People with diabetes are at increased risk of hospitalization for infection, as well as infection-related mortality, shows a large U.S. study that suggests the risk is even higher in younger and Black individuals.

Michael Fang, PhD, Johns Hopkins University, Baltimore, and colleagues studied more than 12,000 participants in a community cohort study who were followed for an average of 24 years, between 1987-1989 and 2019.

Participants with diabetes faced a 67% increase risk of infection-related hospitalization, compared with those without diabetes.

Of particular note, the risk of hospitalization with foot infection was almost sixfold higher for people with diabetes than those without.

The research, published in Diabetologia on August 4, also suggests that diabetes may be associated with a 72% increased risk of infection-related mortality, although the absolute numbers were small.

Dr. Fang explained to this news organization that they focused on infection-related hospitalization and mortality “because these are comprehensively tracked in administrative data and ... are the most severe types of outcomes.”

However, this is probably just the tip of the iceberg, as people with diabetes are “likely at increased risk for milder infection too,” which can have a “significant adverse impact on people’s well-being and quality of life.”

As a result of their findings, the authors call for “broader guidance on infection prevention and management” in people with diabetes. To achieve this, Dr. Fang said, “we need to better understand why diabetes is associated with an increased risk of infection-related complications.”

“One likely factor is glycemic control: Emerging research suggests patients with diabetes with better glycemic control may be at significantly lower risk of infection-related complications.”

He continued that, in younger patients, a factor for worse outcomes could be that “diabetes tends to be more aggressive when it emerges early in life,” while in Black patients “there is research highlighting Black-White differences in glycemic control, access to care, and beliefs around vaccines.”

Overall, their findings – coupled with recent data showing that diabetes is an important risk factor for adverse outcomes with COVID-19 infection – paint “a common picture,” Dr. Fang said.

“People with diabetes are much more susceptible to infection-related complications, including COVID-related hospitalization and mortality,” which suggests people with diabetes “may need to be especially cautious.”
 

Adds to existing literature; amputations begin with infections

Robert A. Gabbay, MD, PhD, chief scientific and medical officer for the American Diabetes Association (ADA), said the study “does add to the existing literature by having followed a larger number of people over time and linking them to serious complications from infections.”

“Sadly, we have seen this play out in real-time during the COVID-19 pandemic.”

“One of the sobering bits of data is the significant health disparities that exist in Black Americans and the fact that foot infections remain a significant problem,” he said in an interview.

“Given that amputation rates for [Black Americans] are three times higher than White Americans, amputations begin with infections,” Dr. Gabbay added, noting the ADA “has been taking a strong stand to prevent amputations and address the inequities in health that exist.”

Jamie Hartmann-Boyce, PhD, from the University of Oxford, U.K., who was not involved in the study, commented that diabetes is a “well-known risk factor for worse outcomes from all kinds of infection,” which is why they “are prioritized for flu vaccination every year.”

She told this news organization that the current study “further confirms that people with diabetes are more likely to be hospitalized for infection of any type and most markedly for foot infection.”

“These new data further highlight the need for public health interventions to prevent type 2 diabetes, and for preventive health care in people with diabetes, including access to diabetes medications and support and to vaccinations to prevent infection,” added Dr. Hartmann-Boyce, who is a senior research fellow in health behaviors.

Diabetes is thought to be associated with susceptibility to infection via mechanisms such as impaired neutrophil functioning and humoral immune responses, and studies have shown a link with both common and rare infections.

However, the authors point out that “most” of those included “small clinical populations and were cross-sectional or had short follow-up.”

Guidelines for diabetes management, they note, also “pay less attention” to infectious diseases than they do to the prevention of micro- and macrovascular complications.
 

ARIC data mined for infections in those with diabetes

The team analyzed data from the ongoing U.S. community-based Atherosclerosis Risk in Communities (ARIC) study.

The National Heart, Lung, and Blood Institute–sponsored cohort was comprised of adults aged 45-64 years from four U.S. communities, recruited between 1987 and 1989 for clinical examinations, medical interviews, and laboratory tests, repeated over five more visits up to 2018-2019.

For the current analysis, the team included 12,739 individuals with a mean age of 54.5 years, of whom 54.3% were female and 24.7% were Black.

Patients were defined as having diabetes if their baseline fasting blood glucose was greater than or equal to 7 mmol/L, or nonfasting glucose was greater than or equal to 11.1 mmol/l, they self-reported a diagnosis of diabetes by a physician, or they were taking glucose-lowering medication at the first study visit. The researchers weren’t able to distinguish between type 1 and type 2 diabetes.

In total, 1,485 individuals had diabetes at baseline. They were more likely to be older, Black, have a low socioeconomic status, and have worse cardiometabolic health than participants without diabetes.

Over an average follow-up of 23.8 years, there were 4,229 incident hospitalizations for infection, at an overall rate of 15.9 per 1,000 person-years.

Individuals with diabetes at baseline had a higher rate of hospitalizations than those without, at 25.4 per 1,000 person-years versus 15.2 per 1,000 person-years.

After taking into account sociodemographic characteristics, socioeconomic status, and cardiometabolic risk factors, this equated to a hazard ratio for hospitalization with any infection of 1.67 (P < .001).

The risk of hospitalization for any infection was significantly higher for younger patients with diabetes, defined as aged less than 55 years (P = .005), and for Black patients (P < .001).

While the increased risk was generally consistent across infection types, it was markedly increased for foot infection, at a hazard ratio of 5.99 (P < .001).

Overall, there were few deaths due to infection in the study, at just 362. The risk of infection mortality was nevertheless significantly increased in people with diabetes, at an adjusted hazard ratio of 1.72 (P < .001).

Dr. Fang has reported being supported by a grant from the National Institutes of Health/National Heart, Lung, and Blood Institute. Dr. Selvin has reported being supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute and National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Selvin is an associate editor for Diabetologia and had no role in the peer review of the manuscript.

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

People with diabetes are at increased risk of hospitalization for infection, as well as infection-related mortality, shows a large U.S. study that suggests the risk is even higher in younger and Black individuals.

Michael Fang, PhD, Johns Hopkins University, Baltimore, and colleagues studied more than 12,000 participants in a community cohort study who were followed for an average of 24 years, between 1987-1989 and 2019.

Participants with diabetes faced a 67% increase risk of infection-related hospitalization, compared with those without diabetes.

Of particular note, the risk of hospitalization with foot infection was almost sixfold higher for people with diabetes than those without.

The research, published in Diabetologia on August 4, also suggests that diabetes may be associated with a 72% increased risk of infection-related mortality, although the absolute numbers were small.

Dr. Fang explained to this news organization that they focused on infection-related hospitalization and mortality “because these are comprehensively tracked in administrative data and ... are the most severe types of outcomes.”

However, this is probably just the tip of the iceberg, as people with diabetes are “likely at increased risk for milder infection too,” which can have a “significant adverse impact on people’s well-being and quality of life.”

As a result of their findings, the authors call for “broader guidance on infection prevention and management” in people with diabetes. To achieve this, Dr. Fang said, “we need to better understand why diabetes is associated with an increased risk of infection-related complications.”

“One likely factor is glycemic control: Emerging research suggests patients with diabetes with better glycemic control may be at significantly lower risk of infection-related complications.”

He continued that, in younger patients, a factor for worse outcomes could be that “diabetes tends to be more aggressive when it emerges early in life,” while in Black patients “there is research highlighting Black-White differences in glycemic control, access to care, and beliefs around vaccines.”

Overall, their findings – coupled with recent data showing that diabetes is an important risk factor for adverse outcomes with COVID-19 infection – paint “a common picture,” Dr. Fang said.

“People with diabetes are much more susceptible to infection-related complications, including COVID-related hospitalization and mortality,” which suggests people with diabetes “may need to be especially cautious.”
 

Adds to existing literature; amputations begin with infections

Robert A. Gabbay, MD, PhD, chief scientific and medical officer for the American Diabetes Association (ADA), said the study “does add to the existing literature by having followed a larger number of people over time and linking them to serious complications from infections.”

“Sadly, we have seen this play out in real-time during the COVID-19 pandemic.”

“One of the sobering bits of data is the significant health disparities that exist in Black Americans and the fact that foot infections remain a significant problem,” he said in an interview.

“Given that amputation rates for [Black Americans] are three times higher than White Americans, amputations begin with infections,” Dr. Gabbay added, noting the ADA “has been taking a strong stand to prevent amputations and address the inequities in health that exist.”

Jamie Hartmann-Boyce, PhD, from the University of Oxford, U.K., who was not involved in the study, commented that diabetes is a “well-known risk factor for worse outcomes from all kinds of infection,” which is why they “are prioritized for flu vaccination every year.”

She told this news organization that the current study “further confirms that people with diabetes are more likely to be hospitalized for infection of any type and most markedly for foot infection.”

“These new data further highlight the need for public health interventions to prevent type 2 diabetes, and for preventive health care in people with diabetes, including access to diabetes medications and support and to vaccinations to prevent infection,” added Dr. Hartmann-Boyce, who is a senior research fellow in health behaviors.

Diabetes is thought to be associated with susceptibility to infection via mechanisms such as impaired neutrophil functioning and humoral immune responses, and studies have shown a link with both common and rare infections.

However, the authors point out that “most” of those included “small clinical populations and were cross-sectional or had short follow-up.”

Guidelines for diabetes management, they note, also “pay less attention” to infectious diseases than they do to the prevention of micro- and macrovascular complications.
 

ARIC data mined for infections in those with diabetes

The team analyzed data from the ongoing U.S. community-based Atherosclerosis Risk in Communities (ARIC) study.

The National Heart, Lung, and Blood Institute–sponsored cohort was comprised of adults aged 45-64 years from four U.S. communities, recruited between 1987 and 1989 for clinical examinations, medical interviews, and laboratory tests, repeated over five more visits up to 2018-2019.

For the current analysis, the team included 12,739 individuals with a mean age of 54.5 years, of whom 54.3% were female and 24.7% were Black.

Patients were defined as having diabetes if their baseline fasting blood glucose was greater than or equal to 7 mmol/L, or nonfasting glucose was greater than or equal to 11.1 mmol/l, they self-reported a diagnosis of diabetes by a physician, or they were taking glucose-lowering medication at the first study visit. The researchers weren’t able to distinguish between type 1 and type 2 diabetes.

In total, 1,485 individuals had diabetes at baseline. They were more likely to be older, Black, have a low socioeconomic status, and have worse cardiometabolic health than participants without diabetes.

Over an average follow-up of 23.8 years, there were 4,229 incident hospitalizations for infection, at an overall rate of 15.9 per 1,000 person-years.

Individuals with diabetes at baseline had a higher rate of hospitalizations than those without, at 25.4 per 1,000 person-years versus 15.2 per 1,000 person-years.

After taking into account sociodemographic characteristics, socioeconomic status, and cardiometabolic risk factors, this equated to a hazard ratio for hospitalization with any infection of 1.67 (P < .001).

The risk of hospitalization for any infection was significantly higher for younger patients with diabetes, defined as aged less than 55 years (P = .005), and for Black patients (P < .001).

While the increased risk was generally consistent across infection types, it was markedly increased for foot infection, at a hazard ratio of 5.99 (P < .001).

Overall, there were few deaths due to infection in the study, at just 362. The risk of infection mortality was nevertheless significantly increased in people with diabetes, at an adjusted hazard ratio of 1.72 (P < .001).

Dr. Fang has reported being supported by a grant from the National Institutes of Health/National Heart, Lung, and Blood Institute. Dr. Selvin has reported being supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute and National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Selvin is an associate editor for Diabetologia and had no role in the peer review of the manuscript.

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

People with diabetes are at increased risk of hospitalization for infection, as well as infection-related mortality, shows a large U.S. study that suggests the risk is even higher in younger and Black individuals.

Michael Fang, PhD, Johns Hopkins University, Baltimore, and colleagues studied more than 12,000 participants in a community cohort study who were followed for an average of 24 years, between 1987-1989 and 2019.

Participants with diabetes faced a 67% increase risk of infection-related hospitalization, compared with those without diabetes.

Of particular note, the risk of hospitalization with foot infection was almost sixfold higher for people with diabetes than those without.

The research, published in Diabetologia on August 4, also suggests that diabetes may be associated with a 72% increased risk of infection-related mortality, although the absolute numbers were small.

Dr. Fang explained to this news organization that they focused on infection-related hospitalization and mortality “because these are comprehensively tracked in administrative data and ... are the most severe types of outcomes.”

However, this is probably just the tip of the iceberg, as people with diabetes are “likely at increased risk for milder infection too,” which can have a “significant adverse impact on people’s well-being and quality of life.”

As a result of their findings, the authors call for “broader guidance on infection prevention and management” in people with diabetes. To achieve this, Dr. Fang said, “we need to better understand why diabetes is associated with an increased risk of infection-related complications.”

“One likely factor is glycemic control: Emerging research suggests patients with diabetes with better glycemic control may be at significantly lower risk of infection-related complications.”

He continued that, in younger patients, a factor for worse outcomes could be that “diabetes tends to be more aggressive when it emerges early in life,” while in Black patients “there is research highlighting Black-White differences in glycemic control, access to care, and beliefs around vaccines.”

Overall, their findings – coupled with recent data showing that diabetes is an important risk factor for adverse outcomes with COVID-19 infection – paint “a common picture,” Dr. Fang said.

“People with diabetes are much more susceptible to infection-related complications, including COVID-related hospitalization and mortality,” which suggests people with diabetes “may need to be especially cautious.”
 

Adds to existing literature; amputations begin with infections

Robert A. Gabbay, MD, PhD, chief scientific and medical officer for the American Diabetes Association (ADA), said the study “does add to the existing literature by having followed a larger number of people over time and linking them to serious complications from infections.”

“Sadly, we have seen this play out in real-time during the COVID-19 pandemic.”

“One of the sobering bits of data is the significant health disparities that exist in Black Americans and the fact that foot infections remain a significant problem,” he said in an interview.

“Given that amputation rates for [Black Americans] are three times higher than White Americans, amputations begin with infections,” Dr. Gabbay added, noting the ADA “has been taking a strong stand to prevent amputations and address the inequities in health that exist.”

Jamie Hartmann-Boyce, PhD, from the University of Oxford, U.K., who was not involved in the study, commented that diabetes is a “well-known risk factor for worse outcomes from all kinds of infection,” which is why they “are prioritized for flu vaccination every year.”

She told this news organization that the current study “further confirms that people with diabetes are more likely to be hospitalized for infection of any type and most markedly for foot infection.”

“These new data further highlight the need for public health interventions to prevent type 2 diabetes, and for preventive health care in people with diabetes, including access to diabetes medications and support and to vaccinations to prevent infection,” added Dr. Hartmann-Boyce, who is a senior research fellow in health behaviors.

Diabetes is thought to be associated with susceptibility to infection via mechanisms such as impaired neutrophil functioning and humoral immune responses, and studies have shown a link with both common and rare infections.

However, the authors point out that “most” of those included “small clinical populations and were cross-sectional or had short follow-up.”

Guidelines for diabetes management, they note, also “pay less attention” to infectious diseases than they do to the prevention of micro- and macrovascular complications.
 

ARIC data mined for infections in those with diabetes

The team analyzed data from the ongoing U.S. community-based Atherosclerosis Risk in Communities (ARIC) study.

The National Heart, Lung, and Blood Institute–sponsored cohort was comprised of adults aged 45-64 years from four U.S. communities, recruited between 1987 and 1989 for clinical examinations, medical interviews, and laboratory tests, repeated over five more visits up to 2018-2019.

For the current analysis, the team included 12,739 individuals with a mean age of 54.5 years, of whom 54.3% were female and 24.7% were Black.

Patients were defined as having diabetes if their baseline fasting blood glucose was greater than or equal to 7 mmol/L, or nonfasting glucose was greater than or equal to 11.1 mmol/l, they self-reported a diagnosis of diabetes by a physician, or they were taking glucose-lowering medication at the first study visit. The researchers weren’t able to distinguish between type 1 and type 2 diabetes.

In total, 1,485 individuals had diabetes at baseline. They were more likely to be older, Black, have a low socioeconomic status, and have worse cardiometabolic health than participants without diabetes.

Over an average follow-up of 23.8 years, there were 4,229 incident hospitalizations for infection, at an overall rate of 15.9 per 1,000 person-years.

Individuals with diabetes at baseline had a higher rate of hospitalizations than those without, at 25.4 per 1,000 person-years versus 15.2 per 1,000 person-years.

After taking into account sociodemographic characteristics, socioeconomic status, and cardiometabolic risk factors, this equated to a hazard ratio for hospitalization with any infection of 1.67 (P < .001).

The risk of hospitalization for any infection was significantly higher for younger patients with diabetes, defined as aged less than 55 years (P = .005), and for Black patients (P < .001).

While the increased risk was generally consistent across infection types, it was markedly increased for foot infection, at a hazard ratio of 5.99 (P < .001).

Overall, there were few deaths due to infection in the study, at just 362. The risk of infection mortality was nevertheless significantly increased in people with diabetes, at an adjusted hazard ratio of 1.72 (P < .001).

Dr. Fang has reported being supported by a grant from the National Institutes of Health/National Heart, Lung, and Blood Institute. Dr. Selvin has reported being supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute and National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Selvin is an associate editor for Diabetologia and had no role in the peer review of the manuscript.

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

Treatment of central nervous system involvement in pediatric acute lymphoblastic leukemia (ALL) needs to be based on risk, and should no longer be applied in a one-size-fits all approach, say experts writing in an editorial published July 29 in the journal Blood.

“Because cure rates now exceed 90%, using neurotoxic drugs in non–risk-adapted protocols is unacceptable and a paradigm shift in treating CNS ALL is required,” write pediatric leukemia researchers Christina Halsey, PhD, of the University of Glasgow and Gabriele Escherich, MD, of the University Medical Center Hamburg-Eppendorf (Germany).

“We want to reach a Goldilocks point: not too much, not too little, but just right for every child,” they write.

The problem is that “the absence of clinically useful biomarkers prevents accurate risk stratification, resulting in universal use of intensive CNS-directed therapy. This therapy is likely to overtreat many children, exposing them to an unnecessary risk of toxicity,” including long-term cognitive deficits in 20%-40% of them, they point out.

The editorial accompanied a new study in which investigators in China focused on improving CNS control in children with ALL, which the editorialists said was step in the right direction.

In the Chinese Children’s Cancer Group ALL-2015 trial, investigators found that prephase dexamethasone, delayed intrathecal therapy, intravenous anesthesia to reduce traumatic lumbar punctures, and flow cytometry to accurately ascertain initial CNS involvement may improve CNS control.

The trial included 7,640 consecutive children up to age 18 treated from 2015 to 2019 across 20 major medical centers in China. Children received conventional remission induction and subsequent risk-directed therapy, including 16-22 triple intrathecal treatments. Prophylactic cranial irradiation was not used.

The 5-year event-free survival was 80.3% and overall survival 91.1%. The cumulative risk of isolated CNS relapse was 1.9% and of any CNS relapse 2.7%, comparable to reports from other major study groups, both with and without cranial radiation. 

“We attributed our relatively good CNS control to the prephase treatment with dexamethasone, which reduced leukemia cells in blood and the CNS, and to the delayed intrathecal therapy until all (or a large proportion) of circulating leukemic blasts were cleared, thus reducing the consequence of traumatic lumbar puncture with blasts,” said the investigators, led by Jingyan Tang, MD, a hematologist/oncologist at the Shanghai (China) Children’s Medical Center.

“This approach of delayed administration of initial intrathecal therapy after prephase steroid treatment, if confirmed successful by additional studies, can be adopted readily,” they say.

The editorialists concur. The low rates of CNS relapse, despite omission of radiotherapy and inclusion of high-risk subgroups, “might suggest a potential protective effect of steroids before diagnostic lumbar puncture,” they said.

“However, flow cytometry is not sensitive enough to track disease response over time. In the bone marrow, minimal residual disease (MRD) is used to identify children at high or low risk of relapse and modify therapy accordingly. We desperately need a minimal residual disease equivalent for CNS leukemia to allow us to tailor therapy,” Dr. Halsey and Dr. Escherich say.

It’s not surprising that the use of anesthesia led to fewer traumatic lumbar punctures than in “frightened child[ren] undergoing such a painful procedure without anesthesia,” the study team notes. Its correlation with lower CNS relapses is probably because drug delivery was more accurate in sedated children, the editorialists add.

Female sex was also protective against relapse in cases where general anesthesia wasn’t used for lumbar puncture. “One could speculate that it is more difficult to restrict male patients than female patients for successful intrathecal therapy if they were not undergoing anesthesia during the procedure,” the investigators write.

“Unfortunately,” the editorialists add, rapid adoption of anesthesia for lumbar punctures “is tempered by the recent observation that repeated general anesthesia in children with ALL is associated with increased neurotoxicity.”

The work was supported by grants from the National Natural Science Foundation of China, National Cancer Institute, and others. The study authors and editorialists have disclosed no relevant financial relationships.

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

Treatment of central nervous system involvement in pediatric acute lymphoblastic leukemia (ALL) needs to be based on risk, and should no longer be applied in a one-size-fits all approach, say experts writing in an editorial published July 29 in the journal Blood.

“Because cure rates now exceed 90%, using neurotoxic drugs in non–risk-adapted protocols is unacceptable and a paradigm shift in treating CNS ALL is required,” write pediatric leukemia researchers Christina Halsey, PhD, of the University of Glasgow and Gabriele Escherich, MD, of the University Medical Center Hamburg-Eppendorf (Germany).

“We want to reach a Goldilocks point: not too much, not too little, but just right for every child,” they write.

The problem is that “the absence of clinically useful biomarkers prevents accurate risk stratification, resulting in universal use of intensive CNS-directed therapy. This therapy is likely to overtreat many children, exposing them to an unnecessary risk of toxicity,” including long-term cognitive deficits in 20%-40% of them, they point out.

The editorial accompanied a new study in which investigators in China focused on improving CNS control in children with ALL, which the editorialists said was step in the right direction.

In the Chinese Children’s Cancer Group ALL-2015 trial, investigators found that prephase dexamethasone, delayed intrathecal therapy, intravenous anesthesia to reduce traumatic lumbar punctures, and flow cytometry to accurately ascertain initial CNS involvement may improve CNS control.

The trial included 7,640 consecutive children up to age 18 treated from 2015 to 2019 across 20 major medical centers in China. Children received conventional remission induction and subsequent risk-directed therapy, including 16-22 triple intrathecal treatments. Prophylactic cranial irradiation was not used.

The 5-year event-free survival was 80.3% and overall survival 91.1%. The cumulative risk of isolated CNS relapse was 1.9% and of any CNS relapse 2.7%, comparable to reports from other major study groups, both with and without cranial radiation. 

“We attributed our relatively good CNS control to the prephase treatment with dexamethasone, which reduced leukemia cells in blood and the CNS, and to the delayed intrathecal therapy until all (or a large proportion) of circulating leukemic blasts were cleared, thus reducing the consequence of traumatic lumbar puncture with blasts,” said the investigators, led by Jingyan Tang, MD, a hematologist/oncologist at the Shanghai (China) Children’s Medical Center.

“This approach of delayed administration of initial intrathecal therapy after prephase steroid treatment, if confirmed successful by additional studies, can be adopted readily,” they say.

The editorialists concur. The low rates of CNS relapse, despite omission of radiotherapy and inclusion of high-risk subgroups, “might suggest a potential protective effect of steroids before diagnostic lumbar puncture,” they said.

“However, flow cytometry is not sensitive enough to track disease response over time. In the bone marrow, minimal residual disease (MRD) is used to identify children at high or low risk of relapse and modify therapy accordingly. We desperately need a minimal residual disease equivalent for CNS leukemia to allow us to tailor therapy,” Dr. Halsey and Dr. Escherich say.

It’s not surprising that the use of anesthesia led to fewer traumatic lumbar punctures than in “frightened child[ren] undergoing such a painful procedure without anesthesia,” the study team notes. Its correlation with lower CNS relapses is probably because drug delivery was more accurate in sedated children, the editorialists add.

Female sex was also protective against relapse in cases where general anesthesia wasn’t used for lumbar puncture. “One could speculate that it is more difficult to restrict male patients than female patients for successful intrathecal therapy if they were not undergoing anesthesia during the procedure,” the investigators write.

“Unfortunately,” the editorialists add, rapid adoption of anesthesia for lumbar punctures “is tempered by the recent observation that repeated general anesthesia in children with ALL is associated with increased neurotoxicity.”

The work was supported by grants from the National Natural Science Foundation of China, National Cancer Institute, and others. The study authors and editorialists have disclosed no relevant financial relationships.

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

Treatment of central nervous system involvement in pediatric acute lymphoblastic leukemia (ALL) needs to be based on risk, and should no longer be applied in a one-size-fits all approach, say experts writing in an editorial published July 29 in the journal Blood.

“Because cure rates now exceed 90%, using neurotoxic drugs in non–risk-adapted protocols is unacceptable and a paradigm shift in treating CNS ALL is required,” write pediatric leukemia researchers Christina Halsey, PhD, of the University of Glasgow and Gabriele Escherich, MD, of the University Medical Center Hamburg-Eppendorf (Germany).

“We want to reach a Goldilocks point: not too much, not too little, but just right for every child,” they write.

The problem is that “the absence of clinically useful biomarkers prevents accurate risk stratification, resulting in universal use of intensive CNS-directed therapy. This therapy is likely to overtreat many children, exposing them to an unnecessary risk of toxicity,” including long-term cognitive deficits in 20%-40% of them, they point out.

The editorial accompanied a new study in which investigators in China focused on improving CNS control in children with ALL, which the editorialists said was step in the right direction.

In the Chinese Children’s Cancer Group ALL-2015 trial, investigators found that prephase dexamethasone, delayed intrathecal therapy, intravenous anesthesia to reduce traumatic lumbar punctures, and flow cytometry to accurately ascertain initial CNS involvement may improve CNS control.

The trial included 7,640 consecutive children up to age 18 treated from 2015 to 2019 across 20 major medical centers in China. Children received conventional remission induction and subsequent risk-directed therapy, including 16-22 triple intrathecal treatments. Prophylactic cranial irradiation was not used.

The 5-year event-free survival was 80.3% and overall survival 91.1%. The cumulative risk of isolated CNS relapse was 1.9% and of any CNS relapse 2.7%, comparable to reports from other major study groups, both with and without cranial radiation. 

“We attributed our relatively good CNS control to the prephase treatment with dexamethasone, which reduced leukemia cells in blood and the CNS, and to the delayed intrathecal therapy until all (or a large proportion) of circulating leukemic blasts were cleared, thus reducing the consequence of traumatic lumbar puncture with blasts,” said the investigators, led by Jingyan Tang, MD, a hematologist/oncologist at the Shanghai (China) Children’s Medical Center.

“This approach of delayed administration of initial intrathecal therapy after prephase steroid treatment, if confirmed successful by additional studies, can be adopted readily,” they say.

The editorialists concur. The low rates of CNS relapse, despite omission of radiotherapy and inclusion of high-risk subgroups, “might suggest a potential protective effect of steroids before diagnostic lumbar puncture,” they said.

“However, flow cytometry is not sensitive enough to track disease response over time. In the bone marrow, minimal residual disease (MRD) is used to identify children at high or low risk of relapse and modify therapy accordingly. We desperately need a minimal residual disease equivalent for CNS leukemia to allow us to tailor therapy,” Dr. Halsey and Dr. Escherich say.

It’s not surprising that the use of anesthesia led to fewer traumatic lumbar punctures than in “frightened child[ren] undergoing such a painful procedure without anesthesia,” the study team notes. Its correlation with lower CNS relapses is probably because drug delivery was more accurate in sedated children, the editorialists add.

Female sex was also protective against relapse in cases where general anesthesia wasn’t used for lumbar puncture. “One could speculate that it is more difficult to restrict male patients than female patients for successful intrathecal therapy if they were not undergoing anesthesia during the procedure,” the investigators write.

“Unfortunately,” the editorialists add, rapid adoption of anesthesia for lumbar punctures “is tempered by the recent observation that repeated general anesthesia in children with ALL is associated with increased neurotoxicity.”

The work was supported by grants from the National Natural Science Foundation of China, National Cancer Institute, and others. The study authors and editorialists have disclosed no relevant financial relationships.

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

The COVID-19 pandemic doubled international rates of child and adolescent psychological disorders, according to results of a meta-analysis.

In the first year of the pandemic, an estimated one in four youth across various regions of the globe experienced clinically elevated depression symptoms, while one in five experienced clinically elevated anxiety symptoms. These pooled estimates, which increased over time, are double prepandemic estimates, according to Nicole Racine, PhD, RPsych, a clinical psychologist at the University of Calgary (Alta.) and colleagues.

Their meta-analysis of 29 studies, comprising 80,879 young people worldwide aged 18 years or less, found pooled prevalence estimates of clinically elevated youth depression and anxiety of 25.2% (95% confidence interval, 21.2%-29.7%) and 20.5% (95% CI, 17.2%-24.4%), respectively.

“The prevalence of depression and anxiety symptoms during COVID-19 [has] doubled, compared with prepandemic estimates, and moderator analyses revealed that prevalence rates were higher when collected later in the pandemic, in older adolescents, and in girls,” the researchers write online in JAMA Pediatrics.

Prepandemic estimates of clinically significant generalized anxiety and depressive symptoms in large youth cohorts were approximately 11.6% and 12.9%, respectively, the authors say.

The increases revealed in these international findings have implications for targeted mental health resource planning.

“One difficulty in the literature is that there are large discrepancies on the prevalence of child depression and anxiety during the COVID-19 pandemic, with published rates between 2% and 68%,” corresponding author Sheri Madigan, PhD, RPsych, of the University of Calgary department of psychology, said in an interview. “By conducting a synthesis of the 29 studies on over 80,000 children, we were able to determine that, on average across these studies, 25% of youth are experiencing depression and 20% are experiencing anxiety during the COVID-19 pandemic.”
 

The cohort

The mean age in the combined global cohort was 13 years (range 4.1-17.6 ), and the mean proportion of females was 52.7% (standard deviation) 12.3%). The findings were based on international data published from Jan. 1, 2020, to Feb. 16, 2021, in studies conducted in the Middle East (n = 1), Europe (n = 4), South America (n = 2), North America (n = 6), and East Asia (n = 16). Notably absent were data from most of Latin America and the Middle East, Africa, South East Asia, and the Pacific Islands.

As the year progressed, the prevalence of depressive symptoms rose (b = .26; 95% CI, .06-46) with the number of months elapsed. Prevalence rates also rose as both age (b = 0.08, 95% CI, 0.01-0.15), and the percentage of females in samples increased (b = .03; 95% CI, 0.01-0.05).

The authors surmise that this cumulative worsening might be because of prolonged social isolation, family financial difficulties, missed milestones, and school disruptions, which are compounded over time. A second possibility is that studies conducted in the earlier months of the pandemic were more likely to be conducted in East Asia, where the self-reported prevalence of mental health symptoms tends to be lower.

The findings highlight an urgent need for intervention and recovery efforts and also indicate the need to consider individual differences when determining targets for intervention, including age, sex, and exposure to COVID-19 stressors), they add.

Even more concerning, recent data from the Centers for Disease Control and Prevention suggest that the pandemic spurred an increase in suspected suicide attempts by teenage girls. In the United Kingdom, acute mental health presentations to emergency care tripled over 2019 at one pediatric facility during the pandemic.

The authors attribute the toll on the psychological well-being of the world’s young people to pandemic-mandated restrictions. Those entailed loss of peer interactions, social isolation, and reduced contact with support figures such as teachers, and, “In addition, schools are often a primary location for receiving psychological services, with 80% of children relying on school-based services to address their mental health needs.” For many children, these services were rendered unavailable owing to school closures, Dr. Madigan and associates write.

In the context of clinical practice, doctors play a critical role. “With school closures, the physician’s office may be the only mental health checkpoint for youth,” Dr. Madigan said “So I recommend that family physicians screen for, and/or ask children and youth, about their mental health.”

On the home front, emerging research suggests that a predictable home environment can protect children’s mental well-being, with less depression and fewer behavioral problems observed in families adhering to regular routines during COVID-19. “Thus, a tangible solution to help mitigate the adverse effects of COVID-19 on youth is working with children and families to implement consistent and predictable routines around schoolwork, sleep, screen use, and physical activity,” the authors write.

They also point to the need for research on the long-term effects of the pandemic on mental health, including studies in order to “augment understanding of the implications of this crisis on the mental health trajectories of today’s children and youth.”

In an accompanying editorial, Tami D. Benton, MD, psychiatrist-in-chief at Children’s Hospital of Philadelphia, and colleagues, who were not involved in the meta-analysis, note certain limitations to the study. First, the included studies are based on self- or parent-reported symptoms. Second, the studies, more than half of which (55.2%) were done in China, may not be generalizable to all regions of the world, where 90% of children live in low- or middle-income countries.

Still, they write,“The increased mental health needs identified in the meta-analysis call for immediate action for every country. Our responses must consider the range of child mental health infrastructures available, which vary across countries, with some having well-developed and coordinated mental health services, while others have informal, limited, underfunded, or fragmented systems of care.”

Empirically supported and culturally appropriate intervention strategies for children and families according to countries and communities will be crucial, they stress.

“This meta-analysis provides the most complete evidence to date on the toll the COVID-19 pandemic has taken on child and adolescent mental health,” said Katie A. McLaughlin, PhD, a professor of psychology at Harvard University in Boston, who was not involved in the study. “The results confirm the substantial increases in symptoms of youth depression and anxiety that many clinicians and researchers have observed during the pandemic and highlight the critical need for greater investments in mental health services for children and adolescents.”

This study received no specific funding other than research support to the investigators from nonprivate entities. The authors disclosed no relevant conflicts of interest. Dr. Benton and associates and Dr. McLaughlin declared no competing interests.

The COVID-19 pandemic doubled international rates of child and adolescent psychological disorders, according to results of a meta-analysis.

In the first year of the pandemic, an estimated one in four youth across various regions of the globe experienced clinically elevated depression symptoms, while one in five experienced clinically elevated anxiety symptoms. These pooled estimates, which increased over time, are double prepandemic estimates, according to Nicole Racine, PhD, RPsych, a clinical psychologist at the University of Calgary (Alta.) and colleagues.

Their meta-analysis of 29 studies, comprising 80,879 young people worldwide aged 18 years or less, found pooled prevalence estimates of clinically elevated youth depression and anxiety of 25.2% (95% confidence interval, 21.2%-29.7%) and 20.5% (95% CI, 17.2%-24.4%), respectively.

“The prevalence of depression and anxiety symptoms during COVID-19 [has] doubled, compared with prepandemic estimates, and moderator analyses revealed that prevalence rates were higher when collected later in the pandemic, in older adolescents, and in girls,” the researchers write online in JAMA Pediatrics.

Prepandemic estimates of clinically significant generalized anxiety and depressive symptoms in large youth cohorts were approximately 11.6% and 12.9%, respectively, the authors say.

The increases revealed in these international findings have implications for targeted mental health resource planning.

“One difficulty in the literature is that there are large discrepancies on the prevalence of child depression and anxiety during the COVID-19 pandemic, with published rates between 2% and 68%,” corresponding author Sheri Madigan, PhD, RPsych, of the University of Calgary department of psychology, said in an interview. “By conducting a synthesis of the 29 studies on over 80,000 children, we were able to determine that, on average across these studies, 25% of youth are experiencing depression and 20% are experiencing anxiety during the COVID-19 pandemic.”
 

The cohort

The mean age in the combined global cohort was 13 years (range 4.1-17.6 ), and the mean proportion of females was 52.7% (standard deviation) 12.3%). The findings were based on international data published from Jan. 1, 2020, to Feb. 16, 2021, in studies conducted in the Middle East (n = 1), Europe (n = 4), South America (n = 2), North America (n = 6), and East Asia (n = 16). Notably absent were data from most of Latin America and the Middle East, Africa, South East Asia, and the Pacific Islands.

As the year progressed, the prevalence of depressive symptoms rose (b = .26; 95% CI, .06-46) with the number of months elapsed. Prevalence rates also rose as both age (b = 0.08, 95% CI, 0.01-0.15), and the percentage of females in samples increased (b = .03; 95% CI, 0.01-0.05).

The authors surmise that this cumulative worsening might be because of prolonged social isolation, family financial difficulties, missed milestones, and school disruptions, which are compounded over time. A second possibility is that studies conducted in the earlier months of the pandemic were more likely to be conducted in East Asia, where the self-reported prevalence of mental health symptoms tends to be lower.

The findings highlight an urgent need for intervention and recovery efforts and also indicate the need to consider individual differences when determining targets for intervention, including age, sex, and exposure to COVID-19 stressors), they add.

Even more concerning, recent data from the Centers for Disease Control and Prevention suggest that the pandemic spurred an increase in suspected suicide attempts by teenage girls. In the United Kingdom, acute mental health presentations to emergency care tripled over 2019 at one pediatric facility during the pandemic.

The authors attribute the toll on the psychological well-being of the world’s young people to pandemic-mandated restrictions. Those entailed loss of peer interactions, social isolation, and reduced contact with support figures such as teachers, and, “In addition, schools are often a primary location for receiving psychological services, with 80% of children relying on school-based services to address their mental health needs.” For many children, these services were rendered unavailable owing to school closures, Dr. Madigan and associates write.

In the context of clinical practice, doctors play a critical role. “With school closures, the physician’s office may be the only mental health checkpoint for youth,” Dr. Madigan said “So I recommend that family physicians screen for, and/or ask children and youth, about their mental health.”

On the home front, emerging research suggests that a predictable home environment can protect children’s mental well-being, with less depression and fewer behavioral problems observed in families adhering to regular routines during COVID-19. “Thus, a tangible solution to help mitigate the adverse effects of COVID-19 on youth is working with children and families to implement consistent and predictable routines around schoolwork, sleep, screen use, and physical activity,” the authors write.

They also point to the need for research on the long-term effects of the pandemic on mental health, including studies in order to “augment understanding of the implications of this crisis on the mental health trajectories of today’s children and youth.”

In an accompanying editorial, Tami D. Benton, MD, psychiatrist-in-chief at Children’s Hospital of Philadelphia, and colleagues, who were not involved in the meta-analysis, note certain limitations to the study. First, the included studies are based on self- or parent-reported symptoms. Second, the studies, more than half of which (55.2%) were done in China, may not be generalizable to all regions of the world, where 90% of children live in low- or middle-income countries.

Still, they write,“The increased mental health needs identified in the meta-analysis call for immediate action for every country. Our responses must consider the range of child mental health infrastructures available, which vary across countries, with some having well-developed and coordinated mental health services, while others have informal, limited, underfunded, or fragmented systems of care.”

Empirically supported and culturally appropriate intervention strategies for children and families according to countries and communities will be crucial, they stress.

“This meta-analysis provides the most complete evidence to date on the toll the COVID-19 pandemic has taken on child and adolescent mental health,” said Katie A. McLaughlin, PhD, a professor of psychology at Harvard University in Boston, who was not involved in the study. “The results confirm the substantial increases in symptoms of youth depression and anxiety that many clinicians and researchers have observed during the pandemic and highlight the critical need for greater investments in mental health services for children and adolescents.”

This study received no specific funding other than research support to the investigators from nonprivate entities. The authors disclosed no relevant conflicts of interest. Dr. Benton and associates and Dr. McLaughlin declared no competing interests.

The COVID-19 pandemic doubled international rates of child and adolescent psychological disorders, according to results of a meta-analysis.

In the first year of the pandemic, an estimated one in four youth across various regions of the globe experienced clinically elevated depression symptoms, while one in five experienced clinically elevated anxiety symptoms. These pooled estimates, which increased over time, are double prepandemic estimates, according to Nicole Racine, PhD, RPsych, a clinical psychologist at the University of Calgary (Alta.) and colleagues.

Their meta-analysis of 29 studies, comprising 80,879 young people worldwide aged 18 years or less, found pooled prevalence estimates of clinically elevated youth depression and anxiety of 25.2% (95% confidence interval, 21.2%-29.7%) and 20.5% (95% CI, 17.2%-24.4%), respectively.

“The prevalence of depression and anxiety symptoms during COVID-19 [has] doubled, compared with prepandemic estimates, and moderator analyses revealed that prevalence rates were higher when collected later in the pandemic, in older adolescents, and in girls,” the researchers write online in JAMA Pediatrics.

Prepandemic estimates of clinically significant generalized anxiety and depressive symptoms in large youth cohorts were approximately 11.6% and 12.9%, respectively, the authors say.

The increases revealed in these international findings have implications for targeted mental health resource planning.

“One difficulty in the literature is that there are large discrepancies on the prevalence of child depression and anxiety during the COVID-19 pandemic, with published rates between 2% and 68%,” corresponding author Sheri Madigan, PhD, RPsych, of the University of Calgary department of psychology, said in an interview. “By conducting a synthesis of the 29 studies on over 80,000 children, we were able to determine that, on average across these studies, 25% of youth are experiencing depression and 20% are experiencing anxiety during the COVID-19 pandemic.”
 

The cohort

The mean age in the combined global cohort was 13 years (range 4.1-17.6 ), and the mean proportion of females was 52.7% (standard deviation) 12.3%). The findings were based on international data published from Jan. 1, 2020, to Feb. 16, 2021, in studies conducted in the Middle East (n = 1), Europe (n = 4), South America (n = 2), North America (n = 6), and East Asia (n = 16). Notably absent were data from most of Latin America and the Middle East, Africa, South East Asia, and the Pacific Islands.

As the year progressed, the prevalence of depressive symptoms rose (b = .26; 95% CI, .06-46) with the number of months elapsed. Prevalence rates also rose as both age (b = 0.08, 95% CI, 0.01-0.15), and the percentage of females in samples increased (b = .03; 95% CI, 0.01-0.05).

The authors surmise that this cumulative worsening might be because of prolonged social isolation, family financial difficulties, missed milestones, and school disruptions, which are compounded over time. A second possibility is that studies conducted in the earlier months of the pandemic were more likely to be conducted in East Asia, where the self-reported prevalence of mental health symptoms tends to be lower.

The findings highlight an urgent need for intervention and recovery efforts and also indicate the need to consider individual differences when determining targets for intervention, including age, sex, and exposure to COVID-19 stressors), they add.

Even more concerning, recent data from the Centers for Disease Control and Prevention suggest that the pandemic spurred an increase in suspected suicide attempts by teenage girls. In the United Kingdom, acute mental health presentations to emergency care tripled over 2019 at one pediatric facility during the pandemic.

The authors attribute the toll on the psychological well-being of the world’s young people to pandemic-mandated restrictions. Those entailed loss of peer interactions, social isolation, and reduced contact with support figures such as teachers, and, “In addition, schools are often a primary location for receiving psychological services, with 80% of children relying on school-based services to address their mental health needs.” For many children, these services were rendered unavailable owing to school closures, Dr. Madigan and associates write.

In the context of clinical practice, doctors play a critical role. “With school closures, the physician’s office may be the only mental health checkpoint for youth,” Dr. Madigan said “So I recommend that family physicians screen for, and/or ask children and youth, about their mental health.”

On the home front, emerging research suggests that a predictable home environment can protect children’s mental well-being, with less depression and fewer behavioral problems observed in families adhering to regular routines during COVID-19. “Thus, a tangible solution to help mitigate the adverse effects of COVID-19 on youth is working with children and families to implement consistent and predictable routines around schoolwork, sleep, screen use, and physical activity,” the authors write.

They also point to the need for research on the long-term effects of the pandemic on mental health, including studies in order to “augment understanding of the implications of this crisis on the mental health trajectories of today’s children and youth.”

In an accompanying editorial, Tami D. Benton, MD, psychiatrist-in-chief at Children’s Hospital of Philadelphia, and colleagues, who were not involved in the meta-analysis, note certain limitations to the study. First, the included studies are based on self- or parent-reported symptoms. Second, the studies, more than half of which (55.2%) were done in China, may not be generalizable to all regions of the world, where 90% of children live in low- or middle-income countries.

Still, they write,“The increased mental health needs identified in the meta-analysis call for immediate action for every country. Our responses must consider the range of child mental health infrastructures available, which vary across countries, with some having well-developed and coordinated mental health services, while others have informal, limited, underfunded, or fragmented systems of care.”

Empirically supported and culturally appropriate intervention strategies for children and families according to countries and communities will be crucial, they stress.

“This meta-analysis provides the most complete evidence to date on the toll the COVID-19 pandemic has taken on child and adolescent mental health,” said Katie A. McLaughlin, PhD, a professor of psychology at Harvard University in Boston, who was not involved in the study. “The results confirm the substantial increases in symptoms of youth depression and anxiety that many clinicians and researchers have observed during the pandemic and highlight the critical need for greater investments in mental health services for children and adolescents.”

This study received no specific funding other than research support to the investigators from nonprivate entities. The authors disclosed no relevant conflicts of interest. Dr. Benton and associates and Dr. McLaughlin declared no competing interests.

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

Expert insights on new data

---

 

Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.¹

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”²

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.²

A problem with our VeLVET trial,³ which was published in Menopause, and the Cruz and colleagues’ trial from South America,⁴ both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.⁵ For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.² According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.⁵

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,² and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,⁴ or even our trial that compared vaginal estrogen with laser,³ when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

Expert insights on new data

---

 

Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.¹

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”²

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.²

A problem with our VeLVET trial,³ which was published in Menopause, and the Cruz and colleagues’ trial from South America,⁴ both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.⁵ For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.² According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.⁵

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,² and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,⁴ or even our trial that compared vaginal estrogen with laser,³ when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

Expert insights on new data

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Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.¹

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”²

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.²

A problem with our VeLVET trial,³ which was published in Menopause, and the Cruz and colleagues’ trial from South America,⁴ both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.⁵ For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.² According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.⁵

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,² and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,⁴ or even our trial that compared vaginal estrogen with laser,³ when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.¹ Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.^2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.⁴ We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.⁵ Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.⁶

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.^7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.^9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.¹¹ This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.¹²

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.¹³ In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.¹⁴ Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.^15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.¹⁷

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.¹ Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.^2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.⁴ We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.⁵ Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.⁶

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.^7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.^9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.¹¹ This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.¹²

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.¹³ In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.¹⁴ Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.^15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.¹⁷

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.¹ Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.^2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.⁴ We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.⁵ Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.⁶

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.^7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.^9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.¹¹ This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.¹²

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.¹³ In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.¹⁴ Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.^15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.¹⁷

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

Alcoholic drinks are in the news again, served with a twist. A large cohort study saw a familiar J-shaped curve detailing risk for new atrial fibrillation (AFib) in which the risk rose steadily with greater number of drinks per week, except at the lowest levels of alcohol intake.

Kirby Hamilton/iStockphoto

There, the curve turned the other way. Light drinkers overall showed no higher AFib risk than nondrinkers, and the risk was lowest at any degree of alcohol intake up to 56 g per week.

On closer analysis of risk patterns, the type of alcoholic beverage mattered. Modest weekly intake of red wine, at least one serving but no more than seven, may have actually protected against new AFib, compared with zero intake.

Alcohol content per drink was defined by standards in the United Kingdom, where the cohort was based.

The risk of AFib also didn’t climb at low intake levels of white wine or with “very low” use of liquor or spirits. But it went up consistently at any level of beer or cider consumption, and to be sure, “high intake of any beverage was associated with greater AF[ib] risk,” notes a report on the study published July 27, 2021, in JACC: Clinical Electrophysiology.

The results, based on more than 400,000 adults in the community, “raise the possibility that, for current consumers, drinking red or white wine could potentially be a safer alternative to other types of alcoholic beverages with respect to AF[ib] risk,” the report proposes.

The J-shaped risk curve for new AFib by degree of alcohol consumption follows the pattern sometimes seen for cardiovascular risk in general. But the intake level at which AFib risk is flat or reduced “is at a far lower dose of alcohol than what we’ve seen for cardiovascular disease,” lead author Samuel J. Tu, BHlthMedSc, said in an interview.

“That being said, even with the threshold sitting quite low, it still tells us that cutting down on alcohol is a good thing and perhaps one of the best things for our heart,” said Mr. Tu, University of Adelaide and Royal Adelaide Hospital, who also presented the findings at the Heart Rhythm Society 2021 Scientific Sessions, held in Boston and virtually.
 

How much alcohol is in a drink?

In a caution for anyone looking to beer, wine, or liquor to protect against AFib, or at least not cause it, the weekly number of drinks associated with the lowest AFib risk may be fewer than expected. That bottom of 56 g per week works out to one drink a day or less for British and only four or fewer per week for Americans, according to the study’s internationally varying definitions for the alcohol content of one drink.

For example, a drink was considered to have 8 g of alcohol in the United Kingdom, 14 g in the United States and some other countries, and up to 20 g in Austria. Those numbers came from definitions used by the respective national health agencies, such as the National Health Service in the United Kingdom and Centers for Disease Control and Prevention in the United States, Mr. Tu explained.

“They all defined standard drinks slightly differently. But wherever we looked, the threshold we found was far lower than what our governments recommend” based on what is known about alcohol and overall cardiovascular risk, he said.
 

First to show a hint of protection

The current study “is especially noteworthy because it’s the really the first to demonstrate any hint that there could be a protective effect from any particular amount of alcohol in regard to atrial fibrillation,” Gregory M. Marcus, MD, MAS, University of California, San Francisco, said in an interview. “The J-shaped association fits with what’s been observed with myocardial infarction and overall mortality, and hasn’t previously been seen in the setting of atrial fibrillation.”

Quite interestingly, “it appeared to be the wine drinkers, rather than those who consumed other types of alcohol, that enjoyed this benefit,” said Dr. Marcus, who was not involved in the research but co-authored an accompanying editorial with UCSF colleague Thomas A. Dewland, MD.

“It’s important to recognize the overwhelming evidence that alcohol in general increases the risk for atrial fibrillation,” he said. But “perhaps there’s something in wine that is anti-inflammatory that has some beneficial effect that maybe overwhelms the proarrhythmic aspect.”

The current study “opens the door to the question as to whether there is a small amount of alcohol, perhaps in the form of wine, where there are some benefits that outweigh the risks of atrial fibrillation.”

Still, the findings are observational and “clearly prone to confounding,” Dr. Marcus said. “We need to be very cautious in inferring causality.”

For example, it’s possible that “there is something about individuals that are able to drink alcohol on a regular basis and in small amounts that is the actual causal factor in reducing atrial fibrillation episodes.”

The analysis was based on 403,281 participants in the UK Biobank registry, a prospective cohort study in the United Kingdom, who were aged 40-69 when recruited from 2006 to 2010; it excluded anyone with a history of AFib or who was a former drinker. About 52% were women, the report noted.

Their median alcohol consumption was eight U.K. drinks per week, with 5.5% reporting they had never consumed alcohol. About 21,300 incident cases of AFib or atrial flutter were documented over almost 4.5 million person-years, or a median follow-up of 11.4 years.

The hazard ratio for incident AFib among those with a weekly alcohol consumption corresponding to 1-7 U.K. drinks, compared with intake of less than 1 U.K. drink per week, was 0.95 (95% confidence interval, 0.91-1.00). Within that range of 1-7 drinks, the absolute lowest AFib risk on the J curve was at 5 per week.
 

No increased risk of new AFib was seen in association with weekly U.K. drink levels of 10 for red wine, 8 for white wine, and 3 for spirits.

Compared with weekly intake of less than 1 U.K. drink per week, red wine intake at 1-7 per week showed an HR for AFib of 0.94 (95% CI, 0.91-0.97). Indeed, at no observed consumption level was red wine associated with a significant increase in AFib risk. White wine until the highest observed level of intake, above 28 U.K. drinks per week, at which point the HR for AFib was 1.48 (98% CI 1.19-1.86). The curve for spirit intake followed a similar but steeper curve, its HR risk reaching 1.61 (95% CI, 1.34-1.93) at intake levels beyond 28 U.K. drinks per week.

Consumption of beer or cider showed a linear association with AFib risk, which was elevated at all recorded intake levels, including 8-14 U.K. drinks per week (HR, 1.11; 95% CI 1.06-1.17) and up to 28 or more per week (HR, 1.35; 95% CI, 1.26-1.45).

The analysis is hypothesis generating at best, Dr. Marcus emphasized. “Ultimately, a randomized trial would be the only way to be fairly certain if there is indeed a causal protective relationship between red wine, in low amounts, and atrial fib.”

The message for patients, proposed Dr. Dewland and Dr. Marcus, is that alcohol abstinence is best for secondary AFib prevention, “especially if alcohol is a personal trigger for acute AF[ib] episodes,” and that for primary AFib prevention, “continued consumption of some alcohol may be reasonable, but the exact threshold is unclear and is likely a very low amount.”

Mr. Tu has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Marcus disclosed receiving research funding from Baylis Medical; consulting for Johnson & Johnson and InCarda; and holding equity interest in InCarda. Dr. Dewland reports no relevant financial relationships.

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

On May 25, 2020, George Floyd was murdered by a White police officer who held his knee on Floyd’s neck for nine and a half minutes. Nine and a half minutes. George Floyd was not the first Black person killed by law enforcement. He has not been the last. Much has been written about why Floyd’s murder sparked unprecedented worldwide outrage despite being far from unprecedented itself. We cannot be so naive as to think what happened was new, and we should not ignore the tireless work that so many have been doing to fight racism up to this point. But for many who have been stirred to do something for the first time, especially White people, the question has been,

“What do I do?” The answer is, do the work.

This article is centered on anti-Black racism with a focus on medicine. We recognize that there is racism against other minoritized groups. Each group deserves attention and to have their stories told. We recognize intersectionality and that an individual has multiple identities and that these may compound the marginalization they experience. This too deserves attention.

However, we cannot satisfactorily explore any of these concepts within the confines of a single article. Our intention is to use this forum to promote further conversation, specifically about anti-Black racism in medicine. We hope it compels you to begin learning to recognize and dismantle racism in yourself and your surroundings, both at home and at work.

Being a health care provider requires lifelong learning. If we practiced only what we learned in training, our patients could suffer. So we continually seek out updated research and guidelines to best treat our patients. Understanding how racism impacts your patients, colleagues, family, and friends is your responsibility as much as understanding guidelines for standards of care. We must resist the urge to feel this is someone else’s duty. It is the job of each and every one of us. We must do the work.

Race is real but it’s not biologic

It is imperative to understand that race is not a biologic category. Phenotypic differences between humans do not reliably map to racial categories. Racial categories themselves have morphed over the centuries, and interpretation of race has been litigated in this country since its founding.¹ People who identify as a given race do not have inherent biology that is different from those who identify as another race. It may then be tempting to try to erase race from our thinking, and, indeed, the idea of being “color blind” was long worn as a badge of honor signifying a commitment to equality. So this is the tension: if race exists, it must be a biologic trait and with it must go other inherent traits. But if race is not a biologic entity, perhaps it is not real and, therefore, should be ignored. In fact, neither is true. Race is not based on genetic or biologic inheritance, but it is a social and political categorization that is real and has very real ramifications. As we will discuss further, race does have a biologic impact on individuals. The mechanism by which that happens is racism.

Continue to: What is racism, and who is racist?...

What is racism, and who is racist?

Various definitions of racism have been offered:

• prejudice, discrimination, or antagonism directed against a person or people on the basis of their membership in a particular racial or ethnic group, typically one that is minoritized or marginalized²
• a belief that race is a fundamental determinant of human traits and capacities and that racial differences produce an inherent superiority of a particular race³
• the systemic oppression of a racial group to the social, economic, and political advantage of another; a political or social system founded on racism and designed to execute its principles.³

The common themes in these definitions are power, hierarchy, and oppression. Racism is a fabricated system to justify and reinforce power for some and disenfranchisement for others based on race. The system is pervasive and beneficial to the group that it serves.

Ibram X. Kendi posits that all racism is structural racism: “‘Institutional racism’ and ‘structural racism’ and ‘systemic racism’ are redundant. Racism itself is institutional, structural, and systemic.”⁴ This is not saying that individuals don’t enact racism, but it emphasizes that racism is not the action of a “few bad apples.” Furthermore, it underscores that race was created to bolster power structures ensuring White dominance. The racism that has followed, in all of its forms, is both because these ideas were created in the first place and to perpetuate that ongoing power structure.⁴

Dorothy Roberts, JD, writes in her book Fatal Invention that, while grouping people and creating hierarchy has always happened amongst humans, there is a specific history in our country of using race to create and perpetuate the dominance of White people and the subjugation of Black people.

Kendi also asserts that there is no neutrality with regard to racism—there is racist and antiracist: “A racist: one who is supporting a racist policy through their actions or inaction or expressing a racist idea. An antiracist: one who is supporting an antiracist policy through their actions or expressing an antiracist idea.”⁴ He describes all people as moving in and out of being racist and antiracist, and states “being an antiracist requires persistent self-awareness, constant self-criticism, and regular self-examination.”⁴ In thinking about race and racism in this way, we all must grapple with our own racism, but in so doing are taking a step toward antiracism.

History is important

Among the most important things one can do in a journey to dismantle racism is learn the history of racism.

The infrastructure and institutions of our nation were created on a foundation of slavery, including the origins of American medicine and gynecology. Physicians in the antebellum South performed inspections of enslaved people’s bodies to certify them for sale.⁵ The ability to assign market value to a Black person’s body was published as an essential physician competency.⁵

Gynecology has a particularly painful history with regard to slavery. By 1808, transatlantic slave trade was banned in the United States and, as Dr. Cooper Owens describes in her book Medical Bondage: Race, Gender, and the Origins of American Gynecology, this made reproduction of enslaved people within the United States a priority for slave owners and those invested in an economy that depended on slavery.⁶ Gynecologists were permitted unrestricted access to enslaved women for experiments to optimize reproduction. Many of these physicians became prominent voices adding to the canon of racialized medicine. Medical journals themselves gained reverence because of heightened interest in keeping enslaved people alive and just well enough to work and reproduce.⁶ Today, we hold sacred the relationship between a patient and their physician. We must understand that there was no such relationship between a doctor and an enslaved person. The relationship was between the doctor and slave owner.^6,7 Slavery does not allow for the autonomy of the enslaved. This is the context in which we must understand the discoveries of gynecologists during that time.

Despite the abolition of slavery with the passage of the 13th amendment, racist policies remained ubiquitous in the United States. Segregation of Black people was codified not only in the Jim Crow South but also in the North. Interracial marriage was outlawed by all but 9 states.

While there are numerous federal policies that led to cumulative and egregious disadvantage for Black Americans, one powerful example is redlining. In 1934 the Federal Housing Administration was created, and by insuring private mortgages, the FHA made it easier for eligible home buyers to obtain financing. The FHA used a system of maps that graded neighborhoods. Racial composition of neighborhoods was overtly used as a component of grading, and the presence of Black people led a neighborhood to be downgraded or redlined.^8,9 This meant Black people were largely ineligible for FHA-backed loans. In The Color of Law, Richard Rothstein writes, “Today’s residential segregation in the North, South, Midwest, and West is not the unintended consequence of individual choices and of otherwise well-meaning law or regulation but of unhidden public policy that explicitly segregated every metropolitan area in the United States.The policy was so systematic and forceful that its effects endure to the present time.”⁹

Though these specific policies are no longer in place, many correlations have been found between historically redlined neighborhoods and higher rates of diseases today, including diabetes, hypertension, asthma, and preterm deliveries.¹⁰ These policies also have played a role in creating the wealth gap—directly by limiting the opportunity for home ownership, which translates to intergenerational wealth, and indirectly by the disinvestment in neighborhoods where Black people live, leading to reduced access to quality education, decreased employment opportunities, and increased environmental hazards.^8,11

Continue to: Health disparities...

Health disparities

The numerous health disparities, more accurately termed health inequities, suffered by racial minority groups is well documented.¹²

COVID-19 death and vaccination-rate inequities. Early in the COVID-19 pandemic, data emerged that racial minorities were being disparately affected.¹³ In December 2020, the Centers for Disease Control and Prevention (CDC) reported that Hispanic or Latino, non-Hispanic Black, and non-Hispanic American Indian or Alaska Native people had all died at higher rates than White Americans.¹⁴ These racial groups had higher hospitalization rates across age groups and, after adjusting for age, rates of hospitalization were 2.8 to 3.4 times higher.¹⁵ We are continuing to learn what factors contribute to these inequities, but it has highlighted how racist policies have led to disparate access to health care, or even clean air, clean water, and nutritious food, and left communities of color more vulnerable to severe illness and death from COVID-19. With the advent of vaccines for COVID-19, we continue to see racial disparities as Black Americans have the lowest rates of vaccination.¹⁶ All of these inequities have to be understood in the context of the racist structures that exist in our society. As medical providers, we must understand and help to dismantle these structures.

Pregnancy-related mortality (PRM) inequities. A powerful example of a persistent health inequity in our field is the well-known disparity in pregnancy-related mortality when examining this outcome by race. Per CDC analysis of data on PRM from 2007–2016, Black women died at a rate 3.2 times higher than White women. This disparity was even greater in patients older than 30 years of age. When they compared rates while controlling for the highest level of education, the disparity is even more pronounced: PRM rate for those with a college degree or higher was 5.2 times greater for Black people compared with White people.¹⁶The CDC also reported that, in 2018, the infant mortality for non-Hispanic Black infants was 10.8 per 1,000 live births, compared with 4.6 per 1,000 live births for White infants. This is a rate 2.4-times higher for Black infants.¹⁷ Dr. Cooper Owens and Dr. Fett note in their article, “Black maternal and infant health: Historical legacies of slavery,” that in 1850 this rate was 1.6-times higher for Black infants, which means the inequity was worse in 2018 America than in the antebellum South.⁵

The role of patient experience

As discussed, governmental policies have created persistent inequities in wealth, access to health care, and exposure to environmental toxins, among many other disparities. However, the data finding that highly educated Black pregnant patients suffer markedly increased risk of maternal death, indicate that inequities cannot be attributed only to education or lack of access to health care. This is where some will once again lean on the idea that there is something inherently different about Black people. But if we know that race was created and is not an empiric category, we must consider the social variables impacting Black patients’ experience.

As Linda Blount, President and CEO of the Black Women’s Health Imperative, put it, “Race is not a risk factor. It is the lived experience of being a Black woman in this society that is the risk factor.”¹⁸ So how much of these inequities can be accounted for by differential treatment of Black patients? There is, for example, data on the disproportionately lower rates of Black renal transplant recipients and inordinately higher rates of amputations among Black patients.^19,20 None of us wants to think we are treating our Black patients differently, but the data demand that we ask ourselves if we are. Some of this is built into the system. For example, in their article “Hidden in plain sight—Reconsidering the use of race correction in clinical algorithms,” Vyas and colleagues outline a list of calculators and algorithms that include race.²¹ This means we may be using these calculators and changing outcomes for our patients based on their race. This is only one example of racism hidden within guidelines and standards of care.

The existence of racism on an interpersonal level also cannot be denied. This could lead to differential care specifically, but also can manifest by way of the toll it takes on a patient generally. This is the concept of allostatic load or weathering: the chronic stress of experiencing racism creates detrimental physiologic change. There is ongoing research into epigenetic modifications from stress that could be impacting health outcomes in Black populations.

Continue to: What is the work we need to do?...

What is the work we need to do?

Become educated. We have discussed taking the initiative to learn about the history of racism, including the legacies of slavery and the ongoing impact of racism on health. This knowledge is foundational and sometimes transformative. It allows us to see opportunities for antiracism and gives us the knowledge to begin meaningful conversations.

Take action. We must take inventory within our lives. What are our spheres of influence? What are our resources? Where can we make an impact? Right now, you can take out a pen and paper and write down all the roles you play. Look for opportunities in personal interactions and daily routines. Unfortunately, there will be many opportunities to speak up against racism—although this is rarely easy. Find articles, podcasts, and workshops on upstander training. One framework to respond to microaggressions has been proposed by faculty at Boston University Medical Center using the acronym LIFT (Lights on, Impact vs Intent, Full stop, Teach).²² It advises highlighting, clarifying, and directly addressing problematic comments with such statements as “I heard you say…” or “What did you mean by that comment?”, or a more direct “Statements like that are not OK with me,” or a teaching statement of “I read an article that made me think differently about comments like the one you made...”²² How and when to employ these strategies takes deliberate practice and will be uncomfortable. But we must do the work.

Practice empathetic listening. In a podcast discussion with Brené Brown on creating transformative cultures, Aiko Bethea, a leader in diversity and equity innovation, implores listeners to believe people of color.^23,24 Draw on the history you’ve learned and understand the context in which Black people live in our society. Don’t brush off your Black friend who is upset about being stopped by security. That wasn’t the first time she was in that situation. Take seriously your patient’s concern that they are not being treated appropriately because of being Black. At the same time, do not think of Black people as a monolith or a stereotype. Respect people’s individuality.

Teach our kids all of this. We must also find ways to make change on a larger scale—within our practices, hospitals, medical schools, places of worship, town councils, school boards, state legislatures, and so on. If you are in a faculty position, you can reach out to leadership to scrutinize the curriculum while also ensuring that what and how you are teaching aligns with your antiracist principles. Question the theories, calculators, and algorithms being used and taught. Inquire about policies around recruitment of trainees and faculty as well as promotion, and implement strategies to make this inclusive and equitable. If you run a practice, you can ensure hiring and compensation policies are equitable. Examine patient access and barriers that your minoritized patients are facing, and address those barriers. Share resources and tools that you find helpful and develop a community of colleagues to develop with and hold one another accountable.

In her June 2020 article, An Open Letter to Corporate America, Philanthropy, Academia, etc: What now?, Bethea lays out an extensive framework for approaching antiracism at a high level.²⁵ Among the principles she emphasizes is that the work of diversity, equity, and inclusion should not be siloed and cannot continue to be undervalued. It must be viewed as leadership and engaged in by leadership. The work of diversity, equity, and inclusion for any given institution must be explicit, intentional, measured, and transparent. Within that work, antiracism deserves individual attention. This work must center the people of color for whom you are pursuing equity. White people must resist the urge to make this about them.²⁵

Drs. Esther Choo and J. Nwando Olayiwola present their proposals for combating racism in two 2020 Lancet articles.^26,27 They discuss anticipating failure and backlash and learning from them but not being derailed by them. They emphasize the need for ongoing, serious financial investment and transformation in leadership. They also point out the need for data, discouraging more research on well-established inequities while recommending investigating interventions.^26,27 If you are in leadership positions, read these articles and many more. Enact these principles. Make the investment. If you are not in such a position, find ways to hold your organization’s leadership accountable. Find ways to get a seat at the table and steer the conversation. In medicine, we have to make change at every level of our organizations. That will include the very difficult work of changing climate and culture. In addition, we have to look not only within our organizations but also to the communities we serve. Those voices must be valued in this conversation.

Will this take time? Yes. Will this be hard? Yes. Can you do everything? No. Can you do your part? Yes! Do the work. 

On May 25, 2020, George Floyd was murdered by a White police officer who held his knee on Floyd’s neck for nine and a half minutes. Nine and a half minutes. George Floyd was not the first Black person killed by law enforcement. He has not been the last. Much has been written about why Floyd’s murder sparked unprecedented worldwide outrage despite being far from unprecedented itself. We cannot be so naive as to think what happened was new, and we should not ignore the tireless work that so many have been doing to fight racism up to this point. But for many who have been stirred to do something for the first time, especially White people, the question has been,

“What do I do?” The answer is, do the work.

This article is centered on anti-Black racism with a focus on medicine. We recognize that there is racism against other minoritized groups. Each group deserves attention and to have their stories told. We recognize intersectionality and that an individual has multiple identities and that these may compound the marginalization they experience. This too deserves attention.

However, we cannot satisfactorily explore any of these concepts within the confines of a single article. Our intention is to use this forum to promote further conversation, specifically about anti-Black racism in medicine. We hope it compels you to begin learning to recognize and dismantle racism in yourself and your surroundings, both at home and at work.

Being a health care provider requires lifelong learning. If we practiced only what we learned in training, our patients could suffer. So we continually seek out updated research and guidelines to best treat our patients. Understanding how racism impacts your patients, colleagues, family, and friends is your responsibility as much as understanding guidelines for standards of care. We must resist the urge to feel this is someone else’s duty. It is the job of each and every one of us. We must do the work.

Race is real but it’s not biologic

It is imperative to understand that race is not a biologic category. Phenotypic differences between humans do not reliably map to racial categories. Racial categories themselves have morphed over the centuries, and interpretation of race has been litigated in this country since its founding.¹ People who identify as a given race do not have inherent biology that is different from those who identify as another race. It may then be tempting to try to erase race from our thinking, and, indeed, the idea of being “color blind” was long worn as a badge of honor signifying a commitment to equality. So this is the tension: if race exists, it must be a biologic trait and with it must go other inherent traits. But if race is not a biologic entity, perhaps it is not real and, therefore, should be ignored. In fact, neither is true. Race is not based on genetic or biologic inheritance, but it is a social and political categorization that is real and has very real ramifications. As we will discuss further, race does have a biologic impact on individuals. The mechanism by which that happens is racism.

Continue to: What is racism, and who is racist?...

What is racism, and who is racist?

Various definitions of racism have been offered:

• prejudice, discrimination, or antagonism directed against a person or people on the basis of their membership in a particular racial or ethnic group, typically one that is minoritized or marginalized²
• a belief that race is a fundamental determinant of human traits and capacities and that racial differences produce an inherent superiority of a particular race³
• the systemic oppression of a racial group to the social, economic, and political advantage of another; a political or social system founded on racism and designed to execute its principles.³

The common themes in these definitions are power, hierarchy, and oppression. Racism is a fabricated system to justify and reinforce power for some and disenfranchisement for others based on race. The system is pervasive and beneficial to the group that it serves.

Ibram X. Kendi posits that all racism is structural racism: “‘Institutional racism’ and ‘structural racism’ and ‘systemic racism’ are redundant. Racism itself is institutional, structural, and systemic.”⁴ This is not saying that individuals don’t enact racism, but it emphasizes that racism is not the action of a “few bad apples.” Furthermore, it underscores that race was created to bolster power structures ensuring White dominance. The racism that has followed, in all of its forms, is both because these ideas were created in the first place and to perpetuate that ongoing power structure.⁴

Dorothy Roberts, JD, writes in her book Fatal Invention that, while grouping people and creating hierarchy has always happened amongst humans, there is a specific history in our country of using race to create and perpetuate the dominance of White people and the subjugation of Black people.

Kendi also asserts that there is no neutrality with regard to racism—there is racist and antiracist: “A racist: one who is supporting a racist policy through their actions or inaction or expressing a racist idea. An antiracist: one who is supporting an antiracist policy through their actions or expressing an antiracist idea.”⁴ He describes all people as moving in and out of being racist and antiracist, and states “being an antiracist requires persistent self-awareness, constant self-criticism, and regular self-examination.”⁴ In thinking about race and racism in this way, we all must grapple with our own racism, but in so doing are taking a step toward antiracism.

History is important

Among the most important things one can do in a journey to dismantle racism is learn the history of racism.

The infrastructure and institutions of our nation were created on a foundation of slavery, including the origins of American medicine and gynecology. Physicians in the antebellum South performed inspections of enslaved people’s bodies to certify them for sale.⁵ The ability to assign market value to a Black person’s body was published as an essential physician competency.⁵

Gynecology has a particularly painful history with regard to slavery. By 1808, transatlantic slave trade was banned in the United States and, as Dr. Cooper Owens describes in her book Medical Bondage: Race, Gender, and the Origins of American Gynecology, this made reproduction of enslaved people within the United States a priority for slave owners and those invested in an economy that depended on slavery.⁶ Gynecologists were permitted unrestricted access to enslaved women for experiments to optimize reproduction. Many of these physicians became prominent voices adding to the canon of racialized medicine. Medical journals themselves gained reverence because of heightened interest in keeping enslaved people alive and just well enough to work and reproduce.⁶ Today, we hold sacred the relationship between a patient and their physician. We must understand that there was no such relationship between a doctor and an enslaved person. The relationship was between the doctor and slave owner.^6,7 Slavery does not allow for the autonomy of the enslaved. This is the context in which we must understand the discoveries of gynecologists during that time.

Despite the abolition of slavery with the passage of the 13th amendment, racist policies remained ubiquitous in the United States. Segregation of Black people was codified not only in the Jim Crow South but also in the North. Interracial marriage was outlawed by all but 9 states.

While there are numerous federal policies that led to cumulative and egregious disadvantage for Black Americans, one powerful example is redlining. In 1934 the Federal Housing Administration was created, and by insuring private mortgages, the FHA made it easier for eligible home buyers to obtain financing. The FHA used a system of maps that graded neighborhoods. Racial composition of neighborhoods was overtly used as a component of grading, and the presence of Black people led a neighborhood to be downgraded or redlined.^8,9 This meant Black people were largely ineligible for FHA-backed loans. In The Color of Law, Richard Rothstein writes, “Today’s residential segregation in the North, South, Midwest, and West is not the unintended consequence of individual choices and of otherwise well-meaning law or regulation but of unhidden public policy that explicitly segregated every metropolitan area in the United States.The policy was so systematic and forceful that its effects endure to the present time.”⁹

Though these specific policies are no longer in place, many correlations have been found between historically redlined neighborhoods and higher rates of diseases today, including diabetes, hypertension, asthma, and preterm deliveries.¹⁰ These policies also have played a role in creating the wealth gap—directly by limiting the opportunity for home ownership, which translates to intergenerational wealth, and indirectly by the disinvestment in neighborhoods where Black people live, leading to reduced access to quality education, decreased employment opportunities, and increased environmental hazards.^8,11

Continue to: Health disparities...

Health disparities

The numerous health disparities, more accurately termed health inequities, suffered by racial minority groups is well documented.¹²

COVID-19 death and vaccination-rate inequities. Early in the COVID-19 pandemic, data emerged that racial minorities were being disparately affected.¹³ In December 2020, the Centers for Disease Control and Prevention (CDC) reported that Hispanic or Latino, non-Hispanic Black, and non-Hispanic American Indian or Alaska Native people had all died at higher rates than White Americans.¹⁴ These racial groups had higher hospitalization rates across age groups and, after adjusting for age, rates of hospitalization were 2.8 to 3.4 times higher.¹⁵ We are continuing to learn what factors contribute to these inequities, but it has highlighted how racist policies have led to disparate access to health care, or even clean air, clean water, and nutritious food, and left communities of color more vulnerable to severe illness and death from COVID-19. With the advent of vaccines for COVID-19, we continue to see racial disparities as Black Americans have the lowest rates of vaccination.¹⁶ All of these inequities have to be understood in the context of the racist structures that exist in our society. As medical providers, we must understand and help to dismantle these structures.

Pregnancy-related mortality (PRM) inequities. A powerful example of a persistent health inequity in our field is the well-known disparity in pregnancy-related mortality when examining this outcome by race. Per CDC analysis of data on PRM from 2007–2016, Black women died at a rate 3.2 times higher than White women. This disparity was even greater in patients older than 30 years of age. When they compared rates while controlling for the highest level of education, the disparity is even more pronounced: PRM rate for those with a college degree or higher was 5.2 times greater for Black people compared with White people.¹⁶The CDC also reported that, in 2018, the infant mortality for non-Hispanic Black infants was 10.8 per 1,000 live births, compared with 4.6 per 1,000 live births for White infants. This is a rate 2.4-times higher for Black infants.¹⁷ Dr. Cooper Owens and Dr. Fett note in their article, “Black maternal and infant health: Historical legacies of slavery,” that in 1850 this rate was 1.6-times higher for Black infants, which means the inequity was worse in 2018 America than in the antebellum South.⁵

The role of patient experience

As discussed, governmental policies have created persistent inequities in wealth, access to health care, and exposure to environmental toxins, among many other disparities. However, the data finding that highly educated Black pregnant patients suffer markedly increased risk of maternal death, indicate that inequities cannot be attributed only to education or lack of access to health care. This is where some will once again lean on the idea that there is something inherently different about Black people. But if we know that race was created and is not an empiric category, we must consider the social variables impacting Black patients’ experience.

As Linda Blount, President and CEO of the Black Women’s Health Imperative, put it, “Race is not a risk factor. It is the lived experience of being a Black woman in this society that is the risk factor.”¹⁸ So how much of these inequities can be accounted for by differential treatment of Black patients? There is, for example, data on the disproportionately lower rates of Black renal transplant recipients and inordinately higher rates of amputations among Black patients.^19,20 None of us wants to think we are treating our Black patients differently, but the data demand that we ask ourselves if we are. Some of this is built into the system. For example, in their article “Hidden in plain sight—Reconsidering the use of race correction in clinical algorithms,” Vyas and colleagues outline a list of calculators and algorithms that include race.²¹ This means we may be using these calculators and changing outcomes for our patients based on their race. This is only one example of racism hidden within guidelines and standards of care.

The existence of racism on an interpersonal level also cannot be denied. This could lead to differential care specifically, but also can manifest by way of the toll it takes on a patient generally. This is the concept of allostatic load or weathering: the chronic stress of experiencing racism creates detrimental physiologic change. There is ongoing research into epigenetic modifications from stress that could be impacting health outcomes in Black populations.

Continue to: What is the work we need to do?...

What is the work we need to do?

Become educated. We have discussed taking the initiative to learn about the history of racism, including the legacies of slavery and the ongoing impact of racism on health. This knowledge is foundational and sometimes transformative. It allows us to see opportunities for antiracism and gives us the knowledge to begin meaningful conversations.

Take action. We must take inventory within our lives. What are our spheres of influence? What are our resources? Where can we make an impact? Right now, you can take out a pen and paper and write down all the roles you play. Look for opportunities in personal interactions and daily routines. Unfortunately, there will be many opportunities to speak up against racism—although this is rarely easy. Find articles, podcasts, and workshops on upstander training. One framework to respond to microaggressions has been proposed by faculty at Boston University Medical Center using the acronym LIFT (Lights on, Impact vs Intent, Full stop, Teach).²² It advises highlighting, clarifying, and directly addressing problematic comments with such statements as “I heard you say…” or “What did you mean by that comment?”, or a more direct “Statements like that are not OK with me,” or a teaching statement of “I read an article that made me think differently about comments like the one you made...”²² How and when to employ these strategies takes deliberate practice and will be uncomfortable. But we must do the work.

Practice empathetic listening. In a podcast discussion with Brené Brown on creating transformative cultures, Aiko Bethea, a leader in diversity and equity innovation, implores listeners to believe people of color.^23,24 Draw on the history you’ve learned and understand the context in which Black people live in our society. Don’t brush off your Black friend who is upset about being stopped by security. That wasn’t the first time she was in that situation. Take seriously your patient’s concern that they are not being treated appropriately because of being Black. At the same time, do not think of Black people as a monolith or a stereotype. Respect people’s individuality.

Teach our kids all of this. We must also find ways to make change on a larger scale—within our practices, hospitals, medical schools, places of worship, town councils, school boards, state legislatures, and so on. If you are in a faculty position, you can reach out to leadership to scrutinize the curriculum while also ensuring that what and how you are teaching aligns with your antiracist principles. Question the theories, calculators, and algorithms being used and taught. Inquire about policies around recruitment of trainees and faculty as well as promotion, and implement strategies to make this inclusive and equitable. If you run a practice, you can ensure hiring and compensation policies are equitable. Examine patient access and barriers that your minoritized patients are facing, and address those barriers. Share resources and tools that you find helpful and develop a community of colleagues to develop with and hold one another accountable.

In her June 2020 article, An Open Letter to Corporate America, Philanthropy, Academia, etc: What now?, Bethea lays out an extensive framework for approaching antiracism at a high level.²⁵ Among the principles she emphasizes is that the work of diversity, equity, and inclusion should not be siloed and cannot continue to be undervalued. It must be viewed as leadership and engaged in by leadership. The work of diversity, equity, and inclusion for any given institution must be explicit, intentional, measured, and transparent. Within that work, antiracism deserves individual attention. This work must center the people of color for whom you are pursuing equity. White people must resist the urge to make this about them.²⁵

Drs. Esther Choo and J. Nwando Olayiwola present their proposals for combating racism in two 2020 Lancet articles.^26,27 They discuss anticipating failure and backlash and learning from them but not being derailed by them. They emphasize the need for ongoing, serious financial investment and transformation in leadership. They also point out the need for data, discouraging more research on well-established inequities while recommending investigating interventions.^26,27 If you are in leadership positions, read these articles and many more. Enact these principles. Make the investment. If you are not in such a position, find ways to hold your organization’s leadership accountable. Find ways to get a seat at the table and steer the conversation. In medicine, we have to make change at every level of our organizations. That will include the very difficult work of changing climate and culture. In addition, we have to look not only within our organizations but also to the communities we serve. Those voices must be valued in this conversation.

Will this take time? Yes. Will this be hard? Yes. Can you do everything? No. Can you do your part? Yes! Do the work. 

On May 25, 2020, George Floyd was murdered by a White police officer who held his knee on Floyd’s neck for nine and a half minutes. Nine and a half minutes. George Floyd was not the first Black person killed by law enforcement. He has not been the last. Much has been written about why Floyd’s murder sparked unprecedented worldwide outrage despite being far from unprecedented itself. We cannot be so naive as to think what happened was new, and we should not ignore the tireless work that so many have been doing to fight racism up to this point. But for many who have been stirred to do something for the first time, especially White people, the question has been,

“What do I do?” The answer is, do the work.

This article is centered on anti-Black racism with a focus on medicine. We recognize that there is racism against other minoritized groups. Each group deserves attention and to have their stories told. We recognize intersectionality and that an individual has multiple identities and that these may compound the marginalization they experience. This too deserves attention.

However, we cannot satisfactorily explore any of these concepts within the confines of a single article. Our intention is to use this forum to promote further conversation, specifically about anti-Black racism in medicine. We hope it compels you to begin learning to recognize and dismantle racism in yourself and your surroundings, both at home and at work.

Being a health care provider requires lifelong learning. If we practiced only what we learned in training, our patients could suffer. So we continually seek out updated research and guidelines to best treat our patients. Understanding how racism impacts your patients, colleagues, family, and friends is your responsibility as much as understanding guidelines for standards of care. We must resist the urge to feel this is someone else’s duty. It is the job of each and every one of us. We must do the work.

Race is real but it’s not biologic

It is imperative to understand that race is not a biologic category. Phenotypic differences between humans do not reliably map to racial categories. Racial categories themselves have morphed over the centuries, and interpretation of race has been litigated in this country since its founding.¹ People who identify as a given race do not have inherent biology that is different from those who identify as another race. It may then be tempting to try to erase race from our thinking, and, indeed, the idea of being “color blind” was long worn as a badge of honor signifying a commitment to equality. So this is the tension: if race exists, it must be a biologic trait and with it must go other inherent traits. But if race is not a biologic entity, perhaps it is not real and, therefore, should be ignored. In fact, neither is true. Race is not based on genetic or biologic inheritance, but it is a social and political categorization that is real and has very real ramifications. As we will discuss further, race does have a biologic impact on individuals. The mechanism by which that happens is racism.

Continue to: What is racism, and who is racist?...

What is racism, and who is racist?

Various definitions of racism have been offered:

• prejudice, discrimination, or antagonism directed against a person or people on the basis of their membership in a particular racial or ethnic group, typically one that is minoritized or marginalized²
• a belief that race is a fundamental determinant of human traits and capacities and that racial differences produce an inherent superiority of a particular race³
• the systemic oppression of a racial group to the social, economic, and political advantage of another; a political or social system founded on racism and designed to execute its principles.³

The common themes in these definitions are power, hierarchy, and oppression. Racism is a fabricated system to justify and reinforce power for some and disenfranchisement for others based on race. The system is pervasive and beneficial to the group that it serves.

Ibram X. Kendi posits that all racism is structural racism: “‘Institutional racism’ and ‘structural racism’ and ‘systemic racism’ are redundant. Racism itself is institutional, structural, and systemic.”⁴ This is not saying that individuals don’t enact racism, but it emphasizes that racism is not the action of a “few bad apples.” Furthermore, it underscores that race was created to bolster power structures ensuring White dominance. The racism that has followed, in all of its forms, is both because these ideas were created in the first place and to perpetuate that ongoing power structure.⁴

Dorothy Roberts, JD, writes in her book Fatal Invention that, while grouping people and creating hierarchy has always happened amongst humans, there is a specific history in our country of using race to create and perpetuate the dominance of White people and the subjugation of Black people.

Kendi also asserts that there is no neutrality with regard to racism—there is racist and antiracist: “A racist: one who is supporting a racist policy through their actions or inaction or expressing a racist idea. An antiracist: one who is supporting an antiracist policy through their actions or expressing an antiracist idea.”⁴ He describes all people as moving in and out of being racist and antiracist, and states “being an antiracist requires persistent self-awareness, constant self-criticism, and regular self-examination.”⁴ In thinking about race and racism in this way, we all must grapple with our own racism, but in so doing are taking a step toward antiracism.

History is important

Among the most important things one can do in a journey to dismantle racism is learn the history of racism.

The infrastructure and institutions of our nation were created on a foundation of slavery, including the origins of American medicine and gynecology. Physicians in the antebellum South performed inspections of enslaved people’s bodies to certify them for sale.⁵ The ability to assign market value to a Black person’s body was published as an essential physician competency.⁵

Gynecology has a particularly painful history with regard to slavery. By 1808, transatlantic slave trade was banned in the United States and, as Dr. Cooper Owens describes in her book Medical Bondage: Race, Gender, and the Origins of American Gynecology, this made reproduction of enslaved people within the United States a priority for slave owners and those invested in an economy that depended on slavery.⁶ Gynecologists were permitted unrestricted access to enslaved women for experiments to optimize reproduction. Many of these physicians became prominent voices adding to the canon of racialized medicine. Medical journals themselves gained reverence because of heightened interest in keeping enslaved people alive and just well enough to work and reproduce.⁶ Today, we hold sacred the relationship between a patient and their physician. We must understand that there was no such relationship between a doctor and an enslaved person. The relationship was between the doctor and slave owner.^6,7 Slavery does not allow for the autonomy of the enslaved. This is the context in which we must understand the discoveries of gynecologists during that time.

Despite the abolition of slavery with the passage of the 13th amendment, racist policies remained ubiquitous in the United States. Segregation of Black people was codified not only in the Jim Crow South but also in the North. Interracial marriage was outlawed by all but 9 states.

While there are numerous federal policies that led to cumulative and egregious disadvantage for Black Americans, one powerful example is redlining. In 1934 the Federal Housing Administration was created, and by insuring private mortgages, the FHA made it easier for eligible home buyers to obtain financing. The FHA used a system of maps that graded neighborhoods. Racial composition of neighborhoods was overtly used as a component of grading, and the presence of Black people led a neighborhood to be downgraded or redlined.^8,9 This meant Black people were largely ineligible for FHA-backed loans. In The Color of Law, Richard Rothstein writes, “Today’s residential segregation in the North, South, Midwest, and West is not the unintended consequence of individual choices and of otherwise well-meaning law or regulation but of unhidden public policy that explicitly segregated every metropolitan area in the United States.The policy was so systematic and forceful that its effects endure to the present time.”⁹

Though these specific policies are no longer in place, many correlations have been found between historically redlined neighborhoods and higher rates of diseases today, including diabetes, hypertension, asthma, and preterm deliveries.¹⁰ These policies also have played a role in creating the wealth gap—directly by limiting the opportunity for home ownership, which translates to intergenerational wealth, and indirectly by the disinvestment in neighborhoods where Black people live, leading to reduced access to quality education, decreased employment opportunities, and increased environmental hazards.^8,11

Continue to: Health disparities...

Health disparities

The numerous health disparities, more accurately termed health inequities, suffered by racial minority groups is well documented.¹²

COVID-19 death and vaccination-rate inequities. Early in the COVID-19 pandemic, data emerged that racial minorities were being disparately affected.¹³ In December 2020, the Centers for Disease Control and Prevention (CDC) reported that Hispanic or Latino, non-Hispanic Black, and non-Hispanic American Indian or Alaska Native people had all died at higher rates than White Americans.¹⁴ These racial groups had higher hospitalization rates across age groups and, after adjusting for age, rates of hospitalization were 2.8 to 3.4 times higher.¹⁵ We are continuing to learn what factors contribute to these inequities, but it has highlighted how racist policies have led to disparate access to health care, or even clean air, clean water, and nutritious food, and left communities of color more vulnerable to severe illness and death from COVID-19. With the advent of vaccines for COVID-19, we continue to see racial disparities as Black Americans have the lowest rates of vaccination.¹⁶ All of these inequities have to be understood in the context of the racist structures that exist in our society. As medical providers, we must understand and help to dismantle these structures.

Pregnancy-related mortality (PRM) inequities. A powerful example of a persistent health inequity in our field is the well-known disparity in pregnancy-related mortality when examining this outcome by race. Per CDC analysis of data on PRM from 2007–2016, Black women died at a rate 3.2 times higher than White women. This disparity was even greater in patients older than 30 years of age. When they compared rates while controlling for the highest level of education, the disparity is even more pronounced: PRM rate for those with a college degree or higher was 5.2 times greater for Black people compared with White people.¹⁶The CDC also reported that, in 2018, the infant mortality for non-Hispanic Black infants was 10.8 per 1,000 live births, compared with 4.6 per 1,000 live births for White infants. This is a rate 2.4-times higher for Black infants.¹⁷ Dr. Cooper Owens and Dr. Fett note in their article, “Black maternal and infant health: Historical legacies of slavery,” that in 1850 this rate was 1.6-times higher for Black infants, which means the inequity was worse in 2018 America than in the antebellum South.⁵

The role of patient experience

As discussed, governmental policies have created persistent inequities in wealth, access to health care, and exposure to environmental toxins, among many other disparities. However, the data finding that highly educated Black pregnant patients suffer markedly increased risk of maternal death, indicate that inequities cannot be attributed only to education or lack of access to health care. This is where some will once again lean on the idea that there is something inherently different about Black people. But if we know that race was created and is not an empiric category, we must consider the social variables impacting Black patients’ experience.

As Linda Blount, President and CEO of the Black Women’s Health Imperative, put it, “Race is not a risk factor. It is the lived experience of being a Black woman in this society that is the risk factor.”¹⁸ So how much of these inequities can be accounted for by differential treatment of Black patients? There is, for example, data on the disproportionately lower rates of Black renal transplant recipients and inordinately higher rates of amputations among Black patients.^19,20 None of us wants to think we are treating our Black patients differently, but the data demand that we ask ourselves if we are. Some of this is built into the system. For example, in their article “Hidden in plain sight—Reconsidering the use of race correction in clinical algorithms,” Vyas and colleagues outline a list of calculators and algorithms that include race.²¹ This means we may be using these calculators and changing outcomes for our patients based on their race. This is only one example of racism hidden within guidelines and standards of care.

The existence of racism on an interpersonal level also cannot be denied. This could lead to differential care specifically, but also can manifest by way of the toll it takes on a patient generally. This is the concept of allostatic load or weathering: the chronic stress of experiencing racism creates detrimental physiologic change. There is ongoing research into epigenetic modifications from stress that could be impacting health outcomes in Black populations.

Continue to: What is the work we need to do?...

What is the work we need to do?

Become educated. We have discussed taking the initiative to learn about the history of racism, including the legacies of slavery and the ongoing impact of racism on health. This knowledge is foundational and sometimes transformative. It allows us to see opportunities for antiracism and gives us the knowledge to begin meaningful conversations.

Take action. We must take inventory within our lives. What are our spheres of influence? What are our resources? Where can we make an impact? Right now, you can take out a pen and paper and write down all the roles you play. Look for opportunities in personal interactions and daily routines. Unfortunately, there will be many opportunities to speak up against racism—although this is rarely easy. Find articles, podcasts, and workshops on upstander training. One framework to respond to microaggressions has been proposed by faculty at Boston University Medical Center using the acronym LIFT (Lights on, Impact vs Intent, Full stop, Teach).²² It advises highlighting, clarifying, and directly addressing problematic comments with such statements as “I heard you say…” or “What did you mean by that comment?”, or a more direct “Statements like that are not OK with me,” or a teaching statement of “I read an article that made me think differently about comments like the one you made...”²² How and when to employ these strategies takes deliberate practice and will be uncomfortable. But we must do the work.

Practice empathetic listening. In a podcast discussion with Brené Brown on creating transformative cultures, Aiko Bethea, a leader in diversity and equity innovation, implores listeners to believe people of color.^23,24 Draw on the history you’ve learned and understand the context in which Black people live in our society. Don’t brush off your Black friend who is upset about being stopped by security. That wasn’t the first time she was in that situation. Take seriously your patient’s concern that they are not being treated appropriately because of being Black. At the same time, do not think of Black people as a monolith or a stereotype. Respect people’s individuality.

Teach our kids all of this. We must also find ways to make change on a larger scale—within our practices, hospitals, medical schools, places of worship, town councils, school boards, state legislatures, and so on. If you are in a faculty position, you can reach out to leadership to scrutinize the curriculum while also ensuring that what and how you are teaching aligns with your antiracist principles. Question the theories, calculators, and algorithms being used and taught. Inquire about policies around recruitment of trainees and faculty as well as promotion, and implement strategies to make this inclusive and equitable. If you run a practice, you can ensure hiring and compensation policies are equitable. Examine patient access and barriers that your minoritized patients are facing, and address those barriers. Share resources and tools that you find helpful and develop a community of colleagues to develop with and hold one another accountable.

In her June 2020 article, An Open Letter to Corporate America, Philanthropy, Academia, etc: What now?, Bethea lays out an extensive framework for approaching antiracism at a high level.²⁵ Among the principles she emphasizes is that the work of diversity, equity, and inclusion should not be siloed and cannot continue to be undervalued. It must be viewed as leadership and engaged in by leadership. The work of diversity, equity, and inclusion for any given institution must be explicit, intentional, measured, and transparent. Within that work, antiracism deserves individual attention. This work must center the people of color for whom you are pursuing equity. White people must resist the urge to make this about them.²⁵

Drs. Esther Choo and J. Nwando Olayiwola present their proposals for combating racism in two 2020 Lancet articles.^26,27 They discuss anticipating failure and backlash and learning from them but not being derailed by them. They emphasize the need for ongoing, serious financial investment and transformation in leadership. They also point out the need for data, discouraging more research on well-established inequities while recommending investigating interventions.^26,27 If you are in leadership positions, read these articles and many more. Enact these principles. Make the investment. If you are not in such a position, find ways to hold your organization’s leadership accountable. Find ways to get a seat at the table and steer the conversation. In medicine, we have to make change at every level of our organizations. That will include the very difficult work of changing climate and culture. In addition, we have to look not only within our organizations but also to the communities we serve. Those voices must be valued in this conversation.

Will this take time? Yes. Will this be hard? Yes. Can you do everything? No. Can you do your part? Yes! Do the work. 

Exposure to secondhand marijuana smoke is more strongly associated with viral respiratory infections in children, compared with children who were exposed to tobacco smoke and those with no smoke exposure, new research shows.

“The findings of this study are interesting and pleasantly raise further questions,” said Kristen Miller, MD, attending physician in the division of pulmonary and sleep medicine at Children’s Hospital of Philadelphia, who was not involved in the study. “Given the robust literature regarding secondhand smoke exposure and the current landscape surrounding marijuana, this is a timely study to evaluate the prevalence of marijuana use and the associated effects of marijuana exposure among children.”

Prior research has linked primary marijuana use with respiratory effects. A 2020 study associated cannabis use with an increased risk of severe bronchitis, lung hyperinflation, and increased central airway resistance. However, according to the Centers for Disease Control and Prevention, there are still a lot of unanswered questions surrounding secondhand marijuana smoke exposure and its effects.

“If kids are exposed to enough secondhand smoke, regardless of what the substance is, they’re going to have some negative health outcomes with it,” study author Adam Johnson, MD, of Wake Forest University, Winston-Salem, N.C., said in an interview.

The study, published in Pediatric Research, looked at rates of reported ED and urgent care visits and specific illnesses – such as otitis media, viral respiratory infections, and asthma exacerbations – among children with marijuana exposure and tobacco exposure.

For the study, Dr. Johnson and colleagues surveyed 1,500 parents and caregivers who went to an academic children’s hospital between Dec. 1, 2015, and July 30, 2017. Researchers found that children exposed to marijuana smoke had higher rates of ED visits at 2.21 within the past 12 months, compared with those exposed to tobacco smoke (2.14 within the past 12 months) and those with no smoke exposure (1.94 within the past 12 months). However, the difference in these visits were not statistically significant.

Researchers saw that children exposed to secondhand marijuana smoke saw a 30% increase in viral respiratory infections, compared with those who were not exposed to tobacco or marijuana smoke, Dr. Johnson said. Caregivers who smoked marijuana reported a rate of 1.31 viral infections in their children within the last year. Meanwhile those who smoked tobacco reported a rate of 1.00 infections within the last 12 months and caregivers who did not smoke reported 1.04 infections within the year.

“It suggests that components in marijuana smoke may depress the body’s immune responses to viral infections in children,” Dr. Miller said in an interview.

When it came to otitis media episodes, children exposed to marijuana had a rate of 0.96 episodes within the past 12 months. Children experiencing secondhand tobacco smoke had a rate of 0.83 episodes and those with no smoke exposure had 0.75 episodes within the past 12 months. Researchers did not note this difference as statistically significant.

When it came to asthma exacerbations, children exposed to marijuana smoke also had statistically insignificantly higher rates of exacerbations, compared with those exposed to tobacco smoke and those not exposed to smoke.

“I think it was surprising that the survey results found that marijuana seemed to be more strongly associated with the viral respiratory infections than tobacco,” Dr. Johnson said. “We know that secondhand tobacco smoke exposure in kids does lead to things like otitis media or ear infections, asthma attacks, and other processes, including colds. It was interesting that we didn’t find that association [in the new study], but we found that with marijuana.”

Dr. Johnson said the findings are especially concerning with increases in the acceptance and accessibility of marijuana as it becomes legalized in many states.

A 2015 study examined the effect of secondhand marijuana smoke exposure. Researchers found that exposure to secondhand marijuana smoke can increase heart rate, have mild to moderate sedative effects and can produce detectable cannabinoid levels in blood and urine. However, another study published in 2012 found that low to moderate primary marijuana use is less harmful to users’ lungs than tobacco exposure.

Dr. Miller added that little is known about how exposure to marijuana smoke can affect the innate responses to pathogens and there is a need to “study this in more detail” to figure out if secondhand marijuana smoke is a risk factor for either an increase in respiratory virus infections or their severity.

“These questions could have considerable implications for the health of our children and public health measures regarding marijuana use,” she explained. “As documented marijuana use increases, health care providers need to be aware of the effects of marijuana use and exposure.”

Neither Dr. Johnson nor Dr. Miller has any relevant financial disclosures.

Exposure to secondhand marijuana smoke is more strongly associated with viral respiratory infections in children, compared with children who were exposed to tobacco smoke and those with no smoke exposure, new research shows.

“The findings of this study are interesting and pleasantly raise further questions,” said Kristen Miller, MD, attending physician in the division of pulmonary and sleep medicine at Children’s Hospital of Philadelphia, who was not involved in the study. “Given the robust literature regarding secondhand smoke exposure and the current landscape surrounding marijuana, this is a timely study to evaluate the prevalence of marijuana use and the associated effects of marijuana exposure among children.”

Prior research has linked primary marijuana use with respiratory effects. A 2020 study associated cannabis use with an increased risk of severe bronchitis, lung hyperinflation, and increased central airway resistance. However, according to the Centers for Disease Control and Prevention, there are still a lot of unanswered questions surrounding secondhand marijuana smoke exposure and its effects.

“If kids are exposed to enough secondhand smoke, regardless of what the substance is, they’re going to have some negative health outcomes with it,” study author Adam Johnson, MD, of Wake Forest University, Winston-Salem, N.C., said in an interview.

The study, published in Pediatric Research, looked at rates of reported ED and urgent care visits and specific illnesses – such as otitis media, viral respiratory infections, and asthma exacerbations – among children with marijuana exposure and tobacco exposure.

For the study, Dr. Johnson and colleagues surveyed 1,500 parents and caregivers who went to an academic children’s hospital between Dec. 1, 2015, and July 30, 2017. Researchers found that children exposed to marijuana smoke had higher rates of ED visits at 2.21 within the past 12 months, compared with those exposed to tobacco smoke (2.14 within the past 12 months) and those with no smoke exposure (1.94 within the past 12 months). However, the difference in these visits were not statistically significant.

Researchers saw that children exposed to secondhand marijuana smoke saw a 30% increase in viral respiratory infections, compared with those who were not exposed to tobacco or marijuana smoke, Dr. Johnson said. Caregivers who smoked marijuana reported a rate of 1.31 viral infections in their children within the last year. Meanwhile those who smoked tobacco reported a rate of 1.00 infections within the last 12 months and caregivers who did not smoke reported 1.04 infections within the year.

“It suggests that components in marijuana smoke may depress the body’s immune responses to viral infections in children,” Dr. Miller said in an interview.

When it came to otitis media episodes, children exposed to marijuana had a rate of 0.96 episodes within the past 12 months. Children experiencing secondhand tobacco smoke had a rate of 0.83 episodes and those with no smoke exposure had 0.75 episodes within the past 12 months. Researchers did not note this difference as statistically significant.

When it came to asthma exacerbations, children exposed to marijuana smoke also had statistically insignificantly higher rates of exacerbations, compared with those exposed to tobacco smoke and those not exposed to smoke.

“I think it was surprising that the survey results found that marijuana seemed to be more strongly associated with the viral respiratory infections than tobacco,” Dr. Johnson said. “We know that secondhand tobacco smoke exposure in kids does lead to things like otitis media or ear infections, asthma attacks, and other processes, including colds. It was interesting that we didn’t find that association [in the new study], but we found that with marijuana.”

Dr. Johnson said the findings are especially concerning with increases in the acceptance and accessibility of marijuana as it becomes legalized in many states.

A 2015 study examined the effect of secondhand marijuana smoke exposure. Researchers found that exposure to secondhand marijuana smoke can increase heart rate, have mild to moderate sedative effects and can produce detectable cannabinoid levels in blood and urine. However, another study published in 2012 found that low to moderate primary marijuana use is less harmful to users’ lungs than tobacco exposure.

Dr. Miller added that little is known about how exposure to marijuana smoke can affect the innate responses to pathogens and there is a need to “study this in more detail” to figure out if secondhand marijuana smoke is a risk factor for either an increase in respiratory virus infections or their severity.

“These questions could have considerable implications for the health of our children and public health measures regarding marijuana use,” she explained. “As documented marijuana use increases, health care providers need to be aware of the effects of marijuana use and exposure.”

Neither Dr. Johnson nor Dr. Miller has any relevant financial disclosures.

Exposure to secondhand marijuana smoke is more strongly associated with viral respiratory infections in children, compared with children who were exposed to tobacco smoke and those with no smoke exposure, new research shows.

“The findings of this study are interesting and pleasantly raise further questions,” said Kristen Miller, MD, attending physician in the division of pulmonary and sleep medicine at Children’s Hospital of Philadelphia, who was not involved in the study. “Given the robust literature regarding secondhand smoke exposure and the current landscape surrounding marijuana, this is a timely study to evaluate the prevalence of marijuana use and the associated effects of marijuana exposure among children.”

Prior research has linked primary marijuana use with respiratory effects. A 2020 study associated cannabis use with an increased risk of severe bronchitis, lung hyperinflation, and increased central airway resistance. However, according to the Centers for Disease Control and Prevention, there are still a lot of unanswered questions surrounding secondhand marijuana smoke exposure and its effects.

“If kids are exposed to enough secondhand smoke, regardless of what the substance is, they’re going to have some negative health outcomes with it,” study author Adam Johnson, MD, of Wake Forest University, Winston-Salem, N.C., said in an interview.

The study, published in Pediatric Research, looked at rates of reported ED and urgent care visits and specific illnesses – such as otitis media, viral respiratory infections, and asthma exacerbations – among children with marijuana exposure and tobacco exposure.

For the study, Dr. Johnson and colleagues surveyed 1,500 parents and caregivers who went to an academic children’s hospital between Dec. 1, 2015, and July 30, 2017. Researchers found that children exposed to marijuana smoke had higher rates of ED visits at 2.21 within the past 12 months, compared with those exposed to tobacco smoke (2.14 within the past 12 months) and those with no smoke exposure (1.94 within the past 12 months). However, the difference in these visits were not statistically significant.

Researchers saw that children exposed to secondhand marijuana smoke saw a 30% increase in viral respiratory infections, compared with those who were not exposed to tobacco or marijuana smoke, Dr. Johnson said. Caregivers who smoked marijuana reported a rate of 1.31 viral infections in their children within the last year. Meanwhile those who smoked tobacco reported a rate of 1.00 infections within the last 12 months and caregivers who did not smoke reported 1.04 infections within the year.

“It suggests that components in marijuana smoke may depress the body’s immune responses to viral infections in children,” Dr. Miller said in an interview.

When it came to otitis media episodes, children exposed to marijuana had a rate of 0.96 episodes within the past 12 months. Children experiencing secondhand tobacco smoke had a rate of 0.83 episodes and those with no smoke exposure had 0.75 episodes within the past 12 months. Researchers did not note this difference as statistically significant.

When it came to asthma exacerbations, children exposed to marijuana smoke also had statistically insignificantly higher rates of exacerbations, compared with those exposed to tobacco smoke and those not exposed to smoke.

“I think it was surprising that the survey results found that marijuana seemed to be more strongly associated with the viral respiratory infections than tobacco,” Dr. Johnson said. “We know that secondhand tobacco smoke exposure in kids does lead to things like otitis media or ear infections, asthma attacks, and other processes, including colds. It was interesting that we didn’t find that association [in the new study], but we found that with marijuana.”

Dr. Johnson said the findings are especially concerning with increases in the acceptance and accessibility of marijuana as it becomes legalized in many states.

A 2015 study examined the effect of secondhand marijuana smoke exposure. Researchers found that exposure to secondhand marijuana smoke can increase heart rate, have mild to moderate sedative effects and can produce detectable cannabinoid levels in blood and urine. However, another study published in 2012 found that low to moderate primary marijuana use is less harmful to users’ lungs than tobacco exposure.

Dr. Miller added that little is known about how exposure to marijuana smoke can affect the innate responses to pathogens and there is a need to “study this in more detail” to figure out if secondhand marijuana smoke is a risk factor for either an increase in respiratory virus infections or their severity.

“These questions could have considerable implications for the health of our children and public health measures regarding marijuana use,” she explained. “As documented marijuana use increases, health care providers need to be aware of the effects of marijuana use and exposure.”

Neither Dr. Johnson nor Dr. Miller has any relevant financial disclosures.

The vast amounts of information generated this past year related to the COVID-19 pandemic was a feat of wonder – recommendations and guidelines on the hospital level and on the national level came in a flurry, more often overwhelming and confusing than clarifying for the frontline provider. In addition, “routine” hospital care for non-infected patients and improvement processes had to continue as we all dealt with the whirlwind of increasing COVID cases, torrents of new guidelines, and educating our trainees.

Thus, the individual-level question: how does a clinician stay engaged and distill the relentless stream of new information?

In Spring 2020, when the first patients with COVID were admitted, our hospital medicine section was tasked to create a surge plan. This included organizing, orienting, and educating off-service providers on how to become hospitalists. Undoubtedly, the call to arms for our center was heard, and many responded. However, backgrounds were diverse in specialty – clinicians and trainees from psychiatry, general surgery, and various fellowships all answered. It was an exhausting and inefficient effort to produce the material, hold webinars, and schedule training, especially for those who were more removed from a hospital medicine experience. We knew we had to come up with an alternative plan moving forward.

Thus, the systems-level question: how does a health care system educate its clinicians, or any other health care providers, when reallocation of their talents and skills is both necessary, time-sensitive, and occuring during a period where new information is constantly being produced and changing?

To reach the most clinicians as possible, with the most succinct and distilled information, we had to come up with a method to do so. Ultimately, in considering the situation at hand, we had to understand who we were as the provider of the information, and who the recipient would be. We would like to share the initiatives and processes by which we constructed our solution to the two questions – microlearning through hospital podcasting.
 

Learning from our health care colleagues

With the initial webinars and training sessions for our staff, we assessed our learners’ motivations and background in managing in a hospital medicine capacity. Overall, we discovered that our trainees and clinicians have an innate drive to learn; all of them recognized the importance of keeping up with evidence-based information. However, the difficulty highlighted was the individual time available to dedicate to acquiring new information and awareness of new information being available to the health care sector during the chaotic times of the pandemic.

From our section’s perspective, we had a difficulty with coordinating among multiple professional development groups within our hospital, cost, and resources to execute training. These difficulties between providing knowledge and receiving knowledge have already been expertly analyzed.¹

Parallel to this, the pedagogic paradigm shifts as we progress through our careers – the methods and skills we used in school contrast in many ways with those we use on a daily basis when it comes to learning. Instead of dedicating hours at a time to new challenges in our workflow or our interests, we watch videos, search retailers for product solutions, check our email correspondence, and peruse social media accounts several times a day. Information comes at us very quickly, but in small pieces.

One such innovation in pedagogy is the practice of microlearning. This refers to the use of small lesson modules and short-term activities intended to teach and reinforce concepts.² It is the opposite of “macrolearning,” which is the principle of dedicating reading material, structured coursework, and traditional knowledge evaluation in the form of exams to reinforce learning. Certainly, microlearning has other names as well – “just-in-time,” “just-enough,” and “micro-courses” are a few synonyms seen in the current literature. Though a highly relevant concept for our situation, translating it to an endproduct for our trainees and clinicians required more thought.
 

From theory to application

Microlearning allows for faster delivery of information – fewer things to write means shorter course distribution times, allowing the learner to respond faster to changing educational goals and training demands. Microlearning is flexible – “micro-courses” can give a broad overview of a subject or cover complex topics broken down into simple parts. In addition, micro-learning promotes retention of key concepts – given the length of each lesson, repetition of the topic by the learner is possible at any point in time. The whole experience is similar to checking your favorite social media application on your smartphone.

Certainly, many examples of the application of microlearning are available in the health care sector – pharmaceutical and nursing training both have utilized the theory extensively.^3-4 However, in many instances, individuals were still required to sit at a workstation to complete modules and lessons. We envisioned our application of microlearning to be “on-the-go,” without necessarily requiring a computer workstation or laptop to complete.

In thinking about how social media attracts and influences clinicians, many content creators on social media come to mind. In addition, most, if not all, have branched into various social media platforms – podcasting, blogging, YouTube, for example. In thinking about our colleagues and trainees, we wanted a platform that they could take on the go, without the need to focus their visual attention (such as while driving or running). Ultimately, we believe the podcast would be the best platform to disseminate our information.

Podcasting is not foreign to medicine. A variety of medical podcasts exist, whether produced by major medical journals or by various independent health care practitioners. Both, however, have their drawbacks – the podcasts created by major medical journals are typically a summary of the publication’s content and are less engaging. Alternatively, podcasts produced by independent creators are certainly engaging and entertaining, and have a wealth of information, but the line is often blurred between just that: education and entertainment. In both instances, there is no follow-up or feedback offered to the learner in the form of surveys, or other types of feedback, which is arguably an important piece in any form of pedagogy. Thus, we sought to strike a balance between the two forms for our purposes.
 

Process of two podcasts

Our section was aware of the two aims during the pandemic – (1) disseminate new information regarding COVID-19 to the rest of our staff members and trainees as quickly as possible, and (2) maintain and improve the current quality of care of our patients. Thus, we sought to apply the reach and efficiency of the podcasting medium to provide ongoing education and feedback with respect to these two aims.

“The Cure” podcast. We recognized the constant flow of new COVID-19 information and updates and we wanted to find a readily accessible platform to reach staff with timely updates. Our marketing & communications team later helped us realize that the content we wanted to share was relevant to our patients and the community, so we formatted the material to be practical and easily digestible- something that may help an individual make decisions at the bedside as well as have conversations at the dinner table. Most recently, we engaged with our human resources department to use our platform in orienting new hires with the goal of helping staff familiarize with the institutions policies, procedures, and job aids that keep staff and patients safe.

“Antibiotry” podcast. Prior to the COVID-19 pandemic, our antibiotic stewardship group noticed an increase in antibiotic use on our medical floors. This is monitored not only through internal metrics by our pharmacy department, but also via the SAAR (standardized antibiotic administration ratio). Both sources demonstrated an increase in antibiotic use, greater than expected. An initiative was formed between our hospital medicine and infectious disease sections, and our pharmacy department to raise awareness of this increase in use, provide education to our trainees, and to create systems solutions for clinicians.

Initially, we sought to hold in-person sessions once a month for our trainees. This was led by a senior resident at the time. Topics of discussion were geared towards clinical decision making regarding empiric antibiotic use on the hospital medicine service. At the same time, our team published empiric antibiotic use guidelines, accessible through our electronic medical record. In addition, the resident leader gave a voluntary survey at the end of the session to assess not only confidence of antibiotic use, but also baseline knowledge regarding antibiotics in various clinical scenarios. This survey was repeated at the end of the resident group’s month-long rotation. Altogether, each in-person session was no longer than 10 minutes.

Unfortunately, the initiative was just gaining momentum when the COVID-19 pandemic was declared. However, we sought to take this challenge and translate it into an opportunity.

We directed our focus towards stewardship during pandemic times. Initially, our resident leader sent out email primers, approximately 3-5 minute reads, as a substitute for the in-person sessions. Our primers’ uniqueness was in its incorporation of prescription pattern data that was developed by our resident leader and our initiative’s data analyst. In doing so, we provided professional feedback regarding our antibiotic use based on the clinical indication. This was a powerful tool to not only engage our learners and staff clinicians, but also as a benchmarking tool for continued quality improvement.

But email primers are not engaging, and despite the ubiquity of teleconferencing, it was difficult to ask our housestaff to break from their morning rounds for a 10 minute tele-meeting. Thus, we devised a podcast method of education – 5-10 minute audio clips with conversation regarding a topic of discussion. This way, our trainees and learners can access episodes of education on their own time throughout the pandemic without disrupting their workflow. Given the brevity of, but high-yield content in, each episode, it would not only be convenient for listeners to access and repeat, but also for the podcaster (our resident leader) to create, as recording of the audio portion takes anywhere between 10-20 minutes for each episode, with postprocessing similarly fast.

The interdisciplinary nature of continued medical education cannot be stressed enough. With the help of our professional development team and their educators, we were able to centralize our podcast and attach surveys and additional graphics for each episode, if appropriate. This additional detail allowed for feedback, engagement with our learners, and the chance to provide additional educational points, if the learner was interested. Given the integrated nature of this platform, quality metrics could easily be recorded in the form of “click” data and various other more conventional metrics, such as listener counts and the duration of each podcast played.
 

Future applications and initiatives

Thus far, we have had great success in the reception and use of both podcasts within our institution as an application of microlearning. “The Cure” has been widely listened to by all hospital staff from various services; it has caught the attention of state-wide radio programs, and plans to expand it into the community are being discussed.

As for “Antibiotry” podcast, the concept has been lauded by our medical educators. Given its centralization within our institution, we are able to publish institution-based data as a form of professional and educational feedback to our trainees and staff physicians. This is currently coupled with the development of a provider dashboard, visualizing antibiotic prescriptions and narrowing patterns of practice within our medicine department. We plan to expand “Antibiotry” to other services at the hospital.

For both podcasts, the steps it took to achieve the final product from the microlearning concept were possible through a combination of institutional need and a motivated team. We are fortunate to have highly energetic individuals, making the coordination and planning with our hospitalists, various sub-specialists, and professional development teams straightforward. As the team grows with more individuals interested in the initiatives, keen insight into interests, individual clinical expertise, presentation skills, and technical skills ought to be carefully weighed to sustain our podcasts most efficiently, and perhaps expand them through different social media platforms.

Our objective for sustainability is through the continued outreach to and recruitment of residents and medical students, who can play key roles in the development of future projects related to these educational innovations. Both microlearning podcasts were developed through the initial planning, trial and error, and execution by two resident leaders. Their initiative and motivation to educate our institution through these platforms were highly unique; their pathfinding set the foundation for sustainability and expansion to other services.

Of course, one of the key measures we would like to investigate is whether our microlearning platform translates to improved patient outcomes. Regarding “Antibiotry,” we hope to see a decrease in unnecessary broad-spectrum antibiotic use by drawing attention to clinician practice patterns. Quality and outcome metrics will continue to be developed and measured. In addition to patient care metrics, further investigation of pedagogical metrics will be conducted, especially in the evolving realm of graduate and continuing medical education.

Measuring educational quality is neither a new ethical nor philosophical debate – neither does it carry a definitive answer. Further help from education experts may be needed to assess the quality of the information provided and its impact on our learners.
 

Conclusion

Medicine is ever-changing – the guidelines and criteria for patient care and pathology that we learned in medical school have likely changed. There is no single “best” method of learning new information in medicine, simply due to the breadth and volume of such information generated on a daily basis. This poses both a challenge for present-day clinicians and trainees, and a stimulus for change in the methods of acquiring, absorbing, and applying new information to clinical decision making and practice.

We have found that podcasting is a well-received medium of information transfer that is convenient for both the learner and the content creator. Through the podcast format, we were able to distill non-engaging pieces of education and information and transform them into short-duration lessons that the learner can listen to at their own convenience. This proved to be especially handy during the chaos of the pandemic, not only for dissemination of information regarding the management of COVID-19, but also for sustaining quality improvement goals within our institution.

Further investigation on patient outcomes and information quality are the planned next steps. In addition, expansion of other microlearning media, such as group SMS texting, YouTube videos, and Twitter, ought to be considered. Though many publications discuss the theory, potential benefits, and predicted pitfalls of microlearning, few assess the real-world application of microlearning to the clinical setting for medical education.

So what did we learn? We should think of microlearning as moments when you turn to your smartphone or tablet in order to discover something, answer a question, or complete a task. These are moments when decisions are made and knowledge is reinforced. The goal is to capture these moments and fill them with essential pieces of information.

We offer these suggestions as a place to start. The microlearning platform allows for the collection of data on the interaction between user and course content. The data collected can be used for continuous quality improvement of the curriculum. Microlearning is a dynamic platform where creative ideas are encouraged and a multi-disciplinary approach is valuable to keeping an audience engaged. In the future, we hope to be able to correlate microlearning courses to provider performance and measurable patient outcomes.
 

Dr. Mercado is medical director at Alice Peck Day Memorial Hospital, and associate hospital epidemiologist, Dartmouth-Hitchcock Medical Center, both in Lebanon, N.H., and assistant professor at the Geisel School of Medicine at Dartmouth, Hanover, N.H. Dr. Feng is a Fellow in the Leadership/Preventive Medicine Program in the Department of Internal Medicine at Dartmouth-Hitchcock Medical Center.

References

1. Duggan F and Banwell L. Constructing a model of effective information dissemination in a crisis. Information Research. 2004;9(3). Paper 178 [Available at http://InformationR.net/ir/9-3/paper178.html].

2. Filipe HP, et al. Microlearning to improve CPD learning objectives. Clin Teach. 2020 Dec;17(6):695-699. doi: 10.1111/tct.13208.

3. Hegerius A, et al. E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre. Drug Saf. 2020 Nov;43(11):1171-1180. doi: 10.1007/s40264-020-00981-w.

4. Orwoll B, et al. Gamification and Microlearning for Engagement With Quality Improvement (GAMEQI): A Bundled Digital Intervention for the Prevention of Central Line-Associated Bloodstream Infection. Am J Med Qual. Jan/Feb 2018;33(1):21-29. doi: 10.1177/1062860617706542.

The vast amounts of information generated this past year related to the COVID-19 pandemic was a feat of wonder – recommendations and guidelines on the hospital level and on the national level came in a flurry, more often overwhelming and confusing than clarifying for the frontline provider. In addition, “routine” hospital care for non-infected patients and improvement processes had to continue as we all dealt with the whirlwind of increasing COVID cases, torrents of new guidelines, and educating our trainees.

Thus, the individual-level question: how does a clinician stay engaged and distill the relentless stream of new information?

In Spring 2020, when the first patients with COVID were admitted, our hospital medicine section was tasked to create a surge plan. This included organizing, orienting, and educating off-service providers on how to become hospitalists. Undoubtedly, the call to arms for our center was heard, and many responded. However, backgrounds were diverse in specialty – clinicians and trainees from psychiatry, general surgery, and various fellowships all answered. It was an exhausting and inefficient effort to produce the material, hold webinars, and schedule training, especially for those who were more removed from a hospital medicine experience. We knew we had to come up with an alternative plan moving forward.

Thus, the systems-level question: how does a health care system educate its clinicians, or any other health care providers, when reallocation of their talents and skills is both necessary, time-sensitive, and occuring during a period where new information is constantly being produced and changing?

To reach the most clinicians as possible, with the most succinct and distilled information, we had to come up with a method to do so. Ultimately, in considering the situation at hand, we had to understand who we were as the provider of the information, and who the recipient would be. We would like to share the initiatives and processes by which we constructed our solution to the two questions – microlearning through hospital podcasting.
 

Learning from our health care colleagues

With the initial webinars and training sessions for our staff, we assessed our learners’ motivations and background in managing in a hospital medicine capacity. Overall, we discovered that our trainees and clinicians have an innate drive to learn; all of them recognized the importance of keeping up with evidence-based information. However, the difficulty highlighted was the individual time available to dedicate to acquiring new information and awareness of new information being available to the health care sector during the chaotic times of the pandemic.

From our section’s perspective, we had a difficulty with coordinating among multiple professional development groups within our hospital, cost, and resources to execute training. These difficulties between providing knowledge and receiving knowledge have already been expertly analyzed.¹

Parallel to this, the pedagogic paradigm shifts as we progress through our careers – the methods and skills we used in school contrast in many ways with those we use on a daily basis when it comes to learning. Instead of dedicating hours at a time to new challenges in our workflow or our interests, we watch videos, search retailers for product solutions, check our email correspondence, and peruse social media accounts several times a day. Information comes at us very quickly, but in small pieces.

One such innovation in pedagogy is the practice of microlearning. This refers to the use of small lesson modules and short-term activities intended to teach and reinforce concepts.² It is the opposite of “macrolearning,” which is the principle of dedicating reading material, structured coursework, and traditional knowledge evaluation in the form of exams to reinforce learning. Certainly, microlearning has other names as well – “just-in-time,” “just-enough,” and “micro-courses” are a few synonyms seen in the current literature. Though a highly relevant concept for our situation, translating it to an endproduct for our trainees and clinicians required more thought.
 

From theory to application

Microlearning allows for faster delivery of information – fewer things to write means shorter course distribution times, allowing the learner to respond faster to changing educational goals and training demands. Microlearning is flexible – “micro-courses” can give a broad overview of a subject or cover complex topics broken down into simple parts. In addition, micro-learning promotes retention of key concepts – given the length of each lesson, repetition of the topic by the learner is possible at any point in time. The whole experience is similar to checking your favorite social media application on your smartphone.

Certainly, many examples of the application of microlearning are available in the health care sector – pharmaceutical and nursing training both have utilized the theory extensively.^3-4 However, in many instances, individuals were still required to sit at a workstation to complete modules and lessons. We envisioned our application of microlearning to be “on-the-go,” without necessarily requiring a computer workstation or laptop to complete.

In thinking about how social media attracts and influences clinicians, many content creators on social media come to mind. In addition, most, if not all, have branched into various social media platforms – podcasting, blogging, YouTube, for example. In thinking about our colleagues and trainees, we wanted a platform that they could take on the go, without the need to focus their visual attention (such as while driving or running). Ultimately, we believe the podcast would be the best platform to disseminate our information.

Podcasting is not foreign to medicine. A variety of medical podcasts exist, whether produced by major medical journals or by various independent health care practitioners. Both, however, have their drawbacks – the podcasts created by major medical journals are typically a summary of the publication’s content and are less engaging. Alternatively, podcasts produced by independent creators are certainly engaging and entertaining, and have a wealth of information, but the line is often blurred between just that: education and entertainment. In both instances, there is no follow-up or feedback offered to the learner in the form of surveys, or other types of feedback, which is arguably an important piece in any form of pedagogy. Thus, we sought to strike a balance between the two forms for our purposes.
 

Process of two podcasts

Our section was aware of the two aims during the pandemic – (1) disseminate new information regarding COVID-19 to the rest of our staff members and trainees as quickly as possible, and (2) maintain and improve the current quality of care of our patients. Thus, we sought to apply the reach and efficiency of the podcasting medium to provide ongoing education and feedback with respect to these two aims.

“The Cure” podcast. We recognized the constant flow of new COVID-19 information and updates and we wanted to find a readily accessible platform to reach staff with timely updates. Our marketing & communications team later helped us realize that the content we wanted to share was relevant to our patients and the community, so we formatted the material to be practical and easily digestible- something that may help an individual make decisions at the bedside as well as have conversations at the dinner table. Most recently, we engaged with our human resources department to use our platform in orienting new hires with the goal of helping staff familiarize with the institutions policies, procedures, and job aids that keep staff and patients safe.

“Antibiotry” podcast. Prior to the COVID-19 pandemic, our antibiotic stewardship group noticed an increase in antibiotic use on our medical floors. This is monitored not only through internal metrics by our pharmacy department, but also via the SAAR (standardized antibiotic administration ratio). Both sources demonstrated an increase in antibiotic use, greater than expected. An initiative was formed between our hospital medicine and infectious disease sections, and our pharmacy department to raise awareness of this increase in use, provide education to our trainees, and to create systems solutions for clinicians.

Initially, we sought to hold in-person sessions once a month for our trainees. This was led by a senior resident at the time. Topics of discussion were geared towards clinical decision making regarding empiric antibiotic use on the hospital medicine service. At the same time, our team published empiric antibiotic use guidelines, accessible through our electronic medical record. In addition, the resident leader gave a voluntary survey at the end of the session to assess not only confidence of antibiotic use, but also baseline knowledge regarding antibiotics in various clinical scenarios. This survey was repeated at the end of the resident group’s month-long rotation. Altogether, each in-person session was no longer than 10 minutes.

Unfortunately, the initiative was just gaining momentum when the COVID-19 pandemic was declared. However, we sought to take this challenge and translate it into an opportunity.

We directed our focus towards stewardship during pandemic times. Initially, our resident leader sent out email primers, approximately 3-5 minute reads, as a substitute for the in-person sessions. Our primers’ uniqueness was in its incorporation of prescription pattern data that was developed by our resident leader and our initiative’s data analyst. In doing so, we provided professional feedback regarding our antibiotic use based on the clinical indication. This was a powerful tool to not only engage our learners and staff clinicians, but also as a benchmarking tool for continued quality improvement.

But email primers are not engaging, and despite the ubiquity of teleconferencing, it was difficult to ask our housestaff to break from their morning rounds for a 10 minute tele-meeting. Thus, we devised a podcast method of education – 5-10 minute audio clips with conversation regarding a topic of discussion. This way, our trainees and learners can access episodes of education on their own time throughout the pandemic without disrupting their workflow. Given the brevity of, but high-yield content in, each episode, it would not only be convenient for listeners to access and repeat, but also for the podcaster (our resident leader) to create, as recording of the audio portion takes anywhere between 10-20 minutes for each episode, with postprocessing similarly fast.

The interdisciplinary nature of continued medical education cannot be stressed enough. With the help of our professional development team and their educators, we were able to centralize our podcast and attach surveys and additional graphics for each episode, if appropriate. This additional detail allowed for feedback, engagement with our learners, and the chance to provide additional educational points, if the learner was interested. Given the integrated nature of this platform, quality metrics could easily be recorded in the form of “click” data and various other more conventional metrics, such as listener counts and the duration of each podcast played.
 

Future applications and initiatives

Thus far, we have had great success in the reception and use of both podcasts within our institution as an application of microlearning. “The Cure” has been widely listened to by all hospital staff from various services; it has caught the attention of state-wide radio programs, and plans to expand it into the community are being discussed.

As for “Antibiotry” podcast, the concept has been lauded by our medical educators. Given its centralization within our institution, we are able to publish institution-based data as a form of professional and educational feedback to our trainees and staff physicians. This is currently coupled with the development of a provider dashboard, visualizing antibiotic prescriptions and narrowing patterns of practice within our medicine department. We plan to expand “Antibiotry” to other services at the hospital.

For both podcasts, the steps it took to achieve the final product from the microlearning concept were possible through a combination of institutional need and a motivated team. We are fortunate to have highly energetic individuals, making the coordination and planning with our hospitalists, various sub-specialists, and professional development teams straightforward. As the team grows with more individuals interested in the initiatives, keen insight into interests, individual clinical expertise, presentation skills, and technical skills ought to be carefully weighed to sustain our podcasts most efficiently, and perhaps expand them through different social media platforms.

Our objective for sustainability is through the continued outreach to and recruitment of residents and medical students, who can play key roles in the development of future projects related to these educational innovations. Both microlearning podcasts were developed through the initial planning, trial and error, and execution by two resident leaders. Their initiative and motivation to educate our institution through these platforms were highly unique; their pathfinding set the foundation for sustainability and expansion to other services.

Of course, one of the key measures we would like to investigate is whether our microlearning platform translates to improved patient outcomes. Regarding “Antibiotry,” we hope to see a decrease in unnecessary broad-spectrum antibiotic use by drawing attention to clinician practice patterns. Quality and outcome metrics will continue to be developed and measured. In addition to patient care metrics, further investigation of pedagogical metrics will be conducted, especially in the evolving realm of graduate and continuing medical education.

Measuring educational quality is neither a new ethical nor philosophical debate – neither does it carry a definitive answer. Further help from education experts may be needed to assess the quality of the information provided and its impact on our learners.
 

Conclusion

Medicine is ever-changing – the guidelines and criteria for patient care and pathology that we learned in medical school have likely changed. There is no single “best” method of learning new information in medicine, simply due to the breadth and volume of such information generated on a daily basis. This poses both a challenge for present-day clinicians and trainees, and a stimulus for change in the methods of acquiring, absorbing, and applying new information to clinical decision making and practice.

We have found that podcasting is a well-received medium of information transfer that is convenient for both the learner and the content creator. Through the podcast format, we were able to distill non-engaging pieces of education and information and transform them into short-duration lessons that the learner can listen to at their own convenience. This proved to be especially handy during the chaos of the pandemic, not only for dissemination of information regarding the management of COVID-19, but also for sustaining quality improvement goals within our institution.

Further investigation on patient outcomes and information quality are the planned next steps. In addition, expansion of other microlearning media, such as group SMS texting, YouTube videos, and Twitter, ought to be considered. Though many publications discuss the theory, potential benefits, and predicted pitfalls of microlearning, few assess the real-world application of microlearning to the clinical setting for medical education.

So what did we learn? We should think of microlearning as moments when you turn to your smartphone or tablet in order to discover something, answer a question, or complete a task. These are moments when decisions are made and knowledge is reinforced. The goal is to capture these moments and fill them with essential pieces of information.

We offer these suggestions as a place to start. The microlearning platform allows for the collection of data on the interaction between user and course content. The data collected can be used for continuous quality improvement of the curriculum. Microlearning is a dynamic platform where creative ideas are encouraged and a multi-disciplinary approach is valuable to keeping an audience engaged. In the future, we hope to be able to correlate microlearning courses to provider performance and measurable patient outcomes.
 

Dr. Mercado is medical director at Alice Peck Day Memorial Hospital, and associate hospital epidemiologist, Dartmouth-Hitchcock Medical Center, both in Lebanon, N.H., and assistant professor at the Geisel School of Medicine at Dartmouth, Hanover, N.H. Dr. Feng is a Fellow in the Leadership/Preventive Medicine Program in the Department of Internal Medicine at Dartmouth-Hitchcock Medical Center.

References

1. Duggan F and Banwell L. Constructing a model of effective information dissemination in a crisis. Information Research. 2004;9(3). Paper 178 [Available at http://InformationR.net/ir/9-3/paper178.html].

2. Filipe HP, et al. Microlearning to improve CPD learning objectives. Clin Teach. 2020 Dec;17(6):695-699. doi: 10.1111/tct.13208.

3. Hegerius A, et al. E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre. Drug Saf. 2020 Nov;43(11):1171-1180. doi: 10.1007/s40264-020-00981-w.

4. Orwoll B, et al. Gamification and Microlearning for Engagement With Quality Improvement (GAMEQI): A Bundled Digital Intervention for the Prevention of Central Line-Associated Bloodstream Infection. Am J Med Qual. Jan/Feb 2018;33(1):21-29. doi: 10.1177/1062860617706542.

The vast amounts of information generated this past year related to the COVID-19 pandemic was a feat of wonder – recommendations and guidelines on the hospital level and on the national level came in a flurry, more often overwhelming and confusing than clarifying for the frontline provider. In addition, “routine” hospital care for non-infected patients and improvement processes had to continue as we all dealt with the whirlwind of increasing COVID cases, torrents of new guidelines, and educating our trainees.

Thus, the individual-level question: how does a clinician stay engaged and distill the relentless stream of new information?

In Spring 2020, when the first patients with COVID were admitted, our hospital medicine section was tasked to create a surge plan. This included organizing, orienting, and educating off-service providers on how to become hospitalists. Undoubtedly, the call to arms for our center was heard, and many responded. However, backgrounds were diverse in specialty – clinicians and trainees from psychiatry, general surgery, and various fellowships all answered. It was an exhausting and inefficient effort to produce the material, hold webinars, and schedule training, especially for those who were more removed from a hospital medicine experience. We knew we had to come up with an alternative plan moving forward.

Thus, the systems-level question: how does a health care system educate its clinicians, or any other health care providers, when reallocation of their talents and skills is both necessary, time-sensitive, and occuring during a period where new information is constantly being produced and changing?

To reach the most clinicians as possible, with the most succinct and distilled information, we had to come up with a method to do so. Ultimately, in considering the situation at hand, we had to understand who we were as the provider of the information, and who the recipient would be. We would like to share the initiatives and processes by which we constructed our solution to the two questions – microlearning through hospital podcasting.
 

Learning from our health care colleagues

With the initial webinars and training sessions for our staff, we assessed our learners’ motivations and background in managing in a hospital medicine capacity. Overall, we discovered that our trainees and clinicians have an innate drive to learn; all of them recognized the importance of keeping up with evidence-based information. However, the difficulty highlighted was the individual time available to dedicate to acquiring new information and awareness of new information being available to the health care sector during the chaotic times of the pandemic.

From our section’s perspective, we had a difficulty with coordinating among multiple professional development groups within our hospital, cost, and resources to execute training. These difficulties between providing knowledge and receiving knowledge have already been expertly analyzed.¹

Parallel to this, the pedagogic paradigm shifts as we progress through our careers – the methods and skills we used in school contrast in many ways with those we use on a daily basis when it comes to learning. Instead of dedicating hours at a time to new challenges in our workflow or our interests, we watch videos, search retailers for product solutions, check our email correspondence, and peruse social media accounts several times a day. Information comes at us very quickly, but in small pieces.

One such innovation in pedagogy is the practice of microlearning. This refers to the use of small lesson modules and short-term activities intended to teach and reinforce concepts.² It is the opposite of “macrolearning,” which is the principle of dedicating reading material, structured coursework, and traditional knowledge evaluation in the form of exams to reinforce learning. Certainly, microlearning has other names as well – “just-in-time,” “just-enough,” and “micro-courses” are a few synonyms seen in the current literature. Though a highly relevant concept for our situation, translating it to an endproduct for our trainees and clinicians required more thought.
 

From theory to application

Microlearning allows for faster delivery of information – fewer things to write means shorter course distribution times, allowing the learner to respond faster to changing educational goals and training demands. Microlearning is flexible – “micro-courses” can give a broad overview of a subject or cover complex topics broken down into simple parts. In addition, micro-learning promotes retention of key concepts – given the length of each lesson, repetition of the topic by the learner is possible at any point in time. The whole experience is similar to checking your favorite social media application on your smartphone.

Certainly, many examples of the application of microlearning are available in the health care sector – pharmaceutical and nursing training both have utilized the theory extensively.^3-4 However, in many instances, individuals were still required to sit at a workstation to complete modules and lessons. We envisioned our application of microlearning to be “on-the-go,” without necessarily requiring a computer workstation or laptop to complete.

In thinking about how social media attracts and influences clinicians, many content creators on social media come to mind. In addition, most, if not all, have branched into various social media platforms – podcasting, blogging, YouTube, for example. In thinking about our colleagues and trainees, we wanted a platform that they could take on the go, without the need to focus their visual attention (such as while driving or running). Ultimately, we believe the podcast would be the best platform to disseminate our information.

Podcasting is not foreign to medicine. A variety of medical podcasts exist, whether produced by major medical journals or by various independent health care practitioners. Both, however, have their drawbacks – the podcasts created by major medical journals are typically a summary of the publication’s content and are less engaging. Alternatively, podcasts produced by independent creators are certainly engaging and entertaining, and have a wealth of information, but the line is often blurred between just that: education and entertainment. In both instances, there is no follow-up or feedback offered to the learner in the form of surveys, or other types of feedback, which is arguably an important piece in any form of pedagogy. Thus, we sought to strike a balance between the two forms for our purposes.
 

Process of two podcasts

Our section was aware of the two aims during the pandemic – (1) disseminate new information regarding COVID-19 to the rest of our staff members and trainees as quickly as possible, and (2) maintain and improve the current quality of care of our patients. Thus, we sought to apply the reach and efficiency of the podcasting medium to provide ongoing education and feedback with respect to these two aims.

“The Cure” podcast. We recognized the constant flow of new COVID-19 information and updates and we wanted to find a readily accessible platform to reach staff with timely updates. Our marketing & communications team later helped us realize that the content we wanted to share was relevant to our patients and the community, so we formatted the material to be practical and easily digestible- something that may help an individual make decisions at the bedside as well as have conversations at the dinner table. Most recently, we engaged with our human resources department to use our platform in orienting new hires with the goal of helping staff familiarize with the institutions policies, procedures, and job aids that keep staff and patients safe.

“Antibiotry” podcast. Prior to the COVID-19 pandemic, our antibiotic stewardship group noticed an increase in antibiotic use on our medical floors. This is monitored not only through internal metrics by our pharmacy department, but also via the SAAR (standardized antibiotic administration ratio). Both sources demonstrated an increase in antibiotic use, greater than expected. An initiative was formed between our hospital medicine and infectious disease sections, and our pharmacy department to raise awareness of this increase in use, provide education to our trainees, and to create systems solutions for clinicians.

Initially, we sought to hold in-person sessions once a month for our trainees. This was led by a senior resident at the time. Topics of discussion were geared towards clinical decision making regarding empiric antibiotic use on the hospital medicine service. At the same time, our team published empiric antibiotic use guidelines, accessible through our electronic medical record. In addition, the resident leader gave a voluntary survey at the end of the session to assess not only confidence of antibiotic use, but also baseline knowledge regarding antibiotics in various clinical scenarios. This survey was repeated at the end of the resident group’s month-long rotation. Altogether, each in-person session was no longer than 10 minutes.

Unfortunately, the initiative was just gaining momentum when the COVID-19 pandemic was declared. However, we sought to take this challenge and translate it into an opportunity.

We directed our focus towards stewardship during pandemic times. Initially, our resident leader sent out email primers, approximately 3-5 minute reads, as a substitute for the in-person sessions. Our primers’ uniqueness was in its incorporation of prescription pattern data that was developed by our resident leader and our initiative’s data analyst. In doing so, we provided professional feedback regarding our antibiotic use based on the clinical indication. This was a powerful tool to not only engage our learners and staff clinicians, but also as a benchmarking tool for continued quality improvement.

But email primers are not engaging, and despite the ubiquity of teleconferencing, it was difficult to ask our housestaff to break from their morning rounds for a 10 minute tele-meeting. Thus, we devised a podcast method of education – 5-10 minute audio clips with conversation regarding a topic of discussion. This way, our trainees and learners can access episodes of education on their own time throughout the pandemic without disrupting their workflow. Given the brevity of, but high-yield content in, each episode, it would not only be convenient for listeners to access and repeat, but also for the podcaster (our resident leader) to create, as recording of the audio portion takes anywhere between 10-20 minutes for each episode, with postprocessing similarly fast.

The interdisciplinary nature of continued medical education cannot be stressed enough. With the help of our professional development team and their educators, we were able to centralize our podcast and attach surveys and additional graphics for each episode, if appropriate. This additional detail allowed for feedback, engagement with our learners, and the chance to provide additional educational points, if the learner was interested. Given the integrated nature of this platform, quality metrics could easily be recorded in the form of “click” data and various other more conventional metrics, such as listener counts and the duration of each podcast played.
 

Future applications and initiatives

Thus far, we have had great success in the reception and use of both podcasts within our institution as an application of microlearning. “The Cure” has been widely listened to by all hospital staff from various services; it has caught the attention of state-wide radio programs, and plans to expand it into the community are being discussed.

As for “Antibiotry” podcast, the concept has been lauded by our medical educators. Given its centralization within our institution, we are able to publish institution-based data as a form of professional and educational feedback to our trainees and staff physicians. This is currently coupled with the development of a provider dashboard, visualizing antibiotic prescriptions and narrowing patterns of practice within our medicine department. We plan to expand “Antibiotry” to other services at the hospital.

For both podcasts, the steps it took to achieve the final product from the microlearning concept were possible through a combination of institutional need and a motivated team. We are fortunate to have highly energetic individuals, making the coordination and planning with our hospitalists, various sub-specialists, and professional development teams straightforward. As the team grows with more individuals interested in the initiatives, keen insight into interests, individual clinical expertise, presentation skills, and technical skills ought to be carefully weighed to sustain our podcasts most efficiently, and perhaps expand them through different social media platforms.

Our objective for sustainability is through the continued outreach to and recruitment of residents and medical students, who can play key roles in the development of future projects related to these educational innovations. Both microlearning podcasts were developed through the initial planning, trial and error, and execution by two resident leaders. Their initiative and motivation to educate our institution through these platforms were highly unique; their pathfinding set the foundation for sustainability and expansion to other services.

Of course, one of the key measures we would like to investigate is whether our microlearning platform translates to improved patient outcomes. Regarding “Antibiotry,” we hope to see a decrease in unnecessary broad-spectrum antibiotic use by drawing attention to clinician practice patterns. Quality and outcome metrics will continue to be developed and measured. In addition to patient care metrics, further investigation of pedagogical metrics will be conducted, especially in the evolving realm of graduate and continuing medical education.

Measuring educational quality is neither a new ethical nor philosophical debate – neither does it carry a definitive answer. Further help from education experts may be needed to assess the quality of the information provided and its impact on our learners.
 

Conclusion

Medicine is ever-changing – the guidelines and criteria for patient care and pathology that we learned in medical school have likely changed. There is no single “best” method of learning new information in medicine, simply due to the breadth and volume of such information generated on a daily basis. This poses both a challenge for present-day clinicians and trainees, and a stimulus for change in the methods of acquiring, absorbing, and applying new information to clinical decision making and practice.

We have found that podcasting is a well-received medium of information transfer that is convenient for both the learner and the content creator. Through the podcast format, we were able to distill non-engaging pieces of education and information and transform them into short-duration lessons that the learner can listen to at their own convenience. This proved to be especially handy during the chaos of the pandemic, not only for dissemination of information regarding the management of COVID-19, but also for sustaining quality improvement goals within our institution.

Further investigation on patient outcomes and information quality are the planned next steps. In addition, expansion of other microlearning media, such as group SMS texting, YouTube videos, and Twitter, ought to be considered. Though many publications discuss the theory, potential benefits, and predicted pitfalls of microlearning, few assess the real-world application of microlearning to the clinical setting for medical education.

So what did we learn? We should think of microlearning as moments when you turn to your smartphone or tablet in order to discover something, answer a question, or complete a task. These are moments when decisions are made and knowledge is reinforced. The goal is to capture these moments and fill them with essential pieces of information.

We offer these suggestions as a place to start. The microlearning platform allows for the collection of data on the interaction between user and course content. The data collected can be used for continuous quality improvement of the curriculum. Microlearning is a dynamic platform where creative ideas are encouraged and a multi-disciplinary approach is valuable to keeping an audience engaged. In the future, we hope to be able to correlate microlearning courses to provider performance and measurable patient outcomes.
 

Dr. Mercado is medical director at Alice Peck Day Memorial Hospital, and associate hospital epidemiologist, Dartmouth-Hitchcock Medical Center, both in Lebanon, N.H., and assistant professor at the Geisel School of Medicine at Dartmouth, Hanover, N.H. Dr. Feng is a Fellow in the Leadership/Preventive Medicine Program in the Department of Internal Medicine at Dartmouth-Hitchcock Medical Center.

References

1. Duggan F and Banwell L. Constructing a model of effective information dissemination in a crisis. Information Research. 2004;9(3). Paper 178 [Available at http://InformationR.net/ir/9-3/paper178.html].

2. Filipe HP, et al. Microlearning to improve CPD learning objectives. Clin Teach. 2020 Dec;17(6):695-699. doi: 10.1111/tct.13208.

3. Hegerius A, et al. E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre. Drug Saf. 2020 Nov;43(11):1171-1180. doi: 10.1007/s40264-020-00981-w.

4. Orwoll B, et al. Gamification and Microlearning for Engagement With Quality Improvement (GAMEQI): A Bundled Digital Intervention for the Prevention of Central Line-Associated Bloodstream Infection. Am J Med Qual. Jan/Feb 2018;33(1):21-29. doi: 10.1177/1062860617706542.