MDedge Endocrinology

Doctors are advising women who have had bariatric surgery to wait at least 2 years before trying to conceive to reduce the risk of a small-for-gestational-age baby.

In fact, babies conceived less than 2 years post bariatric surgery are 15 times more likely to be small for gestational age as those conceived after this cut-off point, new study findings indicate.

Ana Carreira, MD, Coimbra Hospital and University Centre, Portugal, presented the findings as a poster at the European Congress on Obesity (ECO) 2022.

“The prevalence of small-for-gestational-age babies was similar across the different types of bariatric surgery, and we calculated that the cut-off for the bariatric-surgery-to-conception interval for a lower risk of small for gestational age babies was 24.5 months,” Dr. Carreira reported.

The study also found that for each additional month after the 2-year time point from bariatric surgery to conception, there was a 4.2-g (0.15-oz) increase in birth weight, and there was a 5% lower risk for a small-for-gestational-age neonate. 

“Clinically, this is very significant,” she told this news organization.

“While it may be possible to slightly adjust this on an individual basis, it is important that women who are undergoing bariatric surgery are aware of the risk of early conception and of the benefits of delaying pregnancy,” she added.

Asked to comment, Kari Johansson, PhD, of the Karolinska Institute, Stockholm, who has worked in the field, said: “These increased risks have been hypothesized to potentially be attributed to the inadequate in utero availability of nutrients to the fetus, especially during the first year post bariatric surgery when the rapid and largest weight loss occurs. This is why many clinical guidelines recommend women wait 12-24 months until getting pregnant.”

Indeed, the American College of Obstetricians and Gynecologists recommends women wait 12-24 months post bariatric surgery before trying to conceive.

Dr. Johansson also noted, however, that there were no significant increased risks of adverse outcomes between pregnancies with a surgery-to-conception interval of 12 months or less versus over 12 months in a recent meta-analysis. But those authors also concluded that large cohorts with sufficient power are needed “before any definite conclusions can be made on the optimal surgery-to-conception interval,” she cautioned.
 

All types of bariatric surgery investigated

Bariatric surgery, which is increasingly popular in women of reproductive age, involves rapid weight loss, which can trigger improved fertility, Dr. Carreira explained. Currently, clinics generally advise women to wait at least 1 year before trying for a baby post-surgery.

Dr. Carreira and colleagues conducted the study because “the optimal bariatric-surgery-to-conception interval has yet to be determined,” and they wanted to examine the issue of small-for-gestational-age babies in particular, she noted. They also examined outcomes after a number of different bariatric procedures.

They retrospectively reviewed a cohort of 48 post surgery pregnancies (in 2008-2020) with a minimum follow-up of 30 weeks and determined the proportion of small-for-gestational-age neonates, defined as having a birth weight less than the 10th percentile according to National Center for Health Statistics growth charts.

Mean maternal age was 34.3 years, mean body mass index at conception was 30.9 kg/m², and 70.8% had a bariatric-surgery-to-conception interval of over 24 months, 14.6% of 12-24 months, and 14.6% of less than 12 months.

Bariatric surgeries included adjustable gastric banding (22.9%), sleeve gastrectomy (35.4%), Roux-en-Y gastric bypass (37.5%), and biliopancreatic diversion (4.2%).

Overall, mean birth weight was 2.98 kg (6.6 lb) and the prevalence of small-for-gestational-age babies was 26.3%.

“For an interval of less than 24 months, around 60% of babies were small for gestational age,” Dr. Carreira noted. 

Most babies who were small for gestational age were conceived at 18 months (median), and those who were not were conceived at 59 months (median).

And, after adjustment for maternal comorbidities, the odds ratio for a small-for-gestational-age neonate was 15.1 (95% confidence interval, 2.4-93.1) for a baby conceived less than 24 months after surgery.  

“Some people think the interval can change according to the type of bariatric surgery, but we found no difference in findings according to [surgery] type,” added Dr. Carreira.

She pointed out that after discharge from their endocrinology clinic (after bariatric surgery), the women are cared for by their family doctor, “and we find that when they return to us in pregnancy their nutrient deficiencies have not been properly addressed. They need to be addressed at least 6 months prior to conception.”

“We recommend that women wait at least 2 years after bariatric surgery before trying to conceive, irrespective of the type of surgery,” she reiterated.

Dr. Carreira and Dr. Johansson have reported no relevant financial relationships.

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

Doctors are advising women who have had bariatric surgery to wait at least 2 years before trying to conceive to reduce the risk of a small-for-gestational-age baby.

In fact, babies conceived less than 2 years post bariatric surgery are 15 times more likely to be small for gestational age as those conceived after this cut-off point, new study findings indicate.

Ana Carreira, MD, Coimbra Hospital and University Centre, Portugal, presented the findings as a poster at the European Congress on Obesity (ECO) 2022.

“The prevalence of small-for-gestational-age babies was similar across the different types of bariatric surgery, and we calculated that the cut-off for the bariatric-surgery-to-conception interval for a lower risk of small for gestational age babies was 24.5 months,” Dr. Carreira reported.

The study also found that for each additional month after the 2-year time point from bariatric surgery to conception, there was a 4.2-g (0.15-oz) increase in birth weight, and there was a 5% lower risk for a small-for-gestational-age neonate. 

“Clinically, this is very significant,” she told this news organization.

“While it may be possible to slightly adjust this on an individual basis, it is important that women who are undergoing bariatric surgery are aware of the risk of early conception and of the benefits of delaying pregnancy,” she added.

Asked to comment, Kari Johansson, PhD, of the Karolinska Institute, Stockholm, who has worked in the field, said: “These increased risks have been hypothesized to potentially be attributed to the inadequate in utero availability of nutrients to the fetus, especially during the first year post bariatric surgery when the rapid and largest weight loss occurs. This is why many clinical guidelines recommend women wait 12-24 months until getting pregnant.”

Indeed, the American College of Obstetricians and Gynecologists recommends women wait 12-24 months post bariatric surgery before trying to conceive.

Dr. Johansson also noted, however, that there were no significant increased risks of adverse outcomes between pregnancies with a surgery-to-conception interval of 12 months or less versus over 12 months in a recent meta-analysis. But those authors also concluded that large cohorts with sufficient power are needed “before any definite conclusions can be made on the optimal surgery-to-conception interval,” she cautioned.
 

All types of bariatric surgery investigated

Bariatric surgery, which is increasingly popular in women of reproductive age, involves rapid weight loss, which can trigger improved fertility, Dr. Carreira explained. Currently, clinics generally advise women to wait at least 1 year before trying for a baby post-surgery.

Dr. Carreira and colleagues conducted the study because “the optimal bariatric-surgery-to-conception interval has yet to be determined,” and they wanted to examine the issue of small-for-gestational-age babies in particular, she noted. They also examined outcomes after a number of different bariatric procedures.

They retrospectively reviewed a cohort of 48 post surgery pregnancies (in 2008-2020) with a minimum follow-up of 30 weeks and determined the proportion of small-for-gestational-age neonates, defined as having a birth weight less than the 10th percentile according to National Center for Health Statistics growth charts.

Mean maternal age was 34.3 years, mean body mass index at conception was 30.9 kg/m², and 70.8% had a bariatric-surgery-to-conception interval of over 24 months, 14.6% of 12-24 months, and 14.6% of less than 12 months.

Bariatric surgeries included adjustable gastric banding (22.9%), sleeve gastrectomy (35.4%), Roux-en-Y gastric bypass (37.5%), and biliopancreatic diversion (4.2%).

Overall, mean birth weight was 2.98 kg (6.6 lb) and the prevalence of small-for-gestational-age babies was 26.3%.

“For an interval of less than 24 months, around 60% of babies were small for gestational age,” Dr. Carreira noted. 

Most babies who were small for gestational age were conceived at 18 months (median), and those who were not were conceived at 59 months (median).

And, after adjustment for maternal comorbidities, the odds ratio for a small-for-gestational-age neonate was 15.1 (95% confidence interval, 2.4-93.1) for a baby conceived less than 24 months after surgery.  

“Some people think the interval can change according to the type of bariatric surgery, but we found no difference in findings according to [surgery] type,” added Dr. Carreira.

She pointed out that after discharge from their endocrinology clinic (after bariatric surgery), the women are cared for by their family doctor, “and we find that when they return to us in pregnancy their nutrient deficiencies have not been properly addressed. They need to be addressed at least 6 months prior to conception.”

“We recommend that women wait at least 2 years after bariatric surgery before trying to conceive, irrespective of the type of surgery,” she reiterated.

Dr. Carreira and Dr. Johansson have reported no relevant financial relationships.

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

Doctors are advising women who have had bariatric surgery to wait at least 2 years before trying to conceive to reduce the risk of a small-for-gestational-age baby.

In fact, babies conceived less than 2 years post bariatric surgery are 15 times more likely to be small for gestational age as those conceived after this cut-off point, new study findings indicate.

Ana Carreira, MD, Coimbra Hospital and University Centre, Portugal, presented the findings as a poster at the European Congress on Obesity (ECO) 2022.

“The prevalence of small-for-gestational-age babies was similar across the different types of bariatric surgery, and we calculated that the cut-off for the bariatric-surgery-to-conception interval for a lower risk of small for gestational age babies was 24.5 months,” Dr. Carreira reported.

The study also found that for each additional month after the 2-year time point from bariatric surgery to conception, there was a 4.2-g (0.15-oz) increase in birth weight, and there was a 5% lower risk for a small-for-gestational-age neonate. 

“Clinically, this is very significant,” she told this news organization.

“While it may be possible to slightly adjust this on an individual basis, it is important that women who are undergoing bariatric surgery are aware of the risk of early conception and of the benefits of delaying pregnancy,” she added.

Asked to comment, Kari Johansson, PhD, of the Karolinska Institute, Stockholm, who has worked in the field, said: “These increased risks have been hypothesized to potentially be attributed to the inadequate in utero availability of nutrients to the fetus, especially during the first year post bariatric surgery when the rapid and largest weight loss occurs. This is why many clinical guidelines recommend women wait 12-24 months until getting pregnant.”

Indeed, the American College of Obstetricians and Gynecologists recommends women wait 12-24 months post bariatric surgery before trying to conceive.

Dr. Johansson also noted, however, that there were no significant increased risks of adverse outcomes between pregnancies with a surgery-to-conception interval of 12 months or less versus over 12 months in a recent meta-analysis. But those authors also concluded that large cohorts with sufficient power are needed “before any definite conclusions can be made on the optimal surgery-to-conception interval,” she cautioned.
 

All types of bariatric surgery investigated

Bariatric surgery, which is increasingly popular in women of reproductive age, involves rapid weight loss, which can trigger improved fertility, Dr. Carreira explained. Currently, clinics generally advise women to wait at least 1 year before trying for a baby post-surgery.

Dr. Carreira and colleagues conducted the study because “the optimal bariatric-surgery-to-conception interval has yet to be determined,” and they wanted to examine the issue of small-for-gestational-age babies in particular, she noted. They also examined outcomes after a number of different bariatric procedures.

They retrospectively reviewed a cohort of 48 post surgery pregnancies (in 2008-2020) with a minimum follow-up of 30 weeks and determined the proportion of small-for-gestational-age neonates, defined as having a birth weight less than the 10th percentile according to National Center for Health Statistics growth charts.

Mean maternal age was 34.3 years, mean body mass index at conception was 30.9 kg/m², and 70.8% had a bariatric-surgery-to-conception interval of over 24 months, 14.6% of 12-24 months, and 14.6% of less than 12 months.

Bariatric surgeries included adjustable gastric banding (22.9%), sleeve gastrectomy (35.4%), Roux-en-Y gastric bypass (37.5%), and biliopancreatic diversion (4.2%).

Overall, mean birth weight was 2.98 kg (6.6 lb) and the prevalence of small-for-gestational-age babies was 26.3%.

“For an interval of less than 24 months, around 60% of babies were small for gestational age,” Dr. Carreira noted. 

Most babies who were small for gestational age were conceived at 18 months (median), and those who were not were conceived at 59 months (median).

And, after adjustment for maternal comorbidities, the odds ratio for a small-for-gestational-age neonate was 15.1 (95% confidence interval, 2.4-93.1) for a baby conceived less than 24 months after surgery.  

“Some people think the interval can change according to the type of bariatric surgery, but we found no difference in findings according to [surgery] type,” added Dr. Carreira.

She pointed out that after discharge from their endocrinology clinic (after bariatric surgery), the women are cared for by their family doctor, “and we find that when they return to us in pregnancy their nutrient deficiencies have not been properly addressed. They need to be addressed at least 6 months prior to conception.”

“We recommend that women wait at least 2 years after bariatric surgery before trying to conceive, irrespective of the type of surgery,” she reiterated.

Dr. Carreira and Dr. Johansson have reported no relevant financial relationships.

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

A new study highlights the importance of avoiding both exogenous hyperthyroidism and exogenous hypothyroidism to decrease cardiovascular risk and death among patients receiving thyroid hormone treatment.

“Our findings suggest that clinicians should make every effort to maintain euthyroidism in patients on thyroid hormone treatment, regardless of underlying cardiovascular risk, particularly in vulnerable populations, such as older adults,” senior author Maria Papaleontiou, MD, said in an interview.

Commenting on the study, David S. Cooper, MD, of Johns Hopkins University School of Medicine, Baltimore, agreed that the findings are significant.

“Both undertreatment and overtreatment were associated with adverse cardiovascular outcomes, meaning that patients’ thyroid function needs to be monitored, and levothyroxine adjusted if need be, on an ongoing basis,” he told this news organization.
 

Getting the balance right: a tricky task

Variations in thyroid hormone levels falling above or below target ranges are common with thyroid hormone therapy, as a wide array of factors can prompt the need to regularly adjust dosing to maintain “index” levels. And while guidelines from the American Thyroid Association (ATA) recommend maintaining serum thyroid stimulating hormone (TSH) levels in the normal ranges during treatment, the task is tricky.

“Despite these [ATA] guidelines, prior studies in adults with hypothyroidism have shown that up to 30% are undertreated and up to 48% are overtreated,” said Dr. Papaleontiou, an assistant professor in the Division of Metabolism, Endocrinology at the University of Michigan, Ann Arbor.

In a previous study, Dr. Papaleontiou and colleagues showed that the intensity of thyroid hormone treatment is a modifiable risk factor for incident atrial fibrillation and stroke, however, less is understood about the association with cardiovascular mortality.

For the new study, published in JAMA Network Open, Josh M. Evron, MD, of the University of North Carolina, Chapel Hill, and colleagues further investigated the issue in a large, retrospective cohort of 705,307 adults in the Veterans Health Administration Corporate Data Warehouse treated with thyroid hormone during 2004-2017 who had a median follow-up of 4 years.

They investigated the roles of TSH as well as free thyroxine (FT4) levels among 701,929 adults in the group with data on TSH and 373,981 patients with FT4 measurements.

The mean age of participants was 67 years and 88.7% were male.

Over the course of the study, 10.8% of patients (75,963) died of cardiovascular causes.

Compared with patients with normal thyroid levels, those with exogenous hyperthyroidism related to thyroid hormone treatment had an increased risk of cardiovascular mortality, specifically including when TSH levels were below 0.1 mIU/L (adjusted hazard ratio, 1.39) and when FT4 levels were above 1.9 ng/dL (AHR, 1.29), independent of factors including age, sex, and traditional cardiovascular risk factors, including hypertension, smoking, and previous cardiovascular disease or arrhythmia.

In addition, the increased risk of cardiovascular mortality was observed with exogenous hypothyroidism, specifically among those with TSH levels above 20 mIU/L (AHR, 2.67) and FT4 levels below 0.7 ng/dL (AHR, 1.56), after multivariate adjustment.

Of note, the risk of cardiovascular mortality was dose-dependent, with the risk increasing progressively with the lower and higher TSH levels, compared with normal levels.

The increased mortality risk in relation to TSH levels was more pronounced among older patients, compared with FT4 associations, the authors note.

“From a clinical perspective, older adults, and particularly the oldest old (aged 85 years), appear to be the most vulnerable, with increased risk of cardiovascular mortality with both exogenous hyperthyroidism and hypothyroidism,” they report.

Among key limitations is that women, who make up the majority of patients with thyroid disease, are under-represented in the predominantly male population of the Veterans Health Administration.

Nevertheless, “because the risk of cardiovascular disease is higher for men than for women, and because more than 70,000 women were included in this cohort, the results of this study are highly clinically relevant,” the authors note.

Addressing over- and under-treatment will avoid harm

The results are also important considering the status of levothyroxine (for hypothyroidism) as consistently ranking among the top three prescription medications in the United States.

And with the common occurrence of exogenous hyperthyroidism or hypothyroidism, the findings have important implications.

“Addressing over- and under-treatment of hypothyroidism promptly will help reduce patient harm, particularly in vulnerable populations such as older adults who are at higher risk for adverse effects,” Dr. Papaleontiou said.

Dr. Cooper further commented that the findings underscore the need to be aware of treatment adjustments and targets that may vary according to patient age.

“In older persons, over 65-70, the target TSH may be higher [for example, 2-4 mIU/L] than in younger persons, and in patients above ages 70 or 80, serum TSH levels may be allowed to rise even further into the 4-6 mIU/L range,” he explained.

“The older the patient, the higher the chance for an adverse cardiovascular outcome if the TSH is subnormal due to iatrogenic thyrotoxicosis,” Dr. Cooper explained.

“In contrast, in younger individuals, an elevated TSH, indicating mild [subclinical] hypothyroidism may be associated with increased cardiovascular risk, especially with serum TSH levels greater than 7 mIU/L.”

The authors have reported no relevant financial relationships.

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

A new study highlights the importance of avoiding both exogenous hyperthyroidism and exogenous hypothyroidism to decrease cardiovascular risk and death among patients receiving thyroid hormone treatment.

“Our findings suggest that clinicians should make every effort to maintain euthyroidism in patients on thyroid hormone treatment, regardless of underlying cardiovascular risk, particularly in vulnerable populations, such as older adults,” senior author Maria Papaleontiou, MD, said in an interview.

Commenting on the study, David S. Cooper, MD, of Johns Hopkins University School of Medicine, Baltimore, agreed that the findings are significant.

“Both undertreatment and overtreatment were associated with adverse cardiovascular outcomes, meaning that patients’ thyroid function needs to be monitored, and levothyroxine adjusted if need be, on an ongoing basis,” he told this news organization.
 

Getting the balance right: a tricky task

Variations in thyroid hormone levels falling above or below target ranges are common with thyroid hormone therapy, as a wide array of factors can prompt the need to regularly adjust dosing to maintain “index” levels. And while guidelines from the American Thyroid Association (ATA) recommend maintaining serum thyroid stimulating hormone (TSH) levels in the normal ranges during treatment, the task is tricky.

“Despite these [ATA] guidelines, prior studies in adults with hypothyroidism have shown that up to 30% are undertreated and up to 48% are overtreated,” said Dr. Papaleontiou, an assistant professor in the Division of Metabolism, Endocrinology at the University of Michigan, Ann Arbor.

In a previous study, Dr. Papaleontiou and colleagues showed that the intensity of thyroid hormone treatment is a modifiable risk factor for incident atrial fibrillation and stroke, however, less is understood about the association with cardiovascular mortality.

For the new study, published in JAMA Network Open, Josh M. Evron, MD, of the University of North Carolina, Chapel Hill, and colleagues further investigated the issue in a large, retrospective cohort of 705,307 adults in the Veterans Health Administration Corporate Data Warehouse treated with thyroid hormone during 2004-2017 who had a median follow-up of 4 years.

They investigated the roles of TSH as well as free thyroxine (FT4) levels among 701,929 adults in the group with data on TSH and 373,981 patients with FT4 measurements.

The mean age of participants was 67 years and 88.7% were male.

Over the course of the study, 10.8% of patients (75,963) died of cardiovascular causes.

Compared with patients with normal thyroid levels, those with exogenous hyperthyroidism related to thyroid hormone treatment had an increased risk of cardiovascular mortality, specifically including when TSH levels were below 0.1 mIU/L (adjusted hazard ratio, 1.39) and when FT4 levels were above 1.9 ng/dL (AHR, 1.29), independent of factors including age, sex, and traditional cardiovascular risk factors, including hypertension, smoking, and previous cardiovascular disease or arrhythmia.

In addition, the increased risk of cardiovascular mortality was observed with exogenous hypothyroidism, specifically among those with TSH levels above 20 mIU/L (AHR, 2.67) and FT4 levels below 0.7 ng/dL (AHR, 1.56), after multivariate adjustment.

Of note, the risk of cardiovascular mortality was dose-dependent, with the risk increasing progressively with the lower and higher TSH levels, compared with normal levels.

The increased mortality risk in relation to TSH levels was more pronounced among older patients, compared with FT4 associations, the authors note.

“From a clinical perspective, older adults, and particularly the oldest old (aged 85 years), appear to be the most vulnerable, with increased risk of cardiovascular mortality with both exogenous hyperthyroidism and hypothyroidism,” they report.

Among key limitations is that women, who make up the majority of patients with thyroid disease, are under-represented in the predominantly male population of the Veterans Health Administration.

Nevertheless, “because the risk of cardiovascular disease is higher for men than for women, and because more than 70,000 women were included in this cohort, the results of this study are highly clinically relevant,” the authors note.

Addressing over- and under-treatment will avoid harm

The results are also important considering the status of levothyroxine (for hypothyroidism) as consistently ranking among the top three prescription medications in the United States.

And with the common occurrence of exogenous hyperthyroidism or hypothyroidism, the findings have important implications.

“Addressing over- and under-treatment of hypothyroidism promptly will help reduce patient harm, particularly in vulnerable populations such as older adults who are at higher risk for adverse effects,” Dr. Papaleontiou said.

Dr. Cooper further commented that the findings underscore the need to be aware of treatment adjustments and targets that may vary according to patient age.

“In older persons, over 65-70, the target TSH may be higher [for example, 2-4 mIU/L] than in younger persons, and in patients above ages 70 or 80, serum TSH levels may be allowed to rise even further into the 4-6 mIU/L range,” he explained.

“The older the patient, the higher the chance for an adverse cardiovascular outcome if the TSH is subnormal due to iatrogenic thyrotoxicosis,” Dr. Cooper explained.

“In contrast, in younger individuals, an elevated TSH, indicating mild [subclinical] hypothyroidism may be associated with increased cardiovascular risk, especially with serum TSH levels greater than 7 mIU/L.”

The authors have reported no relevant financial relationships.

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

A new study highlights the importance of avoiding both exogenous hyperthyroidism and exogenous hypothyroidism to decrease cardiovascular risk and death among patients receiving thyroid hormone treatment.

“Our findings suggest that clinicians should make every effort to maintain euthyroidism in patients on thyroid hormone treatment, regardless of underlying cardiovascular risk, particularly in vulnerable populations, such as older adults,” senior author Maria Papaleontiou, MD, said in an interview.

Commenting on the study, David S. Cooper, MD, of Johns Hopkins University School of Medicine, Baltimore, agreed that the findings are significant.

“Both undertreatment and overtreatment were associated with adverse cardiovascular outcomes, meaning that patients’ thyroid function needs to be monitored, and levothyroxine adjusted if need be, on an ongoing basis,” he told this news organization.
 

Getting the balance right: a tricky task

Variations in thyroid hormone levels falling above or below target ranges are common with thyroid hormone therapy, as a wide array of factors can prompt the need to regularly adjust dosing to maintain “index” levels. And while guidelines from the American Thyroid Association (ATA) recommend maintaining serum thyroid stimulating hormone (TSH) levels in the normal ranges during treatment, the task is tricky.

“Despite these [ATA] guidelines, prior studies in adults with hypothyroidism have shown that up to 30% are undertreated and up to 48% are overtreated,” said Dr. Papaleontiou, an assistant professor in the Division of Metabolism, Endocrinology at the University of Michigan, Ann Arbor.

In a previous study, Dr. Papaleontiou and colleagues showed that the intensity of thyroid hormone treatment is a modifiable risk factor for incident atrial fibrillation and stroke, however, less is understood about the association with cardiovascular mortality.

For the new study, published in JAMA Network Open, Josh M. Evron, MD, of the University of North Carolina, Chapel Hill, and colleagues further investigated the issue in a large, retrospective cohort of 705,307 adults in the Veterans Health Administration Corporate Data Warehouse treated with thyroid hormone during 2004-2017 who had a median follow-up of 4 years.

They investigated the roles of TSH as well as free thyroxine (FT4) levels among 701,929 adults in the group with data on TSH and 373,981 patients with FT4 measurements.

The mean age of participants was 67 years and 88.7% were male.

Over the course of the study, 10.8% of patients (75,963) died of cardiovascular causes.

Compared with patients with normal thyroid levels, those with exogenous hyperthyroidism related to thyroid hormone treatment had an increased risk of cardiovascular mortality, specifically including when TSH levels were below 0.1 mIU/L (adjusted hazard ratio, 1.39) and when FT4 levels were above 1.9 ng/dL (AHR, 1.29), independent of factors including age, sex, and traditional cardiovascular risk factors, including hypertension, smoking, and previous cardiovascular disease or arrhythmia.

In addition, the increased risk of cardiovascular mortality was observed with exogenous hypothyroidism, specifically among those with TSH levels above 20 mIU/L (AHR, 2.67) and FT4 levels below 0.7 ng/dL (AHR, 1.56), after multivariate adjustment.

Of note, the risk of cardiovascular mortality was dose-dependent, with the risk increasing progressively with the lower and higher TSH levels, compared with normal levels.

The increased mortality risk in relation to TSH levels was more pronounced among older patients, compared with FT4 associations, the authors note.

“From a clinical perspective, older adults, and particularly the oldest old (aged 85 years), appear to be the most vulnerable, with increased risk of cardiovascular mortality with both exogenous hyperthyroidism and hypothyroidism,” they report.

Among key limitations is that women, who make up the majority of patients with thyroid disease, are under-represented in the predominantly male population of the Veterans Health Administration.

Nevertheless, “because the risk of cardiovascular disease is higher for men than for women, and because more than 70,000 women were included in this cohort, the results of this study are highly clinically relevant,” the authors note.

Addressing over- and under-treatment will avoid harm

The results are also important considering the status of levothyroxine (for hypothyroidism) as consistently ranking among the top three prescription medications in the United States.

And with the common occurrence of exogenous hyperthyroidism or hypothyroidism, the findings have important implications.

“Addressing over- and under-treatment of hypothyroidism promptly will help reduce patient harm, particularly in vulnerable populations such as older adults who are at higher risk for adverse effects,” Dr. Papaleontiou said.

Dr. Cooper further commented that the findings underscore the need to be aware of treatment adjustments and targets that may vary according to patient age.

“In older persons, over 65-70, the target TSH may be higher [for example, 2-4 mIU/L] than in younger persons, and in patients above ages 70 or 80, serum TSH levels may be allowed to rise even further into the 4-6 mIU/L range,” he explained.

“The older the patient, the higher the chance for an adverse cardiovascular outcome if the TSH is subnormal due to iatrogenic thyrotoxicosis,” Dr. Cooper explained.

“In contrast, in younger individuals, an elevated TSH, indicating mild [subclinical] hypothyroidism may be associated with increased cardiovascular risk, especially with serum TSH levels greater than 7 mIU/L.”

The authors have reported no relevant financial relationships.

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

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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