Type 2 diabetes patients could lower their risk for death from any cause by up to a third by exercising at a moderate to high level or by cycling, according to data from two studies reported at the virtual annual meeting of the European Association for the Study of Diabetes.

Yun-Ju Lai, MD, and colleagues from the Puli branch of Taichung Veterans General Hospital in Nantou, Taiwan, found that persons with type 2 diabetes who exercised at moderate to high intensity had a 25%-32% decreased risk for death, compared with those who did not exercise.

In a separate study, Mathias Ried-Larsen, MSc, PhD, group leader at the Centre for Physical Activity Research, Rigshospitalet, Copenhagen, and associates found that cycling was associated with a 25%-31% decreased risk for all-cause death compared to no cycling, and that cycling also reduced cardiovascular mortality.
 

Results fit with ADA recommendations

“There is really nothing surprising about these results as others have shown that regular participation in physical activity lowers both overall mortality rates and morbidity,” commented Sheri Colberg-Ochs, PhD, professor emerita in exercise science at Old Dominion University in Norfolk, Va., in an interview.

“Regular exercise participation lowers the risk of mortality in almost all populations with many different health conditions. It is not specific to people with type 2 diabetes,” Dr. Colberg-Ochs said. “These data add further support to the ADA [American Diabetes Association] recommendations by again suggesting that being more active leads to many health benefits for people with type 2 diabetes.”

Dr. Colberg-Ochs, who was not involved in either study, is recognized by the ADA as an Outstanding Educator in Diabetes. She was also involved in writing the ADA’s position statement on physical activity/exercise in diabetes, which advocate that adults with type 2 diabetes should reduce sedentary time and undertake both aerobic and resistance exercise training to help optimize their glycemic and general health outcomes.
 

Asian population understudied

In an interview Dr. Lai acknowledged that epidemiologic studies had shown that exercise reduced the risk of cardiovascular events and mortality in subjects with type 2 diabetes. “However, the dose of exercise capacity for reducing mortality risk in people with type 2 diabetes was not yet well investigated, especially in the Asian population.”

Dr. Lai and colleagues analyzed data on 4,859 subjects drawn from two Taiwanese databases – the National Health Interview Survey and the National Health Insurance research database – to study what effect exercise “capacity” had on the risk for death in those with type 2 diabetes.

“Information about physical activity during leisure time was collected by asking the questions: ‘How often do you exercise every week? What kind of exercise do you do? How long do you do the exercise?’, Dr. Lai said. “We included nearly all kinds of exercise in the analysis, such as jogging, swimming, walking, dancing, riding, and so on.”

Each exercise had an activity intensity code expressed as kilocalories per minute. This was used to determine the exercise “capacity” by multiplying it by how frequently the exercise was performed per week and for how long each time.

“I don’t think ‘capacity’ is the right word to use here. The equation they used describes their exercise ‘volume,’ not their capacity. Self-reported exercise is notoriously inaccurate,” Dr. Colberg-Ochs observed. Furthermore, “just asking people how much they exercise and at what intensity [without using a validated exercise questionnaire] gives questionable results.”

The study’s findings, however, were clear: Those who exercised at a higher level had a significantly decreased risk for all-cause mortality than did those with no exercise habits. The hazard ratio for death by any cause was 0.75 for those who undertook a moderate level of exercise, burning 0-800 kcal per week. Exercising at a higher level burned more than 800 kcal had a HR of 0.68. A significant (P < .01) trend in favor of more exercise was noted.
 

Cycling reduces all-cause and cardiovascular mortality

In their prospective cohort study, Dr. Ried-Larsen and associates took a more specific look at the effects of exercise on mortality in diabetes by studying a single exercise: cycling. They sampled data on more than 5,000 people collected as part of the European Prospective Investigation into Cancer and Nutrition study. First, they identified participants with diabetes – although they couldn’t distinguish type 1 from type 2 forms because this was self-reported or obtained from registries. They then identified those who reported cycling at their baseline assessment and those who reported a change in cycling habits at their second examination around 5 years later.

At baseline, 38% of participants reported that they cycled every week. The mean age was 56 years, diabetes duration was 8 years, one-fifth were smokers, and the average body mass index was 29 kg/m².

Participants who reported cycling up to 1 hour every week at baseline had a 25% reduction in all-cause mortality, compared with those who did not cycle. The biggest reduction (31%) in all-cause mortality was seen for cycling 2.5-5 hours a week; cycling for 1-2.5 hours, and for more than 5 hours, yielded 23% and 24% risk reductions, respectively.

A reverse J–shaped relationship between cycling duration and reduction in all-cause mortality was seen, Dr. Ried-Larsen noted during a live oral session at the virtual meeting. “The maximum benefit [was at] around 5 hours per week, and the benefits persisted until around 9 hours per week.” Adjustment for the prevalence of stroke, MI, cancer, hyperlipidemia, hypertension, and central obesity did not alter the findings.

“The direction of the association was the same for cardiovascular mortality as all-cause mortality, although a bit weaker, with the maximum benefit being around 4 hours per week, and that persisted up until around 8 hours per week,” Dr. Ried-Larsen said.

The benefits of cycling on all-cause and cardiovascular mortality were lost, however, if those who cycled at baseline stopped by the second examination. Those who did not cycle at the first but did at the second examination got a benefit on both, as did those who continued cycling.

“Cycling is among one of the preferred activities for diabetes patients, so it actually may help them to achieve the recommend level of physical activity,” Dr. Ried-Larsen said.
 

Tailored exercise program important

Advice for exercise “should be tailored to the individual and based on starting fitness levels and activity levels,” Dr. Colberg-Ochs recommended.

“Those who are the most sedentary and the least fit have the most to gain from doing any activity. They should be advised to start out slowly and progress slowly with both aerobic activities and some resistance training,” Dr. Colberg-Ochs said.

She added: “In addition, individuals over 40 should engage in regular balance training, and all individuals should do some flexibility exercises.”

The studies received no commercial funding and all those mentioned in this article had no conflicts of interest to disclose.

SOURCE: Lai Y-J et al. EASD 2020, Poster presentation 267; Ried-Larsen M et al. EASD 2020, Oral presentation 194.

Type 2 diabetes patients could lower their risk for death from any cause by up to a third by exercising at a moderate to high level or by cycling, according to data from two studies reported at the virtual annual meeting of the European Association for the Study of Diabetes.

Yun-Ju Lai, MD, and colleagues from the Puli branch of Taichung Veterans General Hospital in Nantou, Taiwan, found that persons with type 2 diabetes who exercised at moderate to high intensity had a 25%-32% decreased risk for death, compared with those who did not exercise.

In a separate study, Mathias Ried-Larsen, MSc, PhD, group leader at the Centre for Physical Activity Research, Rigshospitalet, Copenhagen, and associates found that cycling was associated with a 25%-31% decreased risk for all-cause death compared to no cycling, and that cycling also reduced cardiovascular mortality.
 

Results fit with ADA recommendations

“There is really nothing surprising about these results as others have shown that regular participation in physical activity lowers both overall mortality rates and morbidity,” commented Sheri Colberg-Ochs, PhD, professor emerita in exercise science at Old Dominion University in Norfolk, Va., in an interview.

“Regular exercise participation lowers the risk of mortality in almost all populations with many different health conditions. It is not specific to people with type 2 diabetes,” Dr. Colberg-Ochs said. “These data add further support to the ADA [American Diabetes Association] recommendations by again suggesting that being more active leads to many health benefits for people with type 2 diabetes.”

Dr. Colberg-Ochs, who was not involved in either study, is recognized by the ADA as an Outstanding Educator in Diabetes. She was also involved in writing the ADA’s position statement on physical activity/exercise in diabetes, which advocate that adults with type 2 diabetes should reduce sedentary time and undertake both aerobic and resistance exercise training to help optimize their glycemic and general health outcomes.
 

Asian population understudied

In an interview Dr. Lai acknowledged that epidemiologic studies had shown that exercise reduced the risk of cardiovascular events and mortality in subjects with type 2 diabetes. “However, the dose of exercise capacity for reducing mortality risk in people with type 2 diabetes was not yet well investigated, especially in the Asian population.”

Dr. Lai and colleagues analyzed data on 4,859 subjects drawn from two Taiwanese databases – the National Health Interview Survey and the National Health Insurance research database – to study what effect exercise “capacity” had on the risk for death in those with type 2 diabetes.

“Information about physical activity during leisure time was collected by asking the questions: ‘How often do you exercise every week? What kind of exercise do you do? How long do you do the exercise?’, Dr. Lai said. “We included nearly all kinds of exercise in the analysis, such as jogging, swimming, walking, dancing, riding, and so on.”

Each exercise had an activity intensity code expressed as kilocalories per minute. This was used to determine the exercise “capacity” by multiplying it by how frequently the exercise was performed per week and for how long each time.

“I don’t think ‘capacity’ is the right word to use here. The equation they used describes their exercise ‘volume,’ not their capacity. Self-reported exercise is notoriously inaccurate,” Dr. Colberg-Ochs observed. Furthermore, “just asking people how much they exercise and at what intensity [without using a validated exercise questionnaire] gives questionable results.”

The study’s findings, however, were clear: Those who exercised at a higher level had a significantly decreased risk for all-cause mortality than did those with no exercise habits. The hazard ratio for death by any cause was 0.75 for those who undertook a moderate level of exercise, burning 0-800 kcal per week. Exercising at a higher level burned more than 800 kcal had a HR of 0.68. A significant (P < .01) trend in favor of more exercise was noted.
 

Cycling reduces all-cause and cardiovascular mortality

In their prospective cohort study, Dr. Ried-Larsen and associates took a more specific look at the effects of exercise on mortality in diabetes by studying a single exercise: cycling. They sampled data on more than 5,000 people collected as part of the European Prospective Investigation into Cancer and Nutrition study. First, they identified participants with diabetes – although they couldn’t distinguish type 1 from type 2 forms because this was self-reported or obtained from registries. They then identified those who reported cycling at their baseline assessment and those who reported a change in cycling habits at their second examination around 5 years later.

At baseline, 38% of participants reported that they cycled every week. The mean age was 56 years, diabetes duration was 8 years, one-fifth were smokers, and the average body mass index was 29 kg/m².

Participants who reported cycling up to 1 hour every week at baseline had a 25% reduction in all-cause mortality, compared with those who did not cycle. The biggest reduction (31%) in all-cause mortality was seen for cycling 2.5-5 hours a week; cycling for 1-2.5 hours, and for more than 5 hours, yielded 23% and 24% risk reductions, respectively.

A reverse J–shaped relationship between cycling duration and reduction in all-cause mortality was seen, Dr. Ried-Larsen noted during a live oral session at the virtual meeting. “The maximum benefit [was at] around 5 hours per week, and the benefits persisted until around 9 hours per week.” Adjustment for the prevalence of stroke, MI, cancer, hyperlipidemia, hypertension, and central obesity did not alter the findings.

“The direction of the association was the same for cardiovascular mortality as all-cause mortality, although a bit weaker, with the maximum benefit being around 4 hours per week, and that persisted up until around 8 hours per week,” Dr. Ried-Larsen said.

The benefits of cycling on all-cause and cardiovascular mortality were lost, however, if those who cycled at baseline stopped by the second examination. Those who did not cycle at the first but did at the second examination got a benefit on both, as did those who continued cycling.

“Cycling is among one of the preferred activities for diabetes patients, so it actually may help them to achieve the recommend level of physical activity,” Dr. Ried-Larsen said.
 

Tailored exercise program important

Advice for exercise “should be tailored to the individual and based on starting fitness levels and activity levels,” Dr. Colberg-Ochs recommended.

“Those who are the most sedentary and the least fit have the most to gain from doing any activity. They should be advised to start out slowly and progress slowly with both aerobic activities and some resistance training,” Dr. Colberg-Ochs said.

She added: “In addition, individuals over 40 should engage in regular balance training, and all individuals should do some flexibility exercises.”

The studies received no commercial funding and all those mentioned in this article had no conflicts of interest to disclose.

SOURCE: Lai Y-J et al. EASD 2020, Poster presentation 267; Ried-Larsen M et al. EASD 2020, Oral presentation 194.

Type 2 diabetes patients could lower their risk for death from any cause by up to a third by exercising at a moderate to high level or by cycling, according to data from two studies reported at the virtual annual meeting of the European Association for the Study of Diabetes.

Yun-Ju Lai, MD, and colleagues from the Puli branch of Taichung Veterans General Hospital in Nantou, Taiwan, found that persons with type 2 diabetes who exercised at moderate to high intensity had a 25%-32% decreased risk for death, compared with those who did not exercise.

In a separate study, Mathias Ried-Larsen, MSc, PhD, group leader at the Centre for Physical Activity Research, Rigshospitalet, Copenhagen, and associates found that cycling was associated with a 25%-31% decreased risk for all-cause death compared to no cycling, and that cycling also reduced cardiovascular mortality.
 

Results fit with ADA recommendations

“There is really nothing surprising about these results as others have shown that regular participation in physical activity lowers both overall mortality rates and morbidity,” commented Sheri Colberg-Ochs, PhD, professor emerita in exercise science at Old Dominion University in Norfolk, Va., in an interview.

“Regular exercise participation lowers the risk of mortality in almost all populations with many different health conditions. It is not specific to people with type 2 diabetes,” Dr. Colberg-Ochs said. “These data add further support to the ADA [American Diabetes Association] recommendations by again suggesting that being more active leads to many health benefits for people with type 2 diabetes.”

Dr. Colberg-Ochs, who was not involved in either study, is recognized by the ADA as an Outstanding Educator in Diabetes. She was also involved in writing the ADA’s position statement on physical activity/exercise in diabetes, which advocate that adults with type 2 diabetes should reduce sedentary time and undertake both aerobic and resistance exercise training to help optimize their glycemic and general health outcomes.
 

Asian population understudied

In an interview Dr. Lai acknowledged that epidemiologic studies had shown that exercise reduced the risk of cardiovascular events and mortality in subjects with type 2 diabetes. “However, the dose of exercise capacity for reducing mortality risk in people with type 2 diabetes was not yet well investigated, especially in the Asian population.”

Dr. Lai and colleagues analyzed data on 4,859 subjects drawn from two Taiwanese databases – the National Health Interview Survey and the National Health Insurance research database – to study what effect exercise “capacity” had on the risk for death in those with type 2 diabetes.

“Information about physical activity during leisure time was collected by asking the questions: ‘How often do you exercise every week? What kind of exercise do you do? How long do you do the exercise?’, Dr. Lai said. “We included nearly all kinds of exercise in the analysis, such as jogging, swimming, walking, dancing, riding, and so on.”

Each exercise had an activity intensity code expressed as kilocalories per minute. This was used to determine the exercise “capacity” by multiplying it by how frequently the exercise was performed per week and for how long each time.

“I don’t think ‘capacity’ is the right word to use here. The equation they used describes their exercise ‘volume,’ not their capacity. Self-reported exercise is notoriously inaccurate,” Dr. Colberg-Ochs observed. Furthermore, “just asking people how much they exercise and at what intensity [without using a validated exercise questionnaire] gives questionable results.”

The study’s findings, however, were clear: Those who exercised at a higher level had a significantly decreased risk for all-cause mortality than did those with no exercise habits. The hazard ratio for death by any cause was 0.75 for those who undertook a moderate level of exercise, burning 0-800 kcal per week. Exercising at a higher level burned more than 800 kcal had a HR of 0.68. A significant (P < .01) trend in favor of more exercise was noted.
 

Cycling reduces all-cause and cardiovascular mortality

In their prospective cohort study, Dr. Ried-Larsen and associates took a more specific look at the effects of exercise on mortality in diabetes by studying a single exercise: cycling. They sampled data on more than 5,000 people collected as part of the European Prospective Investigation into Cancer and Nutrition study. First, they identified participants with diabetes – although they couldn’t distinguish type 1 from type 2 forms because this was self-reported or obtained from registries. They then identified those who reported cycling at their baseline assessment and those who reported a change in cycling habits at their second examination around 5 years later.

At baseline, 38% of participants reported that they cycled every week. The mean age was 56 years, diabetes duration was 8 years, one-fifth were smokers, and the average body mass index was 29 kg/m².

Participants who reported cycling up to 1 hour every week at baseline had a 25% reduction in all-cause mortality, compared with those who did not cycle. The biggest reduction (31%) in all-cause mortality was seen for cycling 2.5-5 hours a week; cycling for 1-2.5 hours, and for more than 5 hours, yielded 23% and 24% risk reductions, respectively.

A reverse J–shaped relationship between cycling duration and reduction in all-cause mortality was seen, Dr. Ried-Larsen noted during a live oral session at the virtual meeting. “The maximum benefit [was at] around 5 hours per week, and the benefits persisted until around 9 hours per week.” Adjustment for the prevalence of stroke, MI, cancer, hyperlipidemia, hypertension, and central obesity did not alter the findings.

“The direction of the association was the same for cardiovascular mortality as all-cause mortality, although a bit weaker, with the maximum benefit being around 4 hours per week, and that persisted up until around 8 hours per week,” Dr. Ried-Larsen said.

The benefits of cycling on all-cause and cardiovascular mortality were lost, however, if those who cycled at baseline stopped by the second examination. Those who did not cycle at the first but did at the second examination got a benefit on both, as did those who continued cycling.

“Cycling is among one of the preferred activities for diabetes patients, so it actually may help them to achieve the recommend level of physical activity,” Dr. Ried-Larsen said.
 

Tailored exercise program important

Advice for exercise “should be tailored to the individual and based on starting fitness levels and activity levels,” Dr. Colberg-Ochs recommended.

“Those who are the most sedentary and the least fit have the most to gain from doing any activity. They should be advised to start out slowly and progress slowly with both aerobic activities and some resistance training,” Dr. Colberg-Ochs said.

She added: “In addition, individuals over 40 should engage in regular balance training, and all individuals should do some flexibility exercises.”

The studies received no commercial funding and all those mentioned in this article had no conflicts of interest to disclose.

SOURCE: Lai Y-J et al. EASD 2020, Poster presentation 267; Ried-Larsen M et al. EASD 2020, Oral presentation 194.

I had been in practice only 6 or 7 years when I got the itch to do some writing. I had been exchanging letters with my father since I left for college. He was a professional writer but I had never done more than was required to get through school. What motivated me to sit down at the keyboard of his old hand-me-down portable typewriter was my frustration with grandmothers, as nearly every day I found myself struggling to counter some grandmother’s well-intentioned but somewhat off-the-mark childrearing advice.

supersizer/Getty Images

Occasionally this would be during a face-to-face encounter with a grandmother who had tagged along to the well-baby visit. More often, I was trying to arm a mother or father with the “facts” (at least as I understood them) that they could carry home and use to defend my position as the child care expert for the family.

These were not knock-down-drag-out disagreements but I always felt badly that I might be tarnishing a grandmother’s reputation. Grandfathers seemed to have learned it was best to keep silent on childrearing. I knew from my own family that most grandmothers had years of experience raising children that, if properly delivered, could make childrearing a more positive experience for new parents. My father, whose mother was widowed when he was an infant, was raised by his grandmother. However, too often I found that grandmotherly advice came packaged with just enough old wives’ tales and factually incorrect medical information to be dangerous.

The title of my opus would be “The Good Grandmother Handbook” and it would be an effort to update grandmothers with the latest information on childrearing from a recently trained and cocky board-certified pediatrician with only 6 years’ practice under his belt. The book would reassure grandmothers that, although some of the things they had done as parents are now frowned upon, most of what they did has stood the test of time and probably is worth sharing.

The final chapter of the book would be about grandparent etiquette. How to deal with the fact that there is another set of grandparents who have opinions and would like to have time with their grandchildren. When and how to give advice: Basically, only if asked or you feel your grandchild’s life is at stake. And, finally, how to deal with the disappointment of not being asked for advice and not being involved.

Not surprisingly that sophomoric and condescending effort never got further than the first draft. It reflected my early experiences in a minimally diverse and relatively affluent community. As my world view broadened, I realized that for many families it’s not a question of how to deal with a grandmother’s unsolicited advice. There are numerous grandparents who have been forced to become safe havens in which a family in distress can ride out the turbulent economic times and societal upheaval. In many cases, grandmothers are essential workers – not just occasional babysitters – but surrogate parents.

A Pediatrics article estimates that 2% of children in this country are being raised by their grandparents. And, it turns out that grandparents are doing a surprisingly good job. The researchers concluded that: “Despite caring for children with greater developmental problems and poorer temperament grandparent caregivers seem to cope with parenting about as well as parents.”

As pediatricians we must continue to reach out to grandmothers and grandfathers who are caring for some of our most challenged patients. They need our medical advice but even more they need our compassion and emotional support. Over the last 5 decades I’ve come to learn that, although there are some grandmothers who can be meddlesome dispensers of old wives’ tales, many are the backbone of families in need.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

I had been in practice only 6 or 7 years when I got the itch to do some writing. I had been exchanging letters with my father since I left for college. He was a professional writer but I had never done more than was required to get through school. What motivated me to sit down at the keyboard of his old hand-me-down portable typewriter was my frustration with grandmothers, as nearly every day I found myself struggling to counter some grandmother’s well-intentioned but somewhat off-the-mark childrearing advice.

supersizer/Getty Images

Occasionally this would be during a face-to-face encounter with a grandmother who had tagged along to the well-baby visit. More often, I was trying to arm a mother or father with the “facts” (at least as I understood them) that they could carry home and use to defend my position as the child care expert for the family.

These were not knock-down-drag-out disagreements but I always felt badly that I might be tarnishing a grandmother’s reputation. Grandfathers seemed to have learned it was best to keep silent on childrearing. I knew from my own family that most grandmothers had years of experience raising children that, if properly delivered, could make childrearing a more positive experience for new parents. My father, whose mother was widowed when he was an infant, was raised by his grandmother. However, too often I found that grandmotherly advice came packaged with just enough old wives’ tales and factually incorrect medical information to be dangerous.

The title of my opus would be “The Good Grandmother Handbook” and it would be an effort to update grandmothers with the latest information on childrearing from a recently trained and cocky board-certified pediatrician with only 6 years’ practice under his belt. The book would reassure grandmothers that, although some of the things they had done as parents are now frowned upon, most of what they did has stood the test of time and probably is worth sharing.

The final chapter of the book would be about grandparent etiquette. How to deal with the fact that there is another set of grandparents who have opinions and would like to have time with their grandchildren. When and how to give advice: Basically, only if asked or you feel your grandchild’s life is at stake. And, finally, how to deal with the disappointment of not being asked for advice and not being involved.

Not surprisingly that sophomoric and condescending effort never got further than the first draft. It reflected my early experiences in a minimally diverse and relatively affluent community. As my world view broadened, I realized that for many families it’s not a question of how to deal with a grandmother’s unsolicited advice. There are numerous grandparents who have been forced to become safe havens in which a family in distress can ride out the turbulent economic times and societal upheaval. In many cases, grandmothers are essential workers – not just occasional babysitters – but surrogate parents.

A Pediatrics article estimates that 2% of children in this country are being raised by their grandparents. And, it turns out that grandparents are doing a surprisingly good job. The researchers concluded that: “Despite caring for children with greater developmental problems and poorer temperament grandparent caregivers seem to cope with parenting about as well as parents.”

As pediatricians we must continue to reach out to grandmothers and grandfathers who are caring for some of our most challenged patients. They need our medical advice but even more they need our compassion and emotional support. Over the last 5 decades I’ve come to learn that, although there are some grandmothers who can be meddlesome dispensers of old wives’ tales, many are the backbone of families in need.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

I had been in practice only 6 or 7 years when I got the itch to do some writing. I had been exchanging letters with my father since I left for college. He was a professional writer but I had never done more than was required to get through school. What motivated me to sit down at the keyboard of his old hand-me-down portable typewriter was my frustration with grandmothers, as nearly every day I found myself struggling to counter some grandmother’s well-intentioned but somewhat off-the-mark childrearing advice.

supersizer/Getty Images

Occasionally this would be during a face-to-face encounter with a grandmother who had tagged along to the well-baby visit. More often, I was trying to arm a mother or father with the “facts” (at least as I understood them) that they could carry home and use to defend my position as the child care expert for the family.

These were not knock-down-drag-out disagreements but I always felt badly that I might be tarnishing a grandmother’s reputation. Grandfathers seemed to have learned it was best to keep silent on childrearing. I knew from my own family that most grandmothers had years of experience raising children that, if properly delivered, could make childrearing a more positive experience for new parents. My father, whose mother was widowed when he was an infant, was raised by his grandmother. However, too often I found that grandmotherly advice came packaged with just enough old wives’ tales and factually incorrect medical information to be dangerous.

The title of my opus would be “The Good Grandmother Handbook” and it would be an effort to update grandmothers with the latest information on childrearing from a recently trained and cocky board-certified pediatrician with only 6 years’ practice under his belt. The book would reassure grandmothers that, although some of the things they had done as parents are now frowned upon, most of what they did has stood the test of time and probably is worth sharing.

The final chapter of the book would be about grandparent etiquette. How to deal with the fact that there is another set of grandparents who have opinions and would like to have time with their grandchildren. When and how to give advice: Basically, only if asked or you feel your grandchild’s life is at stake. And, finally, how to deal with the disappointment of not being asked for advice and not being involved.

Not surprisingly that sophomoric and condescending effort never got further than the first draft. It reflected my early experiences in a minimally diverse and relatively affluent community. As my world view broadened, I realized that for many families it’s not a question of how to deal with a grandmother’s unsolicited advice. There are numerous grandparents who have been forced to become safe havens in which a family in distress can ride out the turbulent economic times and societal upheaval. In many cases, grandmothers are essential workers – not just occasional babysitters – but surrogate parents.

A Pediatrics article estimates that 2% of children in this country are being raised by their grandparents. And, it turns out that grandparents are doing a surprisingly good job. The researchers concluded that: “Despite caring for children with greater developmental problems and poorer temperament grandparent caregivers seem to cope with parenting about as well as parents.”

As pediatricians we must continue to reach out to grandmothers and grandfathers who are caring for some of our most challenged patients. They need our medical advice but even more they need our compassion and emotional support. Over the last 5 decades I’ve come to learn that, although there are some grandmothers who can be meddlesome dispensers of old wives’ tales, many are the backbone of families in need.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Many factors can prompt individuals with irritable bowel syndrome (IBS) to seek consultation with a specialist said Anthony Lembo, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, in a virtual presentation at the conference jointly provided by Rutgers and Global Academy for Medical Education.

Most patients with IBS suffer with symptoms for years before seeking care, he said.

Common reasons to cause an individual with IBS to seek care include severity of abdominal pain, psychological disturbance such as anxiety, and concerns about organic disease such as colon cancer, perhaps because they know someone who was recently diagnosed with it,” he said.

Our understanding of the pathophysiology of IBS has expanded dramatically over the past decade, Dr. Lembo said. IBS was once thought to be primarily a motility disorder, but currently the many interacting factors include not only motility but also diet, gut microflora, visceral hypersensitivity, immune dysregulation, and brain-gut interactions, he said.

The pathophysiology of postinfectious IBS has been particularly well described and includes the role of anti-CdtB and antivinculin antibodies, and low-grade inflammation in the lining of the intestines, Dr. Lembo explained.

These cases of postinfection IBS can linger for up to a year in approximately 10% of patients, he said.

IBS can affect anyone, anywhere, but it tends to be more common in younger individuals than older adults, and more common in women than men, Dr. Lembo said.

When diagnosing IBS in the clinic setting, a history should include a timeline and triggers for symptoms, he advised. A detailed dietary history, review of medications, and an assessment for alarm features (such as family history of colon cancer or celiac disease, weight loss, anemia, blood in stools, nocturnal awakening, or an onset of symptoms at age older than 50 years) should also be included he said.

Physical signs of systemic and local disease, and a digital rectal exam to assess patients for dyssynergia, especially those with constipation should also be performed, Dr. Lembo added.

In some cases, consider a colonoscopy for patients with IBS, namely those with alarm features, age-appropriate screening criteria, the presence of persistent and frequent watery diarrhea, or in patients who don’t respond to therapy, he added.

Treatment strategies for IBS should start with diet and lifestyle modifications when appropriate, Dr. Lembo said. Encourage patients to pursue moderate to vigorous exercise or some physical activity 3-5 times a week, to get enough sleep, and to start with a traditional IBS diet. Such a diet involves three meals a day, with three or fewer snacks, and not overeating at any of these times, he said. Other diet tips include reducing consumption of fatty or spicy foods, as well as coffee, alcohol, onions, beans, and cabbage. He also advised encouraging patients to avoid gum and soft drinks, as well as artificial sweeteners, and to use soluble rather than insoluble fiber. The low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet has shown benefit in some patients. For those who respond to the low-FODMAP diet it is important to reintroduce foods into their diet. Nutrition consultation should be considered for most patients.

Follow a stepwise approach to treatment, Dr. Lembo emphasized that, if IBS patients with constipation are not improving with diet and lifestyle, over-the-counter medications such as polyethylene glycol can be considered to improve bowel consistency, although the drug’s effect on pain is limited. Prescription options include secretogogues (linaclotide, plenecatide, lubiprostone), and prokinetics (tegaserod, a 5-HT4 partial agonist that was recently reapproved by the FDA for women < 65 years without cardiovascular risk factors). In general, prescription drugs for IBS-C have similar efficacy in most endpoints though differences in their mechanisms of action and side effects should be considered when prescribing a particular agent, he said.

Other perspectives on managing IBS include cognitive behavior therapy and fecal microbiota transplant, Dr. Lembo said. Cognitive behavior therapy improves IBS symptoms after 12 weeks in patients who had weekly sessions compared with controls who received 4 weeks of basic patient education, he noted. As for fecal microbiota transplant, the jury is still out and it is important to note that FMT is not currently approved for clinical practice for patients with IBS, he noted.

Dr. Lembo disclosed relationships with Allergan, Ardelyx, Bayer, Bioamerica, Ironwood, Mylan and Takeda.

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

Many factors can prompt individuals with irritable bowel syndrome (IBS) to seek consultation with a specialist said Anthony Lembo, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, in a virtual presentation at the conference jointly provided by Rutgers and Global Academy for Medical Education.

Most patients with IBS suffer with symptoms for years before seeking care, he said.

Common reasons to cause an individual with IBS to seek care include severity of abdominal pain, psychological disturbance such as anxiety, and concerns about organic disease such as colon cancer, perhaps because they know someone who was recently diagnosed with it,” he said.

Our understanding of the pathophysiology of IBS has expanded dramatically over the past decade, Dr. Lembo said. IBS was once thought to be primarily a motility disorder, but currently the many interacting factors include not only motility but also diet, gut microflora, visceral hypersensitivity, immune dysregulation, and brain-gut interactions, he said.

The pathophysiology of postinfectious IBS has been particularly well described and includes the role of anti-CdtB and antivinculin antibodies, and low-grade inflammation in the lining of the intestines, Dr. Lembo explained.

These cases of postinfection IBS can linger for up to a year in approximately 10% of patients, he said.

IBS can affect anyone, anywhere, but it tends to be more common in younger individuals than older adults, and more common in women than men, Dr. Lembo said.

When diagnosing IBS in the clinic setting, a history should include a timeline and triggers for symptoms, he advised. A detailed dietary history, review of medications, and an assessment for alarm features (such as family history of colon cancer or celiac disease, weight loss, anemia, blood in stools, nocturnal awakening, or an onset of symptoms at age older than 50 years) should also be included he said.

Physical signs of systemic and local disease, and a digital rectal exam to assess patients for dyssynergia, especially those with constipation should also be performed, Dr. Lembo added.

In some cases, consider a colonoscopy for patients with IBS, namely those with alarm features, age-appropriate screening criteria, the presence of persistent and frequent watery diarrhea, or in patients who don’t respond to therapy, he added.

Treatment strategies for IBS should start with diet and lifestyle modifications when appropriate, Dr. Lembo said. Encourage patients to pursue moderate to vigorous exercise or some physical activity 3-5 times a week, to get enough sleep, and to start with a traditional IBS diet. Such a diet involves three meals a day, with three or fewer snacks, and not overeating at any of these times, he said. Other diet tips include reducing consumption of fatty or spicy foods, as well as coffee, alcohol, onions, beans, and cabbage. He also advised encouraging patients to avoid gum and soft drinks, as well as artificial sweeteners, and to use soluble rather than insoluble fiber. The low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet has shown benefit in some patients. For those who respond to the low-FODMAP diet it is important to reintroduce foods into their diet. Nutrition consultation should be considered for most patients.

Follow a stepwise approach to treatment, Dr. Lembo emphasized that, if IBS patients with constipation are not improving with diet and lifestyle, over-the-counter medications such as polyethylene glycol can be considered to improve bowel consistency, although the drug’s effect on pain is limited. Prescription options include secretogogues (linaclotide, plenecatide, lubiprostone), and prokinetics (tegaserod, a 5-HT4 partial agonist that was recently reapproved by the FDA for women < 65 years without cardiovascular risk factors). In general, prescription drugs for IBS-C have similar efficacy in most endpoints though differences in their mechanisms of action and side effects should be considered when prescribing a particular agent, he said.

Other perspectives on managing IBS include cognitive behavior therapy and fecal microbiota transplant, Dr. Lembo said. Cognitive behavior therapy improves IBS symptoms after 12 weeks in patients who had weekly sessions compared with controls who received 4 weeks of basic patient education, he noted. As for fecal microbiota transplant, the jury is still out and it is important to note that FMT is not currently approved for clinical practice for patients with IBS, he noted.

Dr. Lembo disclosed relationships with Allergan, Ardelyx, Bayer, Bioamerica, Ironwood, Mylan and Takeda.

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

Many factors can prompt individuals with irritable bowel syndrome (IBS) to seek consultation with a specialist said Anthony Lembo, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, in a virtual presentation at the conference jointly provided by Rutgers and Global Academy for Medical Education.

Most patients with IBS suffer with symptoms for years before seeking care, he said.

Common reasons to cause an individual with IBS to seek care include severity of abdominal pain, psychological disturbance such as anxiety, and concerns about organic disease such as colon cancer, perhaps because they know someone who was recently diagnosed with it,” he said.

Our understanding of the pathophysiology of IBS has expanded dramatically over the past decade, Dr. Lembo said. IBS was once thought to be primarily a motility disorder, but currently the many interacting factors include not only motility but also diet, gut microflora, visceral hypersensitivity, immune dysregulation, and brain-gut interactions, he said.

The pathophysiology of postinfectious IBS has been particularly well described and includes the role of anti-CdtB and antivinculin antibodies, and low-grade inflammation in the lining of the intestines, Dr. Lembo explained.

These cases of postinfection IBS can linger for up to a year in approximately 10% of patients, he said.

IBS can affect anyone, anywhere, but it tends to be more common in younger individuals than older adults, and more common in women than men, Dr. Lembo said.

When diagnosing IBS in the clinic setting, a history should include a timeline and triggers for symptoms, he advised. A detailed dietary history, review of medications, and an assessment for alarm features (such as family history of colon cancer or celiac disease, weight loss, anemia, blood in stools, nocturnal awakening, or an onset of symptoms at age older than 50 years) should also be included he said.

Physical signs of systemic and local disease, and a digital rectal exam to assess patients for dyssynergia, especially those with constipation should also be performed, Dr. Lembo added.

In some cases, consider a colonoscopy for patients with IBS, namely those with alarm features, age-appropriate screening criteria, the presence of persistent and frequent watery diarrhea, or in patients who don’t respond to therapy, he added.

Treatment strategies for IBS should start with diet and lifestyle modifications when appropriate, Dr. Lembo said. Encourage patients to pursue moderate to vigorous exercise or some physical activity 3-5 times a week, to get enough sleep, and to start with a traditional IBS diet. Such a diet involves three meals a day, with three or fewer snacks, and not overeating at any of these times, he said. Other diet tips include reducing consumption of fatty or spicy foods, as well as coffee, alcohol, onions, beans, and cabbage. He also advised encouraging patients to avoid gum and soft drinks, as well as artificial sweeteners, and to use soluble rather than insoluble fiber. The low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet has shown benefit in some patients. For those who respond to the low-FODMAP diet it is important to reintroduce foods into their diet. Nutrition consultation should be considered for most patients.

Follow a stepwise approach to treatment, Dr. Lembo emphasized that, if IBS patients with constipation are not improving with diet and lifestyle, over-the-counter medications such as polyethylene glycol can be considered to improve bowel consistency, although the drug’s effect on pain is limited. Prescription options include secretogogues (linaclotide, plenecatide, lubiprostone), and prokinetics (tegaserod, a 5-HT4 partial agonist that was recently reapproved by the FDA for women < 65 years without cardiovascular risk factors). In general, prescription drugs for IBS-C have similar efficacy in most endpoints though differences in their mechanisms of action and side effects should be considered when prescribing a particular agent, he said.

Other perspectives on managing IBS include cognitive behavior therapy and fecal microbiota transplant, Dr. Lembo said. Cognitive behavior therapy improves IBS symptoms after 12 weeks in patients who had weekly sessions compared with controls who received 4 weeks of basic patient education, he noted. As for fecal microbiota transplant, the jury is still out and it is important to note that FMT is not currently approved for clinical practice for patients with IBS, he noted.

Dr. Lembo disclosed relationships with Allergan, Ardelyx, Bayer, Bioamerica, Ironwood, Mylan and Takeda.

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

A combination of mifepristone followed by misoprostol was significantly more cost effective for the medical management of miscarriage than misoprostol alone, based on a decision-tree model and simulations using a range of patient income levels, cost variables, and practice patterns.

Sripfoto/Thinkstock

Although the American College of Obstetricians and Gynecologists recommends a combination of mifepristone and misoprostol for the medical management of miscarriage, some physicians may hesitate because of the high cost of mifepristone, wrote Holly H. Berkley, MD, of the Naval Medical Center, San Diego, and colleagues.

Previous research has supported the cost effectiveness of combination therapy, but the data came from a secondary analysis that limited the generalizability of the findings, they wrote. In a study published in Obstetrics & Gynecology, the researchers created a decision-tree model using two standard practice patterns.

In the first, patients received mifepristone and one dose of misoprostol (combination therapy) or one dose of misoprostol alone (monotherapy) at their initial visit with follow-up within 3 days. Combination therapy was defined as 200 mg of oral mifepristone followed by one or two doses of 800 micrograms of vaginal misoprostol; monotherapy was defined as one or two doses of 800 micrograms of vaginal misoprostol.

“If miscarriage is not completed, a second dose of misoprostol is given, and the patient will have a second follow-up visit 8 days after initiation of treatment. If miscarriage is not complete at the second follow-up visit, surgical management is prescribed,” Dr. Berkley and associates reported.

In the second pattern, patients receive two doses of misoprostol at the first visit and an initial follow-up visit 8 days later.

Patient hourly income was based on the wages of three employment levels of the military patient population, estimated at $7.25/hour, $15.90/hour, and $35.10 per hour. “For clinicians outside of the military health system, these wage categories may also serve as an estimate of earnings for low-income, low-middle income, and middle-income patients across the United States,” Dr. Berkley and colleagues noted.

The researchers also considered costs for time of work, transportation, and the costs of the medical visits. Costs also were computed for surgical management with in–operating room dilation and curettage or in-office manual vacuum aspiration, if needed.

The greatest difference in favor of combination therapy resulted in a savings of $190.20 per patient, compared with monotherapy, in the first practice pattern and the lowest wage group (19.5%).

“In every scenario, and for every wage level, the average cost of combination therapy is less than that of monotherapy,” Dr. Berkley and associates noted. In addition, the differences in cost between combination therapy and monotherapy increased with patients’ wages, “reflecting wage differences as well as the net savings owing to increased completion rates.”
 

Completion rates are key to cost effectiveness

“The higher completion rate of combination therapy leads to decreased time spent on treatment and therefore decreased time off work, decreased office visits, and a decreased need for surgical management for persistent pregnancy, which significantly reduces cost,” they noted.

The model shows that the cost of mifepristone, which some clinicians may see as a barrier, contributes little to the overall treatment costs, Dr. Berkley and colleagues emphasized.

The study findings were limited by several factors including the large ranges in costs for office visits and procedures and the inability to replicate all clinical settings and variables, the researchers noted. However, the results were strengthened by the use of current practice patterns and costs, and they support the mifepristone/misoprostol combination as being the most cost effective for medical management of miscarriage, they said.

The findings of the current study, combined with higher effectiveness reported in recent randomized controlled trials and the endorsement of the American College of Obstetricians and Gynecologists “make a strong case for mifepristone followed by misoprostol to become the standard, first-line treatment regimen for the medical management of miscarriage,” Dr. Berkley and associates concluded.
 

Research is clear, policy needs to catch up

“There is clear research showing that using mifepristone with misoprostol to medically manage early pregnancy loss is significantly more effective than misoprostol alone,” Sarah Prager, MD, of the University of Washington, Seattle, said in an interview. “The combination protocol does include an expensive medication, so it’s important to evaluate if the cost of this more effective method is ‘worth it,’ ” she said. “What this research shows is that, not only does the combination method work better at treating miscarriage, it is also cost effective based on many factors, including fewer projected days off work and fewer patients needing procedures to complete their miscarriage.”

Dr. Prager said she was not surprised by the study findings because similar results have been found in other studies evaluating treatment of abortion with misoprostol alone versus mifepristone and misoprostol. “When something is significantly more effective, it usually will also come with a cost benefit.”

Potential barriers to the use of combination therapy are related to policy rather than drug safety or effectiveness, according to Dr. Prager.

“The primary barrier is that mifepristone use is regulated by a REMS [Risk Evaluation and Mitigation Strategy] restriction which requires that providers dispense the medication directly to patients, rather than being able to prescribe it and have patients then pick it up at a pharmacy,” she said. “This restriction is typically used for medications that are dangerous and need to be closely controlled. In the case of mifepristone, the restriction does not serve a safety purpose; it simply limits access to the medication which is still primarily used to medically treat abortion.

“The secondary barrier is stigma against using a medication that is seen as an abortion medication. I fear many providers or practices may avoid putting it on formulary due to this stigma,” Dr. Prager noted.

“There is already sufficient evidence that the combination therapy is superior to monotherapy, and there is also evidence that mifepristone can be safely prescribed [not dispensed] and does not need the REMS requirement,” Dr. Prager said. “I don’t believe more research is needed; just policy change.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose.

SOURCE: Berkley HH et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004063.

A combination of mifepristone followed by misoprostol was significantly more cost effective for the medical management of miscarriage than misoprostol alone, based on a decision-tree model and simulations using a range of patient income levels, cost variables, and practice patterns.

Sripfoto/Thinkstock

Although the American College of Obstetricians and Gynecologists recommends a combination of mifepristone and misoprostol for the medical management of miscarriage, some physicians may hesitate because of the high cost of mifepristone, wrote Holly H. Berkley, MD, of the Naval Medical Center, San Diego, and colleagues.

Previous research has supported the cost effectiveness of combination therapy, but the data came from a secondary analysis that limited the generalizability of the findings, they wrote. In a study published in Obstetrics & Gynecology, the researchers created a decision-tree model using two standard practice patterns.

In the first, patients received mifepristone and one dose of misoprostol (combination therapy) or one dose of misoprostol alone (monotherapy) at their initial visit with follow-up within 3 days. Combination therapy was defined as 200 mg of oral mifepristone followed by one or two doses of 800 micrograms of vaginal misoprostol; monotherapy was defined as one or two doses of 800 micrograms of vaginal misoprostol.

“If miscarriage is not completed, a second dose of misoprostol is given, and the patient will have a second follow-up visit 8 days after initiation of treatment. If miscarriage is not complete at the second follow-up visit, surgical management is prescribed,” Dr. Berkley and associates reported.

In the second pattern, patients receive two doses of misoprostol at the first visit and an initial follow-up visit 8 days later.

Patient hourly income was based on the wages of three employment levels of the military patient population, estimated at $7.25/hour, $15.90/hour, and $35.10 per hour. “For clinicians outside of the military health system, these wage categories may also serve as an estimate of earnings for low-income, low-middle income, and middle-income patients across the United States,” Dr. Berkley and colleagues noted.

The researchers also considered costs for time of work, transportation, and the costs of the medical visits. Costs also were computed for surgical management with in–operating room dilation and curettage or in-office manual vacuum aspiration, if needed.

The greatest difference in favor of combination therapy resulted in a savings of $190.20 per patient, compared with monotherapy, in the first practice pattern and the lowest wage group (19.5%).

“In every scenario, and for every wage level, the average cost of combination therapy is less than that of monotherapy,” Dr. Berkley and associates noted. In addition, the differences in cost between combination therapy and monotherapy increased with patients’ wages, “reflecting wage differences as well as the net savings owing to increased completion rates.”
 

Completion rates are key to cost effectiveness

“The higher completion rate of combination therapy leads to decreased time spent on treatment and therefore decreased time off work, decreased office visits, and a decreased need for surgical management for persistent pregnancy, which significantly reduces cost,” they noted.

The model shows that the cost of mifepristone, which some clinicians may see as a barrier, contributes little to the overall treatment costs, Dr. Berkley and colleagues emphasized.

The study findings were limited by several factors including the large ranges in costs for office visits and procedures and the inability to replicate all clinical settings and variables, the researchers noted. However, the results were strengthened by the use of current practice patterns and costs, and they support the mifepristone/misoprostol combination as being the most cost effective for medical management of miscarriage, they said.

The findings of the current study, combined with higher effectiveness reported in recent randomized controlled trials and the endorsement of the American College of Obstetricians and Gynecologists “make a strong case for mifepristone followed by misoprostol to become the standard, first-line treatment regimen for the medical management of miscarriage,” Dr. Berkley and associates concluded.
 

Research is clear, policy needs to catch up

“There is clear research showing that using mifepristone with misoprostol to medically manage early pregnancy loss is significantly more effective than misoprostol alone,” Sarah Prager, MD, of the University of Washington, Seattle, said in an interview. “The combination protocol does include an expensive medication, so it’s important to evaluate if the cost of this more effective method is ‘worth it,’ ” she said. “What this research shows is that, not only does the combination method work better at treating miscarriage, it is also cost effective based on many factors, including fewer projected days off work and fewer patients needing procedures to complete their miscarriage.”

Dr. Prager said she was not surprised by the study findings because similar results have been found in other studies evaluating treatment of abortion with misoprostol alone versus mifepristone and misoprostol. “When something is significantly more effective, it usually will also come with a cost benefit.”

Potential barriers to the use of combination therapy are related to policy rather than drug safety or effectiveness, according to Dr. Prager.

“The primary barrier is that mifepristone use is regulated by a REMS [Risk Evaluation and Mitigation Strategy] restriction which requires that providers dispense the medication directly to patients, rather than being able to prescribe it and have patients then pick it up at a pharmacy,” she said. “This restriction is typically used for medications that are dangerous and need to be closely controlled. In the case of mifepristone, the restriction does not serve a safety purpose; it simply limits access to the medication which is still primarily used to medically treat abortion.

“The secondary barrier is stigma against using a medication that is seen as an abortion medication. I fear many providers or practices may avoid putting it on formulary due to this stigma,” Dr. Prager noted.

“There is already sufficient evidence that the combination therapy is superior to monotherapy, and there is also evidence that mifepristone can be safely prescribed [not dispensed] and does not need the REMS requirement,” Dr. Prager said. “I don’t believe more research is needed; just policy change.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose.

SOURCE: Berkley HH et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004063.

A combination of mifepristone followed by misoprostol was significantly more cost effective for the medical management of miscarriage than misoprostol alone, based on a decision-tree model and simulations using a range of patient income levels, cost variables, and practice patterns.

Sripfoto/Thinkstock

Although the American College of Obstetricians and Gynecologists recommends a combination of mifepristone and misoprostol for the medical management of miscarriage, some physicians may hesitate because of the high cost of mifepristone, wrote Holly H. Berkley, MD, of the Naval Medical Center, San Diego, and colleagues.

Previous research has supported the cost effectiveness of combination therapy, but the data came from a secondary analysis that limited the generalizability of the findings, they wrote. In a study published in Obstetrics & Gynecology, the researchers created a decision-tree model using two standard practice patterns.

In the first, patients received mifepristone and one dose of misoprostol (combination therapy) or one dose of misoprostol alone (monotherapy) at their initial visit with follow-up within 3 days. Combination therapy was defined as 200 mg of oral mifepristone followed by one or two doses of 800 micrograms of vaginal misoprostol; monotherapy was defined as one or two doses of 800 micrograms of vaginal misoprostol.

“If miscarriage is not completed, a second dose of misoprostol is given, and the patient will have a second follow-up visit 8 days after initiation of treatment. If miscarriage is not complete at the second follow-up visit, surgical management is prescribed,” Dr. Berkley and associates reported.

In the second pattern, patients receive two doses of misoprostol at the first visit and an initial follow-up visit 8 days later.

Patient hourly income was based on the wages of three employment levels of the military patient population, estimated at $7.25/hour, $15.90/hour, and $35.10 per hour. “For clinicians outside of the military health system, these wage categories may also serve as an estimate of earnings for low-income, low-middle income, and middle-income patients across the United States,” Dr. Berkley and colleagues noted.

The researchers also considered costs for time of work, transportation, and the costs of the medical visits. Costs also were computed for surgical management with in–operating room dilation and curettage or in-office manual vacuum aspiration, if needed.

The greatest difference in favor of combination therapy resulted in a savings of $190.20 per patient, compared with monotherapy, in the first practice pattern and the lowest wage group (19.5%).

“In every scenario, and for every wage level, the average cost of combination therapy is less than that of monotherapy,” Dr. Berkley and associates noted. In addition, the differences in cost between combination therapy and monotherapy increased with patients’ wages, “reflecting wage differences as well as the net savings owing to increased completion rates.”
 

Completion rates are key to cost effectiveness

“The higher completion rate of combination therapy leads to decreased time spent on treatment and therefore decreased time off work, decreased office visits, and a decreased need for surgical management for persistent pregnancy, which significantly reduces cost,” they noted.

The model shows that the cost of mifepristone, which some clinicians may see as a barrier, contributes little to the overall treatment costs, Dr. Berkley and colleagues emphasized.

The study findings were limited by several factors including the large ranges in costs for office visits and procedures and the inability to replicate all clinical settings and variables, the researchers noted. However, the results were strengthened by the use of current practice patterns and costs, and they support the mifepristone/misoprostol combination as being the most cost effective for medical management of miscarriage, they said.

The findings of the current study, combined with higher effectiveness reported in recent randomized controlled trials and the endorsement of the American College of Obstetricians and Gynecologists “make a strong case for mifepristone followed by misoprostol to become the standard, first-line treatment regimen for the medical management of miscarriage,” Dr. Berkley and associates concluded.
 

Research is clear, policy needs to catch up

“There is clear research showing that using mifepristone with misoprostol to medically manage early pregnancy loss is significantly more effective than misoprostol alone,” Sarah Prager, MD, of the University of Washington, Seattle, said in an interview. “The combination protocol does include an expensive medication, so it’s important to evaluate if the cost of this more effective method is ‘worth it,’ ” she said. “What this research shows is that, not only does the combination method work better at treating miscarriage, it is also cost effective based on many factors, including fewer projected days off work and fewer patients needing procedures to complete their miscarriage.”

Dr. Prager said she was not surprised by the study findings because similar results have been found in other studies evaluating treatment of abortion with misoprostol alone versus mifepristone and misoprostol. “When something is significantly more effective, it usually will also come with a cost benefit.”

Potential barriers to the use of combination therapy are related to policy rather than drug safety or effectiveness, according to Dr. Prager.

“The primary barrier is that mifepristone use is regulated by a REMS [Risk Evaluation and Mitigation Strategy] restriction which requires that providers dispense the medication directly to patients, rather than being able to prescribe it and have patients then pick it up at a pharmacy,” she said. “This restriction is typically used for medications that are dangerous and need to be closely controlled. In the case of mifepristone, the restriction does not serve a safety purpose; it simply limits access to the medication which is still primarily used to medically treat abortion.

“The secondary barrier is stigma against using a medication that is seen as an abortion medication. I fear many providers or practices may avoid putting it on formulary due to this stigma,” Dr. Prager noted.

“There is already sufficient evidence that the combination therapy is superior to monotherapy, and there is also evidence that mifepristone can be safely prescribed [not dispensed] and does not need the REMS requirement,” Dr. Prager said. “I don’t believe more research is needed; just policy change.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose.

SOURCE: Berkley HH et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004063.

Limited data are available to guide treatment of recurrent bacterial vaginosis, but behavioral changes and switching between approved medication regimens may help, according to a presenter at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

Investigational treatments – such as a live biotherapeutic product delivered vaginally or vaginal microbiome transplantation – could someday be additional options if they prove safe and effective. “The current research is emphasizing biofilm disruption and products that will reestablish normal acidic vaginal pH,” said Debra L. Birenbaum, MD, assistant professor of obstetrics and gynecology at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

As for home remedies, Dr. Birenbaum and another presenter at the conference, Cynthia Rasmussen, MD, urged caution during a panel discussion.

“I think the vagina knows its business, and the more you mess with it, the more you invite trouble,” said Dr. Rasmussen, director emerita of vulvovaginal services at Atrius Health in Burlington, Mass. For instance, tea tree oil, often cited as a home remedy, can be an allergen and very irritating.

“I want to know what women are using, but I try and dissuade them,” said Dr. Birenbaum. “I have to be careful what I say, because you’ll antagonize patients” if you come out strongly against home treatments. “I try to encourage them not to go by things they read on the Internet, because I think that’s where many people are finding their home remedies.”

When counseling patients, an analogy shared during the meeting – the vagina is a self-cleaning oven – may help get the point across. “I love the comment,” Dr. Birenbaum said. “I’ve never used that before. I’m going to start saying that.”
 

Possible causes and risk factors

Bacterial vaginosis, also known as vaginal dysbiosis, is the most common cause of discharge in women of reproductive age worldwide. Growth of a biofilm may cause the condition, which is characterized by a shift in vaginal flora from a Lactobacilli-dominant environment to one of other bacterial types.

Risk factors include douching, smoking, sex with an uncircumcised partner, and having multiple sexual partners. Bacterial vaginosis may be associated with various complications and infections, including increased risk of preterm delivery, postpartum endometritis, postabortal infection, Trichomonas, chlamydia, and HIV.

Unlike recurrent yeast, which is characterized by four or more episodes per year, recurrent bacterial vaginosis has no official criteria, Dr. Birenbaum said. However, recurrence of bacterial vaginosis “is extremely common,” she said. “Up to 30% of women with [bacterial vaginosis] may recur within 3 months, and up to 50% after 12 months.”
 

Lifestyle changes and treatments

Recommendations to use condoms, stop smoking, and not douche are important.

In addition, 11 treatment regimens for four drugs – metronidazole, clindamycin, tinidazole, or secnidazole – are available for the treatment of bacterial vaginosis. For recurrent cases, adjusting and switching between the drugs and modes of delivery may help. If a patient started with vaginal gel, they can try an oral medication, or vice versa.

“There’s very little data to guide the optimal therapy for this,” Dr. Birenbaum said. “All of this is worth a try to see if you can beat this before this becomes an ongoing issue.”

As an example of one possible regimen for recurrent bacterial vaginosis, Dr. Birenbaum suggested that a patient could complete a 2- to 4-week course of oral metronidazole instead of the usual 1-week course. The regimen could incorporate boric acid vaginal suppositories 600 mg nightly for 21 days, followed by metronidazole gel 0.75% (one applicator twice per week for 6 months).
 

New therapies may be on the horizon

In a randomized, double-blind, phase 2b trial published in the New England Journal of Medicine that included more than 220 participants, patients who received an investigational product containing Lactobacillus crispatus CTV-05 (Lactin-V) were less likely to have recurrent bacterial vaginosis at 12 weeks, compared with those who received placebo (30% vs. 45%).

A product in development known as TOL-463, a boric acid–based vaginal anti-infective enhanced with ethylenediaminetetraacetic acid, may be safe and effective, a phase 2 study published in Clinical Infectious Diseases suggests.

Investigators in the United Kingdom designed a trial to compare lactic acid gel and metronidazole, and the findings published in the Trials journal may clarify inconsistent results from prior studies.

Furthermore, preclinical research in Pathogens and Disease has identified cationic amphiphiles that might help fight the biofilm that is formed with Gardnerella vaginalis in patients with bacterial vaginosis, Dr. Birenbaum said.

Finally, an exploratory study in Israel published in Nature Medicine evaluated vaginal microbiome transplants in five patients, three of whom required repeat transplantation. Four patients had long-term remission, and one had a reduction in symptoms

Dr. Birenbaum is a reviewer for UpToDate. Dr. Rasmussen had no relevant disclosures.

[email protected]

Limited data are available to guide treatment of recurrent bacterial vaginosis, but behavioral changes and switching between approved medication regimens may help, according to a presenter at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

Investigational treatments – such as a live biotherapeutic product delivered vaginally or vaginal microbiome transplantation – could someday be additional options if they prove safe and effective. “The current research is emphasizing biofilm disruption and products that will reestablish normal acidic vaginal pH,” said Debra L. Birenbaum, MD, assistant professor of obstetrics and gynecology at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

As for home remedies, Dr. Birenbaum and another presenter at the conference, Cynthia Rasmussen, MD, urged caution during a panel discussion.

“I think the vagina knows its business, and the more you mess with it, the more you invite trouble,” said Dr. Rasmussen, director emerita of vulvovaginal services at Atrius Health in Burlington, Mass. For instance, tea tree oil, often cited as a home remedy, can be an allergen and very irritating.

“I want to know what women are using, but I try and dissuade them,” said Dr. Birenbaum. “I have to be careful what I say, because you’ll antagonize patients” if you come out strongly against home treatments. “I try to encourage them not to go by things they read on the Internet, because I think that’s where many people are finding their home remedies.”

When counseling patients, an analogy shared during the meeting – the vagina is a self-cleaning oven – may help get the point across. “I love the comment,” Dr. Birenbaum said. “I’ve never used that before. I’m going to start saying that.”
 

Possible causes and risk factors

Bacterial vaginosis, also known as vaginal dysbiosis, is the most common cause of discharge in women of reproductive age worldwide. Growth of a biofilm may cause the condition, which is characterized by a shift in vaginal flora from a Lactobacilli-dominant environment to one of other bacterial types.

Risk factors include douching, smoking, sex with an uncircumcised partner, and having multiple sexual partners. Bacterial vaginosis may be associated with various complications and infections, including increased risk of preterm delivery, postpartum endometritis, postabortal infection, Trichomonas, chlamydia, and HIV.

Unlike recurrent yeast, which is characterized by four or more episodes per year, recurrent bacterial vaginosis has no official criteria, Dr. Birenbaum said. However, recurrence of bacterial vaginosis “is extremely common,” she said. “Up to 30% of women with [bacterial vaginosis] may recur within 3 months, and up to 50% after 12 months.”
 

Lifestyle changes and treatments

Recommendations to use condoms, stop smoking, and not douche are important.

In addition, 11 treatment regimens for four drugs – metronidazole, clindamycin, tinidazole, or secnidazole – are available for the treatment of bacterial vaginosis. For recurrent cases, adjusting and switching between the drugs and modes of delivery may help. If a patient started with vaginal gel, they can try an oral medication, or vice versa.

“There’s very little data to guide the optimal therapy for this,” Dr. Birenbaum said. “All of this is worth a try to see if you can beat this before this becomes an ongoing issue.”

As an example of one possible regimen for recurrent bacterial vaginosis, Dr. Birenbaum suggested that a patient could complete a 2- to 4-week course of oral metronidazole instead of the usual 1-week course. The regimen could incorporate boric acid vaginal suppositories 600 mg nightly for 21 days, followed by metronidazole gel 0.75% (one applicator twice per week for 6 months).
 

New therapies may be on the horizon

In a randomized, double-blind, phase 2b trial published in the New England Journal of Medicine that included more than 220 participants, patients who received an investigational product containing Lactobacillus crispatus CTV-05 (Lactin-V) were less likely to have recurrent bacterial vaginosis at 12 weeks, compared with those who received placebo (30% vs. 45%).

A product in development known as TOL-463, a boric acid–based vaginal anti-infective enhanced with ethylenediaminetetraacetic acid, may be safe and effective, a phase 2 study published in Clinical Infectious Diseases suggests.

Investigators in the United Kingdom designed a trial to compare lactic acid gel and metronidazole, and the findings published in the Trials journal may clarify inconsistent results from prior studies.

Furthermore, preclinical research in Pathogens and Disease has identified cationic amphiphiles that might help fight the biofilm that is formed with Gardnerella vaginalis in patients with bacterial vaginosis, Dr. Birenbaum said.

Finally, an exploratory study in Israel published in Nature Medicine evaluated vaginal microbiome transplants in five patients, three of whom required repeat transplantation. Four patients had long-term remission, and one had a reduction in symptoms

Dr. Birenbaum is a reviewer for UpToDate. Dr. Rasmussen had no relevant disclosures.

[email protected]

Limited data are available to guide treatment of recurrent bacterial vaginosis, but behavioral changes and switching between approved medication regimens may help, according to a presenter at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

Investigational treatments – such as a live biotherapeutic product delivered vaginally or vaginal microbiome transplantation – could someday be additional options if they prove safe and effective. “The current research is emphasizing biofilm disruption and products that will reestablish normal acidic vaginal pH,” said Debra L. Birenbaum, MD, assistant professor of obstetrics and gynecology at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

As for home remedies, Dr. Birenbaum and another presenter at the conference, Cynthia Rasmussen, MD, urged caution during a panel discussion.

“I think the vagina knows its business, and the more you mess with it, the more you invite trouble,” said Dr. Rasmussen, director emerita of vulvovaginal services at Atrius Health in Burlington, Mass. For instance, tea tree oil, often cited as a home remedy, can be an allergen and very irritating.

“I want to know what women are using, but I try and dissuade them,” said Dr. Birenbaum. “I have to be careful what I say, because you’ll antagonize patients” if you come out strongly against home treatments. “I try to encourage them not to go by things they read on the Internet, because I think that’s where many people are finding their home remedies.”

When counseling patients, an analogy shared during the meeting – the vagina is a self-cleaning oven – may help get the point across. “I love the comment,” Dr. Birenbaum said. “I’ve never used that before. I’m going to start saying that.”
 

Possible causes and risk factors

Bacterial vaginosis, also known as vaginal dysbiosis, is the most common cause of discharge in women of reproductive age worldwide. Growth of a biofilm may cause the condition, which is characterized by a shift in vaginal flora from a Lactobacilli-dominant environment to one of other bacterial types.

Risk factors include douching, smoking, sex with an uncircumcised partner, and having multiple sexual partners. Bacterial vaginosis may be associated with various complications and infections, including increased risk of preterm delivery, postpartum endometritis, postabortal infection, Trichomonas, chlamydia, and HIV.

Unlike recurrent yeast, which is characterized by four or more episodes per year, recurrent bacterial vaginosis has no official criteria, Dr. Birenbaum said. However, recurrence of bacterial vaginosis “is extremely common,” she said. “Up to 30% of women with [bacterial vaginosis] may recur within 3 months, and up to 50% after 12 months.”
 

Lifestyle changes and treatments

Recommendations to use condoms, stop smoking, and not douche are important.

In addition, 11 treatment regimens for four drugs – metronidazole, clindamycin, tinidazole, or secnidazole – are available for the treatment of bacterial vaginosis. For recurrent cases, adjusting and switching between the drugs and modes of delivery may help. If a patient started with vaginal gel, they can try an oral medication, or vice versa.

“There’s very little data to guide the optimal therapy for this,” Dr. Birenbaum said. “All of this is worth a try to see if you can beat this before this becomes an ongoing issue.”

As an example of one possible regimen for recurrent bacterial vaginosis, Dr. Birenbaum suggested that a patient could complete a 2- to 4-week course of oral metronidazole instead of the usual 1-week course. The regimen could incorporate boric acid vaginal suppositories 600 mg nightly for 21 days, followed by metronidazole gel 0.75% (one applicator twice per week for 6 months).
 

New therapies may be on the horizon

In a randomized, double-blind, phase 2b trial published in the New England Journal of Medicine that included more than 220 participants, patients who received an investigational product containing Lactobacillus crispatus CTV-05 (Lactin-V) were less likely to have recurrent bacterial vaginosis at 12 weeks, compared with those who received placebo (30% vs. 45%).

A product in development known as TOL-463, a boric acid–based vaginal anti-infective enhanced with ethylenediaminetetraacetic acid, may be safe and effective, a phase 2 study published in Clinical Infectious Diseases suggests.

Investigators in the United Kingdom designed a trial to compare lactic acid gel and metronidazole, and the findings published in the Trials journal may clarify inconsistent results from prior studies.

Furthermore, preclinical research in Pathogens and Disease has identified cationic amphiphiles that might help fight the biofilm that is formed with Gardnerella vaginalis in patients with bacterial vaginosis, Dr. Birenbaum said.

Finally, an exploratory study in Israel published in Nature Medicine evaluated vaginal microbiome transplants in five patients, three of whom required repeat transplantation. Four patients had long-term remission, and one had a reduction in symptoms

Dr. Birenbaum is a reviewer for UpToDate. Dr. Rasmussen had no relevant disclosures.

[email protected]

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

The National Academies of Science, Engineering, and Medicine have just released a 522-page report, but it’s not the usual compilation of guidelines for treatment of a disease. Instead, the authors of “Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action” argue in stark terms that the American society has colossally failed individuals living with sickle cell disease (SCD), who are mostly Black or Brown. A dramatic overhaul of the country’s medical and societal priorities is needed to turn things around to improve health and longevity among this rare disease population.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

The findings from the NASEM report are explicit: “There has been substantial success in increasing the survival of children with SCD, but this success had not been translated to similar success as they become adults.” One factor posited to contribute to the slow progress in the improvement of quality and quantity of life for adults living with this disease is the fact that “SCD is largely a disease of African Americans, and as such exists in a context of racial discrimination, health and other societal disparities, mistrust of the health care system, and the effects of poverty.” The report also cites the substantial evidence that those with SCD may receive poorer quality of care.

The report’s 14 authors were made up of an ad hoc committee formed at the request of the Department of Health & Human Services’ Office of Minority Health. The office asked NASEM to convene the committee to develop a strategic plan and blueprint for the United States and others regarding SCD.

The NASEM SCD committee members “realized that we can’t address the medical components of SCD if we don’t explore societal issues and why it’s been so hard to get good care for people with sickle cell disease,” hematologist and report coauthor Ifeyinwa (Ify) Osunkwo, MD, professor of medicine and pediatrics at Atrium Health and director of the Sickle Cell Disease Enterprise, Levine Cancer Institute, Charlotte, N.C., said in an interview. Dr. Osunkwo is also the medical editor of Hematology News.

“After almost a year of meetings and digging into the background and history of SCD care, we came out with very comprehensive summary of where we were and where we want to be,” she said. “The report provides short-, intermediate- and long-term recommendations and identifies which entity and organization should be responsible for implementing them.”

The report authors, led by pediatrician and committee chair Marie Clare McCormick, MD, of the Harvard School of Public Health, Boston, stated that about 100,000 people in the United States and millions worldwide live with SCD. The disease kills more than 700 people per year in the United States, and treatment costs an estimated $2 billion a year.

When judged by disability-adjusted life-years lost – a measurement of expected healthy years of life without an illness – the impact of SCD on individuals is estimated to be greater than a long list of other diseases such as Alzheimer’s disease, breast cancer, type 1 diabetes, and AIDS/HIV, the report noted.

“The health care needs of individuals living with SCD have been neglected by the U.S. and global health care systems, causing them and their families to suffer,” the report said. “Many of the complications that afflict individuals with SCD, particularly pain, are invisible. Pain is only diagnosed by self-reports, and in SCD there are few to no external indicators of the pain experience. Nevertheless, the pain can be excruciatingly severe and requires treatment with strong analgesics.”

There’s even more misery to the story of SCD, the report said, and Dr. Osunkwo agreed. “It’s not just about pain. These individuals suffer from multiple organ-system complications that are physical but also psychological and societal. They experience a lot of disparities in every aspect of their lives. You’re sick, so then you can’t get a job or health insurance, you can’t get Social Security benefits. You can’t get the type of health care you need nor can you access the other forms of support you need and often you are judged as a drug seeker for complaining of pain or repeatedly seeking acute care for unresolved pain.”

Multiple factors exacerbate the experience of people living with SCD in America, the report said. “Because of systemic racism, unconscious bias, and the stigma associated with the diagnosis, the disease brings with it a much broader burden.”

Dr. Osunkwo put it this way: “SCD is a disease that mostly affects Brown and Black people, and that gets layered into the whole discrimination issues that Black and Brown people face compounding the health burden from their disease.”

The report added that “the SCD community has developed a significant lack of trust in the health care system due to the nearly universal stigma and lack of belief in their reports of pain, a lack of trust that has been further reinforced by historical events, such as the Tuskegee experiment.”

The report highlighted research that finds that Blacks “are more likely to receive a lower quality of pain management than white patients and may be perceived as having drug-seeking behavior.”

The report also identified gaps in treatment, noting that “many SCD complications are not restricted to any one organ system, and the impact of the disease on [quality of life] can be profound but hard to define and compartmentalize.”

Dr. Osunkwo said medical professionals often fail to understand the full breadth of the disease. “There’s no particular look to SCD. When you have cancer, you come in, and you look like you’re sick because you’re bald. Everyone clues into that cancer look and knows it’s lethal, that you’re may likely die early. We don’t have that “look that generates empathy” for SCD, and people don’t understand the burden on those affected. They don’t understand or appreciate that SCD shortens your lifespan as well ... that people living with SCD die 3 decades earlier than their ethnically matched peers. Also, SCD is associated with a lot of pain, and pain and the treatment of pain with opioids makes people [health care providers] uncomfortable unless it’s cancer pain.”

She added: “People also assume that, if it’s not pain, it’s not SCD even though SCD can cause leg ulcers and blood clots and even affect the tonsils, or lead to a stroke. When a disease complexity is too difficult for providers to understand, they either avoid it or don’t do anything for the patient.”

Screening and surveillance for SCD and sickle cell trait is insufficient, the report said, and the potential cost of missed childhood cases is large. Detecting the condition at birth allows the implementation of appropriate comprehensive care and treatment to prevent early death from infections and strokes. As the authors noted, “tremendous strides have been made in the past few decades in the care of children with SCD, which have led to almost all children in high-income settings surviving to adulthood.” However, there remains gaps in care coordination and follow-up of babies screened at birth and even bigger gaps in translating these life span gains to adults particularly around the period of transition from pediatrics to adult care when there appears to be a spike in morbidity and mortality.

Dr_Microbe/Thinkstock

The report summarized current treatments for SCD and noted “an influx of pipeline products” after years of little progress and identifies “a need for targeted SCD therapies that address the underlying cause of the disease.”

While treatment recommendations exist, Dr. Osunkwo said, “the evidence for them is very poor and many SCD complications have no evidence-based guidelines for providers to follow. We need more research to provide high quality evidence to make guidelines for SCD treatment stronger and more robust.”

In its final section, the report offers a “strategic plan and blueprint for sickle cell disease action.” It offers several strategies to achieve the vision of “long healthy productive lives for those living with sickle cell disease and sickle cell trait”:

• Establish and fund a research agenda to inform effective programs and policies across the life span.
• Implement efforts to advance understanding of the full impact of sickle cell trait on individuals and society.
• Address barriers to accessing current and pipeline therapies for SCD.
• Improve SCD awareness and strengthen advocacy efforts.
• Increase the number of qualified health professionals providing SCD care.
• Strengthen the evidence base for interventions and disease management and implement widespread efforts to monitor the quality of SCD care.
• Establish organized systems of care assuring both clinical and nonclinical supportive services to all persons living with SCD.
• Establish a national system to collect and link data to characterize the burden of disease, outcomes, and the needs of those with SCD across the life span.

“Right now, the average lifespan for SCD is in the mid-40s to mid-50s,” Dr. Osunkwo said. “That’s a horrible statistic. Even if we just take up half of these recommendations, people will live longer with SCD, and they’ll be more productive and contribute more to society. If we value a cancer life the same as a sickle cell life, we’ll be halfway across the finish line. But the stigma of SCD being a Black and Brown problem is going to be the hardest to confront as it requires a systemic change in our culture as a country and a health care system.”

Still, she said, the commissioning of the report “shows that there is a desire to understand the issue in better detail and try to mitigate it.”

Dr. Osunkwo and Dr. McCormick had no relevant disclosures.

SOURCE: National Academies of Sciences, Engineering, and Medicine. Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action. Washington, D.C.: National Academies Press, 2020.

The National Academies of Science, Engineering, and Medicine have just released a 522-page report, but it’s not the usual compilation of guidelines for treatment of a disease. Instead, the authors of “Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action” argue in stark terms that the American society has colossally failed individuals living with sickle cell disease (SCD), who are mostly Black or Brown. A dramatic overhaul of the country’s medical and societal priorities is needed to turn things around to improve health and longevity among this rare disease population.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

The findings from the NASEM report are explicit: “There has been substantial success in increasing the survival of children with SCD, but this success had not been translated to similar success as they become adults.” One factor posited to contribute to the slow progress in the improvement of quality and quantity of life for adults living with this disease is the fact that “SCD is largely a disease of African Americans, and as such exists in a context of racial discrimination, health and other societal disparities, mistrust of the health care system, and the effects of poverty.” The report also cites the substantial evidence that those with SCD may receive poorer quality of care.

The report’s 14 authors were made up of an ad hoc committee formed at the request of the Department of Health & Human Services’ Office of Minority Health. The office asked NASEM to convene the committee to develop a strategic plan and blueprint for the United States and others regarding SCD.

The NASEM SCD committee members “realized that we can’t address the medical components of SCD if we don’t explore societal issues and why it’s been so hard to get good care for people with sickle cell disease,” hematologist and report coauthor Ifeyinwa (Ify) Osunkwo, MD, professor of medicine and pediatrics at Atrium Health and director of the Sickle Cell Disease Enterprise, Levine Cancer Institute, Charlotte, N.C., said in an interview. Dr. Osunkwo is also the medical editor of Hematology News.

“After almost a year of meetings and digging into the background and history of SCD care, we came out with very comprehensive summary of where we were and where we want to be,” she said. “The report provides short-, intermediate- and long-term recommendations and identifies which entity and organization should be responsible for implementing them.”

The report authors, led by pediatrician and committee chair Marie Clare McCormick, MD, of the Harvard School of Public Health, Boston, stated that about 100,000 people in the United States and millions worldwide live with SCD. The disease kills more than 700 people per year in the United States, and treatment costs an estimated $2 billion a year.

When judged by disability-adjusted life-years lost – a measurement of expected healthy years of life without an illness – the impact of SCD on individuals is estimated to be greater than a long list of other diseases such as Alzheimer’s disease, breast cancer, type 1 diabetes, and AIDS/HIV, the report noted.

“The health care needs of individuals living with SCD have been neglected by the U.S. and global health care systems, causing them and their families to suffer,” the report said. “Many of the complications that afflict individuals with SCD, particularly pain, are invisible. Pain is only diagnosed by self-reports, and in SCD there are few to no external indicators of the pain experience. Nevertheless, the pain can be excruciatingly severe and requires treatment with strong analgesics.”

There’s even more misery to the story of SCD, the report said, and Dr. Osunkwo agreed. “It’s not just about pain. These individuals suffer from multiple organ-system complications that are physical but also psychological and societal. They experience a lot of disparities in every aspect of their lives. You’re sick, so then you can’t get a job or health insurance, you can’t get Social Security benefits. You can’t get the type of health care you need nor can you access the other forms of support you need and often you are judged as a drug seeker for complaining of pain or repeatedly seeking acute care for unresolved pain.”

Multiple factors exacerbate the experience of people living with SCD in America, the report said. “Because of systemic racism, unconscious bias, and the stigma associated with the diagnosis, the disease brings with it a much broader burden.”

Dr. Osunkwo put it this way: “SCD is a disease that mostly affects Brown and Black people, and that gets layered into the whole discrimination issues that Black and Brown people face compounding the health burden from their disease.”

The report added that “the SCD community has developed a significant lack of trust in the health care system due to the nearly universal stigma and lack of belief in their reports of pain, a lack of trust that has been further reinforced by historical events, such as the Tuskegee experiment.”

The report highlighted research that finds that Blacks “are more likely to receive a lower quality of pain management than white patients and may be perceived as having drug-seeking behavior.”

The report also identified gaps in treatment, noting that “many SCD complications are not restricted to any one organ system, and the impact of the disease on [quality of life] can be profound but hard to define and compartmentalize.”

Dr. Osunkwo said medical professionals often fail to understand the full breadth of the disease. “There’s no particular look to SCD. When you have cancer, you come in, and you look like you’re sick because you’re bald. Everyone clues into that cancer look and knows it’s lethal, that you’re may likely die early. We don’t have that “look that generates empathy” for SCD, and people don’t understand the burden on those affected. They don’t understand or appreciate that SCD shortens your lifespan as well ... that people living with SCD die 3 decades earlier than their ethnically matched peers. Also, SCD is associated with a lot of pain, and pain and the treatment of pain with opioids makes people [health care providers] uncomfortable unless it’s cancer pain.”

She added: “People also assume that, if it’s not pain, it’s not SCD even though SCD can cause leg ulcers and blood clots and even affect the tonsils, or lead to a stroke. When a disease complexity is too difficult for providers to understand, they either avoid it or don’t do anything for the patient.”

Screening and surveillance for SCD and sickle cell trait is insufficient, the report said, and the potential cost of missed childhood cases is large. Detecting the condition at birth allows the implementation of appropriate comprehensive care and treatment to prevent early death from infections and strokes. As the authors noted, “tremendous strides have been made in the past few decades in the care of children with SCD, which have led to almost all children in high-income settings surviving to adulthood.” However, there remains gaps in care coordination and follow-up of babies screened at birth and even bigger gaps in translating these life span gains to adults particularly around the period of transition from pediatrics to adult care when there appears to be a spike in morbidity and mortality.

Dr_Microbe/Thinkstock

The report summarized current treatments for SCD and noted “an influx of pipeline products” after years of little progress and identifies “a need for targeted SCD therapies that address the underlying cause of the disease.”

While treatment recommendations exist, Dr. Osunkwo said, “the evidence for them is very poor and many SCD complications have no evidence-based guidelines for providers to follow. We need more research to provide high quality evidence to make guidelines for SCD treatment stronger and more robust.”

In its final section, the report offers a “strategic plan and blueprint for sickle cell disease action.” It offers several strategies to achieve the vision of “long healthy productive lives for those living with sickle cell disease and sickle cell trait”:

• Establish and fund a research agenda to inform effective programs and policies across the life span.
• Implement efforts to advance understanding of the full impact of sickle cell trait on individuals and society.
• Address barriers to accessing current and pipeline therapies for SCD.
• Improve SCD awareness and strengthen advocacy efforts.
• Increase the number of qualified health professionals providing SCD care.
• Strengthen the evidence base for interventions and disease management and implement widespread efforts to monitor the quality of SCD care.
• Establish organized systems of care assuring both clinical and nonclinical supportive services to all persons living with SCD.
• Establish a national system to collect and link data to characterize the burden of disease, outcomes, and the needs of those with SCD across the life span.

“Right now, the average lifespan for SCD is in the mid-40s to mid-50s,” Dr. Osunkwo said. “That’s a horrible statistic. Even if we just take up half of these recommendations, people will live longer with SCD, and they’ll be more productive and contribute more to society. If we value a cancer life the same as a sickle cell life, we’ll be halfway across the finish line. But the stigma of SCD being a Black and Brown problem is going to be the hardest to confront as it requires a systemic change in our culture as a country and a health care system.”

Still, she said, the commissioning of the report “shows that there is a desire to understand the issue in better detail and try to mitigate it.”

Dr. Osunkwo and Dr. McCormick had no relevant disclosures.

SOURCE: National Academies of Sciences, Engineering, and Medicine. Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action. Washington, D.C.: National Academies Press, 2020.

The National Academies of Science, Engineering, and Medicine have just released a 522-page report, but it’s not the usual compilation of guidelines for treatment of a disease. Instead, the authors of “Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action” argue in stark terms that the American society has colossally failed individuals living with sickle cell disease (SCD), who are mostly Black or Brown. A dramatic overhaul of the country’s medical and societal priorities is needed to turn things around to improve health and longevity among this rare disease population.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

The findings from the NASEM report are explicit: “There has been substantial success in increasing the survival of children with SCD, but this success had not been translated to similar success as they become adults.” One factor posited to contribute to the slow progress in the improvement of quality and quantity of life for adults living with this disease is the fact that “SCD is largely a disease of African Americans, and as such exists in a context of racial discrimination, health and other societal disparities, mistrust of the health care system, and the effects of poverty.” The report also cites the substantial evidence that those with SCD may receive poorer quality of care.

The report’s 14 authors were made up of an ad hoc committee formed at the request of the Department of Health & Human Services’ Office of Minority Health. The office asked NASEM to convene the committee to develop a strategic plan and blueprint for the United States and others regarding SCD.

The NASEM SCD committee members “realized that we can’t address the medical components of SCD if we don’t explore societal issues and why it’s been so hard to get good care for people with sickle cell disease,” hematologist and report coauthor Ifeyinwa (Ify) Osunkwo, MD, professor of medicine and pediatrics at Atrium Health and director of the Sickle Cell Disease Enterprise, Levine Cancer Institute, Charlotte, N.C., said in an interview. Dr. Osunkwo is also the medical editor of Hematology News.

“After almost a year of meetings and digging into the background and history of SCD care, we came out with very comprehensive summary of where we were and where we want to be,” she said. “The report provides short-, intermediate- and long-term recommendations and identifies which entity and organization should be responsible for implementing them.”

The report authors, led by pediatrician and committee chair Marie Clare McCormick, MD, of the Harvard School of Public Health, Boston, stated that about 100,000 people in the United States and millions worldwide live with SCD. The disease kills more than 700 people per year in the United States, and treatment costs an estimated $2 billion a year.

When judged by disability-adjusted life-years lost – a measurement of expected healthy years of life without an illness – the impact of SCD on individuals is estimated to be greater than a long list of other diseases such as Alzheimer’s disease, breast cancer, type 1 diabetes, and AIDS/HIV, the report noted.

“The health care needs of individuals living with SCD have been neglected by the U.S. and global health care systems, causing them and their families to suffer,” the report said. “Many of the complications that afflict individuals with SCD, particularly pain, are invisible. Pain is only diagnosed by self-reports, and in SCD there are few to no external indicators of the pain experience. Nevertheless, the pain can be excruciatingly severe and requires treatment with strong analgesics.”

There’s even more misery to the story of SCD, the report said, and Dr. Osunkwo agreed. “It’s not just about pain. These individuals suffer from multiple organ-system complications that are physical but also psychological and societal. They experience a lot of disparities in every aspect of their lives. You’re sick, so then you can’t get a job or health insurance, you can’t get Social Security benefits. You can’t get the type of health care you need nor can you access the other forms of support you need and often you are judged as a drug seeker for complaining of pain or repeatedly seeking acute care for unresolved pain.”

Multiple factors exacerbate the experience of people living with SCD in America, the report said. “Because of systemic racism, unconscious bias, and the stigma associated with the diagnosis, the disease brings with it a much broader burden.”

Dr. Osunkwo put it this way: “SCD is a disease that mostly affects Brown and Black people, and that gets layered into the whole discrimination issues that Black and Brown people face compounding the health burden from their disease.”

The report added that “the SCD community has developed a significant lack of trust in the health care system due to the nearly universal stigma and lack of belief in their reports of pain, a lack of trust that has been further reinforced by historical events, such as the Tuskegee experiment.”

The report highlighted research that finds that Blacks “are more likely to receive a lower quality of pain management than white patients and may be perceived as having drug-seeking behavior.”

The report also identified gaps in treatment, noting that “many SCD complications are not restricted to any one organ system, and the impact of the disease on [quality of life] can be profound but hard to define and compartmentalize.”

Dr. Osunkwo said medical professionals often fail to understand the full breadth of the disease. “There’s no particular look to SCD. When you have cancer, you come in, and you look like you’re sick because you’re bald. Everyone clues into that cancer look and knows it’s lethal, that you’re may likely die early. We don’t have that “look that generates empathy” for SCD, and people don’t understand the burden on those affected. They don’t understand or appreciate that SCD shortens your lifespan as well ... that people living with SCD die 3 decades earlier than their ethnically matched peers. Also, SCD is associated with a lot of pain, and pain and the treatment of pain with opioids makes people [health care providers] uncomfortable unless it’s cancer pain.”

She added: “People also assume that, if it’s not pain, it’s not SCD even though SCD can cause leg ulcers and blood clots and even affect the tonsils, or lead to a stroke. When a disease complexity is too difficult for providers to understand, they either avoid it or don’t do anything for the patient.”

Screening and surveillance for SCD and sickle cell trait is insufficient, the report said, and the potential cost of missed childhood cases is large. Detecting the condition at birth allows the implementation of appropriate comprehensive care and treatment to prevent early death from infections and strokes. As the authors noted, “tremendous strides have been made in the past few decades in the care of children with SCD, which have led to almost all children in high-income settings surviving to adulthood.” However, there remains gaps in care coordination and follow-up of babies screened at birth and even bigger gaps in translating these life span gains to adults particularly around the period of transition from pediatrics to adult care when there appears to be a spike in morbidity and mortality.

Dr_Microbe/Thinkstock

The report summarized current treatments for SCD and noted “an influx of pipeline products” after years of little progress and identifies “a need for targeted SCD therapies that address the underlying cause of the disease.”

While treatment recommendations exist, Dr. Osunkwo said, “the evidence for them is very poor and many SCD complications have no evidence-based guidelines for providers to follow. We need more research to provide high quality evidence to make guidelines for SCD treatment stronger and more robust.”

In its final section, the report offers a “strategic plan and blueprint for sickle cell disease action.” It offers several strategies to achieve the vision of “long healthy productive lives for those living with sickle cell disease and sickle cell trait”:

• Establish and fund a research agenda to inform effective programs and policies across the life span.
• Implement efforts to advance understanding of the full impact of sickle cell trait on individuals and society.
• Address barriers to accessing current and pipeline therapies for SCD.
• Improve SCD awareness and strengthen advocacy efforts.
• Increase the number of qualified health professionals providing SCD care.
• Strengthen the evidence base for interventions and disease management and implement widespread efforts to monitor the quality of SCD care.
• Establish organized systems of care assuring both clinical and nonclinical supportive services to all persons living with SCD.
• Establish a national system to collect and link data to characterize the burden of disease, outcomes, and the needs of those with SCD across the life span.

“Right now, the average lifespan for SCD is in the mid-40s to mid-50s,” Dr. Osunkwo said. “That’s a horrible statistic. Even if we just take up half of these recommendations, people will live longer with SCD, and they’ll be more productive and contribute more to society. If we value a cancer life the same as a sickle cell life, we’ll be halfway across the finish line. But the stigma of SCD being a Black and Brown problem is going to be the hardest to confront as it requires a systemic change in our culture as a country and a health care system.”

Still, she said, the commissioning of the report “shows that there is a desire to understand the issue in better detail and try to mitigate it.”

Dr. Osunkwo and Dr. McCormick had no relevant disclosures.

SOURCE: National Academies of Sciences, Engineering, and Medicine. Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action. Washington, D.C.: National Academies Press, 2020.

Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.

The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.

Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.

There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.

Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.

Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.

For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.

In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.

Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.

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

Dr. Barkin had no relevant financial conflicts to disclose.

Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.

The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.

Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.

There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.

Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.

Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.

For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.

In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.

Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.

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

Dr. Barkin had no relevant financial conflicts to disclose.

Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.

The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.

Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.

There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.

Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.

Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.

For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.

In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.

Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.

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

Dr. Barkin had no relevant financial conflicts to disclose.

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at [email protected].

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at [email protected].

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at [email protected].