults following adenoma detection, they wrote.

Dr. Schoenborn and colleagues conducted a national cross-sectional survey of 1,800 primary care physicians and 600 gastroenterologists between April and November 2021. The primary care group included internal medicine, family medicine, general practice, and geriatric medicine physicians.

The research team asked whether physicians would recommend surveillance colonoscopy in a series of 12 vignettes that varied by patient age (75 or 85), patient health (good, medium, or poor), and prior adenoma risk (low or high).

Good health was described as well-controlled hypertension and living independently, whereas moderate health was described as moderate heart failure and has difficulty walking, and poor health was described as severe chronic obstructive pulmonary disease on oxygenand requires help with self-care.

For prior adenomas, high risk involved five tubular adenomas, one of which was 15 mm, and low risk involved two tubular adenomas, both of which were less than 10 mm. The survey also noted that the recommended surveillance intervals were 3 years in the high-risk scenario and 7 years in the low-risk scenario.

Researchers mailed 2,400 surveys and received 1,040 responses. They included 874 in the analysis because the physician respondents provided care to patients ages 65 and older and spent time seeing patients in clinic. Decisions about surveillance colonoscopies for adenomas in the absence of symptoms almost always occur in the outpatient setting, rather than acute or urgent care, the authors wrote.
 

Large variations found

Overall, physicians were less likely to recommend surveillance colonoscopies if the patient was older, had poor health, and had lower-risk adenomas. Patient age and health had larger effects on decision-making than adenoma risk, with health status having the largest effect.

About 20.6% of physicians recommended surveillance if the patient was 85, compared with 49.8% if the patient was 75. In addition, 7.1% of physicians recommended surveillance if the patient was in poor health, compared with 28.8% for those in moderate health, and 67.7% for patients in good health.

If the prior adenoma was low risk, 29.7% of physicians recommended surveillance, compared with 41.6% if the prior adenoma was high risk.

In general, family medicine and general practice physicians were most likely to recommend surveillance, at 40%, and gastroenterologists were least likely to recommend surveillance, at 30.9%. Patient age and health had larger effects among gastroenterologists than among primary care physicians, and adenoma risk had similar effects between the two groups.

“The importance of patient age and health status found in our study mirrors study results on physician decision-making regarding screening colonoscopies in older adults and makes intuitive sense,” the authors wrote. “Whether the priorities reflected in our findings are supported by evidence is not clear, and our results highlight important knowledge gaps in the field that warrant future research.”
 

Physician uncertainty

Additional guidance would be helpful, the authors wrote. In the survey, about 52.3% of primary care physicians and 35.4% of gastroenterologists reported uncertainty about the benefit–harm balance of surveillance in older adults.

“Current guidelines on surveillance colonoscopies are solely based on prior adenoma characteristics,” the authors wrote. “Guidelines need to incorporate guidance that considers patient age and health status, as well as adenoma risk, and explicitly considers when surveillance should stop in older adults.”

In addition, most physicians in the survey – 85.9% of primary care physicians and 77% of gastroenterologists – said they would find a decision support tool helpful. At the same time, 32.8% of primary care physicians and 71.5% of gastroenterologists perceived it as the gastroenterologist’s role to decide about surveillance colonoscopies.

“Developing patient-facing materials, communication tools for clinicians, and tools to support shared decision-making about surveillance colonoscopies that engage both physicians and patients are all important next steps,” the authors wrote. “To our knowledge, there is no existing patient decision aid about surveillance colonoscopies; developing such a tool may be valuable.”

The study was supported by Dr. Schoenborn’s career development award from the National Institute on Aging. The authors reported no conflicts of interest.

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

Transcranial magnetic stimulation (TMS) is associated with both anxiolytic and antidepressant effects in patients with anxious depression, new research suggests.

In an analysis of data from more than 1,800 patients with a diagnosis of major depressive disorder (MDD), more than 75% also had anxiety. Following TMS, those with anxious depression showed reductions from baseline of at least 50% on anxiety and depression scores.

In addition, the anxious and nonanxious groups had equivalent absolute improvement in scores measuring depression.

“The ultimate message is that TMS is quite effective in the more difficult-to-treat and more disabled group of anxious depressives,” coinvestigator Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, and director of the Psychedelic Center of Excellence, Sheppard Pratt, Towson, Md., told this news organization.

The findings were published online in the Journal of Clinical Psychiatry.
 

Large cohort

Dr. Aaronson noted that between 50% and 75% of patients with depression also have significant anxiety symptoms.

“The presence of significant anxiety in a depressed person significantly increases depression symptom severity, functional impairment, chronicity, and suicidality,” he said.

In general, “when patients with anxious depression are identified in a treatment study, they are less likely to respond to the index treatment and are frequently excluded from some treatment trials,” he added.

Dr. Aaronson noted that previously reported outcomes from TMS for anxious depression have been “suggestive of efficacy but have not been well studied within a large cohort.” 

To investigate these issues, the current investigators turned to the NeuroStar Advanced Therapy System Clinical Outcomes Registry. It is the largest database of patients with difficult-to-treat depression, all of whom had undergone TMS.

This “extraordinary” database was able to provide previous insight into how often TMS works, whether some of the treatment parameters can be altered while still preserving efficacy, and whether bilateral TMS works better than unilateral TMS in patients with MDD, Dr. Aaronson said.

In the current study, researchers retrospectively analyzed data on 1,820 patients with MDD. All had completed the Patient Health Questinonaire–9 (PHQ-9) and the Generalized Anxiety Disorder–7 (GAD-7) at baseline and following at least one TMS intervention.

Most patients (n = 1,514) had anxious depression, defined as a baseline GAD-7 score of 10 or higher, and 306 had nonanxious depression, defined as a GAD-7 score below that threshold.

The investigators assessed the total sample of these patients who had been treated with any TMS protocol, as well as a subsample of patients (n = 625) who had been treated only with high-frequency left dorsolateral prefrontal cortex (HF-LUL) stimulation.

Patients were also subdivided into intent-to-treat and Completer samples (n = 1,820 and 1,429, respectively).
 

Consistent effects

There was no difference in gender distribution between the anxious and nonanxious group.

However, the anxious group was significantly younger (by about 5 years), compared with the nonanxious group. They also reported higher severity of depressive symptoms at baseline, with PHQ-9 scores approximately 2.5 points higher.

This was a “notable finding, since the PHQ-9 does not contain items directly assessing anxiety,” the researchers wrote.

There were also differences between the groups in the type of TMS protocol they received, with exclusive HF-LUL more common in the nonanxious depression group compared with other types of TMS protocols or unclassified protocols in the anxious depression group.

“Anxiolytic and antidepressant effects were consistent across the [intent-to-treat] and completed samples and patients who received any TMS protocol or only HF-LUL TMS,” the investigators reported.

GAD-7 scores “decreased markedly” in the anxious depression group. GAD-7 response rates ranged from 47.8% to 60.6% and GAD-7 remission rates ranged from 26.4% to 38.0% (P < .0001 for both).

There were no between-group differences in PHQ-9 scores in the magnitude of change pre- to post treatment. The anxious group scored about 2.5 points higher both pre- and post treatment, compared with the anxious group – with an effect size for change ranging from 1.46 to 1.74 in the anxious group and from 1.66 to 1.95 in the nonanxious group.
 

Response, remission rates

Notably, the anxious and nonanxious groups both showed “marked antidepressant effects,” with response and remission rates in the anxious group ranging from 55.2% to 66.8% and from 24.0% to 33.2%, respectively.

However, response and remission rates were significantly higher in the nonanxious versus the anxious group.

“Thus, despite manifesting the same degree of change in the PHQ-9 scores, the higher baseline and post-TMS scores in the anxious group resulted in significantly lower response and remission rates,” the investigators wrote.

They noted that the difference in post-TMS adjusted means was “small” and the groups also “did not differ in the absolute extent of symptoms improvement after multivariate adjustment.”

The relationship changes in the GAD-7 and the PHQ-9 scores “covaried” for the total IT sample (r1818 = 0.69, P < .001), although the relation was more “robust” in the anxious depression group versus the nonanxious depression group (r1512 = .75 vs. r304 = 0.50; P < .001 for both).

“The anxious depressed folks were sicker and had higher scores on scales capturing the severity of their illness,” Dr. Aaronson said. However, their “outcomes were similar, taking into account the higher baseline scores which had the effect of lowering the percent of anxious participants who met response and remission criteria.”

He reported that the average decline in depression rating scale scores was not significantly different between the groups, and the decline in depression scores tracked similarly to the decline in anxiety scores, “meaning they strongly covaried.”

The authors noted that a limitation was that, although the data was prospectively gathered, the analyses were retrospective.
 

Settles the debate?

Commenting on the study, Shan Siddiqi, MD, assistant professor of psychiatry at Harvard Medical School, Boston, said clinicians know that patients with comorbid anxiety are less likely to be referred for TMS, “probably because of the longstanding perception that TMS doesn’t work as well for them.”

courtesy Brigham and Women’s Medical Center

This perception “has persisted, despite several small studies to the contrary, perhaps because we know that these patients are less responsive to other treatments,” said Dr. Siddiqi, who is also director of psychiatric neuromodulation research at Brigham and Women’s Center for Brain Circuit Therapeutics in Boston. He was not involved with the current research.

“This new study will hopefully settle that debate and let us move on to a new question: How do we optimize the treatment for this important patient population that has largely been excluded from many of our prior studies?”  

The NeuroStar Advanced Therapy System Clinical Outcomes Registry, analysis of the registry data, and the drafting of this manuscript were supported by Neuronetics Inc. Dr. Aaronson serves as a scientific adviser to Genomind, LivaNova, Neuronetics, Janssen Pharmaceuticals, and Sage Therapeutics; and has received research support from Compass Pathways and Neuronetics. Dr. Siddiqi is a scientific consultant for Magnus Medical; a clinical consultant for Acacia Mental Health, Kaizen Brain Center, and Boston Precision Neurotherapeutics; and has received investigator-initiated research funding from Neuronetics and BrainsWay. He has also served as a speaker for BrainsWay and PsychU.org, owns stock in BrainsWay and Magnus Medical, and owns intellectual property involving the use of functional connectivity to target TMS.

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

Transcranial magnetic stimulation (TMS) is associated with both anxiolytic and antidepressant effects in patients with anxious depression, new research suggests.

In an analysis of data from more than 1,800 patients with a diagnosis of major depressive disorder (MDD), more than 75% also had anxiety. Following TMS, those with anxious depression showed reductions from baseline of at least 50% on anxiety and depression scores.

In addition, the anxious and nonanxious groups had equivalent absolute improvement in scores measuring depression.

“The ultimate message is that TMS is quite effective in the more difficult-to-treat and more disabled group of anxious depressives,” coinvestigator Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, and director of the Psychedelic Center of Excellence, Sheppard Pratt, Towson, Md., told this news organization.

The findings were published online in the Journal of Clinical Psychiatry.
 

Large cohort

Dr. Aaronson noted that between 50% and 75% of patients with depression also have significant anxiety symptoms.

“The presence of significant anxiety in a depressed person significantly increases depression symptom severity, functional impairment, chronicity, and suicidality,” he said.

In general, “when patients with anxious depression are identified in a treatment study, they are less likely to respond to the index treatment and are frequently excluded from some treatment trials,” he added.

Dr. Aaronson noted that previously reported outcomes from TMS for anxious depression have been “suggestive of efficacy but have not been well studied within a large cohort.” 

To investigate these issues, the current investigators turned to the NeuroStar Advanced Therapy System Clinical Outcomes Registry. It is the largest database of patients with difficult-to-treat depression, all of whom had undergone TMS.

This “extraordinary” database was able to provide previous insight into how often TMS works, whether some of the treatment parameters can be altered while still preserving efficacy, and whether bilateral TMS works better than unilateral TMS in patients with MDD, Dr. Aaronson said.

In the current study, researchers retrospectively analyzed data on 1,820 patients with MDD. All had completed the Patient Health Questinonaire–9 (PHQ-9) and the Generalized Anxiety Disorder–7 (GAD-7) at baseline and following at least one TMS intervention.

Most patients (n = 1,514) had anxious depression, defined as a baseline GAD-7 score of 10 or higher, and 306 had nonanxious depression, defined as a GAD-7 score below that threshold.

The investigators assessed the total sample of these patients who had been treated with any TMS protocol, as well as a subsample of patients (n = 625) who had been treated only with high-frequency left dorsolateral prefrontal cortex (HF-LUL) stimulation.

Patients were also subdivided into intent-to-treat and Completer samples (n = 1,820 and 1,429, respectively).
 

Consistent effects

There was no difference in gender distribution between the anxious and nonanxious group.

However, the anxious group was significantly younger (by about 5 years), compared with the nonanxious group. They also reported higher severity of depressive symptoms at baseline, with PHQ-9 scores approximately 2.5 points higher.

This was a “notable finding, since the PHQ-9 does not contain items directly assessing anxiety,” the researchers wrote.

There were also differences between the groups in the type of TMS protocol they received, with exclusive HF-LUL more common in the nonanxious depression group compared with other types of TMS protocols or unclassified protocols in the anxious depression group.

“Anxiolytic and antidepressant effects were consistent across the [intent-to-treat] and completed samples and patients who received any TMS protocol or only HF-LUL TMS,” the investigators reported.

GAD-7 scores “decreased markedly” in the anxious depression group. GAD-7 response rates ranged from 47.8% to 60.6% and GAD-7 remission rates ranged from 26.4% to 38.0% (P < .0001 for both).

There were no between-group differences in PHQ-9 scores in the magnitude of change pre- to post treatment. The anxious group scored about 2.5 points higher both pre- and post treatment, compared with the anxious group – with an effect size for change ranging from 1.46 to 1.74 in the anxious group and from 1.66 to 1.95 in the nonanxious group.
 

Response, remission rates

Notably, the anxious and nonanxious groups both showed “marked antidepressant effects,” with response and remission rates in the anxious group ranging from 55.2% to 66.8% and from 24.0% to 33.2%, respectively.

However, response and remission rates were significantly higher in the nonanxious versus the anxious group.

“Thus, despite manifesting the same degree of change in the PHQ-9 scores, the higher baseline and post-TMS scores in the anxious group resulted in significantly lower response and remission rates,” the investigators wrote.

They noted that the difference in post-TMS adjusted means was “small” and the groups also “did not differ in the absolute extent of symptoms improvement after multivariate adjustment.”

The relationship changes in the GAD-7 and the PHQ-9 scores “covaried” for the total IT sample (r1818 = 0.69, P < .001), although the relation was more “robust” in the anxious depression group versus the nonanxious depression group (r1512 = .75 vs. r304 = 0.50; P < .001 for both).

“The anxious depressed folks were sicker and had higher scores on scales capturing the severity of their illness,” Dr. Aaronson said. However, their “outcomes were similar, taking into account the higher baseline scores which had the effect of lowering the percent of anxious participants who met response and remission criteria.”

He reported that the average decline in depression rating scale scores was not significantly different between the groups, and the decline in depression scores tracked similarly to the decline in anxiety scores, “meaning they strongly covaried.”

The authors noted that a limitation was that, although the data was prospectively gathered, the analyses were retrospective.
 

Settles the debate?

Commenting on the study, Shan Siddiqi, MD, assistant professor of psychiatry at Harvard Medical School, Boston, said clinicians know that patients with comorbid anxiety are less likely to be referred for TMS, “probably because of the longstanding perception that TMS doesn’t work as well for them.”

courtesy Brigham and Women’s Medical Center

This perception “has persisted, despite several small studies to the contrary, perhaps because we know that these patients are less responsive to other treatments,” said Dr. Siddiqi, who is also director of psychiatric neuromodulation research at Brigham and Women’s Center for Brain Circuit Therapeutics in Boston. He was not involved with the current research.

“This new study will hopefully settle that debate and let us move on to a new question: How do we optimize the treatment for this important patient population that has largely been excluded from many of our prior studies?”  

The NeuroStar Advanced Therapy System Clinical Outcomes Registry, analysis of the registry data, and the drafting of this manuscript were supported by Neuronetics Inc. Dr. Aaronson serves as a scientific adviser to Genomind, LivaNova, Neuronetics, Janssen Pharmaceuticals, and Sage Therapeutics; and has received research support from Compass Pathways and Neuronetics. Dr. Siddiqi is a scientific consultant for Magnus Medical; a clinical consultant for Acacia Mental Health, Kaizen Brain Center, and Boston Precision Neurotherapeutics; and has received investigator-initiated research funding from Neuronetics and BrainsWay. He has also served as a speaker for BrainsWay and PsychU.org, owns stock in BrainsWay and Magnus Medical, and owns intellectual property involving the use of functional connectivity to target TMS.

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

Transcranial magnetic stimulation (TMS) is associated with both anxiolytic and antidepressant effects in patients with anxious depression, new research suggests.

In an analysis of data from more than 1,800 patients with a diagnosis of major depressive disorder (MDD), more than 75% also had anxiety. Following TMS, those with anxious depression showed reductions from baseline of at least 50% on anxiety and depression scores.

In addition, the anxious and nonanxious groups had equivalent absolute improvement in scores measuring depression.

“The ultimate message is that TMS is quite effective in the more difficult-to-treat and more disabled group of anxious depressives,” coinvestigator Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, and director of the Psychedelic Center of Excellence, Sheppard Pratt, Towson, Md., told this news organization.

The findings were published online in the Journal of Clinical Psychiatry.
 

Large cohort

Dr. Aaronson noted that between 50% and 75% of patients with depression also have significant anxiety symptoms.

“The presence of significant anxiety in a depressed person significantly increases depression symptom severity, functional impairment, chronicity, and suicidality,” he said.

In general, “when patients with anxious depression are identified in a treatment study, they are less likely to respond to the index treatment and are frequently excluded from some treatment trials,” he added.

Dr. Aaronson noted that previously reported outcomes from TMS for anxious depression have been “suggestive of efficacy but have not been well studied within a large cohort.” 

To investigate these issues, the current investigators turned to the NeuroStar Advanced Therapy System Clinical Outcomes Registry. It is the largest database of patients with difficult-to-treat depression, all of whom had undergone TMS.

This “extraordinary” database was able to provide previous insight into how often TMS works, whether some of the treatment parameters can be altered while still preserving efficacy, and whether bilateral TMS works better than unilateral TMS in patients with MDD, Dr. Aaronson said.

In the current study, researchers retrospectively analyzed data on 1,820 patients with MDD. All had completed the Patient Health Questinonaire–9 (PHQ-9) and the Generalized Anxiety Disorder–7 (GAD-7) at baseline and following at least one TMS intervention.

Most patients (n = 1,514) had anxious depression, defined as a baseline GAD-7 score of 10 or higher, and 306 had nonanxious depression, defined as a GAD-7 score below that threshold.

The investigators assessed the total sample of these patients who had been treated with any TMS protocol, as well as a subsample of patients (n = 625) who had been treated only with high-frequency left dorsolateral prefrontal cortex (HF-LUL) stimulation.

Patients were also subdivided into intent-to-treat and Completer samples (n = 1,820 and 1,429, respectively).
 

Consistent effects

There was no difference in gender distribution between the anxious and nonanxious group.

However, the anxious group was significantly younger (by about 5 years), compared with the nonanxious group. They also reported higher severity of depressive symptoms at baseline, with PHQ-9 scores approximately 2.5 points higher.

This was a “notable finding, since the PHQ-9 does not contain items directly assessing anxiety,” the researchers wrote.

There were also differences between the groups in the type of TMS protocol they received, with exclusive HF-LUL more common in the nonanxious depression group compared with other types of TMS protocols or unclassified protocols in the anxious depression group.

“Anxiolytic and antidepressant effects were consistent across the [intent-to-treat] and completed samples and patients who received any TMS protocol or only HF-LUL TMS,” the investigators reported.

GAD-7 scores “decreased markedly” in the anxious depression group. GAD-7 response rates ranged from 47.8% to 60.6% and GAD-7 remission rates ranged from 26.4% to 38.0% (P < .0001 for both).

There were no between-group differences in PHQ-9 scores in the magnitude of change pre- to post treatment. The anxious group scored about 2.5 points higher both pre- and post treatment, compared with the anxious group – with an effect size for change ranging from 1.46 to 1.74 in the anxious group and from 1.66 to 1.95 in the nonanxious group.
 

Response, remission rates

Notably, the anxious and nonanxious groups both showed “marked antidepressant effects,” with response and remission rates in the anxious group ranging from 55.2% to 66.8% and from 24.0% to 33.2%, respectively.

However, response and remission rates were significantly higher in the nonanxious versus the anxious group.

“Thus, despite manifesting the same degree of change in the PHQ-9 scores, the higher baseline and post-TMS scores in the anxious group resulted in significantly lower response and remission rates,” the investigators wrote.

They noted that the difference in post-TMS adjusted means was “small” and the groups also “did not differ in the absolute extent of symptoms improvement after multivariate adjustment.”

The relationship changes in the GAD-7 and the PHQ-9 scores “covaried” for the total IT sample (r1818 = 0.69, P < .001), although the relation was more “robust” in the anxious depression group versus the nonanxious depression group (r1512 = .75 vs. r304 = 0.50; P < .001 for both).

“The anxious depressed folks were sicker and had higher scores on scales capturing the severity of their illness,” Dr. Aaronson said. However, their “outcomes were similar, taking into account the higher baseline scores which had the effect of lowering the percent of anxious participants who met response and remission criteria.”

He reported that the average decline in depression rating scale scores was not significantly different between the groups, and the decline in depression scores tracked similarly to the decline in anxiety scores, “meaning they strongly covaried.”

The authors noted that a limitation was that, although the data was prospectively gathered, the analyses were retrospective.
 

Settles the debate?

Commenting on the study, Shan Siddiqi, MD, assistant professor of psychiatry at Harvard Medical School, Boston, said clinicians know that patients with comorbid anxiety are less likely to be referred for TMS, “probably because of the longstanding perception that TMS doesn’t work as well for them.”

courtesy Brigham and Women’s Medical Center

This perception “has persisted, despite several small studies to the contrary, perhaps because we know that these patients are less responsive to other treatments,” said Dr. Siddiqi, who is also director of psychiatric neuromodulation research at Brigham and Women’s Center for Brain Circuit Therapeutics in Boston. He was not involved with the current research.

“This new study will hopefully settle that debate and let us move on to a new question: How do we optimize the treatment for this important patient population that has largely been excluded from many of our prior studies?”  

The NeuroStar Advanced Therapy System Clinical Outcomes Registry, analysis of the registry data, and the drafting of this manuscript were supported by Neuronetics Inc. Dr. Aaronson serves as a scientific adviser to Genomind, LivaNova, Neuronetics, Janssen Pharmaceuticals, and Sage Therapeutics; and has received research support from Compass Pathways and Neuronetics. Dr. Siddiqi is a scientific consultant for Magnus Medical; a clinical consultant for Acacia Mental Health, Kaizen Brain Center, and Boston Precision Neurotherapeutics; and has received investigator-initiated research funding from Neuronetics and BrainsWay. He has also served as a speaker for BrainsWay and PsychU.org, owns stock in BrainsWay and Magnus Medical, and owns intellectual property involving the use of functional connectivity to target TMS.

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

Eight Navy sailors have died by suicide in less than a year. The most recent death was on January 23. Three sailors who died in the past 2 months have more than suicide in common: They were all stationed aboard Navy aircraft carriers undergoing refits: the USS George Washington and the USS Theodore Roosevelt. 

These deaths come only a month after the Navy released a report on 3 deaths by suicide on the George Washington, all of which happened in a single week last April. Military.com reported that the ship’s commander, Capt. Brent Gaut, had said 10 sailors had died by suicide in under a year. 

In November and December 2022, at least 4 sailors assigned to the Mid-Atlantic Regional Maintenance Center (MARMC) in Virginia died by suicide, multiplying concerns about a fleetwide mental health crisis. “I was inundated with the amount of hopelessness at that command,” Kayla Arestivo, a counselor brought in to help, told nbcnews.com. Sailors spoke of being overworked, undervalued, and not getting the mental health help they needed. “Part of it is toxic leadership. The sailors immediately pointed that out,” Arestivo said. 

She noted that many of the people assigned to MARMC are on limited duty due to mental or physical disabilities or have personal stressors that prevent them from full unrestricted duty. Electronics technician Kody Lee Decker, for instance, was on limited duty due to mental health issues when he died by suicide on October 29, 2022, according to a friend. Those people, Arestivo suggested, should have been provided help earlier.

Disabilities are not the only potential risk factors, though. Sailors living aboard the George Washington from April 2021 until April 2022 reported difficult and noisy living conditions with shortages of power, running water, and heat, and poor ventilation. Sailors would sleep in their cars or rent rooms in town rather than stay on board. 

The George Washington has been docked at Newport News [Virginia] Shipbuilding for a major overhaul and repairs since 2017 (expected to extend into 2023, nearly 2 years later than the original deadline). The Navy investigation acknowledged “overwhelming” stress and noted that the living conditions created by an “intense and complex” maintenance process were posing hardships for the sailors, including sleep deprivation. (The Theodore Roosevelt has been at the Puget Sound shipyard since August 2021, although none of the sailors live onboard.)

However, the Navy investigation concluded that the 3 April suicide deaths were not directly connected to living conditions. According to the US Fleet Forces Command, “each Sailor was experiencing unique and individualized life stressors, which were contributing factors leading to their deaths.” The 3 suicide deaths were deemed independent events, with no direct correlation among them.

But the report also charged that leaders were oblivious to the problems, and the mental health care the Navy offered was insufficient: “Multiple command members knew or should have known that MASR Mitchell-Sandor [who died by suicide] was experiencing displeasure with Navy life and could have intervened to help him better cope or seek out available support services.”

In the official response to the Navy report, Rear Adm. John Meier, Commander, Naval Air Force Atlantic, noted that he had convened a “second and broader investigation” to assess quality of life issues and other systemic issues for aircraft carriers undergoing extensive maintenance or construction in the Newport News shipyard. “It is safe to say,” he wrote, that “generations of Navy leaders had become accustomed to the reduced quality of life in the shipyard, and accepted the status quo as par for the course…” 

He agreed that the general stress of the environment was not the root cause of the deaths but was “certainly a contributing factor” in at least one case. The report, he said, placed too much emphasis on the sailor’s personal decisions to not improve his own living conditions (he was offered the opportunity to change berthing) and thus placed “too much burden on him for his situation.” Senior enlisted leadership knew that the sailor was sleeping in his car and counseled him, but Meier found no evidence of follow-through. More senior sailors or an assigned mentor should have been there to support the sailor, Meier said, and help him make decisions that were in his best interests. “This was a time for intrusive leadership.”

Adm. Daryl Caudle, Commander, US Fleet Forces Command, advised revising the wording in the report to say “No one at the command knew, or had a reason to know, of MASR [Xavier] Mitchell-Sandor’s previous suicidal ideations.” He also advised modifying the wording with: “Had the Navy been aware of MASR Mitchell-Sandor’s previous suicidal ideations, existing programs and procedures were in place that make it likely that he would have been placed in a ‘do not arm’ status and received necessary care.”

Vice Admiral Kenneth Whitesell, Commander, Naval Air Force, US Pacific Fleet, also endorsed the report findings with some revisions, saying, “We cannot assume these issues are isolated to a single ship, or to shipyards alone. Rather, these 3 tragic losses brought to light the ultimate need to remain laser-focused on providing care and guidance to our sailors.”

The Navy is providing mental health support to sailors, including an embedded mental health team and 2 civilian resiliency counselors who work on the George Washington. According to an action update in the report, Commander, Naval Air Force directed all CVNs and Naval Aviation Units to have a minimum of 1 safeTALK (Suicide Alertness For Everyone; Tell, Ask, Listen and KeepSafe) trained member onboard, and 2 to 3 safeTALK trained personnel in each division no later than December 31, 2022. 

At MARMC, Arestivo was brought in for several mandatory suicide prevention sessions but without systemic changes, she said, “We’re putting Band-Aids on bullet holes.”

She said she told MARMC’s commanding officer, “You will have another one.” The fourth sailor died by suicide 10 days later.

If you or someone you know is having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or contact the Veterans Crisis Line. 

Eight Navy sailors have died by suicide in less than a year. The most recent death was on January 23. Three sailors who died in the past 2 months have more than suicide in common: They were all stationed aboard Navy aircraft carriers undergoing refits: the USS George Washington and the USS Theodore Roosevelt. 

These deaths come only a month after the Navy released a report on 3 deaths by suicide on the George Washington, all of which happened in a single week last April. Military.com reported that the ship’s commander, Capt. Brent Gaut, had said 10 sailors had died by suicide in under a year. 

In November and December 2022, at least 4 sailors assigned to the Mid-Atlantic Regional Maintenance Center (MARMC) in Virginia died by suicide, multiplying concerns about a fleetwide mental health crisis. “I was inundated with the amount of hopelessness at that command,” Kayla Arestivo, a counselor brought in to help, told nbcnews.com. Sailors spoke of being overworked, undervalued, and not getting the mental health help they needed. “Part of it is toxic leadership. The sailors immediately pointed that out,” Arestivo said. 

She noted that many of the people assigned to MARMC are on limited duty due to mental or physical disabilities or have personal stressors that prevent them from full unrestricted duty. Electronics technician Kody Lee Decker, for instance, was on limited duty due to mental health issues when he died by suicide on October 29, 2022, according to a friend. Those people, Arestivo suggested, should have been provided help earlier.

Disabilities are not the only potential risk factors, though. Sailors living aboard the George Washington from April 2021 until April 2022 reported difficult and noisy living conditions with shortages of power, running water, and heat, and poor ventilation. Sailors would sleep in their cars or rent rooms in town rather than stay on board. 

The George Washington has been docked at Newport News [Virginia] Shipbuilding for a major overhaul and repairs since 2017 (expected to extend into 2023, nearly 2 years later than the original deadline). The Navy investigation acknowledged “overwhelming” stress and noted that the living conditions created by an “intense and complex” maintenance process were posing hardships for the sailors, including sleep deprivation. (The Theodore Roosevelt has been at the Puget Sound shipyard since August 2021, although none of the sailors live onboard.)

However, the Navy investigation concluded that the 3 April suicide deaths were not directly connected to living conditions. According to the US Fleet Forces Command, “each Sailor was experiencing unique and individualized life stressors, which were contributing factors leading to their deaths.” The 3 suicide deaths were deemed independent events, with no direct correlation among them.

But the report also charged that leaders were oblivious to the problems, and the mental health care the Navy offered was insufficient: “Multiple command members knew or should have known that MASR Mitchell-Sandor [who died by suicide] was experiencing displeasure with Navy life and could have intervened to help him better cope or seek out available support services.”

In the official response to the Navy report, Rear Adm. John Meier, Commander, Naval Air Force Atlantic, noted that he had convened a “second and broader investigation” to assess quality of life issues and other systemic issues for aircraft carriers undergoing extensive maintenance or construction in the Newport News shipyard. “It is safe to say,” he wrote, that “generations of Navy leaders had become accustomed to the reduced quality of life in the shipyard, and accepted the status quo as par for the course…” 

He agreed that the general stress of the environment was not the root cause of the deaths but was “certainly a contributing factor” in at least one case. The report, he said, placed too much emphasis on the sailor’s personal decisions to not improve his own living conditions (he was offered the opportunity to change berthing) and thus placed “too much burden on him for his situation.” Senior enlisted leadership knew that the sailor was sleeping in his car and counseled him, but Meier found no evidence of follow-through. More senior sailors or an assigned mentor should have been there to support the sailor, Meier said, and help him make decisions that were in his best interests. “This was a time for intrusive leadership.”

Adm. Daryl Caudle, Commander, US Fleet Forces Command, advised revising the wording in the report to say “No one at the command knew, or had a reason to know, of MASR [Xavier] Mitchell-Sandor’s previous suicidal ideations.” He also advised modifying the wording with: “Had the Navy been aware of MASR Mitchell-Sandor’s previous suicidal ideations, existing programs and procedures were in place that make it likely that he would have been placed in a ‘do not arm’ status and received necessary care.”

Vice Admiral Kenneth Whitesell, Commander, Naval Air Force, US Pacific Fleet, also endorsed the report findings with some revisions, saying, “We cannot assume these issues are isolated to a single ship, or to shipyards alone. Rather, these 3 tragic losses brought to light the ultimate need to remain laser-focused on providing care and guidance to our sailors.”

The Navy is providing mental health support to sailors, including an embedded mental health team and 2 civilian resiliency counselors who work on the George Washington. According to an action update in the report, Commander, Naval Air Force directed all CVNs and Naval Aviation Units to have a minimum of 1 safeTALK (Suicide Alertness For Everyone; Tell, Ask, Listen and KeepSafe) trained member onboard, and 2 to 3 safeTALK trained personnel in each division no later than December 31, 2022. 

At MARMC, Arestivo was brought in for several mandatory suicide prevention sessions but without systemic changes, she said, “We’re putting Band-Aids on bullet holes.”

She said she told MARMC’s commanding officer, “You will have another one.” The fourth sailor died by suicide 10 days later.

If you or someone you know is having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or contact the Veterans Crisis Line. 

Eight Navy sailors have died by suicide in less than a year. The most recent death was on January 23. Three sailors who died in the past 2 months have more than suicide in common: They were all stationed aboard Navy aircraft carriers undergoing refits: the USS George Washington and the USS Theodore Roosevelt. 

These deaths come only a month after the Navy released a report on 3 deaths by suicide on the George Washington, all of which happened in a single week last April. Military.com reported that the ship’s commander, Capt. Brent Gaut, had said 10 sailors had died by suicide in under a year. 

In November and December 2022, at least 4 sailors assigned to the Mid-Atlantic Regional Maintenance Center (MARMC) in Virginia died by suicide, multiplying concerns about a fleetwide mental health crisis. “I was inundated with the amount of hopelessness at that command,” Kayla Arestivo, a counselor brought in to help, told nbcnews.com. Sailors spoke of being overworked, undervalued, and not getting the mental health help they needed. “Part of it is toxic leadership. The sailors immediately pointed that out,” Arestivo said. 

She noted that many of the people assigned to MARMC are on limited duty due to mental or physical disabilities or have personal stressors that prevent them from full unrestricted duty. Electronics technician Kody Lee Decker, for instance, was on limited duty due to mental health issues when he died by suicide on October 29, 2022, according to a friend. Those people, Arestivo suggested, should have been provided help earlier.

Disabilities are not the only potential risk factors, though. Sailors living aboard the George Washington from April 2021 until April 2022 reported difficult and noisy living conditions with shortages of power, running water, and heat, and poor ventilation. Sailors would sleep in their cars or rent rooms in town rather than stay on board. 

The George Washington has been docked at Newport News [Virginia] Shipbuilding for a major overhaul and repairs since 2017 (expected to extend into 2023, nearly 2 years later than the original deadline). The Navy investigation acknowledged “overwhelming” stress and noted that the living conditions created by an “intense and complex” maintenance process were posing hardships for the sailors, including sleep deprivation. (The Theodore Roosevelt has been at the Puget Sound shipyard since August 2021, although none of the sailors live onboard.)