STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signsreport from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signsreport from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signsreport from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
New evidence indicates that the use of “cracking” technology can significantly reduce the ambient levels of inhaled nitrous oxide (N2O) during labor, especially when women are coached on how best to use it.
The findings, from a quality improvement study conducted by anesthetists and midwives in the United Kingdom, appear to have implications for minimizing staff exposures and for lowering N2O’s environmental effect overall. The potent greenhouse gas has a carbon footprint that is 265 times larger than carbon dioxide.
“Our results indicate that cracking technology can reduce ambient nitrous oxide levels in the obstetric setting, with potential for reductions in environmental impacts and occupational exposure,” reported Annie Pinder, MBChB, a fellow in sustainable anesthesia at North West School of Anaesthesia, Manchester, England, and colleagues in Anaesthesia.
Proportionally, the United Kingdom is one of the largest users of inhaled N2O during labor, often for first-line pain control. A 2017 survey by the Care Quality Commission estimated that 77% of women in labor used inhaled N2O for pain, and that it didn’t preclude them from using other types of analgesia, including opioids, epidurals, and nonpharmacologic approaches.
Previous research has established the effectiveness of cracking, which uses a catalyst to convert N2O into nitrogen and oxygen. However, little is known about the effectiveness of scavenging devices that minimize waste N2O in a real-world setting, the authors said.
For the study, median ambient N2O levels were recorded for 36 women during the final 30 minutes of uncomplicated labor. Ambient N2O levels were initially recorded in 12 patients without use of three N2O scavenging devices, and then in three groups of eight patients using either a mouthpiece, a facemask with an air-filled cushion, or a low-profile facemask. Women were also coached on how to use the devices, and given feedback.
“Given that a similar magnitude of reduction in nitrous oxide levels was seen with mouthpieces and low-profile face masks, we suggest that pregnant women should be offered the option of either device when cracking is used,” the study authors wrote.
Staff feedback was generally positive, but some found use of the technology cumbersome. Sufficient staff engagement is the key to successful implementation, the researchers pointed out.
The results showed that when women consistently exhaled into the mouthpiece, median ambient N2O levels were 71% lower compared with levels recorded prior to use of the scavenging device. When women exhaled into a lightweight face mask with a flexible seal, median ambient N2O levels were 81% lower compared with baseline.
These data are consistent with the United Kingdom’s goal of achieving a net zero carbon footprint for the National Health Service by 2040, the researchers said. The study findings are also in keeping with predictions that cracking technology could reduce greenhouse gas emissions associated with N2O by an estimated 75%.
“Although cracking may make nitrous oxide ‘greener,’ it does not make it ‘green,’ ” noted Dr. Pinder and coauthor Cliff Shelton, MBChB, in an interview. Dr. Shelton is a senior clinical lecturer in anesthesia at Lancaster (England) University and a consultant anesthetist at Wythenshawe Hospital, Manchester.
Even with the use of cracking technology, the occupational effect of inhaled N2O is likely to remain higher than for other, more effective forms of anesthesia, such as epidurals and remifentanil (Ultiva), Dr. Pinder and Dr. Shelton said. Furthermore, ambient N2O levels are not a direct measure of the proportion of nitrous oxide cracked, “so there is scope for further work to more precisely understand the ‘carbon footprint’ impacts,” they pointed out.
Inhaled N20 is widely used for labor pain in the Scandinavian countries, as well as in Canada, Australia, and New Zealand. It’s also making a comeback in the United States, facilitated by the Food and Drug Administration’s (FDA) approval of a portable N2O delivery system in 2012.
The system, which delivers a mixture of 50% nitrous oxide and 50% oxygen, has offered a new option for laboring mothers, said Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, and coauthors in a 2014 report.
“Nitrous oxide works really well as an adjunct to other analgesia,” said Laura Goetzl, MD, MPH, professor of obstetrics, gynecology, and reproductive sciences at University of Texas at Houston Health Science Center. Women in labor really like having the option of inhaled N2O to manage pain, she said in an interview. “The more options that we have to offer, the better for women.”
“Not only does nitrous oxide help with perception of pain, it’s also highly effective for reducing patient anxiety,” Dr. Goetzl explained. “If a patient is waiting for an epidural, the use of nitrous oxide can be particularly helpful.”
Dr. Shelton reported that he is executive editor of Anaesthesia Reports. Dr. Pinder and the remaining coauthors disclosed having no conflicts of interest. Dr. Goetzl reported that she is on the medical advisory board of Mirvie.
New evidence indicates that the use of “cracking” technology can significantly reduce the ambient levels of inhaled nitrous oxide (N2O) during labor, especially when women are coached on how best to use it.
The findings, from a quality improvement study conducted by anesthetists and midwives in the United Kingdom, appear to have implications for minimizing staff exposures and for lowering N2O’s environmental effect overall. The potent greenhouse gas has a carbon footprint that is 265 times larger than carbon dioxide.
“Our results indicate that cracking technology can reduce ambient nitrous oxide levels in the obstetric setting, with potential for reductions in environmental impacts and occupational exposure,” reported Annie Pinder, MBChB, a fellow in sustainable anesthesia at North West School of Anaesthesia, Manchester, England, and colleagues in Anaesthesia.
Proportionally, the United Kingdom is one of the largest users of inhaled N2O during labor, often for first-line pain control. A 2017 survey by the Care Quality Commission estimated that 77% of women in labor used inhaled N2O for pain, and that it didn’t preclude them from using other types of analgesia, including opioids, epidurals, and nonpharmacologic approaches.
Previous research has established the effectiveness of cracking, which uses a catalyst to convert N2O into nitrogen and oxygen. However, little is known about the effectiveness of scavenging devices that minimize waste N2O in a real-world setting, the authors said.
For the study, median ambient N2O levels were recorded for 36 women during the final 30 minutes of uncomplicated labor. Ambient N2O levels were initially recorded in 12 patients without use of three N2O scavenging devices, and then in three groups of eight patients using either a mouthpiece, a facemask with an air-filled cushion, or a low-profile facemask. Women were also coached on how to use the devices, and given feedback.
“Given that a similar magnitude of reduction in nitrous oxide levels was seen with mouthpieces and low-profile face masks, we suggest that pregnant women should be offered the option of either device when cracking is used,” the study authors wrote.
Staff feedback was generally positive, but some found use of the technology cumbersome. Sufficient staff engagement is the key to successful implementation, the researchers pointed out.
The results showed that when women consistently exhaled into the mouthpiece, median ambient N2O levels were 71% lower compared with levels recorded prior to use of the scavenging device. When women exhaled into a lightweight face mask with a flexible seal, median ambient N2O levels were 81% lower compared with baseline.
These data are consistent with the United Kingdom’s goal of achieving a net zero carbon footprint for the National Health Service by 2040, the researchers said. The study findings are also in keeping with predictions that cracking technology could reduce greenhouse gas emissions associated with N2O by an estimated 75%.
“Although cracking may make nitrous oxide ‘greener,’ it does not make it ‘green,’ ” noted Dr. Pinder and coauthor Cliff Shelton, MBChB, in an interview. Dr. Shelton is a senior clinical lecturer in anesthesia at Lancaster (England) University and a consultant anesthetist at Wythenshawe Hospital, Manchester.
Even with the use of cracking technology, the occupational effect of inhaled N2O is likely to remain higher than for other, more effective forms of anesthesia, such as epidurals and remifentanil (Ultiva), Dr. Pinder and Dr. Shelton said. Furthermore, ambient N2O levels are not a direct measure of the proportion of nitrous oxide cracked, “so there is scope for further work to more precisely understand the ‘carbon footprint’ impacts,” they pointed out.
Inhaled N20 is widely used for labor pain in the Scandinavian countries, as well as in Canada, Australia, and New Zealand. It’s also making a comeback in the United States, facilitated by the Food and Drug Administration’s (FDA) approval of a portable N2O delivery system in 2012.
The system, which delivers a mixture of 50% nitrous oxide and 50% oxygen, has offered a new option for laboring mothers, said Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, and coauthors in a 2014 report.
“Nitrous oxide works really well as an adjunct to other analgesia,” said Laura Goetzl, MD, MPH, professor of obstetrics, gynecology, and reproductive sciences at University of Texas at Houston Health Science Center. Women in labor really like having the option of inhaled N2O to manage pain, she said in an interview. “The more options that we have to offer, the better for women.”
“Not only does nitrous oxide help with perception of pain, it’s also highly effective for reducing patient anxiety,” Dr. Goetzl explained. “If a patient is waiting for an epidural, the use of nitrous oxide can be particularly helpful.”
Dr. Shelton reported that he is executive editor of Anaesthesia Reports. Dr. Pinder and the remaining coauthors disclosed having no conflicts of interest. Dr. Goetzl reported that she is on the medical advisory board of Mirvie.
This story was updated on Sept. 27, 2022.
New evidence indicates that the use of “cracking” technology can significantly reduce the ambient levels of inhaled nitrous oxide (N2O) during labor, especially when women are coached on how best to use it.
The findings, from a quality improvement study conducted by anesthetists and midwives in the United Kingdom, appear to have implications for minimizing staff exposures and for lowering N2O’s environmental effect overall. The potent greenhouse gas has a carbon footprint that is 265 times larger than carbon dioxide.
“Our results indicate that cracking technology can reduce ambient nitrous oxide levels in the obstetric setting, with potential for reductions in environmental impacts and occupational exposure,” reported Annie Pinder, MBChB, a fellow in sustainable anesthesia at North West School of Anaesthesia, Manchester, England, and colleagues in Anaesthesia.
Proportionally, the United Kingdom is one of the largest users of inhaled N2O during labor, often for first-line pain control. A 2017 survey by the Care Quality Commission estimated that 77% of women in labor used inhaled N2O for pain, and that it didn’t preclude them from using other types of analgesia, including opioids, epidurals, and nonpharmacologic approaches.
Previous research has established the effectiveness of cracking, which uses a catalyst to convert N2O into nitrogen and oxygen. However, little is known about the effectiveness of scavenging devices that minimize waste N2O in a real-world setting, the authors said.
For the study, median ambient N2O levels were recorded for 36 women during the final 30 minutes of uncomplicated labor. Ambient N2O levels were initially recorded in 12 patients without use of three N2O scavenging devices, and then in three groups of eight patients using either a mouthpiece, a facemask with an air-filled cushion, or a low-profile facemask. Women were also coached on how to use the devices, and given feedback.
“Given that a similar magnitude of reduction in nitrous oxide levels was seen with mouthpieces and low-profile face masks, we suggest that pregnant women should be offered the option of either device when cracking is used,” the study authors wrote.
Staff feedback was generally positive, but some found use of the technology cumbersome. Sufficient staff engagement is the key to successful implementation, the researchers pointed out.
The results showed that when women consistently exhaled into the mouthpiece, median ambient N2O levels were 71% lower compared with levels recorded prior to use of the scavenging device. When women exhaled into a lightweight face mask with a flexible seal, median ambient N2O levels were 81% lower compared with baseline.
These data are consistent with the United Kingdom’s goal of achieving a net zero carbon footprint for the National Health Service by 2040, the researchers said. The study findings are also in keeping with predictions that cracking technology could reduce greenhouse gas emissions associated with N2O by an estimated 75%.
“Although cracking may make nitrous oxide ‘greener,’ it does not make it ‘green,’ ” noted Dr. Pinder and coauthor Cliff Shelton, MBChB, in an interview. Dr. Shelton is a senior clinical lecturer in anesthesia at Lancaster (England) University and a consultant anesthetist at Wythenshawe Hospital, Manchester.
Even with the use of cracking technology, the occupational effect of inhaled N2O is likely to remain higher than for other, more effective forms of anesthesia, such as epidurals and remifentanil (Ultiva), Dr. Pinder and Dr. Shelton said. Furthermore, ambient N2O levels are not a direct measure of the proportion of nitrous oxide cracked, “so there is scope for further work to more precisely understand the ‘carbon footprint’ impacts,” they pointed out.
Inhaled N20 is widely used for labor pain in the Scandinavian countries, as well as in Canada, Australia, and New Zealand. It’s also making a comeback in the United States, facilitated by the Food and Drug Administration’s (FDA) approval of a portable N2O delivery system in 2012.
The system, which delivers a mixture of 50% nitrous oxide and 50% oxygen, has offered a new option for laboring mothers, said Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, and coauthors in a 2014 report.
“Nitrous oxide works really well as an adjunct to other analgesia,” said Laura Goetzl, MD, MPH, professor of obstetrics, gynecology, and reproductive sciences at University of Texas at Houston Health Science Center. Women in labor really like having the option of inhaled N2O to manage pain, she said in an interview. “The more options that we have to offer, the better for women.”
“Not only does nitrous oxide help with perception of pain, it’s also highly effective for reducing patient anxiety,” Dr. Goetzl explained. “If a patient is waiting for an epidural, the use of nitrous oxide can be particularly helpful.”
Dr. Shelton reported that he is executive editor of Anaesthesia Reports. Dr. Pinder and the remaining coauthors disclosed having no conflicts of interest. Dr. Goetzl reported that she is on the medical advisory board of Mirvie.
When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.
While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.
Kendall Ervin
Case
A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?
A. Obtain lipids with her other blood work now.
B. Have her return tomorrow to obtain fasting labs.
In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.
Studies of fasting vs. nonfasting lipids
Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.1 They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.
Mora and colleagues performed a post hoc prospective follow-up of a randomized control
Dr. Douglas S. Paauw
trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.2 Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.
Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.3 Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).3
Benefits of nonfasting lipid labs
There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.
For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.
Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
Summary
Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.
Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.4
Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.
While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.
Kendall Ervin
Case
A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?
A. Obtain lipids with her other blood work now.
B. Have her return tomorrow to obtain fasting labs.
In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.
Studies of fasting vs. nonfasting lipids
Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.1 They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.
Mora and colleagues performed a post hoc prospective follow-up of a randomized control
Dr. Douglas S. Paauw
trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.2 Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.
Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.3 Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).3
Benefits of nonfasting lipid labs
There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.
For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.
Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
Summary
Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.
Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.4
Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
When I worked as a scribe prior to starting medical school, it was commonplace for patients to have fasting labs. I always felt terrible for the patients we saw late in the afternoon that had somehow fasted all day. For many other patients, there was the challenge of finding a time when they could return to have fasting labs drawn.
While in medical school, I have seen the transition of my preceptors’ recommendations, where it seems patients can now have nonfasting labs. However, I have still observed instances when patients need to have fasting labs. We can look at an example case to better understand when and why patients do and do not need to fast prior to having their lipids checked.
Kendall Ervin
Case
A 57-year-old woman presents for an annual wellness visit. She has been healthy this past year with no new concerns. Her blood pressure has been well controlled, and she continues on a statin for hyperlipidemia. She is due for annual labs. She ate breakfast this morning. Which of the following do you recommend?
A. Obtain lipids with her other blood work now.
B. Have her return tomorrow to obtain fasting labs.
In this situation, A is the correct answer. The patient is due for routine screening labs and there are no current indications that fasting labs are necessary.
Studies of fasting vs. nonfasting lipids
Sidhu and Naugler performed a cross-sectional analysis comparing lipid values at fasting intervals of 1 hour to 16 hours.1 They found the mean total cholesterol and HDL cholesterol values differed by greater than 2%. For LDL cholesterol, the values differed by less than 10% and triglycerides values differed by less than 20%. With this information, the researchers concluded fasting for routine lipids is generally unnecessary.
Mora and colleagues performed a post hoc prospective follow-up of a randomized control
Dr. Douglas S. Paauw
trial to assess if nonfasting lipid measurements could cause misclassification of cardiovascular risk assessment.2 Based on 8,270 participants, coronary events associated with fasting vs. nonfasting lipid values were similar when adjusted hazard ratios were compared. They also found an agreement of 94.8% when classifying participants into ASCVD risk categories for fasting and nonfasting lipid values. These outcomes led them to support the use of nonfasting lipid labs for routine cardiovascular risk assessment.
Rahman and colleagues performed a systematic review and found the use of nonfasting lipid values can reliably determine statin management in most situations.3 Circumstances where fasting labs should be used are if patients have a genetic dyslipidemia, if patients have severe hypertriglyceridemia (greater than 500 mg/dL), and if patients have pancreatitis. Triglyceride values fluctuate the most between the fasting and nonfasting state as seen above from Sidhu and Naugler. This could impact triglyceride disorder management and the accuracy of LDL cholesterol estimation (calculated by the Friedewald equation: LDL cholesterol = total cholesterol – HDL cholesterol – triglycerides/5 in mg/dL).3
Benefits of nonfasting lipid labs
There are many benefits of nonfasting labs. For the patients, they do not have to come to their appointments hungry, we can reduce the risk of hypoglycemia for those with diabetes, and they do not have to come back at a later date if they ate something earlier in the day.
For the lab, we can improve efficiency and decrease early morning congestion when patients typically come in for fasting labs.
Lastly, for the provider, nonfasting labs can improve workflow and help decrease the number of patients lost to follow-up who were unable to complete fasting labs the same day as their appointment.
Summary
Patients do not need to fast prior to having lipid levels drawn for routine screening. Fasting labs should be considered for patients who have a genetic dyslipidemia or if there is concern for hypertriglyceridemia.
Per the ACC/AHA guidelines, nonfasting lipids can be used to assess ASCVD risk and to establish a baseline LDL cholesterol in adults 20 years and older. If a patient has nonfasting triglycerides greater than 400 mg/dL, repeat fasting lipids should be drawn to assess fasting triglycerides and to establish a baseline LDL cholesterol.4
Ms. Ervin is a fourth-year medical student at the University of Washington, Seattle. She has no conflicts to disclose. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, and he serves as third-year medical student clerkship director at the university. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.
Why this matters
Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.
Study design
A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
Funding: Gender and Prevention Grant from ZonMw and other.
Key results
During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
–Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
–Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).
The risk of new-onset AF was significantly higher in women who experienced menopause:
–At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
–Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
–At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.
Limitations
Observational design.
A version of this article first appeared on Medscape UK.
Reference
Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.
Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.
Why this matters
Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.
Study design
A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
Funding: Gender and Prevention Grant from ZonMw and other.
Key results
During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
–Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
–Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).
The risk of new-onset AF was significantly higher in women who experienced menopause:
–At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
–Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
–At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.
Limitations
Observational design.
A version of this article first appeared on Medscape UK.
Reference
Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.
Takeaway
Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.
Why this matters
Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.
Study design
A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
Funding: Gender and Prevention Grant from ZonMw and other.
Key results
During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
–Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
–Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).
The risk of new-onset AF was significantly higher in women who experienced menopause:
–At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
–Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
–At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.
Limitations
Observational design.
A version of this article first appeared on Medscape UK.
Reference
Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.
CASE Patient has urine leakage that worsens with exercise
At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.
What nonsurgical treatment options are available for this patient?
Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.1 This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.4 The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.
Types of UI
The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.
Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.5 In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).6
In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.5
Making a diagnosis
A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.7
During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).8 This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.
The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).9 It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.10 Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.
Continue to: Primary therapies for UI...
Primary therapies for UI
Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.
Lifestyle and behavioral modifications
Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.11 Information gained from a 3-day bladder diary (FIGURE 2)12 can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.
Weight loss
Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m2 increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.13
Reducing fluid intake and bladder irritants
Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).14
Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).15 Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.5,16
Continue to: Pelvic floor muscle training...
Pelvic floor muscle training
An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.17 The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.
Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.
Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.17
Vaginal pessaries
Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).
The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.
In a comparative effectiveness trial of a continence pessary and behavior therapy, behavioral therapy was more likely to result in no bothersome incontinence symptoms (49% vs 33%, P = .006) and greater treatment satisfaction at 3 months.20 However, these short-term group differences did not persist at 12 months, presumably due to waning adherence.
UUI-specific nonsurgical treatments
Drug therapy
All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.
A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).21
Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.22
Extended-release formulations are associated with reduced anticholinergic side effects (dry mouth, constipation, somnolence, dry eyes), leading to improved adherence. Notably, the anticholinergic medications are contraindicated in patients with untreated narrow-angle glaucoma, gastric retention, and supraventricular tachycardia. Mirabegron should be used with caution in patients with poorly controlled hypertension. 5 Due to concerns regarding the association between cumulative anticholinergic burden and the development of dementia, clinicians may consider avoiding the anticholinergic medications in older and at-risk patients.23
Continue to: UUI office-based procedure treatments...
UUI office-based procedure treatments
If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.
Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.24
OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.
In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.25 The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.
Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.
SUI-specific nonsurgical treatments
Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.
Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).26
The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.
CASE Symptom presentation guides treatment plan
Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●
References
1. Lee UJ, Feinstein L, Ward JB, et al. Prevalence of urinary incontinence among a nationally representative sample of women, 2005–2016: findings from the Urologic Diseases in America Project. J Urol. 2021;205:1718-1724. doi:10.1097 /JU.0000000000001634
2. Sims J, Browning C, Lundgren-Lindquist B, et al. Urinary incontinence in a community sample of older adults: prevalence and impact on quality of life. Disabil Rehabil. 2011;33:1389-1398. doi:10.3109/09638288.2010.532284
3. Sarikaya S, Yildiz FG, Senocak C, et al. Urinary incontinence as a cause of depression and sexual dysfunction: questionnaire-based study. Rev Int Androl. 2020:18:50-54. doi:10.1016 /j.androl.2018.08.003
4. O’Reilly N, Nelson HD, Conry JM, et al; Women’s Preventive Services Initiative. Screening for urinary incontinence in women: a recommendation from the Women’s Preventive Services Initiative. Ann Intern Med. 2018;169(5):320-328. doi:10.7326/M18-0595
5. Barber MD, Walters MD, Karram MM, et al. Walters & Karram Urogynecology and Reconstructive Pelvic Surgery. 5th ed. Elsevier Saunders; 2021.
6. Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21: 5-26. doi:10.1007/s00192-009-0976-9
7. ACOG practice bulletin no. 155. Urinary incontinence in women. Obstet Gynecol. 2015;126:e66-e81. doi:10.1097 /AOG.0000000000001148
8. Sansone S, Lu J, Drangsholt S, et al. No pelvic exam, no problem: patient satisfaction following the integration of comprehensive urogynecology telemedicine. Int Urogynecol J. 2022;1:3. doi:10.1007/s00192-022-05104-w
9. Brown JS, Bradley CS, Subak LL, et al; Diagnostic Aspects of Incontinence Study (DAISy) Research Group. The sensitivity and specificity of a simple test to distinguish between urge and stress urinary incontinence. Ann Intern Med. 2006;144:715723. doi:10.7326/0003-4819-144-10-200605160-00005
10. Hess R, Huang AJ, Richter HE, et al. Long-term efficacy and safety of questionnaire-based initiation of urgency urinary incontinence treatment. Am J Obstet Gynecol. 2013;209:244. e1-9. doi:10.1016/j.ajog.2013.05.008
11. Sung VW, Borello-France D, Newman DK, et al; NICHD Pelvic Floor Disorders Network. Effect of behavioral and pelvic floor muscle therapy combined with surgery vs surgery alone on incontinence symptoms among women with mixed urinary incontinence. JAMA. 2019;322:1066-1076. doi:10.1001 /jama.2019.12467
12. American Urogynecologic Society. Voices for PFD: intake and voiding diary. Accessed August 11, 2022. https://www .voicesforpfd.org/assets/2/6/Voiding_Diary.pdf
13. Subak LL, Richter HE, Hunskaar S. Obesity and urinary incontinence: epidemiology and clinical research update. J Urol. 2009;182(6 suppl):S2-7. doi:10.1016/j.juro.2009.08.071
14. Arya LA, Myers DL, Jackson ND. Dietary caffeine intake and the risk for detrusor instability: a case-control study. Obstet Gynecol. 2000;96:85-89. doi:10.1016/s0029-7844(00)00808-5
15. Wyman JF, Zhou J, LaCoursiere DY, et al. Normative noninvasive bladder function measurements in healthy women: a systematic review and meta-analysis. Neurourol Urodyn. 2020;39:507-522. doi:10.1002/nau.24265
16. Hashim H, Al Mousa R. Management of fluid intake in patients with overactive bladder. Curr Urol Rep. 2009;10: 428-433. doi:10.1007/s11934-009-0068-x
17. Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018;10:CD005654. doi:10.1002/14651858.CD005654.pub4
18. Araujo CC, de A Marques A, Juliato CRT. The adherence of home pelvic floor muscles training using a mobile device application for women with urinary incontinence: a randomized controlled trial. Female Pelvic Med Reconstr Surg. 2020;26:697-703. doi:10.1097/SPV.0000000000000670
19. Sjöström M, Umefjord G, Stenlund H, et al. Internet-based treatment of stress urinary incontinence: a randomized controlled study with focus on pelvic floor muscle training. BJU Int. 2013;112:362-372. doi:10.1111/j.1464 -410X.2012.11713.x
20. Richter HE, Burgio KL, Brubaker L, et al; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010;115:609617. doi:10.1097/AOG.0b013e3181d055d4
21. Burgio KL, Kraus SR, Menefee S, et al. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008;149(3): 161-169. doi:10.7326/0003-4819-149-3-200808050 -00005
22. Lukacz ES, Santiago-Lastra Y, Albo ME, et al. Urinary incontinence in women: a review. JAMA. 2017;318:1592-1604. doi:10.1001/jama.2017.12137
23. Welk B, Richardson K, Panicker JN. The cognitive effect of anticholinergics for patients with overactive bladder. Nat Rev Urol. 2021;18:686-700. doi:10.1038/s41585-021-00504-x
24. Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012;31:1206-1216. doi:10.1002/nau.22251
25. Amundsen CL, Richter HE, Menefee SA, et al. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: A randomized clinical trial. JAMA. 2016;316:1366-1374. doi:10.1001/jama.2016.14617
26. Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2017;7:CD003881. doi:10.1002/14651858.CD003881.pub4
Dr. Murillo is Fellow, Female Pelvic Medicine and Reconstructive Surgery at UPMC, Pittsburgh, Pennsylvania.
Dr. Zyczynski is Professor, Obstetrics, Gynecology and Reproductive Sciences in the Division of Urogynecology and Pelvic Reconstructive Surgery, University of Pittsburgh School of Medicine.
Dr. Zyczynski reports serving as a consultant to Amara Therapeutics Scientific Advisory Board. Dr. Murillo reports no financial relationships relevant to this article.
Dr. Murillo is Fellow, Female Pelvic Medicine and Reconstructive Surgery at UPMC, Pittsburgh, Pennsylvania.
Dr. Zyczynski is Professor, Obstetrics, Gynecology and Reproductive Sciences in the Division of Urogynecology and Pelvic Reconstructive Surgery, University of Pittsburgh School of Medicine.
Dr. Zyczynski reports serving as a consultant to Amara Therapeutics Scientific Advisory Board. Dr. Murillo reports no financial relationships relevant to this article.
Author and Disclosure Information
Dr. Murillo is Fellow, Female Pelvic Medicine and Reconstructive Surgery at UPMC, Pittsburgh, Pennsylvania.
Dr. Zyczynski is Professor, Obstetrics, Gynecology and Reproductive Sciences in the Division of Urogynecology and Pelvic Reconstructive Surgery, University of Pittsburgh School of Medicine.
Dr. Zyczynski reports serving as a consultant to Amara Therapeutics Scientific Advisory Board. Dr. Murillo reports no financial relationships relevant to this article.
CASE Patient has urine leakage that worsens with exercise
At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.
What nonsurgical treatment options are available for this patient?
Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.1 This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.4 The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.
Types of UI
The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.
Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.5 In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).6
In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.5
Making a diagnosis
A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.7
During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).8 This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.
The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).9 It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.10 Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.
Continue to: Primary therapies for UI...
Primary therapies for UI
Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.
Lifestyle and behavioral modifications
Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.11 Information gained from a 3-day bladder diary (FIGURE 2)12 can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.
Weight loss
Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m2 increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.13
Reducing fluid intake and bladder irritants
Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).14
Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).15 Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.5,16
Continue to: Pelvic floor muscle training...
Pelvic floor muscle training
An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.17 The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.
Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.
Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.17
Vaginal pessaries
Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).
The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.
In a comparative effectiveness trial of a continence pessary and behavior therapy, behavioral therapy was more likely to result in no bothersome incontinence symptoms (49% vs 33%, P = .006) and greater treatment satisfaction at 3 months.20 However, these short-term group differences did not persist at 12 months, presumably due to waning adherence.
UUI-specific nonsurgical treatments
Drug therapy
All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.
A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).21
Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.22
Extended-release formulations are associated with reduced anticholinergic side effects (dry mouth, constipation, somnolence, dry eyes), leading to improved adherence. Notably, the anticholinergic medications are contraindicated in patients with untreated narrow-angle glaucoma, gastric retention, and supraventricular tachycardia. Mirabegron should be used with caution in patients with poorly controlled hypertension. 5 Due to concerns regarding the association between cumulative anticholinergic burden and the development of dementia, clinicians may consider avoiding the anticholinergic medications in older and at-risk patients.23
Continue to: UUI office-based procedure treatments...
UUI office-based procedure treatments
If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.
Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.24
OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.
In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.25 The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.
Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.
SUI-specific nonsurgical treatments
Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.
Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).26
The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.
CASE Symptom presentation guides treatment plan
Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●
CASE Patient has urine leakage that worsens with exercise
At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.
What nonsurgical treatment options are available for this patient?
Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.1 This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.4 The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.
Types of UI
The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.
Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.5 In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).6
In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.5
Making a diagnosis
A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.7
During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).8 This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.
The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).9 It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.10 Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.
Continue to: Primary therapies for UI...
Primary therapies for UI
Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.
Lifestyle and behavioral modifications
Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.11 Information gained from a 3-day bladder diary (FIGURE 2)12 can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.
Weight loss
Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m2 increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.13
Reducing fluid intake and bladder irritants
Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).14
Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).15 Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.5,16
Continue to: Pelvic floor muscle training...
Pelvic floor muscle training
An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.17 The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.
Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.
Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.17
Vaginal pessaries
Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).
The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.
In a comparative effectiveness trial of a continence pessary and behavior therapy, behavioral therapy was more likely to result in no bothersome incontinence symptoms (49% vs 33%, P = .006) and greater treatment satisfaction at 3 months.20 However, these short-term group differences did not persist at 12 months, presumably due to waning adherence.
UUI-specific nonsurgical treatments
Drug therapy
All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.
A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).21
Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.22
Extended-release formulations are associated with reduced anticholinergic side effects (dry mouth, constipation, somnolence, dry eyes), leading to improved adherence. Notably, the anticholinergic medications are contraindicated in patients with untreated narrow-angle glaucoma, gastric retention, and supraventricular tachycardia. Mirabegron should be used with caution in patients with poorly controlled hypertension. 5 Due to concerns regarding the association between cumulative anticholinergic burden and the development of dementia, clinicians may consider avoiding the anticholinergic medications in older and at-risk patients.23
Continue to: UUI office-based procedure treatments...
UUI office-based procedure treatments
If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.
Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.24
OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.
In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.25 The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.
Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.
SUI-specific nonsurgical treatments
Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.
Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).26
The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.
CASE Symptom presentation guides treatment plan
Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●
References
1. Lee UJ, Feinstein L, Ward JB, et al. Prevalence of urinary incontinence among a nationally representative sample of women, 2005–2016: findings from the Urologic Diseases in America Project. J Urol. 2021;205:1718-1724. doi:10.1097 /JU.0000000000001634
2. Sims J, Browning C, Lundgren-Lindquist B, et al. Urinary incontinence in a community sample of older adults: prevalence and impact on quality of life. Disabil Rehabil. 2011;33:1389-1398. doi:10.3109/09638288.2010.532284
3. Sarikaya S, Yildiz FG, Senocak C, et al. Urinary incontinence as a cause of depression and sexual dysfunction: questionnaire-based study. Rev Int Androl. 2020:18:50-54. doi:10.1016 /j.androl.2018.08.003
4. O’Reilly N, Nelson HD, Conry JM, et al; Women’s Preventive Services Initiative. Screening for urinary incontinence in women: a recommendation from the Women’s Preventive Services Initiative. Ann Intern Med. 2018;169(5):320-328. doi:10.7326/M18-0595
5. Barber MD, Walters MD, Karram MM, et al. Walters & Karram Urogynecology and Reconstructive Pelvic Surgery. 5th ed. Elsevier Saunders; 2021.
6. Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21: 5-26. doi:10.1007/s00192-009-0976-9
7. ACOG practice bulletin no. 155. Urinary incontinence in women. Obstet Gynecol. 2015;126:e66-e81. doi:10.1097 /AOG.0000000000001148
8. Sansone S, Lu J, Drangsholt S, et al. No pelvic exam, no problem: patient satisfaction following the integration of comprehensive urogynecology telemedicine. Int Urogynecol J. 2022;1:3. doi:10.1007/s00192-022-05104-w
9. Brown JS, Bradley CS, Subak LL, et al; Diagnostic Aspects of Incontinence Study (DAISy) Research Group. The sensitivity and specificity of a simple test to distinguish between urge and stress urinary incontinence. Ann Intern Med. 2006;144:715723. doi:10.7326/0003-4819-144-10-200605160-00005
10. Hess R, Huang AJ, Richter HE, et al. Long-term efficacy and safety of questionnaire-based initiation of urgency urinary incontinence treatment. Am J Obstet Gynecol. 2013;209:244. e1-9. doi:10.1016/j.ajog.2013.05.008
11. Sung VW, Borello-France D, Newman DK, et al; NICHD Pelvic Floor Disorders Network. Effect of behavioral and pelvic floor muscle therapy combined with surgery vs surgery alone on incontinence symptoms among women with mixed urinary incontinence. JAMA. 2019;322:1066-1076. doi:10.1001 /jama.2019.12467
12. American Urogynecologic Society. Voices for PFD: intake and voiding diary. Accessed August 11, 2022. https://www .voicesforpfd.org/assets/2/6/Voiding_Diary.pdf
13. Subak LL, Richter HE, Hunskaar S. Obesity and urinary incontinence: epidemiology and clinical research update. J Urol. 2009;182(6 suppl):S2-7. doi:10.1016/j.juro.2009.08.071
14. Arya LA, Myers DL, Jackson ND. Dietary caffeine intake and the risk for detrusor instability: a case-control study. Obstet Gynecol. 2000;96:85-89. doi:10.1016/s0029-7844(00)00808-5
15. Wyman JF, Zhou J, LaCoursiere DY, et al. Normative noninvasive bladder function measurements in healthy women: a systematic review and meta-analysis. Neurourol Urodyn. 2020;39:507-522. doi:10.1002/nau.24265
16. Hashim H, Al Mousa R. Management of fluid intake in patients with overactive bladder. Curr Urol Rep. 2009;10: 428-433. doi:10.1007/s11934-009-0068-x
17. Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018;10:CD005654. doi:10.1002/14651858.CD005654.pub4
18. Araujo CC, de A Marques A, Juliato CRT. The adherence of home pelvic floor muscles training using a mobile device application for women with urinary incontinence: a randomized controlled trial. Female Pelvic Med Reconstr Surg. 2020;26:697-703. doi:10.1097/SPV.0000000000000670
19. Sjöström M, Umefjord G, Stenlund H, et al. Internet-based treatment of stress urinary incontinence: a randomized controlled study with focus on pelvic floor muscle training. BJU Int. 2013;112:362-372. doi:10.1111/j.1464 -410X.2012.11713.x
20. Richter HE, Burgio KL, Brubaker L, et al; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010;115:609617. doi:10.1097/AOG.0b013e3181d055d4
21. Burgio KL, Kraus SR, Menefee S, et al. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008;149(3): 161-169. doi:10.7326/0003-4819-149-3-200808050 -00005
22. Lukacz ES, Santiago-Lastra Y, Albo ME, et al. Urinary incontinence in women: a review. JAMA. 2017;318:1592-1604. doi:10.1001/jama.2017.12137
23. Welk B, Richardson K, Panicker JN. The cognitive effect of anticholinergics for patients with overactive bladder. Nat Rev Urol. 2021;18:686-700. doi:10.1038/s41585-021-00504-x
24. Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012;31:1206-1216. doi:10.1002/nau.22251
25. Amundsen CL, Richter HE, Menefee SA, et al. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: A randomized clinical trial. JAMA. 2016;316:1366-1374. doi:10.1001/jama.2016.14617
26. Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2017;7:CD003881. doi:10.1002/14651858.CD003881.pub4
References
1. Lee UJ, Feinstein L, Ward JB, et al. Prevalence of urinary incontinence among a nationally representative sample of women, 2005–2016: findings from the Urologic Diseases in America Project. J Urol. 2021;205:1718-1724. doi:10.1097 /JU.0000000000001634
2. Sims J, Browning C, Lundgren-Lindquist B, et al. Urinary incontinence in a community sample of older adults: prevalence and impact on quality of life. Disabil Rehabil. 2011;33:1389-1398. doi:10.3109/09638288.2010.532284
3. Sarikaya S, Yildiz FG, Senocak C, et al. Urinary incontinence as a cause of depression and sexual dysfunction: questionnaire-based study. Rev Int Androl. 2020:18:50-54. doi:10.1016 /j.androl.2018.08.003
4. O’Reilly N, Nelson HD, Conry JM, et al; Women’s Preventive Services Initiative. Screening for urinary incontinence in women: a recommendation from the Women’s Preventive Services Initiative. Ann Intern Med. 2018;169(5):320-328. doi:10.7326/M18-0595
5. Barber MD, Walters MD, Karram MM, et al. Walters & Karram Urogynecology and Reconstructive Pelvic Surgery. 5th ed. Elsevier Saunders; 2021.
6. Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21: 5-26. doi:10.1007/s00192-009-0976-9
7. ACOG practice bulletin no. 155. Urinary incontinence in women. Obstet Gynecol. 2015;126:e66-e81. doi:10.1097 /AOG.0000000000001148
8. Sansone S, Lu J, Drangsholt S, et al. No pelvic exam, no problem: patient satisfaction following the integration of comprehensive urogynecology telemedicine. Int Urogynecol J. 2022;1:3. doi:10.1007/s00192-022-05104-w
9. Brown JS, Bradley CS, Subak LL, et al; Diagnostic Aspects of Incontinence Study (DAISy) Research Group. The sensitivity and specificity of a simple test to distinguish between urge and stress urinary incontinence. Ann Intern Med. 2006;144:715723. doi:10.7326/0003-4819-144-10-200605160-00005
10. Hess R, Huang AJ, Richter HE, et al. Long-term efficacy and safety of questionnaire-based initiation of urgency urinary incontinence treatment. Am J Obstet Gynecol. 2013;209:244. e1-9. doi:10.1016/j.ajog.2013.05.008
11. Sung VW, Borello-France D, Newman DK, et al; NICHD Pelvic Floor Disorders Network. Effect of behavioral and pelvic floor muscle therapy combined with surgery vs surgery alone on incontinence symptoms among women with mixed urinary incontinence. JAMA. 2019;322:1066-1076. doi:10.1001 /jama.2019.12467
12. American Urogynecologic Society. Voices for PFD: intake and voiding diary. Accessed August 11, 2022. https://www .voicesforpfd.org/assets/2/6/Voiding_Diary.pdf
13. Subak LL, Richter HE, Hunskaar S. Obesity and urinary incontinence: epidemiology and clinical research update. J Urol. 2009;182(6 suppl):S2-7. doi:10.1016/j.juro.2009.08.071
14. Arya LA, Myers DL, Jackson ND. Dietary caffeine intake and the risk for detrusor instability: a case-control study. Obstet Gynecol. 2000;96:85-89. doi:10.1016/s0029-7844(00)00808-5
15. Wyman JF, Zhou J, LaCoursiere DY, et al. Normative noninvasive bladder function measurements in healthy women: a systematic review and meta-analysis. Neurourol Urodyn. 2020;39:507-522. doi:10.1002/nau.24265
16. Hashim H, Al Mousa R. Management of fluid intake in patients with overactive bladder. Curr Urol Rep. 2009;10: 428-433. doi:10.1007/s11934-009-0068-x
17. Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018;10:CD005654. doi:10.1002/14651858.CD005654.pub4
18. Araujo CC, de A Marques A, Juliato CRT. The adherence of home pelvic floor muscles training using a mobile device application for women with urinary incontinence: a randomized controlled trial. Female Pelvic Med Reconstr Surg. 2020;26:697-703. doi:10.1097/SPV.0000000000000670
19. Sjöström M, Umefjord G, Stenlund H, et al. Internet-based treatment of stress urinary incontinence: a randomized controlled study with focus on pelvic floor muscle training. BJU Int. 2013;112:362-372. doi:10.1111/j.1464 -410X.2012.11713.x
20. Richter HE, Burgio KL, Brubaker L, et al; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010;115:609617. doi:10.1097/AOG.0b013e3181d055d4
21. Burgio KL, Kraus SR, Menefee S, et al. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008;149(3): 161-169. doi:10.7326/0003-4819-149-3-200808050 -00005
22. Lukacz ES, Santiago-Lastra Y, Albo ME, et al. Urinary incontinence in women: a review. JAMA. 2017;318:1592-1604. doi:10.1001/jama.2017.12137
23. Welk B, Richardson K, Panicker JN. The cognitive effect of anticholinergics for patients with overactive bladder. Nat Rev Urol. 2021;18:686-700. doi:10.1038/s41585-021-00504-x
24. Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012;31:1206-1216. doi:10.1002/nau.22251
25. Amundsen CL, Richter HE, Menefee SA, et al. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: A randomized clinical trial. JAMA. 2016;316:1366-1374. doi:10.1001/jama.2016.14617
26. Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2017;7:CD003881. doi:10.1002/14651858.CD003881.pub4
In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.
COVID-19 vaccination had minimal effects on menstrual cycle length
Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.
Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,1,2 as the menstrual cycle is often considered a sign of health and fertility.
To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.3 Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.
The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the 2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)
Increase in cycle length clinically negligible
The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).
An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.
Counseling takeaway
This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.
WHAT THIS EVIDENCE MEANS FOR PRACTICE This robust study by Edelman and colleagues on COVID-19 vaccination effects on menstrual cycle length had more than 99% power to detect an unadjusted 1-day difference in cycle length. However, given that most of the study participants were White and had access to the Natural Cycles app, the results may not be generalizable to all individuals who receive the vaccine.
Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...
Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel
Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.
A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as combined oral contraceptives (COCs).
Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG) 0.075 mg, which is commonly used in Europe.4 Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.
Top reasons for stopping a POP
The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.
New oral contraception option
This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.
WHAT THIS EVIDENCE MEANS FOR PRACTICE Adherence to a contraceptive method is influenced by patient satisfaction, and this is particularly important in patients who cannot take COCs. It also should be noted that the discontinuation rate for DRSP as a POP used in this 24/4 regimen was similar to discontinuation rates for COCs containing 20 µg and 30 µg of ethinyl estradiol. Cost, however, may be an issue with DRSP, depending on a patient’s insurance coverage.
Continue to: Placing an LNG IUS after endometrial ablation for heavy menstrual bleeding reduced risk of hysterectomy...
Placing an LNG IUS after endometrial ablation for heavy menstrual bleeding reduced risk of hysterectomy
Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.
Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.
Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.5 These included 4 retrospective cohort studies with control groups, 2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.
Promising results for combined therapy
Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first 6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.
The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.
Bottom line
The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.
WHAT THIS EVIDENCE MEANS FOR PRACTICE The data provided by Oderkerk and colleagues’ systematic review are promising and, although not studied in the reviewed publications, the potential may exist to reduce the risk of endometrial hyperplasia and endometrial cancer by adding an LNG IUS.
Continue to: LNG IUS is less expensive, and less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...
LNG IUS is less expensive, and less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows
van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.
To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.6
Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.
Cost-effectiveness and noninferiority assessed
A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.
At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.
Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).
Key takeaway
Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial ablation. ●
WHAT THIS EVIDENCE MEANS FOR PRACTICE It is interesting that there are minimal differences between satisfaction rates and PBAC scores less than 75, yet the mean PBAC scores were significantly more favorable for endometrial ablation. This study’s results support the use of a sequential therapy of a less invasive therapy, such as the LNG IUS, prior to performing endometrial ablation.
References
Blumfiel G. Why reports of menstrual changes after COVID vaccine are tough to study. NPR. August 9, 2021. Accessed August 30, 2022. https://www.npr.org/sections/health-shots/2021/08/09/1024190379/covid-vaccine-period-menstrual-cycle-research
Lee KMN, Junkins EJ, Fatima UA, et al. Characterizing menstrual bleeding changes occurring after SARSCoV-2 vaccinations. MedRxiv. February 11, 2022. doi:10.1101/2021.10.11.21264863
Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.
Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.
Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. T he combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.
van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.
Dr. Sharp is Jon M. Huntsman Presidential Endowed Professor, Vice Chair for Clinical Activities, Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah.
Dr. Adelman is Associate Professor, Department of Obstetrics and Gynecology, University of Utah Health.
Dr. Sharp reports being an author and editor and receiving royalties from UpToDate, Inc. Dr. Adelman reports no financial relationships relevant to this article.
Dr. Sharp is Jon M. Huntsman Presidential Endowed Professor, Vice Chair for Clinical Activities, Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah.
Dr. Adelman is Associate Professor, Department of Obstetrics and Gynecology, University of Utah Health.
Dr. Sharp reports being an author and editor and receiving royalties from UpToDate, Inc. Dr. Adelman reports no financial relationships relevant to this article.
Author and Disclosure Information
Dr. Sharp is Jon M. Huntsman Presidential Endowed Professor, Vice Chair for Clinical Activities, Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah.
Dr. Adelman is Associate Professor, Department of Obstetrics and Gynecology, University of Utah Health.
Dr. Sharp reports being an author and editor and receiving royalties from UpToDate, Inc. Dr. Adelman reports no financial relationships relevant to this article.
In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.
COVID-19 vaccination had minimal effects on menstrual cycle length
Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.
Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,1,2 as the menstrual cycle is often considered a sign of health and fertility.
To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.3 Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.
The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the 2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)
Increase in cycle length clinically negligible
The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).
An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.
Counseling takeaway
This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.
WHAT THIS EVIDENCE MEANS FOR PRACTICE This robust study by Edelman and colleagues on COVID-19 vaccination effects on menstrual cycle length had more than 99% power to detect an unadjusted 1-day difference in cycle length. However, given that most of the study participants were White and had access to the Natural Cycles app, the results may not be generalizable to all individuals who receive the vaccine.
Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...
Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel
Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.
A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as combined oral contraceptives (COCs).
Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG) 0.075 mg, which is commonly used in Europe.4 Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.
Top reasons for stopping a POP
The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.
New oral contraception option
This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.
WHAT THIS EVIDENCE MEANS FOR PRACTICE Adherence to a contraceptive method is influenced by patient satisfaction, and this is particularly important in patients who cannot take COCs. It also should be noted that the discontinuation rate for DRSP as a POP used in this 24/4 regimen was similar to discontinuation rates for COCs containing 20 µg and 30 µg of ethinyl estradiol. Cost, however, may be an issue with DRSP, depending on a patient’s insurance coverage.
Continue to: Placing an LNG IUS after endometrial ablation for heavy menstrual bleeding reduced risk of hysterectomy...
Placing an LNG IUS after endometrial ablation for heavy menstrual bleeding reduced risk of hysterectomy
Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.
Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.
Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.5 These included 4 retrospective cohort studies with control groups, 2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.
Promising results for combined therapy
Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first 6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.
The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.
Bottom line
The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.
WHAT THIS EVIDENCE MEANS FOR PRACTICE The data provided by Oderkerk and colleagues’ systematic review are promising and, although not studied in the reviewed publications, the potential may exist to reduce the risk of endometrial hyperplasia and endometrial cancer by adding an LNG IUS.
Continue to: LNG IUS is less expensive, and less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...
LNG IUS is less expensive, and less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows
van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.
To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.6
Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.
Cost-effectiveness and noninferiority assessed
A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.
At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.
Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).
Key takeaway
Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial ablation. ●
WHAT THIS EVIDENCE MEANS FOR PRACTICE It is interesting that there are minimal differences between satisfaction rates and PBAC scores less than 75, yet the mean PBAC scores were significantly more favorable for endometrial ablation. This study’s results support the use of a sequential therapy of a less invasive therapy, such as the LNG IUS, prior to performing endometrial ablation.
In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.
COVID-19 vaccination had minimal effects on menstrual cycle length
Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.
Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,1,2 as the menstrual cycle is often considered a sign of health and fertility.
To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.3 Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.
The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the 2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)
Increase in cycle length clinically negligible
The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).
An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.
Counseling takeaway
This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.
WHAT THIS EVIDENCE MEANS FOR PRACTICE This robust study by Edelman and colleagues on COVID-19 vaccination effects on menstrual cycle length had more than 99% power to detect an unadjusted 1-day difference in cycle length. However, given that most of the study participants were White and had access to the Natural Cycles app, the results may not be generalizable to all individuals who receive the vaccine.
Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...
Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel
Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.
A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as combined oral contraceptives (COCs).
Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG) 0.075 mg, which is commonly used in Europe.4 Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.
Top reasons for stopping a POP
The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.
New oral contraception option
This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.
WHAT THIS EVIDENCE MEANS FOR PRACTICE Adherence to a contraceptive method is influenced by patient satisfaction, and this is particularly important in patients who cannot take COCs. It also should be noted that the discontinuation rate for DRSP as a POP used in this 24/4 regimen was similar to discontinuation rates for COCs containing 20 µg and 30 µg of ethinyl estradiol. Cost, however, may be an issue with DRSP, depending on a patient’s insurance coverage.
Continue to: Placing an LNG IUS after endometrial ablation for heavy menstrual bleeding reduced risk of hysterectomy...
Placing an LNG IUS after endometrial ablation for heavy menstrual bleeding reduced risk of hysterectomy
Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.
Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.
Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.5 These included 4 retrospective cohort studies with control groups, 2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.
Promising results for combined therapy
Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first 6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.
The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.
Bottom line
The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.
WHAT THIS EVIDENCE MEANS FOR PRACTICE The data provided by Oderkerk and colleagues’ systematic review are promising and, although not studied in the reviewed publications, the potential may exist to reduce the risk of endometrial hyperplasia and endometrial cancer by adding an LNG IUS.
Continue to: LNG IUS is less expensive, and less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...
LNG IUS is less expensive, and less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows
van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.
To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.6
Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.
Cost-effectiveness and noninferiority assessed
A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.
At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.
Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).
Key takeaway
Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial ablation. ●
WHAT THIS EVIDENCE MEANS FOR PRACTICE It is interesting that there are minimal differences between satisfaction rates and PBAC scores less than 75, yet the mean PBAC scores were significantly more favorable for endometrial ablation. This study’s results support the use of a sequential therapy of a less invasive therapy, such as the LNG IUS, prior to performing endometrial ablation.
References
Blumfiel G. Why reports of menstrual changes after COVID vaccine are tough to study. NPR. August 9, 2021. Accessed August 30, 2022. https://www.npr.org/sections/health-shots/2021/08/09/1024190379/covid-vaccine-period-menstrual-cycle-research
Lee KMN, Junkins EJ, Fatima UA, et al. Characterizing menstrual bleeding changes occurring after SARSCoV-2 vaccinations. MedRxiv. February 11, 2022. doi:10.1101/2021.10.11.21264863
Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.
Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.
Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. T he combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.
van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.
References
Blumfiel G. Why reports of menstrual changes after COVID vaccine are tough to study. NPR. August 9, 2021. Accessed August 30, 2022. https://www.npr.org/sections/health-shots/2021/08/09/1024190379/covid-vaccine-period-menstrual-cycle-research
Lee KMN, Junkins EJ, Fatima UA, et al. Characterizing menstrual bleeding changes occurring after SARSCoV-2 vaccinations. MedRxiv. February 11, 2022. doi:10.1101/2021.10.11.21264863
Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.
Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.
Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. T he combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.
van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.
The 2021–2022 US Supreme Court Term was a blockbuster medical Term. The bookends of the Term were COVID-19 vaccinations and abortion rights. Between the bookends were Medicare reimbursement, criminal liability for prescribing controlled substances, gun control, and carbon dioxide emissions. In this article, we focus on the significant medical issues, briefly note other important decisions, and consider the implications of this Term.
Abortion decisions
Dobbs v Jackson Women’s Health Organization1 was the most controversial decision and, for ObGyns, perhaps the most important decision in decades. The basic holding of the case can be stated simply: Roe v Wade2and Planned Parenthood of Southeastern Pennsylvania v Casey3 (which essentially created a constitutional right to abortion) are overruled. The law related to abortion is for the states and Congress to determine, not federal courts. (For a review of earlier reproductive freedom cases in the Court, see our previous article, “The Supreme Court and reproductive rights.”4)
Dobbs arose from a Mississippi statute that made it illegal to perform abortions after 15 weeks of gestation, well before viability. Six members of the Court held that the Mississippi law was constitutional and 3 would have struck down the state law. There were 5 opinions, covering a total of 213 pages in the U.S. Reports. The Court fell into 4 camps, ranging from the most to the least protective of abortion rights, as follows:
Three justices (Breyer, Kagan, and Sotomayor) voted to strike down the Mississippi statute and uphold Roe and Casey and wrote a joint dissent. They believe the Constitution makes abortion an issue “off limits to majority rule.” They also warned that other areas of “substantive due process” (discussed below), including contraception and same-sex marriage, might be under threat.
The Chief Justice voted to uphold the statute but wanted an incremental approach; that is, not to overturn Roe and Casey entirely in this case because the Dobbs case requiredthe Court only to determine the more limited question of whether the 15-week limit on abortion was constitutional. He found that the viability standard did not make sense, but he suggested that the Court “leave for another day” whether to overturn Roe.
Five justices joined the opinion to uphold the statute and overturn Roe. Justice Alito wrote the decision joined by Justices Thomas, Kavanaugh, Gorsuch, and Barrett. They found that a right to abortion was not “deeply rooted in our Nation’s history,” as evidenced by the fact that when the 14th Amendment was adopted, abortion was a criminal offense in most states and not a protected right in any state. In 2 lengthy appendices, the Court reviewed the criminalization of abortion in the states in 1868 and in the territories that later became states. Even when Roe was decided in 1973, abortion was not “deeply rooted” because it was not generally legal in the states. Justice Kavanaugh joined this opinion and wrote separately to emphasize that the majority opinion does not outlaw abortion, but rather leaves the issue to “the people and their representatives.” He also emphasized that the case did not overturn all of the substantive due process cases.
Justice Thomas would have gone further and abandoned “substantive due process” completely.
The constitutional issue
The majority said that the issue before the Court was not whether the law should permit or prohibit abortions—that is a question for the political branches. Rather, the question was only whether the Constitution precludes the political branches from allowing abortions. There is no mention of abortion in the Constitution and no specific reference to a right to privacy that includes medical decisions. A central constitutional question has been to identify where exactly in the Constitution the right to privacy resides. The Court has generally used “substantive due process” to locate privacy rights. The 14th Amendment provides, in part, that no state may “deprive any person of life, liberty, or property, without due process of law.” “Process” generally refers to procedural protections, but the Court sometimes has used it to encompass substantive rights (for example, privacy)—hence, “substantive due process.”
Over the decades, the legitimacy of substantive due process has remained controversial. Justice Thomas called it an “oxymoron” to turn “process” into substantive rights. And its use has a somewhat checkered history. For nearly 50 years (1890–1937), it was used to preclude states from protecting employees (for example, hour and wage laws violated “the right to contract”) and was discredited. More recently the Court has used substantive due process to protect contraception access, abortion, and same-sex marriages.
A critical question is knowing what rights substantive due process protects. The Court sometimes has said that it protects rights “deeply rooted in the Nation’s history and traditions” and “implicit in the concept of ordered liberty,”5 although in other cases suggested a more ambiguous definition.6 The next constitutional question is how to state or define the right to be protected. For example, is it the right to intimately personal decisions, bodily integrity, reproductive choice, abortion, or late-term abortion? Some of those may be deeply rooted in history and traditions (intimate decisions), and others not so much (late-term abortion). Finally, a question is whether a substantive right is defined at the time the 14th Amendment was adopted (1868) or now—is it a “living Constitution” that, without much guidance, means whatever 5 justices believe at the moment, or is it a Constitution grounded in the distant past?
The future of substantive due process is uncertain following Dobbs. Although the majority said it was not disclaiming substantive due process, the dissent said it doubted that claim because other rights are “part of the same constitutional fabric” (substantive due process). The Court might, in future cases, find some other constitutional provision in which to ground rights. The source of those rights might be the 9th Amendment (in addition to the Constitution’s enumerated rights, there are “others retained by the people”) or another provision of the 14th (“No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States…”). Each of these possibilities has its problems, many of which are similar to substantive due process, but they avoid the “oxymoron” issue.
Additional interesting cases in 2021–2022
Among the other important cases this Term, the Court made these determinations:
Held that the 2nd Amendment, as applied to the states through the 14th Amendment, includes a general right to carry a gun for self-defense outside the home.1 It struck down a New York law that required people to show a special need to have and carry a gun.
Determined that the US Environmental Protection Agency exceeded the authority Congress had granted it with a “Clean Power Plan” that was intended to reduce carbon dioxide emissions.2 It is up to Congress, not the agency, to expand agency authority.
Gave trial courts discretion in determining whether (and under what conditions) children in international custody disputes must be returned to their home countries where there is a serious risk of harm to them.3
Held that there is an implied right of action to sue medical providers for disability discrimination, but under the Rehabilitation Act and the Affordable Care Act the damages do not include emotional harm.4
Decided several “free exercise of religion” cases, and in each found the state had violated religious rights, holding that: A state improperly prevented religious schools from being eligible for a state tuition grant system,5 a coach was wrongfully fired for kneeling in prayer following football games,6 Boston denied free speech in allowing other organizations to fly their flags but denying a Christian flag to be displayed,7 and a state must permit prisoners to have a spiritual advisor to be present and pray and touch them during their execution.8
Held that the administration’s rescission of the “stay in Mexico” immigration policy was permitted by existing statutes.9
References
1. New York State Rifle & Pistol Association, Inc. v Bruen, 20-843, decided June 23, 2022. https://www.supremecourt.gov/opinions/21pdf/20-843_7j80.pdf
2. West Virginia v Environmental Protection Agency, 20-1530, decided June 30, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1530_new_l537.pdf
3. Golan v Saada, 20-1034, decided June 15, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1034_b8dg.pdf
4. Cummings v Premier Rehab Keller, 20-219, decided April 28, 2022. https://www.supremecourt.gov/opinions/21pdf/20-219_1b82.pdf
5. Carson v Makin, 20-1088, decided June 21, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1088_dbfi.pdf
6. Kennedy v Bremerton School District., 21-418, decided June 27, 2022. https://www.supremecourt.gov/opinions/21pdf/21-418_new_onkq.pdf
7. Shurtleff v Boston, 20-1800, decided May 2, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1800_7lho.pdf
8. Ramirez v Collier, 21-5592, decided March 24, 2022. https://www.supremecourt.gov/opinions/21pdf/21-5592_feah.pdf
9. Biden v Texas, 21-9 54, decided June 30, 2022. https://www.supremecourt.gov/opinions/21pdf/21-954_7l48.pdf
Continue to: ObGyn briefs in the case...
ObGyn briefs in the case
The medical profession filed several amicus curiae briefs in the Dobbs case. (These are “friends of the court” briefs filed by nonparties to the litigation. The purpose is to give a court a perspective on the case not presented by the parties.) The American College of Obstetricians and Gynecologists (ACOG) took the lead in filing an amicus brief.7 Nearly 2 dozen other medical organizations joined the brief, including the American Academy of Pediatrics, American College of Osteopathic Obstetricians and Gynecologists, American Gynecological and Obstetrical Society, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics and Gynecology, North American Society for Pediatric and Adolescent Gynecology, Society for Academic Specialists in General Obstetrics and Gynecology, Society of Gynecologic Oncology, and Society of OB/GYN Hospitalists.
The brief argued that abortion is a safe procedure, an abortion ban would harm the health of pregnant patients, and it would undermine the physician-patient relationship and interfere with patient autonomy. It also discussed the issue of fetal pain,8 telling the Court that “Every major medical organization that has examined the issue of fetal pain and peer-reviewed studies on the matter have consistently concluded that pre-viability abortion does not result in fetal pain perception.”9 The brief was cited in the dissent for the fact that “About 18 percent of pregnancies in this country end in abortion, and about one-quarter of American women will have an abortion before the age of 45.”10
The Court received a different view from an amicus brief filed by the American Association of Pro-Life Obstetricians and Gynecologists.11 It told the Court that abortion, especially later-term, poses health risks: the abortion process itself may injure the woman, abortion puts women at risk for future preterm births, later-term abortion raises a woman’s risk of developing breast cancer, and abortions (especially those later in the pregnancy) are linked to a greater risk of psychological harm.12 The brief also noted that 93% of obstetrician-gynecologists do not perform abortions, and “abortion has been deemed contrary to sound medicine for thousands of years” (citing the Hippocratic oath).13 The brief was not cited by the Court.
Many other medical and pro-life medical groups presented amicus briefs. A list of and links to all the briefs is available on the SCOTUSblog website at https://www.scotusblog.com/case-files/cases/dobbs-v-jackson-womens-health-organization/.
Ramifications
The Court decision does not make abortion illegal but allows states (and possibly Congress) to decide whether, when, and how abortions may be performed. Some states may ban most abortions (making it illegal to have or to perform abortions). Thirteen states had “trigger laws” to go into effect limiting abortion if the Court permitted such limitations. Most of those states were almost immediately entangled in lawsuits challenging the state laws. Some states, for example, have privacy provisions in their state constitution that state courts could interpret as allowing abortion, thereby voiding the state statutes prohibiting abortion.
At least a few states have abortion laws still on the books that were passed decades ago (perhaps before Roe) and were never repealed. Those laws may once again be valid, although state courts might hold that those statutes were repealed by Roe and must be passed again to be valid. Some experts anticipate that 28 states will eventually have significant limitations on abortion.
The Guttmacher Institute maintains a frequently updated table on the abortion laws in each state.14 According to one estimate, 29 states are hostile to abortion rights (or lean that way), with about 40 million women aged 13 to 44 (58% of the United States) living in states with some hostility to abortion.15 Congress may pass some national abortion laws, but that seems unlikely and there may be some limits on its ability to control private medical practice within states.
An additional legal issue will arise from medication-induced abortions, generally through the use of mifepristone and misoprostol. They now account for the majority of abortions. These medications might be used for abortion, up to about 9 weeks of pregnancy, in states prohibiting abortion. The drugs once were available only with an in-person visit, but now the US Food and Drug Administration (FDA) permits mail-order delivery. The potential exists, therefore, to circumvent states’ prohibition on abortion through mail-order postal shipments. The FDA controls the licensing of pharmaceuticals in interstate commerce, but not the practice of medicine within a state. Therefore the ability of individuals (within a state) to possess or use drugs is unclear.
The abortion wars of the last 50 years gave rise to state laws related to abortion, including consent by minors, information to parents, special informed consent, and facilities requirements. If these laws were once struck down because they were inconsistent with Roe, but were never formally repealed, they may now become legal requirements.
In the foreseeable future, abortion laws generally will not be determined by federal courts but by state law, generally legislatures. In legislative hearings, town hall meetings, and conversations with lawmakers, ObGyns should engage the topic of abortion with scientific expertise, reason, openness, and humility. It will be impossible for the profession to speak with a single voice, as the briefs filed this Term demonstrate. Where there are honest differences in science, the reasons for the different interpretations should be explainable to lay decision makers. The profession, who are not being pseudo-lobbyists, can contribute a great deal to the rational consideration of this emotional topic.
Farewell to Justice Breyer and welcome to Justice Jackson
On January 27, 2022, Justice Stephen Breyer informed President Biden of his intention to retire from the Court at the end of the Term. At age 84, he was the oldest member of the Court, but he continued to be among the most active of the justices and seemed to relish the work of the Court. He had been under pressure from liberal groups to retire earlier so a successor could be confirmed by a Democratic Senate. In many ways he was the Renaissance man of the Court: he spoke fluent French, wrote books, and famously sprinkled his questions with complex and funny hypotheticals.
Justice Breyer was a law professor before becoming a judge and enjoyed presentations to many groups, from children to law professors. He loved the Court and defended it—most recently against partisan attacks from both the right and the left. In the decisions of the Court, he was one of the more liberal justices. He had, for example, indicated that the death penalty is unconstitutional.
In his January retirement letter, he said that he would step down at the end of the Term if his replacement had been appointed and confirmed. She had. The new justice had clerked for Justice Breyer in 1999–2000.
Ketanji Brown Jackson was nominated by President Biden on February 28, confirmed by the Senate on April 7 by a 53–47 margin, and sworn in on June 30, 2022. Justice Jackson had previously been a federal district court judge and on the Court of Appeals for the D.C. Circuit. She attended Harvard-Radcliffe College and received her law degree from Harvard Law School. She worked as a criminal defense attorney and was active in the US Sentencing Commission.
Continue to: What is a practitioner to do?...
What is a practitioner to do?
For many practitioners, the Dobbs decision will have little effect because their state laws are consistent with Roe, and the legislature is not going to change the law. They may, of course, see an influx of patients from other states (that restrict abortion) seeking treatment. At the other extreme, in some states, most abortions will become prohibited. State courts may ease the restrictions. In many states, there will be an ongoing battle over when abortion is legal and when it is not, resulting in shifting laws and regulations. Keeping up with the shifts that affect practice will be a challenge.
All states are likely to permit abortions “to save the life of the mother,” and many will have a version of “to preserve the health of the mother.” Other exceptions may be for pregnancy resulting from rape or incest or in the case of serious fetal abnormality. ObGyns, of course, will be called on to certify that one of these exceptions exists. Determining that pregnancy resulted from rape or incest, of course, can be challenging. Before Roe, there was a cottage industry opining that pregnancy seriously affected the health of the mother, which often involved physical manifestations of mental health. ObGyns in some states may be asked once again to make such determinations.
Laws not directly related to abortions will, in some states, be changed as a way of discouraging abortion. For example, child abuse reporting laws may be modified to require reporting of any known or suspected abortion or attempted abortion, and medical licensing standards may make it a violation to participate in or facilitate abortion in any way.
Particularly in states where the rules keep shifting, practitioners must keep up with the current law. Professional organizations can help with that, but there is no substitute for practitioners having an ongoing professional relationship with an attorney who has expertise in health law.
Other abortion decisions this Term
In other abortion decisions this Term, the Court refused to suspend a Texas law that prohibited abortions after a fetal heartbeat could be detected.16 The law has remarkable enforcement mechanisms that preclude state officers from enforcing it; instead, it creates what amounts to a private attorney general (PAG) provision that allows private citizens to file suit against anyone performing or assisting in performing abortions. This PAG made pre-enforcement challenges to the law difficult.17
In a Kentucky case, the Court allowed the Kentucky attorney general to intervene in a case that challenged a Kentucky law that prohibits physicians from using dilation and evacuation procedures to end second-trimester pregnancies.18
Criminal convictions for physicians’ overprescription of controlled substances
Perhaps the least sympathetic of the physicians involved with the Court this Term were the 2 in Ruan v U.S.19 Their trials indicate that Dr. Ruan’s clinic issued more than 300,000 controlled substance prescriptions over 4 years and was one of the most frequent prescribers of fentanyl. Dr. Kahn prescribed controlled substances without an examination, falsified notes, and sold controlled substances for cash and guns.20
Both physicians were convicted of “knowingly or intentionally” dispensing a controlled substance without authorization.21 They were authorized to prescribe drugs, but only “for a legitimate medical purpose.”22 Appeals to their respective Circuit courts confirmed their convictions. The Supreme Court, however, held that to convict them, the government must prove that they knowingly or intentionally acted in an unauthorized manner. That proof can be by circumstantial evidence, but it must be beyond a reasonable doubt.
Health care reimbursement
Hospitals won one and lost one Medicare-Medicaid reimbursement case that involved payments for low-income patients.
In the loss, the Court held that the US Department of Health and Human Services (HHS) properly calculated the disproportionate share adjustments (DSH), or Medicare fraction,23 that provides a supplemental payment for hospitals with a large proportion of low-income patients. The lower DSH payments calculated by HHS were upheld, thereby reducing the number of hospitals receiving DSH payments and decreasing the amounts others will receive.
The win involved payments for prescription drugs that hospitals provide to outpatients in safety-net hospitals.24 HHS determined that it was overpaying hospitals for drugs and cut the reimbursement rate. The Court held that before HHS can change the drug rate, it must conduct a survey of hospitals regarding actual costs. It had not done that, so the rate reduction was not permitted by the law.
An accidental disincentive to (some) malpractice suits
Medicaid requires states to obtain part of a tort recovery that recipients obtain if Medicaid is covering medical expenses related to their injuries. In implementing that law, a state may provide a disincentive for injured beneficiaries to file malpractice cases. At issue was a Florida law that provided the Medicaid state would take 37.5% of the beneficiary’s total tort recovery (being one-half of the recovery after deducting 25% for attorney’s fees and costs). In a 7-2 decision, the Court upheld the Florida law.25
The disincentive to filing a lawsuit is that the state is taking 37.5%, plus contingency fee attorneys will typically take 33.3% (and there will be some fees). This is especially true when there is a state cap on noneconomic damages. In the case the Court decided, the plaintiff received a settlement of $850,000. If we assume a typical contingency fee, less the state’s Medicaid claim of $300,000, the plaintiff possibly received $266,667. That is not trivial, but it is only 31% of the settlement.
The Medicaid expectation of reimbursement and the Florida approach, however, impose heavy burdens on severely injured beneficiaries. The plaintiff had catastrophic injuries and was in a vegetative state. There are some things Medicaid does not pay for, as well as nonmedical expenses. The amount left for such expenses is likely well below what the family will need.
Continue to: COVID-19 vaccinations...
COVID-19 vaccinations
Had it not been for the abortion decisions, 2021–2022 might have been “the COVID Term.” Two of the most anticipated decisions involved mandatory vaccinations (or masking/testing instead). The question in each of these cases was whether Congress had authorized 2 federal agencies to issue the emergency regulations requiring vaccination. Emergency regulations are held to higher standards because they bypass the usual protections of the Administrative Procedure Act.
One case involved a regulation issued by the Occupational Safety and Health Administration (OSHA) that employers (with more than 100 employees) must require their employees to be vaccinated. In a 6-3 decision, the Court held that OSHA did not have the authority to enforce this as an emergency regulation. The other case was a regulation issued by HHS that health care institutions receiving Medicare and Medicaid funding must require all staff to be vaccinated.26 In a 5-4 decision, the Court upheld this emergency regulation because of the very broad authority Congress had given HHS to ensure the safety of patients and the quality of Medicare- and Medicaid-funded programs.27
In another case, in the shadow docket (orders and opinions in cases without full arguments), the Court struck down the Centers for Disease Control and Prevention’s eviction moratorium.28 The Court said the government claimed “a breathtaking amount of authority” that Congress did not intend. In other shadow docket cases, the Court refused to hold unconstitutional state laws that require COVID-19 vaccination but did not have religious exemptions.29
Analysis of this Term
It was an extraordinary Term. The Court decided 66 cases (excluding most cases in the shadow docket), a low number historically. Not only were there many seminal cases but also the Court appears to be shifting toward a new direction. That direction may be oriented more toward the original understanding of the words of the Constitution and statutes and less toward policy; Congress rather than administrative agencies; racial nondiscrimination rather than preferences; and the free exercise rather than the establishment of religion. Whether there is such a shift or not, of course, only time will tell.
Chief Justice Roberts and Justice Kavanaugh were in the majority most often (95% of the cases), followed by Justices Barrett (90%), Alito (85%), Thomas (80%), and Gorsuch (75%). Justices Kagan (69%) and Breyer (68%) were not far behind. Justice Sotomayor was in the majority 58%. The Court was unanimous 29% of the time, well below the decade average (43%), and 6-3 accounted for 30% of the decisions.
A major, potentially scarring, event this Term was the leak of an early draft of the majority opinion in Dobbs. Although leaks have occurred before, the early leak of an opinion was unprecedented. It will almost inevitably change the openness and candor within the Court and the justices’ clerks. Although not unprecedented, the attempt on the life of Justice Kavanaugh and the organized efforts to harass some justices in their homes are likely to have lasting impact. Almost certainly it means that justices and their families will have constant security and their movements and connection with the general public will become less frequent, which is sad for the justices and our democracy.
Looking toward the next Term
When the Court next convenes, Justice Ketanji Brown Jackson will take her seat on the left end of the Court (the traditional seat for a new justice, not a commentary on judicial philosophy). The Court has already taken many cases, including issues about university affirmative action programs, web designers and same-sex couples, redistricting and voting rights, DNA testing in criminal cases, and overtime pay for someone making over $200,000 per year. It begins Monday, October 3, and promises to be another interesting Term. ●
References
Dobbs v Jackson Women’s Health Organization, 19-1392, decided June 24, 2022. https://www.supremecourt.gov /opinions/21pdf/19-1392_6j37.pdf
Roe v Wade, 410 U.S. 113, 163 (1973).
Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U.S. 833 (1992).
Smith SR, Sanfilippo JR. The Supreme Court and reproductive rights. OBG Manag. 2022;34(1):36-41, 46. https://cdn.mdedge. com/files/s3fs-public/issues/articles/obgm0340136_smith.pdf
Washington v Glucksberg, 521 U.S. 702 (1997).
Obergefell v Hodges, 576 U.S. 644, 654-70 (2015).
Brief of amici curiae of American College of Obstetricians and Gynecologists, American Medical Association, et al, in Dobbs v Jackson Women’s Health Organization, in Support of Respondents (Sep. 2021). https://www.supremecourt .gov/DocketPDF/19/19-1392/193074/20210920174518042 _19-1392%20bsacACOGetal.pdf
Id. at 8, 13-15.
Id. at 14.
Justices Breyer, Kagan, and Sotomayor, dissenting, at 48, note 22.
Brief for American Association of Pro-Life Obstetricians And Gynecologists as Amicus Curiae, in Dobbs v Jackson Women’s Health Organization, in Support of Petitioners (July 2021). https://www.supremecourt.gov /DocketPDF/19/19-1392/185350/20210729163532595_No. %2019-1392%20-%20American%20Association%20of%20 Pro-Life%20Obstetricians%20and%20Gynecologists%20-%20 Amicus%20Brief%20in%20Support%20of%20Petitioner%20-%20 7-29-21.pdf
Id. at 3-4, 7-29.
Id. at 30.
Guttmacher Institute. An overview of abortion laws. July 11, 2022. https://www.guttmacher.org/state-policy/explore/overview -abortion-laws
Guttmacher Institute. State abortion policy landscape: from hostile to supportive. Dec. 2020. https://www .guttmacher.org/article/2019/08/state-abortion-policy -landscape-hostile-supportive
Whole Woman’s Health v Jackson, 21-463, decided Dec. 10, 2021. https://www.supremecourt.gov/opinions/21pdf/21-463_ new_8o6b.pdf
United States v Texas, 21-588, decided Dec. 10, 2021. (Per curiam, Sotomayor dissenting). https://www.supremecourt.gov /opinions/21pdf/21-588_c07d.pdf
Cameron v EMW Women’s Surgical Center, 20-601, decided Mar. 3, 2022. https://www.supremecourt.gov/opinions/21pdf/20-601 _new_g20h.pdf
Xiulu Ruan v United States, 20-1410, decided June 27, 2022. https:// www.supremecourt.gov/opinions/21pdf/20-1410_1an2.pdf
Adam Liptak. Supreme Court sides with doctors accused of running pill mills. The New York Times. June 27, 2022. https://www .nytimes.com/2022/06/27/us/politics/supreme-court-controlled -substance-act.html
84 Stat. 1260, 21 U.S.C. §841(a).
21 CFR §1306.04(a) (2021).
Becerra v Empire Health Foundation, For Valley Hospital Medical Center, 20-1312, decided June 24, 2022. https://www.supremecourt .gov/opinions/21pdf/20-1312_j42l.pdf
American Hospital Association v Becerra, 20-1114, decided June 15, 2022. https://www.supremecourt.gov/opinions/21pdf/20 -1114_09m1.pdf
Gallardo v Marstiller, 20-1263, decided June 6, 2022. https:// www.supremecourt.gov/opinions/21pdf/20-1263_new_hfci.pdf
National Federation of Independent Business v Department of Labor, Occupational Safety and Health Administration, 21A244, decided Jan. 13, 2022. https://www.supremecourt.gov /opinions/21pdf/21a244_hgci.pdf
Biden v Missouri, 21A240, decided Jan. 13, 2022. https://www .supremecourt.gov/opinions/21pdf/21a240_d18e.pdf
Alabama Association of Realtors v Department of Health and Human Services, 21A23, decided Aug. 26, 2021. https://www .supremecourt.gov/opinions/20pdf/21a23_ap6c.pdf
Does v Mills, 21A90, decided Oct. 29, 2021. https://www .supremecourt.gov/opinions/21pdf/21a90_6j37.pdf
Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.
Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Academic Division Director, Reproductive Endocrinology and Infertility, Magee Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors.
The authors report no financial relationships relevant to this article.
Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.
Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Academic Division Director, Reproductive Endocrinology and Infertility, Magee Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors.
The authors report no financial relationships relevant to this article.
Author and Disclosure Information
Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.
Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Academic Division Director, Reproductive Endocrinology and Infertility, Magee Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors.
The authors report no financial relationships relevant to this article.
The 2021–2022 US Supreme Court Term was a blockbuster medical Term. The bookends of the Term were COVID-19 vaccinations and abortion rights. Between the bookends were Medicare reimbursement, criminal liability for prescribing controlled substances, gun control, and carbon dioxide emissions. In this article, we focus on the significant medical issues, briefly note other important decisions, and consider the implications of this Term.
Abortion decisions
Dobbs v Jackson Women’s Health Organization1 was the most controversial decision and, for ObGyns, perhaps the most important decision in decades. The basic holding of the case can be stated simply: Roe v Wade2and Planned Parenthood of Southeastern Pennsylvania v Casey3 (which essentially created a constitutional right to abortion) are overruled. The law related to abortion is for the states and Congress to determine, not federal courts. (For a review of earlier reproductive freedom cases in the Court, see our previous article, “The Supreme Court and reproductive rights.”4)
Dobbs arose from a Mississippi statute that made it illegal to perform abortions after 15 weeks of gestation, well before viability. Six members of the Court held that the Mississippi law was constitutional and 3 would have struck down the state law. There were 5 opinions, covering a total of 213 pages in the U.S. Reports. The Court fell into 4 camps, ranging from the most to the least protective of abortion rights, as follows:
Three justices (Breyer, Kagan, and Sotomayor) voted to strike down the Mississippi statute and uphold Roe and Casey and wrote a joint dissent. They believe the Constitution makes abortion an issue “off limits to majority rule.” They also warned that other areas of “substantive due process” (discussed below), including contraception and same-sex marriage, might be under threat.
The Chief Justice voted to uphold the statute but wanted an incremental approach; that is, not to overturn Roe and Casey entirely in this case because the Dobbs case requiredthe Court only to determine the more limited question of whether the 15-week limit on abortion was constitutional. He found that the viability standard did not make sense, but he suggested that the Court “leave for another day” whether to overturn Roe.
Five justices joined the opinion to uphold the statute and overturn Roe. Justice Alito wrote the decision joined by Justices Thomas, Kavanaugh, Gorsuch, and Barrett. They found that a right to abortion was not “deeply rooted in our Nation’s history,” as evidenced by the fact that when the 14th Amendment was adopted, abortion was a criminal offense in most states and not a protected right in any state. In 2 lengthy appendices, the Court reviewed the criminalization of abortion in the states in 1868 and in the territories that later became states. Even when Roe was decided in 1973, abortion was not “deeply rooted” because it was not generally legal in the states. Justice Kavanaugh joined this opinion and wrote separately to emphasize that the majority opinion does not outlaw abortion, but rather leaves the issue to “the people and their representatives.” He also emphasized that the case did not overturn all of the substantive due process cases.
Justice Thomas would have gone further and abandoned “substantive due process” completely.
The constitutional issue
The majority said that the issue before the Court was not whether the law should permit or prohibit abortions—that is a question for the political branches. Rather, the question was only whether the Constitution precludes the political branches from allowing abortions. There is no mention of abortion in the Constitution and no specific reference to a right to privacy that includes medical decisions. A central constitutional question has been to identify where exactly in the Constitution the right to privacy resides. The Court has generally used “substantive due process” to locate privacy rights. The 14th Amendment provides, in part, that no state may “deprive any person of life, liberty, or property, without due process of law.” “Process” generally refers to procedural protections, but the Court sometimes has used it to encompass substantive rights (for example, privacy)—hence, “substantive due process.”
Over the decades, the legitimacy of substantive due process has remained controversial. Justice Thomas called it an “oxymoron” to turn “process” into substantive rights. And its use has a somewhat checkered history. For nearly 50 years (1890–1937), it was used to preclude states from protecting employees (for example, hour and wage laws violated “the right to contract”) and was discredited. More recently the Court has used substantive due process to protect contraception access, abortion, and same-sex marriages.
A critical question is knowing what rights substantive due process protects. The Court sometimes has said that it protects rights “deeply rooted in the Nation’s history and traditions” and “implicit in the concept of ordered liberty,”5 although in other cases suggested a more ambiguous definition.6 The next constitutional question is how to state or define the right to be protected. For example, is it the right to intimately personal decisions, bodily integrity, reproductive choice, abortion, or late-term abortion? Some of those may be deeply rooted in history and traditions (intimate decisions), and others not so much (late-term abortion). Finally, a question is whether a substantive right is defined at the time the 14th Amendment was adopted (1868) or now—is it a “living Constitution” that, without much guidance, means whatever 5 justices believe at the moment, or is it a Constitution grounded in the distant past?
The future of substantive due process is uncertain following Dobbs. Although the majority said it was not disclaiming substantive due process, the dissent said it doubted that claim because other rights are “part of the same constitutional fabric” (substantive due process). The Court might, in future cases, find some other constitutional provision in which to ground rights. The source of those rights might be the 9th Amendment (in addition to the Constitution’s enumerated rights, there are “others retained by the people”) or another provision of the 14th (“No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States…”). Each of these possibilities has its problems, many of which are similar to substantive due process, but they avoid the “oxymoron” issue.
Additional interesting cases in 2021–2022
Among the other important cases this Term, the Court made these determinations:
Held that the 2nd Amendment, as applied to the states through the 14th Amendment, includes a general right to carry a gun for self-defense outside the home.1 It struck down a New York law that required people to show a special need to have and carry a gun.
Determined that the US Environmental Protection Agency exceeded the authority Congress had granted it with a “Clean Power Plan” that was intended to reduce carbon dioxide emissions.2 It is up to Congress, not the agency, to expand agency authority.
Gave trial courts discretion in determining whether (and under what conditions) children in international custody disputes must be returned to their home countries where there is a serious risk of harm to them.3
Held that there is an implied right of action to sue medical providers for disability discrimination, but under the Rehabilitation Act and the Affordable Care Act the damages do not include emotional harm.4
Decided several “free exercise of religion” cases, and in each found the state had violated religious rights, holding that: A state improperly prevented religious schools from being eligible for a state tuition grant system,5 a coach was wrongfully fired for kneeling in prayer following football games,6 Boston denied free speech in allowing other organizations to fly their flags but denying a Christian flag to be displayed,7 and a state must permit prisoners to have a spiritual advisor to be present and pray and touch them during their execution.8
Held that the administration’s rescission of the “stay in Mexico” immigration policy was permitted by existing statutes.9
References
1. New York State Rifle & Pistol Association, Inc. v Bruen, 20-843, decided June 23, 2022. https://www.supremecourt.gov/opinions/21pdf/20-843_7j80.pdf
2. West Virginia v Environmental Protection Agency, 20-1530, decided June 30, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1530_new_l537.pdf
3. Golan v Saada, 20-1034, decided June 15, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1034_b8dg.pdf
4. Cummings v Premier Rehab Keller, 20-219, decided April 28, 2022. https://www.supremecourt.gov/opinions/21pdf/20-219_1b82.pdf
5. Carson v Makin, 20-1088, decided June 21, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1088_dbfi.pdf
6. Kennedy v Bremerton School District., 21-418, decided June 27, 2022. https://www.supremecourt.gov/opinions/21pdf/21-418_new_onkq.pdf
7. Shurtleff v Boston, 20-1800, decided May 2, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1800_7lho.pdf
8. Ramirez v Collier, 21-5592, decided March 24, 2022. https://www.supremecourt.gov/opinions/21pdf/21-5592_feah.pdf
9. Biden v Texas, 21-9 54, decided June 30, 2022. https://www.supremecourt.gov/opinions/21pdf/21-954_7l48.pdf
Continue to: ObGyn briefs in the case...
ObGyn briefs in the case
The medical profession filed several amicus curiae briefs in the Dobbs case. (These are “friends of the court” briefs filed by nonparties to the litigation. The purpose is to give a court a perspective on the case not presented by the parties.) The American College of Obstetricians and Gynecologists (ACOG) took the lead in filing an amicus brief.7 Nearly 2 dozen other medical organizations joined the brief, including the American Academy of Pediatrics, American College of Osteopathic Obstetricians and Gynecologists, American Gynecological and Obstetrical Society, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics and Gynecology, North American Society for Pediatric and Adolescent Gynecology, Society for Academic Specialists in General Obstetrics and Gynecology, Society of Gynecologic Oncology, and Society of OB/GYN Hospitalists.
The brief argued that abortion is a safe procedure, an abortion ban would harm the health of pregnant patients, and it would undermine the physician-patient relationship and interfere with patient autonomy. It also discussed the issue of fetal pain,8 telling the Court that “Every major medical organization that has examined the issue of fetal pain and peer-reviewed studies on the matter have consistently concluded that pre-viability abortion does not result in fetal pain perception.”9 The brief was cited in the dissent for the fact that “About 18 percent of pregnancies in this country end in abortion, and about one-quarter of American women will have an abortion before the age of 45.”10
The Court received a different view from an amicus brief filed by the American Association of Pro-Life Obstetricians and Gynecologists.11 It told the Court that abortion, especially later-term, poses health risks: the abortion process itself may injure the woman, abortion puts women at risk for future preterm births, later-term abortion raises a woman’s risk of developing breast cancer, and abortions (especially those later in the pregnancy) are linked to a greater risk of psychological harm.12 The brief also noted that 93% of obstetrician-gynecologists do not perform abortions, and “abortion has been deemed contrary to sound medicine for thousands of years” (citing the Hippocratic oath).13 The brief was not cited by the Court.
Many other medical and pro-life medical groups presented amicus briefs. A list of and links to all the briefs is available on the SCOTUSblog website at https://www.scotusblog.com/case-files/cases/dobbs-v-jackson-womens-health-organization/.
Ramifications
The Court decision does not make abortion illegal but allows states (and possibly Congress) to decide whether, when, and how abortions may be performed. Some states may ban most abortions (making it illegal to have or to perform abortions). Thirteen states had “trigger laws” to go into effect limiting abortion if the Court permitted such limitations. Most of those states were almost immediately entangled in lawsuits challenging the state laws. Some states, for example, have privacy provisions in their state constitution that state courts could interpret as allowing abortion, thereby voiding the state statutes prohibiting abortion.
At least a few states have abortion laws still on the books that were passed decades ago (perhaps before Roe) and were never repealed. Those laws may once again be valid, although state courts might hold that those statutes were repealed by Roe and must be passed again to be valid. Some experts anticipate that 28 states will eventually have significant limitations on abortion.
The Guttmacher Institute maintains a frequently updated table on the abortion laws in each state.14 According to one estimate, 29 states are hostile to abortion rights (or lean that way), with about 40 million women aged 13 to 44 (58% of the United States) living in states with some hostility to abortion.15 Congress may pass some national abortion laws, but that seems unlikely and there may be some limits on its ability to control private medical practice within states.
An additional legal issue will arise from medication-induced abortions, generally through the use of mifepristone and misoprostol. They now account for the majority of abortions. These medications might be used for abortion, up to about 9 weeks of pregnancy, in states prohibiting abortion. The drugs once were available only with an in-person visit, but now the US Food and Drug Administration (FDA) permits mail-order delivery. The potential exists, therefore, to circumvent states’ prohibition on abortion through mail-order postal shipments. The FDA controls the licensing of pharmaceuticals in interstate commerce, but not the practice of medicine within a state. Therefore the ability of individuals (within a state) to possess or use drugs is unclear.
The abortion wars of the last 50 years gave rise to state laws related to abortion, including consent by minors, information to parents, special informed consent, and facilities requirements. If these laws were once struck down because they were inconsistent with Roe, but were never formally repealed, they may now become legal requirements.
In the foreseeable future, abortion laws generally will not be determined by federal courts but by state law, generally legislatures. In legislative hearings, town hall meetings, and conversations with lawmakers, ObGyns should engage the topic of abortion with scientific expertise, reason, openness, and humility. It will be impossible for the profession to speak with a single voice, as the briefs filed this Term demonstrate. Where there are honest differences in science, the reasons for the different interpretations should be explainable to lay decision makers. The profession, who are not being pseudo-lobbyists, can contribute a great deal to the rational consideration of this emotional topic.
Farewell to Justice Breyer and welcome to Justice Jackson
On January 27, 2022, Justice Stephen Breyer informed President Biden of his intention to retire from the Court at the end of the Term. At age 84, he was the oldest member of the Court, but he continued to be among the most active of the justices and seemed to relish the work of the Court. He had been under pressure from liberal groups to retire earlier so a successor could be confirmed by a Democratic Senate. In many ways he was the Renaissance man of the Court: he spoke fluent French, wrote books, and famously sprinkled his questions with complex and funny hypotheticals.
Justice Breyer was a law professor before becoming a judge and enjoyed presentations to many groups, from children to law professors. He loved the Court and defended it—most recently against partisan attacks from both the right and the left. In the decisions of the Court, he was one of the more liberal justices. He had, for example, indicated that the death penalty is unconstitutional.
In his January retirement letter, he said that he would step down at the end of the Term if his replacement had been appointed and confirmed. She had. The new justice had clerked for Justice Breyer in 1999–2000.
Ketanji Brown Jackson was nominated by President Biden on February 28, confirmed by the Senate on April 7 by a 53–47 margin, and sworn in on June 30, 2022. Justice Jackson had previously been a federal district court judge and on the Court of Appeals for the D.C. Circuit. She attended Harvard-Radcliffe College and received her law degree from Harvard Law School. She worked as a criminal defense attorney and was active in the US Sentencing Commission.
Continue to: What is a practitioner to do?...
What is a practitioner to do?
For many practitioners, the Dobbs decision will have little effect because their state laws are consistent with Roe, and the legislature is not going to change the law. They may, of course, see an influx of patients from other states (that restrict abortion) seeking treatment. At the other extreme, in some states, most abortions will become prohibited. State courts may ease the restrictions. In many states, there will be an ongoing battle over when abortion is legal and when it is not, resulting in shifting laws and regulations. Keeping up with the shifts that affect practice will be a challenge.
All states are likely to permit abortions “to save the life of the mother,” and many will have a version of “to preserve the health of the mother.” Other exceptions may be for pregnancy resulting from rape or incest or in the case of serious fetal abnormality. ObGyns, of course, will be called on to certify that one of these exceptions exists. Determining that pregnancy resulted from rape or incest, of course, can be challenging. Before Roe, there was a cottage industry opining that pregnancy seriously affected the health of the mother, which often involved physical manifestations of mental health. ObGyns in some states may be asked once again to make such determinations.
Laws not directly related to abortions will, in some states, be changed as a way of discouraging abortion. For example, child abuse reporting laws may be modified to require reporting of any known or suspected abortion or attempted abortion, and medical licensing standards may make it a violation to participate in or facilitate abortion in any way.
Particularly in states where the rules keep shifting, practitioners must keep up with the current law. Professional organizations can help with that, but there is no substitute for practitioners having an ongoing professional relationship with an attorney who has expertise in health law.
Other abortion decisions this Term
In other abortion decisions this Term, the Court refused to suspend a Texas law that prohibited abortions after a fetal heartbeat could be detected.16 The law has remarkable enforcement mechanisms that preclude state officers from enforcing it; instead, it creates what amounts to a private attorney general (PAG) provision that allows private citizens to file suit against anyone performing or assisting in performing abortions. This PAG made pre-enforcement challenges to the law difficult.17
In a Kentucky case, the Court allowed the Kentucky attorney general to intervene in a case that challenged a Kentucky law that prohibits physicians from using dilation and evacuation procedures to end second-trimester pregnancies.18
Criminal convictions for physicians’ overprescription of controlled substances
Perhaps the least sympathetic of the physicians involved with the Court this Term were the 2 in Ruan v U.S.19 Their trials indicate that Dr. Ruan’s clinic issued more than 300,000 controlled substance prescriptions over 4 years and was one of the most frequent prescribers of fentanyl. Dr. Kahn prescribed controlled substances without an examination, falsified notes, and sold controlled substances for cash and guns.20
Both physicians were convicted of “knowingly or intentionally” dispensing a controlled substance without authorization.21 They were authorized to prescribe drugs, but only “for a legitimate medical purpose.”22 Appeals to their respective Circuit courts confirmed their convictions. The Supreme Court, however, held that to convict them, the government must prove that they knowingly or intentionally acted in an unauthorized manner. That proof can be by circumstantial evidence, but it must be beyond a reasonable doubt.
Health care reimbursement
Hospitals won one and lost one Medicare-Medicaid reimbursement case that involved payments for low-income patients.
In the loss, the Court held that the US Department of Health and Human Services (HHS) properly calculated the disproportionate share adjustments (DSH), or Medicare fraction,23 that provides a supplemental payment for hospitals with a large proportion of low-income patients. The lower DSH payments calculated by HHS were upheld, thereby reducing the number of hospitals receiving DSH payments and decreasing the amounts others will receive.
The win involved payments for prescription drugs that hospitals provide to outpatients in safety-net hospitals.24 HHS determined that it was overpaying hospitals for drugs and cut the reimbursement rate. The Court held that before HHS can change the drug rate, it must conduct a survey of hospitals regarding actual costs. It had not done that, so the rate reduction was not permitted by the law.
An accidental disincentive to (some) malpractice suits
Medicaid requires states to obtain part of a tort recovery that recipients obtain if Medicaid is covering medical expenses related to their injuries. In implementing that law, a state may provide a disincentive for injured beneficiaries to file malpractice cases. At issue was a Florida law that provided the Medicaid state would take 37.5% of the beneficiary’s total tort recovery (being one-half of the recovery after deducting 25% for attorney’s fees and costs). In a 7-2 decision, the Court upheld the Florida law.25
The disincentive to filing a lawsuit is that the state is taking 37.5%, plus contingency fee attorneys will typically take 33.3% (and there will be some fees). This is especially true when there is a state cap on noneconomic damages. In the case the Court decided, the plaintiff received a settlement of $850,000. If we assume a typical contingency fee, less the state’s Medicaid claim of $300,000, the plaintiff possibly received $266,667. That is not trivial, but it is only 31% of the settlement.
The Medicaid expectation of reimbursement and the Florida approach, however, impose heavy burdens on severely injured beneficiaries. The plaintiff had catastrophic injuries and was in a vegetative state. There are some things Medicaid does not pay for, as well as nonmedical expenses. The amount left for such expenses is likely well below what the family will need.
Continue to: COVID-19 vaccinations...
COVID-19 vaccinations
Had it not been for the abortion decisions, 2021–2022 might have been “the COVID Term.” Two of the most anticipated decisions involved mandatory vaccinations (or masking/testing instead). The question in each of these cases was whether Congress had authorized 2 federal agencies to issue the emergency regulations requiring vaccination. Emergency regulations are held to higher standards because they bypass the usual protections of the Administrative Procedure Act.
One case involved a regulation issued by the Occupational Safety and Health Administration (OSHA) that employers (with more than 100 employees) must require their employees to be vaccinated. In a 6-3 decision, the Court held that OSHA did not have the authority to enforce this as an emergency regulation. The other case was a regulation issued by HHS that health care institutions receiving Medicare and Medicaid funding must require all staff to be vaccinated.26 In a 5-4 decision, the Court upheld this emergency regulation because of the very broad authority Congress had given HHS to ensure the safety of patients and the quality of Medicare- and Medicaid-funded programs.27
In another case, in the shadow docket (orders and opinions in cases without full arguments), the Court struck down the Centers for Disease Control and Prevention’s eviction moratorium.28 The Court said the government claimed “a breathtaking amount of authority” that Congress did not intend. In other shadow docket cases, the Court refused to hold unconstitutional state laws that require COVID-19 vaccination but did not have religious exemptions.29
Analysis of this Term
It was an extraordinary Term. The Court decided 66 cases (excluding most cases in the shadow docket), a low number historically. Not only were there many seminal cases but also the Court appears to be shifting toward a new direction. That direction may be oriented more toward the original understanding of the words of the Constitution and statutes and less toward policy; Congress rather than administrative agencies; racial nondiscrimination rather than preferences; and the free exercise rather than the establishment of religion. Whether there is such a shift or not, of course, only time will tell.
Chief Justice Roberts and Justice Kavanaugh were in the majority most often (95% of the cases), followed by Justices Barrett (90%), Alito (85%), Thomas (80%), and Gorsuch (75%). Justices Kagan (69%) and Breyer (68%) were not far behind. Justice Sotomayor was in the majority 58%. The Court was unanimous 29% of the time, well below the decade average (43%), and 6-3 accounted for 30% of the decisions.
A major, potentially scarring, event this Term was the leak of an early draft of the majority opinion in Dobbs. Although leaks have occurred before, the early leak of an opinion was unprecedented. It will almost inevitably change the openness and candor within the Court and the justices’ clerks. Although not unprecedented, the attempt on the life of Justice Kavanaugh and the organized efforts to harass some justices in their homes are likely to have lasting impact. Almost certainly it means that justices and their families will have constant security and their movements and connection with the general public will become less frequent, which is sad for the justices and our democracy.
Looking toward the next Term
When the Court next convenes, Justice Ketanji Brown Jackson will take her seat on the left end of the Court (the traditional seat for a new justice, not a commentary on judicial philosophy). The Court has already taken many cases, including issues about university affirmative action programs, web designers and same-sex couples, redistricting and voting rights, DNA testing in criminal cases, and overtime pay for someone making over $200,000 per year. It begins Monday, October 3, and promises to be another interesting Term. ●
The 2021–2022 US Supreme Court Term was a blockbuster medical Term. The bookends of the Term were COVID-19 vaccinations and abortion rights. Between the bookends were Medicare reimbursement, criminal liability for prescribing controlled substances, gun control, and carbon dioxide emissions. In this article, we focus on the significant medical issues, briefly note other important decisions, and consider the implications of this Term.
Abortion decisions
Dobbs v Jackson Women’s Health Organization1 was the most controversial decision and, for ObGyns, perhaps the most important decision in decades. The basic holding of the case can be stated simply: Roe v Wade2and Planned Parenthood of Southeastern Pennsylvania v Casey3 (which essentially created a constitutional right to abortion) are overruled. The law related to abortion is for the states and Congress to determine, not federal courts. (For a review of earlier reproductive freedom cases in the Court, see our previous article, “The Supreme Court and reproductive rights.”4)
Dobbs arose from a Mississippi statute that made it illegal to perform abortions after 15 weeks of gestation, well before viability. Six members of the Court held that the Mississippi law was constitutional and 3 would have struck down the state law. There were 5 opinions, covering a total of 213 pages in the U.S. Reports. The Court fell into 4 camps, ranging from the most to the least protective of abortion rights, as follows:
Three justices (Breyer, Kagan, and Sotomayor) voted to strike down the Mississippi statute and uphold Roe and Casey and wrote a joint dissent. They believe the Constitution makes abortion an issue “off limits to majority rule.” They also warned that other areas of “substantive due process” (discussed below), including contraception and same-sex marriage, might be under threat.
The Chief Justice voted to uphold the statute but wanted an incremental approach; that is, not to overturn Roe and Casey entirely in this case because the Dobbs case requiredthe Court only to determine the more limited question of whether the 15-week limit on abortion was constitutional. He found that the viability standard did not make sense, but he suggested that the Court “leave for another day” whether to overturn Roe.
Five justices joined the opinion to uphold the statute and overturn Roe. Justice Alito wrote the decision joined by Justices Thomas, Kavanaugh, Gorsuch, and Barrett. They found that a right to abortion was not “deeply rooted in our Nation’s history,” as evidenced by the fact that when the 14th Amendment was adopted, abortion was a criminal offense in most states and not a protected right in any state. In 2 lengthy appendices, the Court reviewed the criminalization of abortion in the states in 1868 and in the territories that later became states. Even when Roe was decided in 1973, abortion was not “deeply rooted” because it was not generally legal in the states. Justice Kavanaugh joined this opinion and wrote separately to emphasize that the majority opinion does not outlaw abortion, but rather leaves the issue to “the people and their representatives.” He also emphasized that the case did not overturn all of the substantive due process cases.
Justice Thomas would have gone further and abandoned “substantive due process” completely.
The constitutional issue
The majority said that the issue before the Court was not whether the law should permit or prohibit abortions—that is a question for the political branches. Rather, the question was only whether the Constitution precludes the political branches from allowing abortions. There is no mention of abortion in the Constitution and no specific reference to a right to privacy that includes medical decisions. A central constitutional question has been to identify where exactly in the Constitution the right to privacy resides. The Court has generally used “substantive due process” to locate privacy rights. The 14th Amendment provides, in part, that no state may “deprive any person of life, liberty, or property, without due process of law.” “Process” generally refers to procedural protections, but the Court sometimes has used it to encompass substantive rights (for example, privacy)—hence, “substantive due process.”
Over the decades, the legitimacy of substantive due process has remained controversial. Justice Thomas called it an “oxymoron” to turn “process” into substantive rights. And its use has a somewhat checkered history. For nearly 50 years (1890–1937), it was used to preclude states from protecting employees (for example, hour and wage laws violated “the right to contract”) and was discredited. More recently the Court has used substantive due process to protect contraception access, abortion, and same-sex marriages.
A critical question is knowing what rights substantive due process protects. The Court sometimes has said that it protects rights “deeply rooted in the Nation’s history and traditions” and “implicit in the concept of ordered liberty,”5 although in other cases suggested a more ambiguous definition.6 The next constitutional question is how to state or define the right to be protected. For example, is it the right to intimately personal decisions, bodily integrity, reproductive choice, abortion, or late-term abortion? Some of those may be deeply rooted in history and traditions (intimate decisions), and others not so much (late-term abortion). Finally, a question is whether a substantive right is defined at the time the 14th Amendment was adopted (1868) or now—is it a “living Constitution” that, without much guidance, means whatever 5 justices believe at the moment, or is it a Constitution grounded in the distant past?
The future of substantive due process is uncertain following Dobbs. Although the majority said it was not disclaiming substantive due process, the dissent said it doubted that claim because other rights are “part of the same constitutional fabric” (substantive due process). The Court might, in future cases, find some other constitutional provision in which to ground rights. The source of those rights might be the 9th Amendment (in addition to the Constitution’s enumerated rights, there are “others retained by the people”) or another provision of the 14th (“No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States…”). Each of these possibilities has its problems, many of which are similar to substantive due process, but they avoid the “oxymoron” issue.
Additional interesting cases in 2021–2022
Among the other important cases this Term, the Court made these determinations:
Held that the 2nd Amendment, as applied to the states through the 14th Amendment, includes a general right to carry a gun for self-defense outside the home.1 It struck down a New York law that required people to show a special need to have and carry a gun.
Determined that the US Environmental Protection Agency exceeded the authority Congress had granted it with a “Clean Power Plan” that was intended to reduce carbon dioxide emissions.2 It is up to Congress, not the agency, to expand agency authority.
Gave trial courts discretion in determining whether (and under what conditions) children in international custody disputes must be returned to their home countries where there is a serious risk of harm to them.3
Held that there is an implied right of action to sue medical providers for disability discrimination, but under the Rehabilitation Act and the Affordable Care Act the damages do not include emotional harm.4
Decided several “free exercise of religion” cases, and in each found the state had violated religious rights, holding that: A state improperly prevented religious schools from being eligible for a state tuition grant system,5 a coach was wrongfully fired for kneeling in prayer following football games,6 Boston denied free speech in allowing other organizations to fly their flags but denying a Christian flag to be displayed,7 and a state must permit prisoners to have a spiritual advisor to be present and pray and touch them during their execution.8
Held that the administration’s rescission of the “stay in Mexico” immigration policy was permitted by existing statutes.9
References
1. New York State Rifle & Pistol Association, Inc. v Bruen, 20-843, decided June 23, 2022. https://www.supremecourt.gov/opinions/21pdf/20-843_7j80.pdf
2. West Virginia v Environmental Protection Agency, 20-1530, decided June 30, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1530_new_l537.pdf
3. Golan v Saada, 20-1034, decided June 15, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1034_b8dg.pdf
4. Cummings v Premier Rehab Keller, 20-219, decided April 28, 2022. https://www.supremecourt.gov/opinions/21pdf/20-219_1b82.pdf
5. Carson v Makin, 20-1088, decided June 21, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1088_dbfi.pdf
6. Kennedy v Bremerton School District., 21-418, decided June 27, 2022. https://www.supremecourt.gov/opinions/21pdf/21-418_new_onkq.pdf
7. Shurtleff v Boston, 20-1800, decided May 2, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1800_7lho.pdf
8. Ramirez v Collier, 21-5592, decided March 24, 2022. https://www.supremecourt.gov/opinions/21pdf/21-5592_feah.pdf
9. Biden v Texas, 21-9 54, decided June 30, 2022. https://www.supremecourt.gov/opinions/21pdf/21-954_7l48.pdf
Continue to: ObGyn briefs in the case...
ObGyn briefs in the case
The medical profession filed several amicus curiae briefs in the Dobbs case. (These are “friends of the court” briefs filed by nonparties to the litigation. The purpose is to give a court a perspective on the case not presented by the parties.) The American College of Obstetricians and Gynecologists (ACOG) took the lead in filing an amicus brief.7 Nearly 2 dozen other medical organizations joined the brief, including the American Academy of Pediatrics, American College of Osteopathic Obstetricians and Gynecologists, American Gynecological and Obstetrical Society, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics and Gynecology, North American Society for Pediatric and Adolescent Gynecology, Society for Academic Specialists in General Obstetrics and Gynecology, Society of Gynecologic Oncology, and Society of OB/GYN Hospitalists.
The brief argued that abortion is a safe procedure, an abortion ban would harm the health of pregnant patients, and it would undermine the physician-patient relationship and interfere with patient autonomy. It also discussed the issue of fetal pain,8 telling the Court that “Every major medical organization that has examined the issue of fetal pain and peer-reviewed studies on the matter have consistently concluded that pre-viability abortion does not result in fetal pain perception.”9 The brief was cited in the dissent for the fact that “About 18 percent of pregnancies in this country end in abortion, and about one-quarter of American women will have an abortion before the age of 45.”10
The Court received a different view from an amicus brief filed by the American Association of Pro-Life Obstetricians and Gynecologists.11 It told the Court that abortion, especially later-term, poses health risks: the abortion process itself may injure the woman, abortion puts women at risk for future preterm births, later-term abortion raises a woman’s risk of developing breast cancer, and abortions (especially those later in the pregnancy) are linked to a greater risk of psychological harm.12 The brief also noted that 93% of obstetrician-gynecologists do not perform abortions, and “abortion has been deemed contrary to sound medicine for thousands of years” (citing the Hippocratic oath).13 The brief was not cited by the Court.
Many other medical and pro-life medical groups presented amicus briefs. A list of and links to all the briefs is available on the SCOTUSblog website at https://www.scotusblog.com/case-files/cases/dobbs-v-jackson-womens-health-organization/.
Ramifications
The Court decision does not make abortion illegal but allows states (and possibly Congress) to decide whether, when, and how abortions may be performed. Some states may ban most abortions (making it illegal to have or to perform abortions). Thirteen states had “trigger laws” to go into effect limiting abortion if the Court permitted such limitations. Most of those states were almost immediately entangled in lawsuits challenging the state laws. Some states, for example, have privacy provisions in their state constitution that state courts could interpret as allowing abortion, thereby voiding the state statutes prohibiting abortion.
At least a few states have abortion laws still on the books that were passed decades ago (perhaps before Roe) and were never repealed. Those laws may once again be valid, although state courts might hold that those statutes were repealed by Roe and must be passed again to be valid. Some experts anticipate that 28 states will eventually have significant limitations on abortion.
The Guttmacher Institute maintains a frequently updated table on the abortion laws in each state.14 According to one estimate, 29 states are hostile to abortion rights (or lean that way), with about 40 million women aged 13 to 44 (58% of the United States) living in states with some hostility to abortion.15 Congress may pass some national abortion laws, but that seems unlikely and there may be some limits on its ability to control private medical practice within states.
An additional legal issue will arise from medication-induced abortions, generally through the use of mifepristone and misoprostol. They now account for the majority of abortions. These medications might be used for abortion, up to about 9 weeks of pregnancy, in states prohibiting abortion. The drugs once were available only with an in-person visit, but now the US Food and Drug Administration (FDA) permits mail-order delivery. The potential exists, therefore, to circumvent states’ prohibition on abortion through mail-order postal shipments. The FDA controls the licensing of pharmaceuticals in interstate commerce, but not the practice of medicine within a state. Therefore the ability of individuals (within a state) to possess or use drugs is unclear.
The abortion wars of the last 50 years gave rise to state laws related to abortion, including consent by minors, information to parents, special informed consent, and facilities requirements. If these laws were once struck down because they were inconsistent with Roe, but were never formally repealed, they may now become legal requirements.
In the foreseeable future, abortion laws generally will not be determined by federal courts but by state law, generally legislatures. In legislative hearings, town hall meetings, and conversations with lawmakers, ObGyns should engage the topic of abortion with scientific expertise, reason, openness, and humility. It will be impossible for the profession to speak with a single voice, as the briefs filed this Term demonstrate. Where there are honest differences in science, the reasons for the different interpretations should be explainable to lay decision makers. The profession, who are not being pseudo-lobbyists, can contribute a great deal to the rational consideration of this emotional topic.
Farewell to Justice Breyer and welcome to Justice Jackson
On January 27, 2022, Justice Stephen Breyer informed President Biden of his intention to retire from the Court at the end of the Term. At age 84, he was the oldest member of the Court, but he continued to be among the most active of the justices and seemed to relish the work of the Court. He had been under pressure from liberal groups to retire earlier so a successor could be confirmed by a Democratic Senate. In many ways he was the Renaissance man of the Court: he spoke fluent French, wrote books, and famously sprinkled his questions with complex and funny hypotheticals.
Justice Breyer was a law professor before becoming a judge and enjoyed presentations to many groups, from children to law professors. He loved the Court and defended it—most recently against partisan attacks from both the right and the left. In the decisions of the Court, he was one of the more liberal justices. He had, for example, indicated that the death penalty is unconstitutional.
In his January retirement letter, he said that he would step down at the end of the Term if his replacement had been appointed and confirmed. She had. The new justice had clerked for Justice Breyer in 1999–2000.
Ketanji Brown Jackson was nominated by President Biden on February 28, confirmed by the Senate on April 7 by a 53–47 margin, and sworn in on June 30, 2022. Justice Jackson had previously been a federal district court judge and on the Court of Appeals for the D.C. Circuit. She attended Harvard-Radcliffe College and received her law degree from Harvard Law School. She worked as a criminal defense attorney and was active in the US Sentencing Commission.
Continue to: What is a practitioner to do?...
What is a practitioner to do?
For many practitioners, the Dobbs decision will have little effect because their state laws are consistent with Roe, and the legislature is not going to change the law. They may, of course, see an influx of patients from other states (that restrict abortion) seeking treatment. At the other extreme, in some states, most abortions will become prohibited. State courts may ease the restrictions. In many states, there will be an ongoing battle over when abortion is legal and when it is not, resulting in shifting laws and regulations. Keeping up with the shifts that affect practice will be a challenge.
All states are likely to permit abortions “to save the life of the mother,” and many will have a version of “to preserve the health of the mother.” Other exceptions may be for pregnancy resulting from rape or incest or in the case of serious fetal abnormality. ObGyns, of course, will be called on to certify that one of these exceptions exists. Determining that pregnancy resulted from rape or incest, of course, can be challenging. Before Roe, there was a cottage industry opining that pregnancy seriously affected the health of the mother, which often involved physical manifestations of mental health. ObGyns in some states may be asked once again to make such determinations.
Laws not directly related to abortions will, in some states, be changed as a way of discouraging abortion. For example, child abuse reporting laws may be modified to require reporting of any known or suspected abortion or attempted abortion, and medical licensing standards may make it a violation to participate in or facilitate abortion in any way.
Particularly in states where the rules keep shifting, practitioners must keep up with the current law. Professional organizations can help with that, but there is no substitute for practitioners having an ongoing professional relationship with an attorney who has expertise in health law.
Other abortion decisions this Term
In other abortion decisions this Term, the Court refused to suspend a Texas law that prohibited abortions after a fetal heartbeat could be detected.16 The law has remarkable enforcement mechanisms that preclude state officers from enforcing it; instead, it creates what amounts to a private attorney general (PAG) provision that allows private citizens to file suit against anyone performing or assisting in performing abortions. This PAG made pre-enforcement challenges to the law difficult.17
In a Kentucky case, the Court allowed the Kentucky attorney general to intervene in a case that challenged a Kentucky law that prohibits physicians from using dilation and evacuation procedures to end second-trimester pregnancies.18
Criminal convictions for physicians’ overprescription of controlled substances
Perhaps the least sympathetic of the physicians involved with the Court this Term were the 2 in Ruan v U.S.19 Their trials indicate that Dr. Ruan’s clinic issued more than 300,000 controlled substance prescriptions over 4 years and was one of the most frequent prescribers of fentanyl. Dr. Kahn prescribed controlled substances without an examination, falsified notes, and sold controlled substances for cash and guns.20
Both physicians were convicted of “knowingly or intentionally” dispensing a controlled substance without authorization.21 They were authorized to prescribe drugs, but only “for a legitimate medical purpose.”22 Appeals to their respective Circuit courts confirmed their convictions. The Supreme Court, however, held that to convict them, the government must prove that they knowingly or intentionally acted in an unauthorized manner. That proof can be by circumstantial evidence, but it must be beyond a reasonable doubt.
Health care reimbursement
Hospitals won one and lost one Medicare-Medicaid reimbursement case that involved payments for low-income patients.
In the loss, the Court held that the US Department of Health and Human Services (HHS) properly calculated the disproportionate share adjustments (DSH), or Medicare fraction,23 that provides a supplemental payment for hospitals with a large proportion of low-income patients. The lower DSH payments calculated by HHS were upheld, thereby reducing the number of hospitals receiving DSH payments and decreasing the amounts others will receive.
The win involved payments for prescription drugs that hospitals provide to outpatients in safety-net hospitals.24 HHS determined that it was overpaying hospitals for drugs and cut the reimbursement rate. The Court held that before HHS can change the drug rate, it must conduct a survey of hospitals regarding actual costs. It had not done that, so the rate reduction was not permitted by the law.
An accidental disincentive to (some) malpractice suits
Medicaid requires states to obtain part of a tort recovery that recipients obtain if Medicaid is covering medical expenses related to their injuries. In implementing that law, a state may provide a disincentive for injured beneficiaries to file malpractice cases. At issue was a Florida law that provided the Medicaid state would take 37.5% of the beneficiary’s total tort recovery (being one-half of the recovery after deducting 25% for attorney’s fees and costs). In a 7-2 decision, the Court upheld the Florida law.25
The disincentive to filing a lawsuit is that the state is taking 37.5%, plus contingency fee attorneys will typically take 33.3% (and there will be some fees). This is especially true when there is a state cap on noneconomic damages. In the case the Court decided, the plaintiff received a settlement of $850,000. If we assume a typical contingency fee, less the state’s Medicaid claim of $300,000, the plaintiff possibly received $266,667. That is not trivial, but it is only 31% of the settlement.
The Medicaid expectation of reimbursement and the Florida approach, however, impose heavy burdens on severely injured beneficiaries. The plaintiff had catastrophic injuries and was in a vegetative state. There are some things Medicaid does not pay for, as well as nonmedical expenses. The amount left for such expenses is likely well below what the family will need.
Continue to: COVID-19 vaccinations...
COVID-19 vaccinations
Had it not been for the abortion decisions, 2021–2022 might have been “the COVID Term.” Two of the most anticipated decisions involved mandatory vaccinations (or masking/testing instead). The question in each of these cases was whether Congress had authorized 2 federal agencies to issue the emergency regulations requiring vaccination. Emergency regulations are held to higher standards because they bypass the usual protections of the Administrative Procedure Act.
One case involved a regulation issued by the Occupational Safety and Health Administration (OSHA) that employers (with more than 100 employees) must require their employees to be vaccinated. In a 6-3 decision, the Court held that OSHA did not have the authority to enforce this as an emergency regulation. The other case was a regulation issued by HHS that health care institutions receiving Medicare and Medicaid funding must require all staff to be vaccinated.26 In a 5-4 decision, the Court upheld this emergency regulation because of the very broad authority Congress had given HHS to ensure the safety of patients and the quality of Medicare- and Medicaid-funded programs.27
In another case, in the shadow docket (orders and opinions in cases without full arguments), the Court struck down the Centers for Disease Control and Prevention’s eviction moratorium.28 The Court said the government claimed “a breathtaking amount of authority” that Congress did not intend. In other shadow docket cases, the Court refused to hold unconstitutional state laws that require COVID-19 vaccination but did not have religious exemptions.29
Analysis of this Term
It was an extraordinary Term. The Court decided 66 cases (excluding most cases in the shadow docket), a low number historically. Not only were there many seminal cases but also the Court appears to be shifting toward a new direction. That direction may be oriented more toward the original understanding of the words of the Constitution and statutes and less toward policy; Congress rather than administrative agencies; racial nondiscrimination rather than preferences; and the free exercise rather than the establishment of religion. Whether there is such a shift or not, of course, only time will tell.
Chief Justice Roberts and Justice Kavanaugh were in the majority most often (95% of the cases), followed by Justices Barrett (90%), Alito (85%), Thomas (80%), and Gorsuch (75%). Justices Kagan (69%) and Breyer (68%) were not far behind. Justice Sotomayor was in the majority 58%. The Court was unanimous 29% of the time, well below the decade average (43%), and 6-3 accounted for 30% of the decisions.
A major, potentially scarring, event this Term was the leak of an early draft of the majority opinion in Dobbs. Although leaks have occurred before, the early leak of an opinion was unprecedented. It will almost inevitably change the openness and candor within the Court and the justices’ clerks. Although not unprecedented, the attempt on the life of Justice Kavanaugh and the organized efforts to harass some justices in their homes are likely to have lasting impact. Almost certainly it means that justices and their families will have constant security and their movements and connection with the general public will become less frequent, which is sad for the justices and our democracy.
Looking toward the next Term
When the Court next convenes, Justice Ketanji Brown Jackson will take her seat on the left end of the Court (the traditional seat for a new justice, not a commentary on judicial philosophy). The Court has already taken many cases, including issues about university affirmative action programs, web designers and same-sex couples, redistricting and voting rights, DNA testing in criminal cases, and overtime pay for someone making over $200,000 per year. It begins Monday, October 3, and promises to be another interesting Term. ●
References
Dobbs v Jackson Women’s Health Organization, 19-1392, decided June 24, 2022. https://www.supremecourt.gov /opinions/21pdf/19-1392_6j37.pdf
Roe v Wade, 410 U.S. 113, 163 (1973).
Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U.S. 833 (1992).
Smith SR, Sanfilippo JR. The Supreme Court and reproductive rights. OBG Manag. 2022;34(1):36-41, 46. https://cdn.mdedge. com/files/s3fs-public/issues/articles/obgm0340136_smith.pdf
Washington v Glucksberg, 521 U.S. 702 (1997).
Obergefell v Hodges, 576 U.S. 644, 654-70 (2015).
Brief of amici curiae of American College of Obstetricians and Gynecologists, American Medical Association, et al, in Dobbs v Jackson Women’s Health Organization, in Support of Respondents (Sep. 2021). https://www.supremecourt .gov/DocketPDF/19/19-1392/193074/20210920174518042 _19-1392%20bsacACOGetal.pdf
Id. at 8, 13-15.
Id. at 14.
Justices Breyer, Kagan, and Sotomayor, dissenting, at 48, note 22.
Brief for American Association of Pro-Life Obstetricians And Gynecologists as Amicus Curiae, in Dobbs v Jackson Women’s Health Organization, in Support of Petitioners (July 2021). https://www.supremecourt.gov /DocketPDF/19/19-1392/185350/20210729163532595_No. %2019-1392%20-%20American%20Association%20of%20 Pro-Life%20Obstetricians%20and%20Gynecologists%20-%20 Amicus%20Brief%20in%20Support%20of%20Petitioner%20-%20 7-29-21.pdf
Id. at 3-4, 7-29.
Id. at 30.
Guttmacher Institute. An overview of abortion laws. July 11, 2022. https://www.guttmacher.org/state-policy/explore/overview -abortion-laws
Guttmacher Institute. State abortion policy landscape: from hostile to supportive. Dec. 2020. https://www .guttmacher.org/article/2019/08/state-abortion-policy -landscape-hostile-supportive
Whole Woman’s Health v Jackson, 21-463, decided Dec. 10, 2021. https://www.supremecourt.gov/opinions/21pdf/21-463_ new_8o6b.pdf
United States v Texas, 21-588, decided Dec. 10, 2021. (Per curiam, Sotomayor dissenting). https://www.supremecourt.gov /opinions/21pdf/21-588_c07d.pdf
Cameron v EMW Women’s Surgical Center, 20-601, decided Mar. 3, 2022. https://www.supremecourt.gov/opinions/21pdf/20-601 _new_g20h.pdf
Xiulu Ruan v United States, 20-1410, decided June 27, 2022. https:// www.supremecourt.gov/opinions/21pdf/20-1410_1an2.pdf
Adam Liptak. Supreme Court sides with doctors accused of running pill mills. The New York Times. June 27, 2022. https://www .nytimes.com/2022/06/27/us/politics/supreme-court-controlled -substance-act.html
84 Stat. 1260, 21 U.S.C. §841(a).
21 CFR §1306.04(a) (2021).
Becerra v Empire Health Foundation, For Valley Hospital Medical Center, 20-1312, decided June 24, 2022. https://www.supremecourt .gov/opinions/21pdf/20-1312_j42l.pdf
American Hospital Association v Becerra, 20-1114, decided June 15, 2022. https://www.supremecourt.gov/opinions/21pdf/20 -1114_09m1.pdf
Gallardo v Marstiller, 20-1263, decided June 6, 2022. https:// www.supremecourt.gov/opinions/21pdf/20-1263_new_hfci.pdf
National Federation of Independent Business v Department of Labor, Occupational Safety and Health Administration, 21A244, decided Jan. 13, 2022. https://www.supremecourt.gov /opinions/21pdf/21a244_hgci.pdf
Biden v Missouri, 21A240, decided Jan. 13, 2022. https://www .supremecourt.gov/opinions/21pdf/21a240_d18e.pdf
Alabama Association of Realtors v Department of Health and Human Services, 21A23, decided Aug. 26, 2021. https://www .supremecourt.gov/opinions/20pdf/21a23_ap6c.pdf
Does v Mills, 21A90, decided Oct. 29, 2021. https://www .supremecourt.gov/opinions/21pdf/21a90_6j37.pdf
References
Dobbs v Jackson Women’s Health Organization, 19-1392, decided June 24, 2022. https://www.supremecourt.gov /opinions/21pdf/19-1392_6j37.pdf
Roe v Wade, 410 U.S. 113, 163 (1973).
Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U.S. 833 (1992).
Smith SR, Sanfilippo JR. The Supreme Court and reproductive rights. OBG Manag. 2022;34(1):36-41, 46. https://cdn.mdedge. com/files/s3fs-public/issues/articles/obgm0340136_smith.pdf
Washington v Glucksberg, 521 U.S. 702 (1997).
Obergefell v Hodges, 576 U.S. 644, 654-70 (2015).
Brief of amici curiae of American College of Obstetricians and Gynecologists, American Medical Association, et al, in Dobbs v Jackson Women’s Health Organization, in Support of Respondents (Sep. 2021). https://www.supremecourt .gov/DocketPDF/19/19-1392/193074/20210920174518042 _19-1392%20bsacACOGetal.pdf
Id. at 8, 13-15.
Id. at 14.
Justices Breyer, Kagan, and Sotomayor, dissenting, at 48, note 22.
Brief for American Association of Pro-Life Obstetricians And Gynecologists as Amicus Curiae, in Dobbs v Jackson Women’s Health Organization, in Support of Petitioners (July 2021). https://www.supremecourt.gov /DocketPDF/19/19-1392/185350/20210729163532595_No. %2019-1392%20-%20American%20Association%20of%20 Pro-Life%20Obstetricians%20and%20Gynecologists%20-%20 Amicus%20Brief%20in%20Support%20of%20Petitioner%20-%20 7-29-21.pdf
Id. at 3-4, 7-29.
Id. at 30.
Guttmacher Institute. An overview of abortion laws. July 11, 2022. https://www.guttmacher.org/state-policy/explore/overview -abortion-laws
Guttmacher Institute. State abortion policy landscape: from hostile to supportive. Dec. 2020. https://www .guttmacher.org/article/2019/08/state-abortion-policy -landscape-hostile-supportive
Whole Woman’s Health v Jackson, 21-463, decided Dec. 10, 2021. https://www.supremecourt.gov/opinions/21pdf/21-463_ new_8o6b.pdf
United States v Texas, 21-588, decided Dec. 10, 2021. (Per curiam, Sotomayor dissenting). https://www.supremecourt.gov /opinions/21pdf/21-588_c07d.pdf
Cameron v EMW Women’s Surgical Center, 20-601, decided Mar. 3, 2022. https://www.supremecourt.gov/opinions/21pdf/20-601 _new_g20h.pdf
Xiulu Ruan v United States, 20-1410, decided June 27, 2022. https:// www.supremecourt.gov/opinions/21pdf/20-1410_1an2.pdf
Adam Liptak. Supreme Court sides with doctors accused of running pill mills. The New York Times. June 27, 2022. https://www .nytimes.com/2022/06/27/us/politics/supreme-court-controlled -substance-act.html
84 Stat. 1260, 21 U.S.C. §841(a).
21 CFR §1306.04(a) (2021).
Becerra v Empire Health Foundation, For Valley Hospital Medical Center, 20-1312, decided June 24, 2022. https://www.supremecourt .gov/opinions/21pdf/20-1312_j42l.pdf
American Hospital Association v Becerra, 20-1114, decided June 15, 2022. https://www.supremecourt.gov/opinions/21pdf/20 -1114_09m1.pdf
Gallardo v Marstiller, 20-1263, decided June 6, 2022. https:// www.supremecourt.gov/opinions/21pdf/20-1263_new_hfci.pdf
National Federation of Independent Business v Department of Labor, Occupational Safety and Health Administration, 21A244, decided Jan. 13, 2022. https://www.supremecourt.gov /opinions/21pdf/21a244_hgci.pdf
Biden v Missouri, 21A240, decided Jan. 13, 2022. https://www .supremecourt.gov/opinions/21pdf/21a240_d18e.pdf
Alabama Association of Realtors v Department of Health and Human Services, 21A23, decided Aug. 26, 2021. https://www .supremecourt.gov/opinions/20pdf/21a23_ap6c.pdf
Does v Mills, 21A90, decided Oct. 29, 2021. https://www .supremecourt.gov/opinions/21pdf/21a90_6j37.pdf
Do you want to support the AGA Research Foundation, but feel overwhelmed by everyday living costs, such as the latest home repair, food expenses, and escalating gas prices?
There’s a solution that doesn’t involve writing a check. You can designate a gift in your estate plan. There are two main benefits to this meaningful step:
Your current income or assets remain the same.
You can change your mind at any time.
The easiest and most popular way to support the AGA Research Foundation while putting your current financial needs first is to include a gift in your will or revocable living trust. It takes as little as one sentence to complete your gift.
Best of all, you have the option to leave a percentage of your estate or an asset so that no matter how the size of your estate changes, gifts to your family and nonprofits remain proportional.
Your gift directly supports the talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.
Do you want to support the AGA Research Foundation, but feel overwhelmed by everyday living costs, such as the latest home repair, food expenses, and escalating gas prices?
There’s a solution that doesn’t involve writing a check. You can designate a gift in your estate plan. There are two main benefits to this meaningful step:
Your current income or assets remain the same.
You can change your mind at any time.
The easiest and most popular way to support the AGA Research Foundation while putting your current financial needs first is to include a gift in your will or revocable living trust. It takes as little as one sentence to complete your gift.
Best of all, you have the option to leave a percentage of your estate or an asset so that no matter how the size of your estate changes, gifts to your family and nonprofits remain proportional.
Your gift directly supports the talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.
Do you want to support the AGA Research Foundation, but feel overwhelmed by everyday living costs, such as the latest home repair, food expenses, and escalating gas prices?
There’s a solution that doesn’t involve writing a check. You can designate a gift in your estate plan. There are two main benefits to this meaningful step:
Your current income or assets remain the same.
You can change your mind at any time.
The easiest and most popular way to support the AGA Research Foundation while putting your current financial needs first is to include a gift in your will or revocable living trust. It takes as little as one sentence to complete your gift.
Best of all, you have the option to leave a percentage of your estate or an asset so that no matter how the size of your estate changes, gifts to your family and nonprofits remain proportional.
Your gift directly supports the talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.
Mitchel L. Zoler/MDedge News
