Clinical Endocrinology News

COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.

Floaria Bicher/iStock/Getty Images Plus

“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.

The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.

“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.

The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.

The initial findings from the registry were published online in the Journal of the American College of Cardiology.
 

Atypical symptoms may explain high death rate

The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls). 

This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.

The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.

These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.

The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.

COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.

Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).

The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.

Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.

“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.  

“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.

Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.

Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.

This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.

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

COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.

Floaria Bicher/iStock/Getty Images Plus

“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.

The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.

“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.

The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.

The initial findings from the registry were published online in the Journal of the American College of Cardiology.
 

Atypical symptoms may explain high death rate

The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls). 

This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.

The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.

These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.

The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.

COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.

Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).

The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.

Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.

“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.  

“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.

Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.

Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.

This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.

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

COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.

Floaria Bicher/iStock/Getty Images Plus

“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.

The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.

“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.

The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.

The initial findings from the registry were published online in the Journal of the American College of Cardiology.
 

Atypical symptoms may explain high death rate

The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls). 

This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.

The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.

These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.

The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.

COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.

Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).

The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.

Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.

“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.  

“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.

Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.

Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.

This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.

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

The United States Preventive Services Task Force recently released a draft of updated recommendations for screening for prediabetes and type 2 diabetes mellitus (DM). If accepted as written, the new recommendation will be to “screen all asymptomatic adults ages 35 to 70 years who are overweight or obese.” Upon diagnosis of prediabetes, the recommendation is to offer or refer patients to preventive interventions.

This new recommendation would replace the one from 2015, which recommended screening adults aged 40-70 who are overweight or obese, lowering the age at which screening begins by 5 years. It would also replace the recommendation of referral to intensive behavioral counseling to promote a healthy diet and exercise.¹

The American Diabetes Association (ADA) identifies A1c, fasting plasma glucose, or oral glucose tolerance tests as appropriate tests for the diagnosis of prediabetes and type 2 DM, and the new draft recommendation does not provide a preference for method of screening.²

The USPSTF’s draft recommendation could expand screening with the hope of identifying patients with prediabetes, or those with diabetes who are asymptomatic, with the intent of beginning treatment before there are serious complications.
 

Unknown diabetes or prediabetes diagnosis common

It has been estimated by the Centers for Disease Control and Prevention that 12% of U.S. adults had DM as of 2015, though nearly 24% were not aware that they had it. Also, according to the CDC, the prevalence of DM increases with age and is higher in those with less than a high school education. The same report indicates that more than 30% of U.S. adults have prediabetes, and with less than 12% of those individuals are aware of it.³ A possible explanation for a patient’s being unaware of a diagnosis could be that it has been documented in a chart but the patient does not know such information is in his or her health record. According to the evidence provided for the updated recommendation, earlier diagnosis may have an important benefit in preventing serious complications.

A modeling study compared simulated screening strategies and found that the most optimal screening strategy from a cost-effectiveness perspective begins between the ages of 30 and 45, with rescreening every 3-5 years. Further models have led researchers to conclude that early diagnosis can lead to decreased cardiovascular events as well as an opportunity for multifactorial treatment.¹ For this reason, it makes sense to expand the ages of screening for obese and overweight individuals.
 

Treatment recommendations are more flexible

The change in treatment recommendations for a new diagnosis of prediabetes is potentially more useful. It may not be feasible or reasonable for physicians to always provide or refer their patients for intensive behavior interventions. The updated recommendation would allow for the inclusion of not only behavioral counseling and health education, but also potential medication options that are currently available but not approved, or that may be available in the future. The evidence review seemed to be mixed in outcome in this area, so the increased flexibility will likely allow for future opportunities.

Screening criteria may be too narrow

This recommendation, does not, however, provide any guidance on screening of individuals who have other risk factors besides a body mass index consistent with overweight or obesity. It seems that this may be a missed opportunity.

The draft statement clearly indicates that there are other factors associated with increased risk of developing DM, but does not consider these factors in determining which patients should be screened. Both the ADA and the American Association of Clinical Endocrinology (AACE) have recommendations for universal screening for all adults 45 and older, acknowledging that incidence of DM increases with age. The ADA also recommends screening individuals who are overweight or obese and have an additional risk factor regardless of age. The AACE recommends screening all individuals for risk factors regardless of age.

The current and draft recommendations by the USPSTF do not address other risk factors and indicate only that further research is needed to understand the risk associated with DM and the natural history of pre-DM and who may progress to DM or revert to normoglycemia. Without comment on other risk factors or universal screening with age, the USPSTF recommendation potentially would not be sensitive enough to capture all those who may meet criteria for prediabetes or DM.^2,4

In addition to not addressing other risk factors and screening for those of normal and underweight BMI, the USPSTF recommendation does not address frequency of screening. The recommendations from both the ADA and the AACE indicate screening at 3-year intervals for those who are eligible – for any reason. The supporting evidence review did not seem to address this aspect, and so it is understandable that there was no comment. However, I feel this will lead physicians to turn to the other guidelines for guidance where there is disagreement in other aspects.

Ultimately, the draft updated recommendation will provide physicians with the opportunity to identify more patients with prediabetes and DM. This will be wonderful in terms of being able to offer treatments and lifestyle interventions to decrease the morbidity patients would face were these conditions not diagnosed. I hope that future recommendations will also address risk factors in addition to BMI as well as frequency of screening for those who remain at increased risk but initially screen negative.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

References

1. Screening for prediabetes and type 2 diabetes mellitus. U.S. Preventive Services Task Force. 2021 Mar 16.

2. Classification and diagnosis of diabetes: Standards of medical care in diabetes – 2020. American Diabetes Association. Diabetes Care. 2020 Jan. doi: 10.2337/dc20-S002.

3. National Diabetes Statistics Report, 2020. Centers for Disease Control and Prevention.

4. American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan. Hadelsman Y et al. Endocr Pract. 2015 Apr. 1-87. doi: 10.4158/EP15672.GL.

The United States Preventive Services Task Force recently released a draft of updated recommendations for screening for prediabetes and type 2 diabetes mellitus (DM). If accepted as written, the new recommendation will be to “screen all asymptomatic adults ages 35 to 70 years who are overweight or obese.” Upon diagnosis of prediabetes, the recommendation is to offer or refer patients to preventive interventions.

This new recommendation would replace the one from 2015, which recommended screening adults aged 40-70 who are overweight or obese, lowering the age at which screening begins by 5 years. It would also replace the recommendation of referral to intensive behavioral counseling to promote a healthy diet and exercise.¹

The American Diabetes Association (ADA) identifies A1c, fasting plasma glucose, or oral glucose tolerance tests as appropriate tests for the diagnosis of prediabetes and type 2 DM, and the new draft recommendation does not provide a preference for method of screening.²

The USPSTF’s draft recommendation could expand screening with the hope of identifying patients with prediabetes, or those with diabetes who are asymptomatic, with the intent of beginning treatment before there are serious complications.
 

Unknown diabetes or prediabetes diagnosis common

It has been estimated by the Centers for Disease Control and Prevention that 12% of U.S. adults had DM as of 2015, though nearly 24% were not aware that they had it. Also, according to the CDC, the prevalence of DM increases with age and is higher in those with less than a high school education. The same report indicates that more than 30% of U.S. adults have prediabetes, and with less than 12% of those individuals are aware of it.³ A possible explanation for a patient’s being unaware of a diagnosis could be that it has been documented in a chart but the patient does not know such information is in his or her health record. According to the evidence provided for the updated recommendation, earlier diagnosis may have an important benefit in preventing serious complications.

A modeling study compared simulated screening strategies and found that the most optimal screening strategy from a cost-effectiveness perspective begins between the ages of 30 and 45, with rescreening every 3-5 years. Further models have led researchers to conclude that early diagnosis can lead to decreased cardiovascular events as well as an opportunity for multifactorial treatment.¹ For this reason, it makes sense to expand the ages of screening for obese and overweight individuals.
 

Treatment recommendations are more flexible

The change in treatment recommendations for a new diagnosis of prediabetes is potentially more useful. It may not be feasible or reasonable for physicians to always provide or refer their patients for intensive behavior interventions. The updated recommendation would allow for the inclusion of not only behavioral counseling and health education, but also potential medication options that are currently available but not approved, or that may be available in the future. The evidence review seemed to be mixed in outcome in this area, so the increased flexibility will likely allow for future opportunities.

Screening criteria may be too narrow

This recommendation, does not, however, provide any guidance on screening of individuals who have other risk factors besides a body mass index consistent with overweight or obesity. It seems that this may be a missed opportunity.

The draft statement clearly indicates that there are other factors associated with increased risk of developing DM, but does not consider these factors in determining which patients should be screened. Both the ADA and the American Association of Clinical Endocrinology (AACE) have recommendations for universal screening for all adults 45 and older, acknowledging that incidence of DM increases with age. The ADA also recommends screening individuals who are overweight or obese and have an additional risk factor regardless of age. The AACE recommends screening all individuals for risk factors regardless of age.

The current and draft recommendations by the USPSTF do not address other risk factors and indicate only that further research is needed to understand the risk associated with DM and the natural history of pre-DM and who may progress to DM or revert to normoglycemia. Without comment on other risk factors or universal screening with age, the USPSTF recommendation potentially would not be sensitive enough to capture all those who may meet criteria for prediabetes or DM.^2,4

In addition to not addressing other risk factors and screening for those of normal and underweight BMI, the USPSTF recommendation does not address frequency of screening. The recommendations from both the ADA and the AACE indicate screening at 3-year intervals for those who are eligible – for any reason. The supporting evidence review did not seem to address this aspect, and so it is understandable that there was no comment. However, I feel this will lead physicians to turn to the other guidelines for guidance where there is disagreement in other aspects.

Ultimately, the draft updated recommendation will provide physicians with the opportunity to identify more patients with prediabetes and DM. This will be wonderful in terms of being able to offer treatments and lifestyle interventions to decrease the morbidity patients would face were these conditions not diagnosed. I hope that future recommendations will also address risk factors in addition to BMI as well as frequency of screening for those who remain at increased risk but initially screen negative.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

References

1. Screening for prediabetes and type 2 diabetes mellitus. U.S. Preventive Services Task Force. 2021 Mar 16.

2. Classification and diagnosis of diabetes: Standards of medical care in diabetes – 2020. American Diabetes Association. Diabetes Care. 2020 Jan. doi: 10.2337/dc20-S002.

3. National Diabetes Statistics Report, 2020. Centers for Disease Control and Prevention.

4. American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan. Hadelsman Y et al. Endocr Pract. 2015 Apr. 1-87. doi: 10.4158/EP15672.GL.

The United States Preventive Services Task Force recently released a draft of updated recommendations for screening for prediabetes and type 2 diabetes mellitus (DM). If accepted as written, the new recommendation will be to “screen all asymptomatic adults ages 35 to 70 years who are overweight or obese.” Upon diagnosis of prediabetes, the recommendation is to offer or refer patients to preventive interventions.

This new recommendation would replace the one from 2015, which recommended screening adults aged 40-70 who are overweight or obese, lowering the age at which screening begins by 5 years. It would also replace the recommendation of referral to intensive behavioral counseling to promote a healthy diet and exercise.¹

The American Diabetes Association (ADA) identifies A1c, fasting plasma glucose, or oral glucose tolerance tests as appropriate tests for the diagnosis of prediabetes and type 2 DM, and the new draft recommendation does not provide a preference for method of screening.²

The USPSTF’s draft recommendation could expand screening with the hope of identifying patients with prediabetes, or those with diabetes who are asymptomatic, with the intent of beginning treatment before there are serious complications.
 

Unknown diabetes or prediabetes diagnosis common

It has been estimated by the Centers for Disease Control and Prevention that 12% of U.S. adults had DM as of 2015, though nearly 24% were not aware that they had it. Also, according to the CDC, the prevalence of DM increases with age and is higher in those with less than a high school education. The same report indicates that more than 30% of U.S. adults have prediabetes, and with less than 12% of those individuals are aware of it.³ A possible explanation for a patient’s being unaware of a diagnosis could be that it has been documented in a chart but the patient does not know such information is in his or her health record. According to the evidence provided for the updated recommendation, earlier diagnosis may have an important benefit in preventing serious complications.

A modeling study compared simulated screening strategies and found that the most optimal screening strategy from a cost-effectiveness perspective begins between the ages of 30 and 45, with rescreening every 3-5 years. Further models have led researchers to conclude that early diagnosis can lead to decreased cardiovascular events as well as an opportunity for multifactorial treatment.¹ For this reason, it makes sense to expand the ages of screening for obese and overweight individuals.
 

Treatment recommendations are more flexible

The change in treatment recommendations for a new diagnosis of prediabetes is potentially more useful. It may not be feasible or reasonable for physicians to always provide or refer their patients for intensive behavior interventions. The updated recommendation would allow for the inclusion of not only behavioral counseling and health education, but also potential medication options that are currently available but not approved, or that may be available in the future. The evidence review seemed to be mixed in outcome in this area, so the increased flexibility will likely allow for future opportunities.

Screening criteria may be too narrow

This recommendation, does not, however, provide any guidance on screening of individuals who have other risk factors besides a body mass index consistent with overweight or obesity. It seems that this may be a missed opportunity.

The draft statement clearly indicates that there are other factors associated with increased risk of developing DM, but does not consider these factors in determining which patients should be screened. Both the ADA and the American Association of Clinical Endocrinology (AACE) have recommendations for universal screening for all adults 45 and older, acknowledging that incidence of DM increases with age. The ADA also recommends screening individuals who are overweight or obese and have an additional risk factor regardless of age. The AACE recommends screening all individuals for risk factors regardless of age.

The current and draft recommendations by the USPSTF do not address other risk factors and indicate only that further research is needed to understand the risk associated with DM and the natural history of pre-DM and who may progress to DM or revert to normoglycemia. Without comment on other risk factors or universal screening with age, the USPSTF recommendation potentially would not be sensitive enough to capture all those who may meet criteria for prediabetes or DM.^2,4

In addition to not addressing other risk factors and screening for those of normal and underweight BMI, the USPSTF recommendation does not address frequency of screening. The recommendations from both the ADA and the AACE indicate screening at 3-year intervals for those who are eligible – for any reason. The supporting evidence review did not seem to address this aspect, and so it is understandable that there was no comment. However, I feel this will lead physicians to turn to the other guidelines for guidance where there is disagreement in other aspects.

Ultimately, the draft updated recommendation will provide physicians with the opportunity to identify more patients with prediabetes and DM. This will be wonderful in terms of being able to offer treatments and lifestyle interventions to decrease the morbidity patients would face were these conditions not diagnosed. I hope that future recommendations will also address risk factors in addition to BMI as well as frequency of screening for those who remain at increased risk but initially screen negative.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

References

1. Screening for prediabetes and type 2 diabetes mellitus. U.S. Preventive Services Task Force. 2021 Mar 16.

2. Classification and diagnosis of diabetes: Standards of medical care in diabetes – 2020. American Diabetes Association. Diabetes Care. 2020 Jan. doi: 10.2337/dc20-S002.

3. National Diabetes Statistics Report, 2020. Centers for Disease Control and Prevention.

4. American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan. Hadelsman Y et al. Endocr Pract. 2015 Apr. 1-87. doi: 10.4158/EP15672.GL.

An updated American Heart Association scientific statement on the role of obesity in cardiovascular disease provides the first new guidance in 15 years, drawing on evidence that’s emerged in that time to clarify the potential of newer drug therapies and interventions like bariatric surgery and lifestyle modifications to curtail cardiovascular disease risks.

“The timing of this information is important because the obesity epidemic contributes significantly to the global burden of cardiovascular disease and numerous chronic health conditions that also impact heart disease,” said Tiffany Powell-Wiley, MD, MPH, chair of the volunteer statement writing group.

“One of the big takeaways that I hope people get from the statement is really making it clear that obesity is a complex disease, and that it is multifactorial,” Dr. Powell-Wiley said in an interview. “There are not just biological reasons why individuals have obesity, but there are environmental, psychosocial, and really multilevel factors that contribute to the development and course of obesity.”

Most significantly, Dr. Powell-Wiley said, “we want to emphasize that we really want to have cardiologists think about and focus on abdominal obesity in particular.”

A metric for cardiovascular risk that seems to gain credibility in the statement is the relationship of waist circumference to height regardless of overall weight. “That is a very important finding that we can now really think of waist circumference as an important measure in our clinical practice,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory in the division of intramural research at the National Heart, Lung, and Blood Institute. “We want to get across to providers that this is something that should be measured and should be followed over time, based on data from the last 15 years that waist circumference and abdominal obesity are associated with higher cardiovascular risk regardless of body mass index.”

The statement provides potentially groundbreaking advice on atrial fibrillation as a consequence of weight, noted Dr. Powell-Wiley. “Up until recently, we haven’t really thought about weight management as a part of managing Afib [atrial fibrillation],” she said. “This statement highlights the need to think about weight management in addition to anticoagulation as part of the pieces for managing Afib.”
 

Evidence on interventions

The statement, published in Circulation, also dives into the evidence surrounding the varied interventions for managing weight.

American Heart Association

“The biggest area where there’s much more data is bariatric surgery,” said Dr. Powell-Wiley. “There’s clear evidence that bariatric surgery lowers cardio mortality and all-cause mortality for patients, but we’ve also seen data around lifestyle interventions, with the Look AHEAD trial, which showed that while there were improvements in CV [cardiovascular] risk factors, we didn’t see the reduction in CV mortality that we wanted to see.”

The statement noted that the Look AHEAD trial (for Action for Health in Diabetes) of people with type 2 diabetes failed to show a significant reduction in major adverse cardiac events or CV mortality after almost 10 years of an intensive weight-loss intervention. Dr. Powell-Wiley added that the result seemed to be related more to the lack of weight loss with lifestyle interventions when compared with bariatric surgery.

The statement also addressed the effectiveness of drug treatments for weight control in managing CV risk, and while the evidence supporting pharmacotherapy specifically for weight loss has been mixed, emerging treatments have shown promise, Dr. Powell-Wiley said. “I think we now have some bright spots with new therapies that have been developed for diabetes and heart failure, such as the SGLT2 inhibitors as well as the GLP-1 agonists, and how they can also appear to improve weight and likely will improve CV mortality in patients with obesity.”

The “obesity paradox,” which Dr. Powell-Wiley noted is “definitely a controversial topic,” is also addressed in the statement. “We try to explain what it is and what we know about it right now,” she said. “We know for instance that patients with obesity, particularly those who have class 1 obesity or patients who are overweight, seem to do better in the short term in relation to coronary artery disease and heart failure, but the reasons for that are not necessarily clear.”

The statement also provides evidence-based insights on the use of diagnostic tools, including stress echocardiography and cardiac MRI as well as coronary angiography, and the clinical significance of specific echocardiographic changes in obese patients.

The writing committee also identified areas that need future research. “It’s really important to emphasize what we learned about the complexity of obesity over this time period,” Dr. Powell-Wiley said. “But again, we don’t have all the answers; there’s a lot more work to be done to understand what type of lifestyle intervention might be most beneficial, especially with addressing abdominal obesity, and how these new therapeutics around heart failure and diabetes may be useful in patients with obesity.

Obesity in adolescents is another area that needs further research, Dr. Powell-Wiley said. “How do we prevent obesity in those populations when we know they’re at risk for so much as they get older? Once you have obesity it’s hard to change that trajectory.”

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Clinical Cardiology, the Council on Epidemiology and Prevention, and the Stroke Council. Committee vice chair Paul Poirier, MD, PhD, reported financial relationships with Abbott, Amgen, AstraZeneca, Bausch Health, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, Novo Nordisk, Sanofi, Servier, and HLS Therapeutics. One committee member disclosed a financial relationship with AstraZeneca. Dr. Powell-Wiley and the other committee members have no relationships to disclose.

An updated American Heart Association scientific statement on the role of obesity in cardiovascular disease provides the first new guidance in 15 years, drawing on evidence that’s emerged in that time to clarify the potential of newer drug therapies and interventions like bariatric surgery and lifestyle modifications to curtail cardiovascular disease risks.

“The timing of this information is important because the obesity epidemic contributes significantly to the global burden of cardiovascular disease and numerous chronic health conditions that also impact heart disease,” said Tiffany Powell-Wiley, MD, MPH, chair of the volunteer statement writing group.

“One of the big takeaways that I hope people get from the statement is really making it clear that obesity is a complex disease, and that it is multifactorial,” Dr. Powell-Wiley said in an interview. “There are not just biological reasons why individuals have obesity, but there are environmental, psychosocial, and really multilevel factors that contribute to the development and course of obesity.”

Most significantly, Dr. Powell-Wiley said, “we want to emphasize that we really want to have cardiologists think about and focus on abdominal obesity in particular.”

A metric for cardiovascular risk that seems to gain credibility in the statement is the relationship of waist circumference to height regardless of overall weight. “That is a very important finding that we can now really think of waist circumference as an important measure in our clinical practice,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory in the division of intramural research at the National Heart, Lung, and Blood Institute. “We want to get across to providers that this is something that should be measured and should be followed over time, based on data from the last 15 years that waist circumference and abdominal obesity are associated with higher cardiovascular risk regardless of body mass index.”

The statement provides potentially groundbreaking advice on atrial fibrillation as a consequence of weight, noted Dr. Powell-Wiley. “Up until recently, we haven’t really thought about weight management as a part of managing Afib [atrial fibrillation],” she said. “This statement highlights the need to think about weight management in addition to anticoagulation as part of the pieces for managing Afib.”
 

Evidence on interventions

The statement, published in Circulation, also dives into the evidence surrounding the varied interventions for managing weight.

American Heart Association

“The biggest area where there’s much more data is bariatric surgery,” said Dr. Powell-Wiley. “There’s clear evidence that bariatric surgery lowers cardio mortality and all-cause mortality for patients, but we’ve also seen data around lifestyle interventions, with the Look AHEAD trial, which showed that while there were improvements in CV [cardiovascular] risk factors, we didn’t see the reduction in CV mortality that we wanted to see.”

The statement noted that the Look AHEAD trial (for Action for Health in Diabetes) of people with type 2 diabetes failed to show a significant reduction in major adverse cardiac events or CV mortality after almost 10 years of an intensive weight-loss intervention. Dr. Powell-Wiley added that the result seemed to be related more to the lack of weight loss with lifestyle interventions when compared with bariatric surgery.

The statement also addressed the effectiveness of drug treatments for weight control in managing CV risk, and while the evidence supporting pharmacotherapy specifically for weight loss has been mixed, emerging treatments have shown promise, Dr. Powell-Wiley said. “I think we now have some bright spots with new therapies that have been developed for diabetes and heart failure, such as the SGLT2 inhibitors as well as the GLP-1 agonists, and how they can also appear to improve weight and likely will improve CV mortality in patients with obesity.”

The “obesity paradox,” which Dr. Powell-Wiley noted is “definitely a controversial topic,” is also addressed in the statement. “We try to explain what it is and what we know about it right now,” she said. “We know for instance that patients with obesity, particularly those who have class 1 obesity or patients who are overweight, seem to do better in the short term in relation to coronary artery disease and heart failure, but the reasons for that are not necessarily clear.”

The statement also provides evidence-based insights on the use of diagnostic tools, including stress echocardiography and cardiac MRI as well as coronary angiography, and the clinical significance of specific echocardiographic changes in obese patients.

The writing committee also identified areas that need future research. “It’s really important to emphasize what we learned about the complexity of obesity over this time period,” Dr. Powell-Wiley said. “But again, we don’t have all the answers; there’s a lot more work to be done to understand what type of lifestyle intervention might be most beneficial, especially with addressing abdominal obesity, and how these new therapeutics around heart failure and diabetes may be useful in patients with obesity.

Obesity in adolescents is another area that needs further research, Dr. Powell-Wiley said. “How do we prevent obesity in those populations when we know they’re at risk for so much as they get older? Once you have obesity it’s hard to change that trajectory.”

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Clinical Cardiology, the Council on Epidemiology and Prevention, and the Stroke Council. Committee vice chair Paul Poirier, MD, PhD, reported financial relationships with Abbott, Amgen, AstraZeneca, Bausch Health, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, Novo Nordisk, Sanofi, Servier, and HLS Therapeutics. One committee member disclosed a financial relationship with AstraZeneca. Dr. Powell-Wiley and the other committee members have no relationships to disclose.

An updated American Heart Association scientific statement on the role of obesity in cardiovascular disease provides the first new guidance in 15 years, drawing on evidence that’s emerged in that time to clarify the potential of newer drug therapies and interventions like bariatric surgery and lifestyle modifications to curtail cardiovascular disease risks.

“The timing of this information is important because the obesity epidemic contributes significantly to the global burden of cardiovascular disease and numerous chronic health conditions that also impact heart disease,” said Tiffany Powell-Wiley, MD, MPH, chair of the volunteer statement writing group.

“One of the big takeaways that I hope people get from the statement is really making it clear that obesity is a complex disease, and that it is multifactorial,” Dr. Powell-Wiley said in an interview. “There are not just biological reasons why individuals have obesity, but there are environmental, psychosocial, and really multilevel factors that contribute to the development and course of obesity.”

Most significantly, Dr. Powell-Wiley said, “we want to emphasize that we really want to have cardiologists think about and focus on abdominal obesity in particular.”

A metric for cardiovascular risk that seems to gain credibility in the statement is the relationship of waist circumference to height regardless of overall weight. “That is a very important finding that we can now really think of waist circumference as an important measure in our clinical practice,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory in the division of intramural research at the National Heart, Lung, and Blood Institute. “We want to get across to providers that this is something that should be measured and should be followed over time, based on data from the last 15 years that waist circumference and abdominal obesity are associated with higher cardiovascular risk regardless of body mass index.”

The statement provides potentially groundbreaking advice on atrial fibrillation as a consequence of weight, noted Dr. Powell-Wiley. “Up until recently, we haven’t really thought about weight management as a part of managing Afib [atrial fibrillation],” she said. “This statement highlights the need to think about weight management in addition to anticoagulation as part of the pieces for managing Afib.”
 

Evidence on interventions

The statement, published in Circulation, also dives into the evidence surrounding the varied interventions for managing weight.

American Heart Association

“The biggest area where there’s much more data is bariatric surgery,” said Dr. Powell-Wiley. “There’s clear evidence that bariatric surgery lowers cardio mortality and all-cause mortality for patients, but we’ve also seen data around lifestyle interventions, with the Look AHEAD trial, which showed that while there were improvements in CV [cardiovascular] risk factors, we didn’t see the reduction in CV mortality that we wanted to see.”

The statement noted that the Look AHEAD trial (for Action for Health in Diabetes) of people with type 2 diabetes failed to show a significant reduction in major adverse cardiac events or CV mortality after almost 10 years of an intensive weight-loss intervention. Dr. Powell-Wiley added that the result seemed to be related more to the lack of weight loss with lifestyle interventions when compared with bariatric surgery.

The statement also addressed the effectiveness of drug treatments for weight control in managing CV risk, and while the evidence supporting pharmacotherapy specifically for weight loss has been mixed, emerging treatments have shown promise, Dr. Powell-Wiley said. “I think we now have some bright spots with new therapies that have been developed for diabetes and heart failure, such as the SGLT2 inhibitors as well as the GLP-1 agonists, and how they can also appear to improve weight and likely will improve CV mortality in patients with obesity.”

The “obesity paradox,” which Dr. Powell-Wiley noted is “definitely a controversial topic,” is also addressed in the statement. “We try to explain what it is and what we know about it right now,” she said. “We know for instance that patients with obesity, particularly those who have class 1 obesity or patients who are overweight, seem to do better in the short term in relation to coronary artery disease and heart failure, but the reasons for that are not necessarily clear.”

The statement also provides evidence-based insights on the use of diagnostic tools, including stress echocardiography and cardiac MRI as well as coronary angiography, and the clinical significance of specific echocardiographic changes in obese patients.

The writing committee also identified areas that need future research. “It’s really important to emphasize what we learned about the complexity of obesity over this time period,” Dr. Powell-Wiley said. “But again, we don’t have all the answers; there’s a lot more work to be done to understand what type of lifestyle intervention might be most beneficial, especially with addressing abdominal obesity, and how these new therapeutics around heart failure and diabetes may be useful in patients with obesity.

Obesity in adolescents is another area that needs further research, Dr. Powell-Wiley said. “How do we prevent obesity in those populations when we know they’re at risk for so much as they get older? Once you have obesity it’s hard to change that trajectory.”

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Clinical Cardiology, the Council on Epidemiology and Prevention, and the Stroke Council. Committee vice chair Paul Poirier, MD, PhD, reported financial relationships with Abbott, Amgen, AstraZeneca, Bausch Health, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, Novo Nordisk, Sanofi, Servier, and HLS Therapeutics. One committee member disclosed a financial relationship with AstraZeneca. Dr. Powell-Wiley and the other committee members have no relationships to disclose.

Excess mortality among people with endogenous Cushing’s syndrome (CS) has declined in the past 20 years yet remains three times higher than in the general population, new research finds.

Among more than 90,000 individuals with endogenous CS, the overall proportion of mortality – defined as the ratio of the number of deaths from CS divided by the total number of CS patients – was 0.05, and the standardized mortality rate was an “unacceptable” three times that of the general population, Padiporn Limumpornpetch, MD, reported on March 20 at ENDO 2021: The Endocrine Society Annual Meeting.

Excess deaths were higher among those with adrenal CS, compared with those with Cushing’s disease. The most common causes of death among those with CS were cardiovascular diseases, cerebrovascular accident, infection, and malignancy, noted Dr. Limumpornpetch, of Songkla University, Hat Yai, Thailand, who is also a PhD student at the University of Leeds, United Kingdom.

“While mortality has improved since 2000, it is still significantly compromised compared to the background population ... The causes of death highlight the need for aggressive management of cardiovascular risk, prevention of thromboembolism, infection control, and a normalized cortisol level,” she said.

Asked to comment, Maria Fleseriu, MD, told this news organization that the new data show “we are making improvements in the care of patients with CS and thus outcomes, but we are not there yet ... This meta-analysis highlights the whole spectrum of acute and life-threatening complications in CS and their high prevalence, even before disease diagnosis and after successful surgery.”

She noted that although she wasn’t surprised by the overall results, “the improvement over time was indeed lower than I expected. However, interestingly here, the risk of mortality in adrenal Cushing’s was unexpectedly high despite patients with adrenal cancer being excluded.”

Dr. Fleseriu, who is director of the Pituitary Center at Oregon Health and Science University, Portland, advised, “Management of hyperglycemia and diabetes, hypertension, hypokalemia, hyperlipidemia, and other cardiovascular risk factors is generally undertaken in accordance with standard of clinical care.”

“But we should focus more on optimizing more aggressively this care in addition to the specific Cushing’s treatment,” she stressed.

In addition, she noted, “Medical therapy for CS may be needed even prior to surgery in severe and/or prolonged hypercortisolism to decrease complications ... We definitely need a multidisciplinary approach to address complications and etiologic treatment as well as the reduced long-term quality of life in patients with CS.”

Largest study in scale and scope of Cushing’s syndrome mortality

Endogenous Cushing’s syndrome occurs when the body overproduces cortisol. The most common cause of the latter is a tumor of the pituitary gland (Cushing’s disease), but another cause is a usually benign tumor of the adrenal glands (adrenal Cushing’s syndrome). Surgery is the mainstay of initial treatment of Cushing’s syndrome. If an operation to remove the tumor fails to cause remission, medications are available.

Prior to this new meta-analysis, there had been limited data on mortality among patients with endogenous CS. Research has mostly been limited to single-cohort studies. A previous systematic review/meta-analysis comprised only seven articles with 780 patients. All the studies were conducted prior to 2012, and most were limited to Cushing’s disease.

“In 2021, we lacked a detailed understanding of patient outcomes and mortality because of the rarity of Cushing’s syndrome,” Dr. Limumpornpetch noted.

The current meta-analysis included 91 articles that reported mortality among patients with endogenous CS. There was a total of 19,181 patients from 92 study cohorts, including 49 studies on CD (n = 14,971), 24 studies on adrenal CS (n = 2304), and 19 studies that included both (n = 1906).

Among 21 studies that reported standardized mortality rate (SMR) data, including 13 CD studies (n = 2160) and seven on adrenal CS (n = 1531), the overall increase in mortality compared to the background population was a significant 3.00 (range, 1.15-7.84).

This SMR was higher among patients with adrenal Cushing’s syndrome (3.3) versus Cushing’s disease (2.8) (P = .003) and among patients who had active disease (5.7) versus those whose disease was in remission (2.3) (P < .001).

The SMR was also worse among patients with Cushing’s disease with larger tumors (macroadenomas), at 7.4, than among patients with very small tumors (microadenomas), at 1.9 (P = .004).

The proportion of death was 0.05 for CS overall, with 0.04 for CD and 0.02 for adrenal adenomas.

Compared to studies published prior to the year 2000, more recent studies seem to reflect advances in treatment and care. The overall proportion of death for all CS cohorts dropped from 0.10 to 0.03 (P < .001); for all CD cohorts, it dropped from 0.14 to 0.03; and for adrenal CS cohorts, it dropped from 0.09 to 0.03 (P = .04).

Causes of death were cardiovascular diseases (29.5% of cases), cerebrovascular accident (11.5%), infection (10.5%), and malignancy (10.1%). Less common causes of death were gastrointestinal bleeding and acute pancreatitis (3.7%), active CS (3.5%), adrenal insufficiency (2.5%), suicide (2.5%), and surgery (1.6%).

Overall, in the CS groups, the proportion of deaths within 30 days of surgery dropped from 0.04 prior to 2000 to 0.01 since (P = .07). For CD, the proportion dropped from 0.02 to 0.01 (P = .25).

Preventing perioperative mortality: Consider thromboprophylaxis

Dr. Fleseriu told this news organization that she believes hypercoagulability is “the least recognized complication with a big role in mortality.” Because most of the perioperative mortality is due to venous thromboembolism and infections, “thromboprophylaxis should be considered for CS patients with severe hypercortisolism and/or postoperatively, based on individual risk factors of thromboembolism and bleeding.”

Recently, Dr. Fleseriu’s group showed in a single retrospective study that the risk for arterial and venous thromboembolic events among patients with CS was approximately 20%. Many patients experienced more than one event. Risk was higher 30 to 60 days postoperatively.

The odds ratio of venous thromoboembolism among patients with CS was 18 times higher than in the normal population.

“Due to the additional thrombotic risk of surgery or any invasive procedure, anticoagulation prophylaxis should be at least considered in all patients with Cushing’s syndrome and balanced with individual bleeding risk,” Dr. Fleseriu advised.

A recent Pituitary Society workshop discussed the management of complications of CS at length; proceedings will be published soon, she noted.

Dr. Limumpornpetch commented, “We look forward to the day when our interdisciplinary approach to managing these challenging patients can deliver outcomes similar to the background population.”

Dr. Limumpornpetch has disclosed no relevant financial relationships. Dr. Fleseriu has been a scientific consultant to Recordati, Sparrow, and Strongbridge and has received grants (inst) from Novartis and Strongbridge.

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

Excess mortality among people with endogenous Cushing’s syndrome (CS) has declined in the past 20 years yet remains three times higher than in the general population, new research finds.

Among more than 90,000 individuals with endogenous CS, the overall proportion of mortality – defined as the ratio of the number of deaths from CS divided by the total number of CS patients – was 0.05, and the standardized mortality rate was an “unacceptable” three times that of the general population, Padiporn Limumpornpetch, MD, reported on March 20 at ENDO 2021: The Endocrine Society Annual Meeting.

Excess deaths were higher among those with adrenal CS, compared with those with Cushing’s disease. The most common causes of death among those with CS were cardiovascular diseases, cerebrovascular accident, infection, and malignancy, noted Dr. Limumpornpetch, of Songkla University, Hat Yai, Thailand, who is also a PhD student at the University of Leeds, United Kingdom.

“While mortality has improved since 2000, it is still significantly compromised compared to the background population ... The causes of death highlight the need for aggressive management of cardiovascular risk, prevention of thromboembolism, infection control, and a normalized cortisol level,” she said.

Asked to comment, Maria Fleseriu, MD, told this news organization that the new data show “we are making improvements in the care of patients with CS and thus outcomes, but we are not there yet ... This meta-analysis highlights the whole spectrum of acute and life-threatening complications in CS and their high prevalence, even before disease diagnosis and after successful surgery.”

She noted that although she wasn’t surprised by the overall results, “the improvement over time was indeed lower than I expected. However, interestingly here, the risk of mortality in adrenal Cushing’s was unexpectedly high despite patients with adrenal cancer being excluded.”

Dr. Fleseriu, who is director of the Pituitary Center at Oregon Health and Science University, Portland, advised, “Management of hyperglycemia and diabetes, hypertension, hypokalemia, hyperlipidemia, and other cardiovascular risk factors is generally undertaken in accordance with standard of clinical care.”

“But we should focus more on optimizing more aggressively this care in addition to the specific Cushing’s treatment,” she stressed.

In addition, she noted, “Medical therapy for CS may be needed even prior to surgery in severe and/or prolonged hypercortisolism to decrease complications ... We definitely need a multidisciplinary approach to address complications and etiologic treatment as well as the reduced long-term quality of life in patients with CS.”

Largest study in scale and scope of Cushing’s syndrome mortality

Endogenous Cushing’s syndrome occurs when the body overproduces cortisol. The most common cause of the latter is a tumor of the pituitary gland (Cushing’s disease), but another cause is a usually benign tumor of the adrenal glands (adrenal Cushing’s syndrome). Surgery is the mainstay of initial treatment of Cushing’s syndrome. If an operation to remove the tumor fails to cause remission, medications are available.

Prior to this new meta-analysis, there had been limited data on mortality among patients with endogenous CS. Research has mostly been limited to single-cohort studies. A previous systematic review/meta-analysis comprised only seven articles with 780 patients. All the studies were conducted prior to 2012, and most were limited to Cushing’s disease.

“In 2021, we lacked a detailed understanding of patient outcomes and mortality because of the rarity of Cushing’s syndrome,” Dr. Limumpornpetch noted.

The current meta-analysis included 91 articles that reported mortality among patients with endogenous CS. There was a total of 19,181 patients from 92 study cohorts, including 49 studies on CD (n = 14,971), 24 studies on adrenal CS (n = 2304), and 19 studies that included both (n = 1906).

Among 21 studies that reported standardized mortality rate (SMR) data, including 13 CD studies (n = 2160) and seven on adrenal CS (n = 1531), the overall increase in mortality compared to the background population was a significant 3.00 (range, 1.15-7.84).

This SMR was higher among patients with adrenal Cushing’s syndrome (3.3) versus Cushing’s disease (2.8) (P = .003) and among patients who had active disease (5.7) versus those whose disease was in remission (2.3) (P < .001).

The SMR was also worse among patients with Cushing’s disease with larger tumors (macroadenomas), at 7.4, than among patients with very small tumors (microadenomas), at 1.9 (P = .004).

The proportion of death was 0.05 for CS overall, with 0.04 for CD and 0.02 for adrenal adenomas.

Compared to studies published prior to the year 2000, more recent studies seem to reflect advances in treatment and care. The overall proportion of death for all CS cohorts dropped from 0.10 to 0.03 (P < .001); for all CD cohorts, it dropped from 0.14 to 0.03; and for adrenal CS cohorts, it dropped from 0.09 to 0.03 (P = .04).

Causes of death were cardiovascular diseases (29.5% of cases), cerebrovascular accident (11.5%), infection (10.5%), and malignancy (10.1%). Less common causes of death were gastrointestinal bleeding and acute pancreatitis (3.7%), active CS (3.5%), adrenal insufficiency (2.5%), suicide (2.5%), and surgery (1.6%).

Overall, in the CS groups, the proportion of deaths within 30 days of surgery dropped from 0.04 prior to 2000 to 0.01 since (P = .07). For CD, the proportion dropped from 0.02 to 0.01 (P = .25).

Preventing perioperative mortality: Consider thromboprophylaxis

Dr. Fleseriu told this news organization that she believes hypercoagulability is “the least recognized complication with a big role in mortality.” Because most of the perioperative mortality is due to venous thromboembolism and infections, “thromboprophylaxis should be considered for CS patients with severe hypercortisolism and/or postoperatively, based on individual risk factors of thromboembolism and bleeding.”

Recently, Dr. Fleseriu’s group showed in a single retrospective study that the risk for arterial and venous thromboembolic events among patients with CS was approximately 20%. Many patients experienced more than one event. Risk was higher 30 to 60 days postoperatively.

The odds ratio of venous thromoboembolism among patients with CS was 18 times higher than in the normal population.

“Due to the additional thrombotic risk of surgery or any invasive procedure, anticoagulation prophylaxis should be at least considered in all patients with Cushing’s syndrome and balanced with individual bleeding risk,” Dr. Fleseriu advised.

A recent Pituitary Society workshop discussed the management of complications of CS at length; proceedings will be published soon, she noted.

Dr. Limumpornpetch commented, “We look forward to the day when our interdisciplinary approach to managing these challenging patients can deliver outcomes similar to the background population.”

Dr. Limumpornpetch has disclosed no relevant financial relationships. Dr. Fleseriu has been a scientific consultant to Recordati, Sparrow, and Strongbridge and has received grants (inst) from Novartis and Strongbridge.

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

Excess mortality among people with endogenous Cushing’s syndrome (CS) has declined in the past 20 years yet remains three times higher than in the general population, new research finds.

Among more than 90,000 individuals with endogenous CS, the overall proportion of mortality – defined as the ratio of the number of deaths from CS divided by the total number of CS patients – was 0.05, and the standardized mortality rate was an “unacceptable” three times that of the general population, Padiporn Limumpornpetch, MD, reported on March 20 at ENDO 2021: The Endocrine Society Annual Meeting.

Excess deaths were higher among those with adrenal CS, compared with those with Cushing’s disease. The most common causes of death among those with CS were cardiovascular diseases, cerebrovascular accident, infection, and malignancy, noted Dr. Limumpornpetch, of Songkla University, Hat Yai, Thailand, who is also a PhD student at the University of Leeds, United Kingdom.

“While mortality has improved since 2000, it is still significantly compromised compared to the background population ... The causes of death highlight the need for aggressive management of cardiovascular risk, prevention of thromboembolism, infection control, and a normalized cortisol level,” she said.

Asked to comment, Maria Fleseriu, MD, told this news organization that the new data show “we are making improvements in the care of patients with CS and thus outcomes, but we are not there yet ... This meta-analysis highlights the whole spectrum of acute and life-threatening complications in CS and their high prevalence, even before disease diagnosis and after successful surgery.”

She noted that although she wasn’t surprised by the overall results, “the improvement over time was indeed lower than I expected. However, interestingly here, the risk of mortality in adrenal Cushing’s was unexpectedly high despite patients with adrenal cancer being excluded.”

Dr. Fleseriu, who is director of the Pituitary Center at Oregon Health and Science University, Portland, advised, “Management of hyperglycemia and diabetes, hypertension, hypokalemia, hyperlipidemia, and other cardiovascular risk factors is generally undertaken in accordance with standard of clinical care.”

“But we should focus more on optimizing more aggressively this care in addition to the specific Cushing’s treatment,” she stressed.

In addition, she noted, “Medical therapy for CS may be needed even prior to surgery in severe and/or prolonged hypercortisolism to decrease complications ... We definitely need a multidisciplinary approach to address complications and etiologic treatment as well as the reduced long-term quality of life in patients with CS.”

Largest study in scale and scope of Cushing’s syndrome mortality

Endogenous Cushing’s syndrome occurs when the body overproduces cortisol. The most common cause of the latter is a tumor of the pituitary gland (Cushing’s disease), but another cause is a usually benign tumor of the adrenal glands (adrenal Cushing’s syndrome). Surgery is the mainstay of initial treatment of Cushing’s syndrome. If an operation to remove the tumor fails to cause remission, medications are available.

Prior to this new meta-analysis, there had been limited data on mortality among patients with endogenous CS. Research has mostly been limited to single-cohort studies. A previous systematic review/meta-analysis comprised only seven articles with 780 patients. All the studies were conducted prior to 2012, and most were limited to Cushing’s disease.

“In 2021, we lacked a detailed understanding of patient outcomes and mortality because of the rarity of Cushing’s syndrome,” Dr. Limumpornpetch noted.

The current meta-analysis included 91 articles that reported mortality among patients with endogenous CS. There was a total of 19,181 patients from 92 study cohorts, including 49 studies on CD (n = 14,971), 24 studies on adrenal CS (n = 2304), and 19 studies that included both (n = 1906).

Among 21 studies that reported standardized mortality rate (SMR) data, including 13 CD studies (n = 2160) and seven on adrenal CS (n = 1531), the overall increase in mortality compared to the background population was a significant 3.00 (range, 1.15-7.84).

This SMR was higher among patients with adrenal Cushing’s syndrome (3.3) versus Cushing’s disease (2.8) (P = .003) and among patients who had active disease (5.7) versus those whose disease was in remission (2.3) (P < .001).

The SMR was also worse among patients with Cushing’s disease with larger tumors (macroadenomas), at 7.4, than among patients with very small tumors (microadenomas), at 1.9 (P = .004).

The proportion of death was 0.05 for CS overall, with 0.04 for CD and 0.02 for adrenal adenomas.

Compared to studies published prior to the year 2000, more recent studies seem to reflect advances in treatment and care. The overall proportion of death for all CS cohorts dropped from 0.10 to 0.03 (P < .001); for all CD cohorts, it dropped from 0.14 to 0.03; and for adrenal CS cohorts, it dropped from 0.09 to 0.03 (P = .04).

Causes of death were cardiovascular diseases (29.5% of cases), cerebrovascular accident (11.5%), infection (10.5%), and malignancy (10.1%). Less common causes of death were gastrointestinal bleeding and acute pancreatitis (3.7%), active CS (3.5%), adrenal insufficiency (2.5%), suicide (2.5%), and surgery (1.6%).

Overall, in the CS groups, the proportion of deaths within 30 days of surgery dropped from 0.04 prior to 2000 to 0.01 since (P = .07). For CD, the proportion dropped from 0.02 to 0.01 (P = .25).

Preventing perioperative mortality: Consider thromboprophylaxis

Dr. Fleseriu told this news organization that she believes hypercoagulability is “the least recognized complication with a big role in mortality.” Because most of the perioperative mortality is due to venous thromboembolism and infections, “thromboprophylaxis should be considered for CS patients with severe hypercortisolism and/or postoperatively, based on individual risk factors of thromboembolism and bleeding.”

Recently, Dr. Fleseriu’s group showed in a single retrospective study that the risk for arterial and venous thromboembolic events among patients with CS was approximately 20%. Many patients experienced more than one event. Risk was higher 30 to 60 days postoperatively.

The odds ratio of venous thromoboembolism among patients with CS was 18 times higher than in the normal population.

“Due to the additional thrombotic risk of surgery or any invasive procedure, anticoagulation prophylaxis should be at least considered in all patients with Cushing’s syndrome and balanced with individual bleeding risk,” Dr. Fleseriu advised.

A recent Pituitary Society workshop discussed the management of complications of CS at length; proceedings will be published soon, she noted.

Dr. Limumpornpetch commented, “We look forward to the day when our interdisciplinary approach to managing these challenging patients can deliver outcomes similar to the background population.”

Dr. Limumpornpetch has disclosed no relevant financial relationships. Dr. Fleseriu has been a scientific consultant to Recordati, Sparrow, and Strongbridge and has received grants (inst) from Novartis and Strongbridge.

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

Transgender people treated with gender-affirming hormone therapy show distinctive changes in blood pressure that begin soon after treatment initiation and do not subside over years of treatment, according to the largest and longest observational study to date to look at the issue.

“Many physicians may not be aware of the changes to blood pressure in trans patients who start hormone therapy,” senior author Michael S. Irwig, MD, director of transgender medicine at Beth Israel Deaconess Medical Center in Boston, told this news organization.

“The take-away message for physicians is to monitor blood pressure both before and after starting hormone therapy in transgender patients, as over a third of transgender individuals had stage 1 hypertension before starting hormone therapy, and many had their blood pressure increase after starting hormone therapy.”

Mean blood pressure increases in transgender males, decreases in females

In the study, published in Hypertension, Katherine Banks, MD, George Washington University, Washington, and colleagues, followed 470 transgender adult patients for up to 5 years.

The mean systolic blood pressure levels in transgender female patients (male at birth) significantly decreased compared with baseline within a few months of them starting gender-affirming hormone treatment.

Conversely, the systolic blood pressure levels in transgender males (females at birth) who were treated with testosterone increased over the same period.

There were no significant changes in the groups in terms of diastolic blood pressure, consistent with other studies.

“Our study is the first to describe the time course of the blood pressure effects of gender-affirming hormone therapy and to compare the rates of elevated blood pressure and stage 1 and stage 2 hypertension using blood pressure readings from gender-diverse individuals pre- and post–gender-affirming hormone therapy,” the authors note.

Gender-affirming hormone therapy – which has been prescribed to transgender patients for more than 25 years – typically involves a combination of estrogen and an anti-androgen for males transitioning to female, while the therapy for those transitioning to male generally only involves testosterone.

The therapy has previously been linked to various cardiac effects, with evidence showing transgender men have as much as a 5-times greater risk of heart attack versus cisgender women, the authors note.

Although the American Heart Association issued a 2020 Scientific Statement addressing the cardiovascular disease risk, evidence on the effects specifically on blood pressure in transgender patients has been inconsistent.

For the new study, Dr. Banks and colleagues enrolled 247 transgender females and 223 transgender males who were treated between 2007 and 2015 at two medical centers in Washington, D.C. Of the individuals, who had a mean age of 27.8, about 27% were non-White and 16% were Latinx.

They had blood pressure measurements taken at baseline and at follow-up clinical visits for up to 57 months following the initiation of gender-affirming hormone therapy.

Over the follow-up period, the transgender females had decreases in mean systolic blood pressure of 4.0 mm Hg within 2 to 4 months of starting hormone therapy (P < .0001) and mean declines of 6.0 mm Hg were further observed at 11 to 21 months compared with baseline.

In transgender males, the mean systolic blood pressure increased by 2.6 mm Hg at 2 to 4 months (P = .02), and by 2.9 mm Hg at 11 to 21 months after starting therapy.

Furthermore, “although the average increase in systolic blood pressure was 2.6 mm Hg in transgender men within 2 to 4 months, some patients had much higher increases,” Dr. Irwig noted.

As many as 40% of transgender men had stage 1 hypertension after 11 to 21 months of hormone therapy.

The blood pressure changes in transgender males and females were observed across all three racial ethnic groups of Whites, Blacks, and Latinx, and the changes remained consistent throughout the entire follow-up period of approximately 5 years while hormone therapy was continued.

In addition to the changes after therapy initiation, the researchers note that more than one-third of individuals in both groups had stage 1 hypertension even before starting hormone therapy.

The findings are a concern in light of “clear evidence linking hypertension and higher blood pressure with cardiovascular events such as stroke and heart attacks,” Dr. Irwig said.

Protective effects for transgender females?

Transgender females showed as much as a 47% decrease in the prevalence of stage 2 hypertension, from 19% to 10%, within 2 to 4 months of treatment with gender-affirming hormone therapy (P = .001), and the rate declined further to 8% at 11 to 21 months, suggesting a protective effect of the treatment.

“The rate of stage 2 hypertension did drop in transgender feminine individuals, which could be protective and lower their risk for cardiovascular events,” Dr. Irwig said.

“This was not a surprise, as lowering testosterone and the use of spironolactone can lower blood pressure,” he noted.

Exceptions in both groups

Of note, a sizable proportion of patients had blood pressure changes that were in fact the opposite of the patterns seen in the majority of their gender group.

Specifically, while 42% to 53% of the transgender females had systolic blood pressure readings of at least 5 mm Hg lower than their baseline readings, up to 32% had increases of at least 5 mm Hg compared to baseline readings.

Likewise, whereas 41% to 59% of transgender males had increases of at least 5 mm Hg compared with baseline, up to 35% had levels that were at least 5 mm Hg lower than baseline.

“It was a surprise that over a quarter of individuals had changes opposite to the mean changes,” Dr. Irwig said.

The differing blood pressure changes underscore that “more research is needed to determine which formulations of estrogen, testosterone, and antiandrogens are optimal regarding blood pressure and cardiovascular health, especially in older individuals,” the authors note.

Gender-affirming hormone therapy formulations differ

Various formulations for gender-affirming hormone regimens are available, including oral, transdermal, sublingual, and intramuscular preparations.

In the study, 77% to 91% of transgender males were on intramuscular testosterone injections, with the rest on transdermal formulations, and 92% of transgender female patients were started on oral estradiol, with mean doses generally increasing over time.  

The study’s results are consistent with evidence from other studies, with 7 of 8 involving transgender males showing mean increases in systolic blood pressure ranging from 1 to 14 mm Hg.

Previous research supports cardiovascular risk

As reported by this news organization, other emerging research on cardiovascular risks to transgender people include a recent study showing more than 10% of transgender males were found to have hematocrit levels that could put them at risk for blood clots.

And further research on transgender youth also shows concerning elevations in lipids and other cardiovascular risks.

The authors have disclosed no relevant financial relationships.

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

Transgender people treated with gender-affirming hormone therapy show distinctive changes in blood pressure that begin soon after treatment initiation and do not subside over years of treatment, according to the largest and longest observational study to date to look at the issue.

“Many physicians may not be aware of the changes to blood pressure in trans patients who start hormone therapy,” senior author Michael S. Irwig, MD, director of transgender medicine at Beth Israel Deaconess Medical Center in Boston, told this news organization.

“The take-away message for physicians is to monitor blood pressure both before and after starting hormone therapy in transgender patients, as over a third of transgender individuals had stage 1 hypertension before starting hormone therapy, and many had their blood pressure increase after starting hormone therapy.”

Mean blood pressure increases in transgender males, decreases in females

In the study, published in Hypertension, Katherine Banks, MD, George Washington University, Washington, and colleagues, followed 470 transgender adult patients for up to 5 years.

The mean systolic blood pressure levels in transgender female patients (male at birth) significantly decreased compared with baseline within a few months of them starting gender-affirming hormone treatment.

Conversely, the systolic blood pressure levels in transgender males (females at birth) who were treated with testosterone increased over the same period.

There were no significant changes in the groups in terms of diastolic blood pressure, consistent with other studies.

“Our study is the first to describe the time course of the blood pressure effects of gender-affirming hormone therapy and to compare the rates of elevated blood pressure and stage 1 and stage 2 hypertension using blood pressure readings from gender-diverse individuals pre- and post–gender-affirming hormone therapy,” the authors note.

Gender-affirming hormone therapy – which has been prescribed to transgender patients for more than 25 years – typically involves a combination of estrogen and an anti-androgen for males transitioning to female, while the therapy for those transitioning to male generally only involves testosterone.

The therapy has previously been linked to various cardiac effects, with evidence showing transgender men have as much as a 5-times greater risk of heart attack versus cisgender women, the authors note.

Although the American Heart Association issued a 2020 Scientific Statement addressing the cardiovascular disease risk, evidence on the effects specifically on blood pressure in transgender patients has been inconsistent.

For the new study, Dr. Banks and colleagues enrolled 247 transgender females and 223 transgender males who were treated between 2007 and 2015 at two medical centers in Washington, D.C. Of the individuals, who had a mean age of 27.8, about 27% were non-White and 16% were Latinx.

They had blood pressure measurements taken at baseline and at follow-up clinical visits for up to 57 months following the initiation of gender-affirming hormone therapy.

Over the follow-up period, the transgender females had decreases in mean systolic blood pressure of 4.0 mm Hg within 2 to 4 months of starting hormone therapy (P < .0001) and mean declines of 6.0 mm Hg were further observed at 11 to 21 months compared with baseline.

In transgender males, the mean systolic blood pressure increased by 2.6 mm Hg at 2 to 4 months (P = .02), and by 2.9 mm Hg at 11 to 21 months after starting therapy.

Furthermore, “although the average increase in systolic blood pressure was 2.6 mm Hg in transgender men within 2 to 4 months, some patients had much higher increases,” Dr. Irwig noted.

As many as 40% of transgender men had stage 1 hypertension after 11 to 21 months of hormone therapy.

The blood pressure changes in transgender males and females were observed across all three racial ethnic groups of Whites, Blacks, and Latinx, and the changes remained consistent throughout the entire follow-up period of approximately 5 years while hormone therapy was continued.

In addition to the changes after therapy initiation, the researchers note that more than one-third of individuals in both groups had stage 1 hypertension even before starting hormone therapy.

The findings are a concern in light of “clear evidence linking hypertension and higher blood pressure with cardiovascular events such as stroke and heart attacks,” Dr. Irwig said.

Protective effects for transgender females?

Transgender females showed as much as a 47% decrease in the prevalence of stage 2 hypertension, from 19% to 10%, within 2 to 4 months of treatment with gender-affirming hormone therapy (P = .001), and the rate declined further to 8% at 11 to 21 months, suggesting a protective effect of the treatment.

“The rate of stage 2 hypertension did drop in transgender feminine individuals, which could be protective and lower their risk for cardiovascular events,” Dr. Irwig said.

“This was not a surprise, as lowering testosterone and the use of spironolactone can lower blood pressure,” he noted.

Exceptions in both groups

Of note, a sizable proportion of patients had blood pressure changes that were in fact the opposite of the patterns seen in the majority of their gender group.

Specifically, while 42% to 53% of the transgender females had systolic blood pressure readings of at least 5 mm Hg lower than their baseline readings, up to 32% had increases of at least 5 mm Hg compared to baseline readings.

Likewise, whereas 41% to 59% of transgender males had increases of at least 5 mm Hg compared with baseline, up to 35% had levels that were at least 5 mm Hg lower than baseline.

“It was a surprise that over a quarter of individuals had changes opposite to the mean changes,” Dr. Irwig said.

The differing blood pressure changes underscore that “more research is needed to determine which formulations of estrogen, testosterone, and antiandrogens are optimal regarding blood pressure and cardiovascular health, especially in older individuals,” the authors note.

Gender-affirming hormone therapy formulations differ

Various formulations for gender-affirming hormone regimens are available, including oral, transdermal, sublingual, and intramuscular preparations.

In the study, 77% to 91% of transgender males were on intramuscular testosterone injections, with the rest on transdermal formulations, and 92% of transgender female patients were started on oral estradiol, with mean doses generally increasing over time.  

The study’s results are consistent with evidence from other studies, with 7 of 8 involving transgender males showing mean increases in systolic blood pressure ranging from 1 to 14 mm Hg.

Previous research supports cardiovascular risk

As reported by this news organization, other emerging research on cardiovascular risks to transgender people include a recent study showing more than 10% of transgender males were found to have hematocrit levels that could put them at risk for blood clots.

And further research on transgender youth also shows concerning elevations in lipids and other cardiovascular risks.

The authors have disclosed no relevant financial relationships.

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

Transgender people treated with gender-affirming hormone therapy show distinctive changes in blood pressure that begin soon after treatment initiation and do not subside over years of treatment, according to the largest and longest observational study to date to look at the issue.

“Many physicians may not be aware of the changes to blood pressure in trans patients who start hormone therapy,” senior author Michael S. Irwig, MD, director of transgender medicine at Beth Israel Deaconess Medical Center in Boston, told this news organization.

“The take-away message for physicians is to monitor blood pressure both before and after starting hormone therapy in transgender patients, as over a third of transgender individuals had stage 1 hypertension before starting hormone therapy, and many had their blood pressure increase after starting hormone therapy.”

Mean blood pressure increases in transgender males, decreases in females

In the study, published in Hypertension, Katherine Banks, MD, George Washington University, Washington, and colleagues, followed 470 transgender adult patients for up to 5 years.

The mean systolic blood pressure levels in transgender female patients (male at birth) significantly decreased compared with baseline within a few months of them starting gender-affirming hormone treatment.

Conversely, the systolic blood pressure levels in transgender males (females at birth) who were treated with testosterone increased over the same period.

There were no significant changes in the groups in terms of diastolic blood pressure, consistent with other studies.

“Our study is the first to describe the time course of the blood pressure effects of gender-affirming hormone therapy and to compare the rates of elevated blood pressure and stage 1 and stage 2 hypertension using blood pressure readings from gender-diverse individuals pre- and post–gender-affirming hormone therapy,” the authors note.

Gender-affirming hormone therapy – which has been prescribed to transgender patients for more than 25 years – typically involves a combination of estrogen and an anti-androgen for males transitioning to female, while the therapy for those transitioning to male generally only involves testosterone.

The therapy has previously been linked to various cardiac effects, with evidence showing transgender men have as much as a 5-times greater risk of heart attack versus cisgender women, the authors note.

Although the American Heart Association issued a 2020 Scientific Statement addressing the cardiovascular disease risk, evidence on the effects specifically on blood pressure in transgender patients has been inconsistent.

For the new study, Dr. Banks and colleagues enrolled 247 transgender females and 223 transgender males who were treated between 2007 and 2015 at two medical centers in Washington, D.C. Of the individuals, who had a mean age of 27.8, about 27% were non-White and 16% were Latinx.

They had blood pressure measurements taken at baseline and at follow-up clinical visits for up to 57 months following the initiation of gender-affirming hormone therapy.

Over the follow-up period, the transgender females had decreases in mean systolic blood pressure of 4.0 mm Hg within 2 to 4 months of starting hormone therapy (P < .0001) and mean declines of 6.0 mm Hg were further observed at 11 to 21 months compared with baseline.

In transgender males, the mean systolic blood pressure increased by 2.6 mm Hg at 2 to 4 months (P = .02), and by 2.9 mm Hg at 11 to 21 months after starting therapy.

Furthermore, “although the average increase in systolic blood pressure was 2.6 mm Hg in transgender men within 2 to 4 months, some patients had much higher increases,” Dr. Irwig noted.

As many as 40% of transgender men had stage 1 hypertension after 11 to 21 months of hormone therapy.

The blood pressure changes in transgender males and females were observed across all three racial ethnic groups of Whites, Blacks, and Latinx, and the changes remained consistent throughout the entire follow-up period of approximately 5 years while hormone therapy was continued.

In addition to the changes after therapy initiation, the researchers note that more than one-third of individuals in both groups had stage 1 hypertension even before starting hormone therapy.

The findings are a concern in light of “clear evidence linking hypertension and higher blood pressure with cardiovascular events such as stroke and heart attacks,” Dr. Irwig said.

Protective effects for transgender females?

Transgender females showed as much as a 47% decrease in the prevalence of stage 2 hypertension, from 19% to 10%, within 2 to 4 months of treatment with gender-affirming hormone therapy (P = .001), and the rate declined further to 8% at 11 to 21 months, suggesting a protective effect of the treatment.

“The rate of stage 2 hypertension did drop in transgender feminine individuals, which could be protective and lower their risk for cardiovascular events,” Dr. Irwig said.

“This was not a surprise, as lowering testosterone and the use of spironolactone can lower blood pressure,” he noted.

Exceptions in both groups

Of note, a sizable proportion of patients had blood pressure changes that were in fact the opposite of the patterns seen in the majority of their gender group.

Specifically, while 42% to 53% of the transgender females had systolic blood pressure readings of at least 5 mm Hg lower than their baseline readings, up to 32% had increases of at least 5 mm Hg compared to baseline readings.

Likewise, whereas 41% to 59% of transgender males had increases of at least 5 mm Hg compared with baseline, up to 35% had levels that were at least 5 mm Hg lower than baseline.

“It was a surprise that over a quarter of individuals had changes opposite to the mean changes,” Dr. Irwig said.

The differing blood pressure changes underscore that “more research is needed to determine which formulations of estrogen, testosterone, and antiandrogens are optimal regarding blood pressure and cardiovascular health, especially in older individuals,” the authors note.

Gender-affirming hormone therapy formulations differ

Various formulations for gender-affirming hormone regimens are available, including oral, transdermal, sublingual, and intramuscular preparations.

In the study, 77% to 91% of transgender males were on intramuscular testosterone injections, with the rest on transdermal formulations, and 92% of transgender female patients were started on oral estradiol, with mean doses generally increasing over time.  

The study’s results are consistent with evidence from other studies, with 7 of 8 involving transgender males showing mean increases in systolic blood pressure ranging from 1 to 14 mm Hg.

Previous research supports cardiovascular risk

As reported by this news organization, other emerging research on cardiovascular risks to transgender people include a recent study showing more than 10% of transgender males were found to have hematocrit levels that could put them at risk for blood clots.

And further research on transgender youth also shows concerning elevations in lipids and other cardiovascular risks.

The authors have disclosed no relevant financial relationships.

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

In a U.K. cohort of more than 260,000 mostly middle-aged adults in primary care with overweight or obesity, body mass index remained relatively stable over a decade.

However, compared to overweight individuals, those with severe (class 3) obesity were more socioeconomically disadvantaged and had triple the risk for incident heart failure or all-cause or cardiovascular disease (CVD)–related mortality in a study published online April 15 in BMC Public Health.

“This is the first study to evaluate the long-term impact of overweight and obese individuals’ BMI trajectory on cardiovascular endpoints, heart failure, and mortality outcomes,” wrote Barbara Iyen, PhD, University of Nottingham, England, and colleagues.

The findings emphasize “the high cardiovascular toll exacted by continuing failure to tackle obesity, particularly among more socioeconomically deprived populations,” they warned.

“We have found that despite widespread efforts to prevent and manage obesity, the majority of adults who are overweight or obese in the general population continue to remain so in the long term,” Dr. Iyen said in a statement from her university.

“More effective policies and weight-management interventions are needed urgently to address this increasing burden and associated adverse health outcomes,” she stressed.

Invited to comment, Sadiya S. Khan, MD, Northwestern University, Chicago, said in an interview: “This research adds to the growing body of evidence [that] earlier and more intensive interventions for weight loss are necessary to promote cardiovascular health and reduce morbidity and mortality.

“Adjunctive pharmacotherapy and bariatric surgery are both options that should be considered in addition to intensive lifestyle interventions in overweight and obesity groups,” she added.

“I would always advocate for earlier prevention efforts focused on weight loss, because years lived with obesity are associated with future CVD, so every year counts,” Dr. Khan said.
 

Does BMI remain elevated, predict worse heart health?

Although obesity is a well-recognized risk factor for CVD, long-term changes in BMI and the impact of BMI on the risk for heart failure, CVD, and mortality have not been quantified among adults with overweight and obesity, Dr. Iyen and colleagues explained.

The researchers examined data from the UK Clinical Practice Research Datalink and secondary care and mortality records to determine BMI trajectories among adults with overweight or obesity and to quantify the risk for heart failure, CVD (defined as coronary heart disease, stroke, transient ischemic attack, or peripheral vascular disease, CVD-related mortality, and all-cause mortality.

They identified 264,230 adults with overweight or obesity who were seen in 790 primary care practices in the United Kingdom from 1999 to 2018 and who did not initially have heart failure or CVD and for whom baseline BMI measurements and at least one other BMI measurement 2, 5, 8, and 10 years later was available.

The researchers divided the cohort into four groups on the basis of initial BMI: overweight (36% of patients; mean BMI, 28.7 kg/m²); class 1 obesity (40%; mean BMI, 33.7 kg/m²); class 2 obesity (19%; mean BMI, 39.9 kg/m²), and class 3 obesity (5%; mean BMI, 49.1 kg/m²).

The mean age of the individuals was 50 years, and 64% were White. Race/ethnicity data were unavailable for 31%. Asian Indian, Asian, and Black patients comprised 5% of the cohort.
 

“Strong significant gradient in heart failure risk”

Compared to the overweight (reference) group, the severe-obesity group comprised a higher percentage of women (74% vs. 70%), and the prevalence of comorbidities and socioeconomic deprivation was higher.

BMI remained relatively stable in each BMI group. The mean BMI increase was 1.06 kg/m² during a median follow-up of 10.9 years.

There were 30,400 incident cases of CVD, 7,662 incident cases of heart failure, and 24,022 deaths, of which 2,827 (11.8%) were from CVD.

The risk for heart failure and CVD-related or all-cause mortality increased with increasing obesity severity.

Compared with overweight individuals, those with class 3 obesity were at significantly increased risk for heart failure (hazard ratio [HR], 3.26), all-cause mortality (HR, 2.72), and CVD-related mortality (HR, 3.31) after adjustment for age, sex, and comorbidities (hypertension, type 2 diabetes, atrial fibrillation, and chronic kidney disease).

The risk for stroke/TIA or coronary heart disease was similar among those with severe obesity and the other individuals. The risk for PVD was significantly lower (HR, 0.73).

The reduced risk for PVD in the most severely obese group is similar to findings in the Framingham heart study, the authors noted, and may be due to underdiagnosis or differences in the underlying mechanism.
 

Compelling evidence of poor health outcomes associated with obesity

Study limitations include the fact that the findings may not be generalizable to other race/ethnicity groups, the lack of information on diet and exercise, and the fact that BMI was used as a surrogate of adiposity. As such, it does not account for an age-related decrease in heavier-than-fat muscle mass and differences between sexes and ethnic groups.

The finding of stable obesity over time accords with two smaller studies that included Canadian and American adults.

The current study did not uncover an obesity paradox, unlike some studies that included patients with preexisting CVD or a history of acute coronary events. Those studies reported better clinical outcomes among patients with overweight or obesity.

The current study included individuals who did not initially have CVD. Those with more severe obesity were younger than individuals with overweight at the time of the occurrence of incident CVD (age 64 vs. 66) and at the age of death (age 67 vs. age 75), which “provides compelling evidence of poor health outcomes associated with obesity,” the authors emphasized.

“Further research is ... needed to explore whether interventions to change BMI trajectories would have an impact on future CVD outcomes,” they concluded.

Dr. Iyen’s clinical academic lectureship is fully funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and are not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. Dr. Khan has disclosed no relevant financial relationships.

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

In a U.K. cohort of more than 260,000 mostly middle-aged adults in primary care with overweight or obesity, body mass index remained relatively stable over a decade.

However, compared to overweight individuals, those with severe (class 3) obesity were more socioeconomically disadvantaged and had triple the risk for incident heart failure or all-cause or cardiovascular disease (CVD)–related mortality in a study published online April 15 in BMC Public Health.

“This is the first study to evaluate the long-term impact of overweight and obese individuals’ BMI trajectory on cardiovascular endpoints, heart failure, and mortality outcomes,” wrote Barbara Iyen, PhD, University of Nottingham, England, and colleagues.

The findings emphasize “the high cardiovascular toll exacted by continuing failure to tackle obesity, particularly among more socioeconomically deprived populations,” they warned.

“We have found that despite widespread efforts to prevent and manage obesity, the majority of adults who are overweight or obese in the general population continue to remain so in the long term,” Dr. Iyen said in a statement from her university.

“More effective policies and weight-management interventions are needed urgently to address this increasing burden and associated adverse health outcomes,” she stressed.

Invited to comment, Sadiya S. Khan, MD, Northwestern University, Chicago, said in an interview: “This research adds to the growing body of evidence [that] earlier and more intensive interventions for weight loss are necessary to promote cardiovascular health and reduce morbidity and mortality.

“Adjunctive pharmacotherapy and bariatric surgery are both options that should be considered in addition to intensive lifestyle interventions in overweight and obesity groups,” she added.

“I would always advocate for earlier prevention efforts focused on weight loss, because years lived with obesity are associated with future CVD, so every year counts,” Dr. Khan said.
 

Does BMI remain elevated, predict worse heart health?

Although obesity is a well-recognized risk factor for CVD, long-term changes in BMI and the impact of BMI on the risk for heart failure, CVD, and mortality have not been quantified among adults with overweight and obesity, Dr. Iyen and colleagues explained.

The researchers examined data from the UK Clinical Practice Research Datalink and secondary care and mortality records to determine BMI trajectories among adults with overweight or obesity and to quantify the risk for heart failure, CVD (defined as coronary heart disease, stroke, transient ischemic attack, or peripheral vascular disease, CVD-related mortality, and all-cause mortality.

They identified 264,230 adults with overweight or obesity who were seen in 790 primary care practices in the United Kingdom from 1999 to 2018 and who did not initially have heart failure or CVD and for whom baseline BMI measurements and at least one other BMI measurement 2, 5, 8, and 10 years later was available.

The researchers divided the cohort into four groups on the basis of initial BMI: overweight (36% of patients; mean BMI, 28.7 kg/m²); class 1 obesity (40%; mean BMI, 33.7 kg/m²); class 2 obesity (19%; mean BMI, 39.9 kg/m²), and class 3 obesity (5%; mean BMI, 49.1 kg/m²).

The mean age of the individuals was 50 years, and 64% were White. Race/ethnicity data were unavailable for 31%. Asian Indian, Asian, and Black patients comprised 5% of the cohort.
 

“Strong significant gradient in heart failure risk”

Compared to the overweight (reference) group, the severe-obesity group comprised a higher percentage of women (74% vs. 70%), and the prevalence of comorbidities and socioeconomic deprivation was higher.

BMI remained relatively stable in each BMI group. The mean BMI increase was 1.06 kg/m² during a median follow-up of 10.9 years.

There were 30,400 incident cases of CVD, 7,662 incident cases of heart failure, and 24,022 deaths, of which 2,827 (11.8%) were from CVD.

The risk for heart failure and CVD-related or all-cause mortality increased with increasing obesity severity.

Compared with overweight individuals, those with class 3 obesity were at significantly increased risk for heart failure (hazard ratio [HR], 3.26), all-cause mortality (HR, 2.72), and CVD-related mortality (HR, 3.31) after adjustment for age, sex, and comorbidities (hypertension, type 2 diabetes, atrial fibrillation, and chronic kidney disease).

The risk for stroke/TIA or coronary heart disease was similar among those with severe obesity and the other individuals. The risk for PVD was significantly lower (HR, 0.73).

The reduced risk for PVD in the most severely obese group is similar to findings in the Framingham heart study, the authors noted, and may be due to underdiagnosis or differences in the underlying mechanism.
 

Compelling evidence of poor health outcomes associated with obesity

Study limitations include the fact that the findings may not be generalizable to other race/ethnicity groups, the lack of information on diet and exercise, and the fact that BMI was used as a surrogate of adiposity. As such, it does not account for an age-related decrease in heavier-than-fat muscle mass and differences between sexes and ethnic groups.

The finding of stable obesity over time accords with two smaller studies that included Canadian and American adults.

The current study did not uncover an obesity paradox, unlike some studies that included patients with preexisting CVD or a history of acute coronary events. Those studies reported better clinical outcomes among patients with overweight or obesity.

The current study included individuals who did not initially have CVD. Those with more severe obesity were younger than individuals with overweight at the time of the occurrence of incident CVD (age 64 vs. 66) and at the age of death (age 67 vs. age 75), which “provides compelling evidence of poor health outcomes associated with obesity,” the authors emphasized.

“Further research is ... needed to explore whether interventions to change BMI trajectories would have an impact on future CVD outcomes,” they concluded.

Dr. Iyen’s clinical academic lectureship is fully funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and are not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. Dr. Khan has disclosed no relevant financial relationships.

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

In a U.K. cohort of more than 260,000 mostly middle-aged adults in primary care with overweight or obesity, body mass index remained relatively stable over a decade.

However, compared to overweight individuals, those with severe (class 3) obesity were more socioeconomically disadvantaged and had triple the risk for incident heart failure or all-cause or cardiovascular disease (CVD)–related mortality in a study published online April 15 in BMC Public Health.

“This is the first study to evaluate the long-term impact of overweight and obese individuals’ BMI trajectory on cardiovascular endpoints, heart failure, and mortality outcomes,” wrote Barbara Iyen, PhD, University of Nottingham, England, and colleagues.

The findings emphasize “the high cardiovascular toll exacted by continuing failure to tackle obesity, particularly among more socioeconomically deprived populations,” they warned.

“We have found that despite widespread efforts to prevent and manage obesity, the majority of adults who are overweight or obese in the general population continue to remain so in the long term,” Dr. Iyen said in a statement from her university.

“More effective policies and weight-management interventions are needed urgently to address this increasing burden and associated adverse health outcomes,” she stressed.

Invited to comment, Sadiya S. Khan, MD, Northwestern University, Chicago, said in an interview: “This research adds to the growing body of evidence [that] earlier and more intensive interventions for weight loss are necessary to promote cardiovascular health and reduce morbidity and mortality.

“Adjunctive pharmacotherapy and bariatric surgery are both options that should be considered in addition to intensive lifestyle interventions in overweight and obesity groups,” she added.

“I would always advocate for earlier prevention efforts focused on weight loss, because years lived with obesity are associated with future CVD, so every year counts,” Dr. Khan said.
 

Does BMI remain elevated, predict worse heart health?

Although obesity is a well-recognized risk factor for CVD, long-term changes in BMI and the impact of BMI on the risk for heart failure, CVD, and mortality have not been quantified among adults with overweight and obesity, Dr. Iyen and colleagues explained.

The researchers examined data from the UK Clinical Practice Research Datalink and secondary care and mortality records to determine BMI trajectories among adults with overweight or obesity and to quantify the risk for heart failure, CVD (defined as coronary heart disease, stroke, transient ischemic attack, or peripheral vascular disease, CVD-related mortality, and all-cause mortality.

They identified 264,230 adults with overweight or obesity who were seen in 790 primary care practices in the United Kingdom from 1999 to 2018 and who did not initially have heart failure or CVD and for whom baseline BMI measurements and at least one other BMI measurement 2, 5, 8, and 10 years later was available.

The researchers divided the cohort into four groups on the basis of initial BMI: overweight (36% of patients; mean BMI, 28.7 kg/m²); class 1 obesity (40%; mean BMI, 33.7 kg/m²); class 2 obesity (19%; mean BMI, 39.9 kg/m²), and class 3 obesity (5%; mean BMI, 49.1 kg/m²).

The mean age of the individuals was 50 years, and 64% were White. Race/ethnicity data were unavailable for 31%. Asian Indian, Asian, and Black patients comprised 5% of the cohort.
 

“Strong significant gradient in heart failure risk”

Compared to the overweight (reference) group, the severe-obesity group comprised a higher percentage of women (74% vs. 70%), and the prevalence of comorbidities and socioeconomic deprivation was higher.

BMI remained relatively stable in each BMI group. The mean BMI increase was 1.06 kg/m² during a median follow-up of 10.9 years.

There were 30,400 incident cases of CVD, 7,662 incident cases of heart failure, and 24,022 deaths, of which 2,827 (11.8%) were from CVD.

The risk for heart failure and CVD-related or all-cause mortality increased with increasing obesity severity.

Compared with overweight individuals, those with class 3 obesity were at significantly increased risk for heart failure (hazard ratio [HR], 3.26), all-cause mortality (HR, 2.72), and CVD-related mortality (HR, 3.31) after adjustment for age, sex, and comorbidities (hypertension, type 2 diabetes, atrial fibrillation, and chronic kidney disease).

The risk for stroke/TIA or coronary heart disease was similar among those with severe obesity and the other individuals. The risk for PVD was significantly lower (HR, 0.73).

The reduced risk for PVD in the most severely obese group is similar to findings in the Framingham heart study, the authors noted, and may be due to underdiagnosis or differences in the underlying mechanism.
 

Compelling evidence of poor health outcomes associated with obesity

Study limitations include the fact that the findings may not be generalizable to other race/ethnicity groups, the lack of information on diet and exercise, and the fact that BMI was used as a surrogate of adiposity. As such, it does not account for an age-related decrease in heavier-than-fat muscle mass and differences between sexes and ethnic groups.

The finding of stable obesity over time accords with two smaller studies that included Canadian and American adults.

The current study did not uncover an obesity paradox, unlike some studies that included patients with preexisting CVD or a history of acute coronary events. Those studies reported better clinical outcomes among patients with overweight or obesity.

The current study included individuals who did not initially have CVD. Those with more severe obesity were younger than individuals with overweight at the time of the occurrence of incident CVD (age 64 vs. 66) and at the age of death (age 67 vs. age 75), which “provides compelling evidence of poor health outcomes associated with obesity,” the authors emphasized.

“Further research is ... needed to explore whether interventions to change BMI trajectories would have an impact on future CVD outcomes,” they concluded.

Dr. Iyen’s clinical academic lectureship is fully funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and are not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. Dr. Khan has disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved a new estrogen for the first time in more than 50 years.

The novel combined oral contraceptive, marketed as Nextstellis, contains 3 mg drospirenone (DRSP) and 14.2 mg of estetrol (E4) in tablet form. Estetrol is an estrogen that is naturally produced during pregnancy, but will now be produced from a plant source; it has not previously been used in oral contraceptives.

Approval of the unique estetrol/drospirenone combination was based on data from a pair of phase 3 clinical trials including 3,725 women. Overall, Nextstellis was safe and effective while meeting its primary endpoint of pregnancy prevention, according to a company press release. Participants also reported favorable results on secondary endpoints including cycle control, bleeding profile, safety, and tolerability.

Although many women take short-acting contraceptives containing estrogen and progestin, concerns persist about side effects, said Mitchell Creinin, MD, of the University of California, in the press release. In addition to providing effective contraception, the drug showed minimal impact on specific markers of concern, including triglycerides, cholesterol, and glucose, as well as weight and endocrine markers, Dr. Creinin said.

Nextstellis was developed by the Belgian biotech company Mithra Pharmaceuticals, and the drug is licensed for distribution in Australia and the United States by Mayne Pharma, with an expected launch at the end of June 2021.

The Food and Drug Administration has approved a new estrogen for the first time in more than 50 years.

The novel combined oral contraceptive, marketed as Nextstellis, contains 3 mg drospirenone (DRSP) and 14.2 mg of estetrol (E4) in tablet form. Estetrol is an estrogen that is naturally produced during pregnancy, but will now be produced from a plant source; it has not previously been used in oral contraceptives.

Approval of the unique estetrol/drospirenone combination was based on data from a pair of phase 3 clinical trials including 3,725 women. Overall, Nextstellis was safe and effective while meeting its primary endpoint of pregnancy prevention, according to a company press release. Participants also reported favorable results on secondary endpoints including cycle control, bleeding profile, safety, and tolerability.

Although many women take short-acting contraceptives containing estrogen and progestin, concerns persist about side effects, said Mitchell Creinin, MD, of the University of California, in the press release. In addition to providing effective contraception, the drug showed minimal impact on specific markers of concern, including triglycerides, cholesterol, and glucose, as well as weight and endocrine markers, Dr. Creinin said.

Nextstellis was developed by the Belgian biotech company Mithra Pharmaceuticals, and the drug is licensed for distribution in Australia and the United States by Mayne Pharma, with an expected launch at the end of June 2021.

The Food and Drug Administration has approved a new estrogen for the first time in more than 50 years.

The novel combined oral contraceptive, marketed as Nextstellis, contains 3 mg drospirenone (DRSP) and 14.2 mg of estetrol (E4) in tablet form. Estetrol is an estrogen that is naturally produced during pregnancy, but will now be produced from a plant source; it has not previously been used in oral contraceptives.

Approval of the unique estetrol/drospirenone combination was based on data from a pair of phase 3 clinical trials including 3,725 women. Overall, Nextstellis was safe and effective while meeting its primary endpoint of pregnancy prevention, according to a company press release. Participants also reported favorable results on secondary endpoints including cycle control, bleeding profile, safety, and tolerability.

Although many women take short-acting contraceptives containing estrogen and progestin, concerns persist about side effects, said Mitchell Creinin, MD, of the University of California, in the press release. In addition to providing effective contraception, the drug showed minimal impact on specific markers of concern, including triglycerides, cholesterol, and glucose, as well as weight and endocrine markers, Dr. Creinin said.

Nextstellis was developed by the Belgian biotech company Mithra Pharmaceuticals, and the drug is licensed for distribution in Australia and the United States by Mayne Pharma, with an expected launch at the end of June 2021.

The scientific evidence for airborne transmission of the SARS-CoV-2 virus from different researchers all point in the same direction – that infectious aerosols are the principal means of person-to-person transmission, according to experts.

Not that it’s without controversy.

The science backing aerosol transmission “is clear-cut, but it is not accepted in many circles,” Trisha Greenhalgh, PhD, said in an interview.

“In particular, some in the evidence-based medicine movement and some infectious diseases clinicians are remarkably resistant to the evidence,” added Dr. Greenhalgh, professor of primary care health sciences at the University of Oxford (England).

“It’s very hard to see why, since the evidence all stacks up,” Dr. Greenhalgh said.

“The scientific evidence on spread from both near-field and far-field aerosols has been clear since early on in the pandemic, but there was resistance to acknowledging this in some circles, including the medical journals,” Joseph G. Allen, DSc, MPH, told this news organization when asked to comment.

“This is the week the dam broke. Three new commentaries came out … in top medical journals – BMJ, The Lancet, JAMA – all making the same point that aerosols are the dominant mode of transmission,” added Dr. Allen, associate professor of exposure assessment science at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Greenhalgh and colleagues point to an increase in COVID-19 cases in the aftermath of so-called “super-spreader” events, spread of SARS-CoV-2 to people across different hotel rooms, and the relatively lower transmission detected after outdoor events.
 

Top 10 reasons

They outlined 10 scientific reasons backing airborne transmission in a commentary published online April 15 in The Lancet:

• The dominance of airborne transmission is supported by long-range transmission observed at super-spreader events.
• Long-range transmission has been reported among rooms at COVID-19 quarantine hotels, settings where infected people never spent time in the same room.
• Asymptomatic individuals account for an estimated 33%-59% of SARS-CoV-2 transmission, and could be spreading the virus through speaking, which produces thousands of aerosol particles and few large droplets.
• Transmission outdoors and in well-ventilated indoor spaces is lower than in enclosed spaces.
• Nosocomial infections are reported in health care settings where protective measures address large droplets but not aerosols.
• Viable SARS-CoV-2 has been detected in the air of hospital rooms and in the car of an infected person.
• Investigators found SARS-CoV-2 in hospital air filters and building ducts.
• It’s not just humans – infected animals can infect animals in other cages connected only through an air duct.
• No strong evidence refutes airborne transmission, and contact tracing supports secondary transmission in crowded, poorly ventilated indoor spaces.
• Only limited evidence supports other means of SARS-CoV-2 transmission, including through fomites or large droplets.

“We thought we’d summarize [the evidence] to clarify the arguments for and against. We looked hard for evidence against but found none,” Dr. Greenhalgh said.

“Although other routes can contribute, we believe that the airborne route is likely to be dominant,” the authors note.

The evidence on airborne transmission was there very early on but the Centers for Disease Control and Prevention, World Health Organization, and others repeated the message that the primary concern was droplets and fomites.
 

Response to a review

The top 10 list is also part rebuttal of a systematic review funded by the WHO and published last month that points to inconclusive evidence for airborne transmission. The researchers involved with that review state that “the lack of recoverable viral culture samples of SARS-CoV-2 prevents firm conclusions to be drawn about airborne transmission.”

However, Dr. Greenhalgh and colleagues note that “this conclusion, and the wide circulation of the review’s findings, is concerning because of the public health implications.”

The current authors also argue that enough evidence already exists on airborne transmission. “Policy should change. We don’t need more research on this topic; we need different policy,” Dr. Greenhalgh said. “We need ventilation front and center, air filtration when necessary, and better-fitting masks worn whenever indoors.”

Dr. Allen agreed that guidance hasn’t always kept pace with the science. “With all of the new evidence accumulated on airborne transmission since last winter, there is still widespread confusion in the public about modes of transmission,” he said. Dr. Allen also serves as commissioner of The Lancet COVID-19 Commission and is chair of the commission’s Task Force on Safe Work, Safe Schools, and Safe Travel.

“It was only just last week that CDC pulled back on guidance on ‘deep cleaning’ and in its place correctly said that the risk from touching surfaces is low,” he added. “The science has been clear on this for over a year, but official guidance was only recently updated.”

As a result, many companies and organizations continued to focus on “hygiene theatre,” Dr. Allen said, “wasting resources on overcleaning surfaces. Unbelievably, many schools still close for an entire day each week for deep cleaning and some still quarantine library books. The message that shared air is the problem, not shared surfaces, is a message that still needs to be reinforced.”

The National Institute for Health Research, Economic and Social Research Council, and Wellcome support Dr. Greenhalgh’s research. Dr. Greenhalgh and Dr. Allen had no relevant financial relationships to disclose.

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

The scientific evidence for airborne transmission of the SARS-CoV-2 virus from different researchers all point in the same direction – that infectious aerosols are the principal means of person-to-person transmission, according to experts.

Not that it’s without controversy.

The science backing aerosol transmission “is clear-cut, but it is not accepted in many circles,” Trisha Greenhalgh, PhD, said in an interview.

“In particular, some in the evidence-based medicine movement and some infectious diseases clinicians are remarkably resistant to the evidence,” added Dr. Greenhalgh, professor of primary care health sciences at the University of Oxford (England).

“It’s very hard to see why, since the evidence all stacks up,” Dr. Greenhalgh said.

“The scientific evidence on spread from both near-field and far-field aerosols has been clear since early on in the pandemic, but there was resistance to acknowledging this in some circles, including the medical journals,” Joseph G. Allen, DSc, MPH, told this news organization when asked to comment.

“This is the week the dam broke. Three new commentaries came out … in top medical journals – BMJ, The Lancet, JAMA – all making the same point that aerosols are the dominant mode of transmission,” added Dr. Allen, associate professor of exposure assessment science at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Greenhalgh and colleagues point to an increase in COVID-19 cases in the aftermath of so-called “super-spreader” events, spread of SARS-CoV-2 to people across different hotel rooms, and the relatively lower transmission detected after outdoor events.
 

Top 10 reasons

They outlined 10 scientific reasons backing airborne transmission in a commentary published online April 15 in The Lancet:

• The dominance of airborne transmission is supported by long-range transmission observed at super-spreader events.
• Long-range transmission has been reported among rooms at COVID-19 quarantine hotels, settings where infected people never spent time in the same room.
• Asymptomatic individuals account for an estimated 33%-59% of SARS-CoV-2 transmission, and could be spreading the virus through speaking, which produces thousands of aerosol particles and few large droplets.
• Transmission outdoors and in well-ventilated indoor spaces is lower than in enclosed spaces.
• Nosocomial infections are reported in health care settings where protective measures address large droplets but not aerosols.
• Viable SARS-CoV-2 has been detected in the air of hospital rooms and in the car of an infected person.
• Investigators found SARS-CoV-2 in hospital air filters and building ducts.
• It’s not just humans – infected animals can infect animals in other cages connected only through an air duct.
• No strong evidence refutes airborne transmission, and contact tracing supports secondary transmission in crowded, poorly ventilated indoor spaces.
• Only limited evidence supports other means of SARS-CoV-2 transmission, including through fomites or large droplets.

“We thought we’d summarize [the evidence] to clarify the arguments for and against. We looked hard for evidence against but found none,” Dr. Greenhalgh said.

“Although other routes can contribute, we believe that the airborne route is likely to be dominant,” the authors note.

The evidence on airborne transmission was there very early on but the Centers for Disease Control and Prevention, World Health Organization, and others repeated the message that the primary concern was droplets and fomites.
 

Response to a review

The top 10 list is also part rebuttal of a systematic review funded by the WHO and published last month that points to inconclusive evidence for airborne transmission. The researchers involved with that review state that “the lack of recoverable viral culture samples of SARS-CoV-2 prevents firm conclusions to be drawn about airborne transmission.”

However, Dr. Greenhalgh and colleagues note that “this conclusion, and the wide circulation of the review’s findings, is concerning because of the public health implications.”

The current authors also argue that enough evidence already exists on airborne transmission. “Policy should change. We don’t need more research on this topic; we need different policy,” Dr. Greenhalgh said. “We need ventilation front and center, air filtration when necessary, and better-fitting masks worn whenever indoors.”

Dr. Allen agreed that guidance hasn’t always kept pace with the science. “With all of the new evidence accumulated on airborne transmission since last winter, there is still widespread confusion in the public about modes of transmission,” he said. Dr. Allen also serves as commissioner of The Lancet COVID-19 Commission and is chair of the commission’s Task Force on Safe Work, Safe Schools, and Safe Travel.

“It was only just last week that CDC pulled back on guidance on ‘deep cleaning’ and in its place correctly said that the risk from touching surfaces is low,” he added. “The science has been clear on this for over a year, but official guidance was only recently updated.”

As a result, many companies and organizations continued to focus on “hygiene theatre,” Dr. Allen said, “wasting resources on overcleaning surfaces. Unbelievably, many schools still close for an entire day each week for deep cleaning and some still quarantine library books. The message that shared air is the problem, not shared surfaces, is a message that still needs to be reinforced.”

The National Institute for Health Research, Economic and Social Research Council, and Wellcome support Dr. Greenhalgh’s research. Dr. Greenhalgh and Dr. Allen had no relevant financial relationships to disclose.

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

The scientific evidence for airborne transmission of the SARS-CoV-2 virus from different researchers all point in the same direction – that infectious aerosols are the principal means of person-to-person transmission, according to experts.

Not that it’s without controversy.

The science backing aerosol transmission “is clear-cut, but it is not accepted in many circles,” Trisha Greenhalgh, PhD, said in an interview.

“In particular, some in the evidence-based medicine movement and some infectious diseases clinicians are remarkably resistant to the evidence,” added Dr. Greenhalgh, professor of primary care health sciences at the University of Oxford (England).

“It’s very hard to see why, since the evidence all stacks up,” Dr. Greenhalgh said.

“The scientific evidence on spread from both near-field and far-field aerosols has been clear since early on in the pandemic, but there was resistance to acknowledging this in some circles, including the medical journals,” Joseph G. Allen, DSc, MPH, told this news organization when asked to comment.

“This is the week the dam broke. Three new commentaries came out … in top medical journals – BMJ, The Lancet, JAMA – all making the same point that aerosols are the dominant mode of transmission,” added Dr. Allen, associate professor of exposure assessment science at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Greenhalgh and colleagues point to an increase in COVID-19 cases in the aftermath of so-called “super-spreader” events, spread of SARS-CoV-2 to people across different hotel rooms, and the relatively lower transmission detected after outdoor events.
 

Top 10 reasons

They outlined 10 scientific reasons backing airborne transmission in a commentary published online April 15 in The Lancet:

• The dominance of airborne transmission is supported by long-range transmission observed at super-spreader events.
• Long-range transmission has been reported among rooms at COVID-19 quarantine hotels, settings where infected people never spent time in the same room.
• Asymptomatic individuals account for an estimated 33%-59% of SARS-CoV-2 transmission, and could be spreading the virus through speaking, which produces thousands of aerosol particles and few large droplets.
• Transmission outdoors and in well-ventilated indoor spaces is lower than in enclosed spaces.
• Nosocomial infections are reported in health care settings where protective measures address large droplets but not aerosols.
• Viable SARS-CoV-2 has been detected in the air of hospital rooms and in the car of an infected person.
• Investigators found SARS-CoV-2 in hospital air filters and building ducts.
• It’s not just humans – infected animals can infect animals in other cages connected only through an air duct.
• No strong evidence refutes airborne transmission, and contact tracing supports secondary transmission in crowded, poorly ventilated indoor spaces.
• Only limited evidence supports other means of SARS-CoV-2 transmission, including through fomites or large droplets.

“We thought we’d summarize [the evidence] to clarify the arguments for and against. We looked hard for evidence against but found none,” Dr. Greenhalgh said.

“Although other routes can contribute, we believe that the airborne route is likely to be dominant,” the authors note.

The evidence on airborne transmission was there very early on but the Centers for Disease Control and Prevention, World Health Organization, and others repeated the message that the primary concern was droplets and fomites.
 

Response to a review

The top 10 list is also part rebuttal of a systematic review funded by the WHO and published last month that points to inconclusive evidence for airborne transmission. The researchers involved with that review state that “the lack of recoverable viral culture samples of SARS-CoV-2 prevents firm conclusions to be drawn about airborne transmission.”

However, Dr. Greenhalgh and colleagues note that “this conclusion, and the wide circulation of the review’s findings, is concerning because of the public health implications.”

The current authors also argue that enough evidence already exists on airborne transmission. “Policy should change. We don’t need more research on this topic; we need different policy,” Dr. Greenhalgh said. “We need ventilation front and center, air filtration when necessary, and better-fitting masks worn whenever indoors.”

Dr. Allen agreed that guidance hasn’t always kept pace with the science. “With all of the new evidence accumulated on airborne transmission since last winter, there is still widespread confusion in the public about modes of transmission,” he said. Dr. Allen also serves as commissioner of The Lancet COVID-19 Commission and is chair of the commission’s Task Force on Safe Work, Safe Schools, and Safe Travel.

“It was only just last week that CDC pulled back on guidance on ‘deep cleaning’ and in its place correctly said that the risk from touching surfaces is low,” he added. “The science has been clear on this for over a year, but official guidance was only recently updated.”

As a result, many companies and organizations continued to focus on “hygiene theatre,” Dr. Allen said, “wasting resources on overcleaning surfaces. Unbelievably, many schools still close for an entire day each week for deep cleaning and some still quarantine library books. The message that shared air is the problem, not shared surfaces, is a message that still needs to be reinforced.”

The National Institute for Health Research, Economic and Social Research Council, and Wellcome support Dr. Greenhalgh’s research. Dr. Greenhalgh and Dr. Allen had no relevant financial relationships to disclose.

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

Physician compensation plummeted in the opening weeks of the COVID-19 pandemic in March and April 2020, but earnings had rebounded for many physicians by the end of the year, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Almost 18,000 physicians in more than 29 specialties told Medscape about their income, hours worked, greatest challenges, and the unexpected impact of COVID-19 on their compensation.
 

How many physicians avoided massive losses

When the pandemic started around March 2020, “a great many physicians saw reductions in volume at first,” says Robert Pearl, MD, former CEO of the Permanente Medical Group and a professor at Stanford (Calif.) University.

Medscape’s survey report shows that a staggering 44% saw a 1%-25% reduction in patient volume, and 9% saw a 26%-50% decline. “That is indeed breathtaking,” Dr. Pearl says.

Several key factors saved many practices from hemorrhaging money, says Michael Belkin, JD, divisional vice president at Merritt Hawkins and Associates in Dallas. “Many physicians used the federal Paycheck Protection Program [PPP] to help keep themselves afloat,” he says. “A large percentage reduced their staff, which reduced their expenses, and many got some of their volume back by transitioning to telemedicine.”

In a 2020 survey for the Physicians Foundation, conducted by Merritt Hawkins, 48% of physicians said their practice had received PPP support, and most of those said the support was enough to allow them to stay open without reducing staff. Only 6% of practices that received PPP support did not stay open.
 

Telemedicine helped many practices

Early in the pandemic, Medicare reimbursements for telemedicine were equal with those for face-to-face visits. “Since telemedicine takes a third less time than an inpatient visit, doctors could see more patients,” Dr. Pearl says.

The switch was almost instantaneous in some practices. Within 3 days, a 200-provider multispecialty practice in Wilmington, N.C., went from not using telehealth to its being used by all physicians, the Medical Group Management Association reported. By late April, the practice was already back up to about 70% of normal overall production.

However, telemedicine could not help every specialty equally. “Generally, allergists can’t do their allergy testing virtually, and patients with mild problems probably put off visits,” Dr. Pearl says. Allergists experienced a large percentage decline in compensation, according to Medscape’s survey. For some, income fell from $301,000 the prior year to $274,000 this year.
 

Primary care struggled

Primary care physicians posted lower compensation than they did the prior year, but most rebounded to some degree. A study released in June 2020 projected that, even with telemedicine, primary care physicians would lose an average of $67,774 for the year.

However, Medscape’s survey found that internists’ average compensation declined from $251,000 in the prior year to $248,000, and average family physicians’ compensation actually rose from $234,000.

Pediatricians had a harder slog. Their average compensation sank from $232,000 to $221,000, according to the report. Even with telemedicine, parents of young children were not contacting the doctor. In May 2020, visits by children aged 3-5 years were down by 56%.
 

Many proceduralists recovered

Procedure-oriented specialties were particularly hard-hit at first, because many hospitals and some states banned all elective surgeries at the beginning of the pandemic.

“In March and April, ophthalmology practices were virtually at a standstill,” says John B. Pinto, an ophthalmology practice management consultant in San Diego. “But by the fourth quarter, operations were back to normal. Practices were fully open, and patients were coming back in.”

Medscape’s survey shows that, by year’s end, compensation was about the same as the year before for orthopedic surgeons ($511,000 in both the 2020 and 2021 reports); cardiologists actually did better ($438,000 in our 2020 report and $459,000 in 2021); and ophthalmologists’ compensation was about the same ($378,000 in our prior report and $379,000 in 2021).

Some other proceduralists, however, did not do as well. Otolaryngologists’ compensation fell to $417,000, the second-biggest percentage drop. “This may be because otolaryngologists’ chief procedures are tonsillectomies, sinus surgery, and nasal surgery, which can be put off,” Dr. Pearl says.

Anesthesiologists, who depend on surgical volume, also did not earn as much in 2020. Their compensation declined from $398,000 in our 2020 report to $378,000 in Medscape’s 2021 report.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day,” an independent anesthesiology practice in Alabama told the MGMA early in the pandemic.
 

Plastic surgeons now the top earners

The biggest increase in compensation by far was made by plastic surgeons, whose income rose 9.8% over the year before, to $526,000. This put them at the top of the list

Dr. Pearl adds that plastic surgeons can perform their procedures in their offices, rather than in a hospital, where elective surgeries were often canceled.

Mr. Belkin says specialties other than plastic surgery had been offering more boutique cosmetic care even before the pandemic. In 2020, nonsurgical cosmetic procedures such as neurotoxin therapy, dermal filler procedures, chemical peels, and hair removal earned $3.1 billion in revenue, according to a survey by the Aesthetic Society.
 

Other specialties that earned more even during COVID

In Medscape’s survey, several specialties actually earned more during the pandemic than in 2019. Some specialties, such as critical care and public health, were integral in managing COVID patients and the pandemic.

However, some specialties involved in COVID care did not see an increase. Compensation for infectious disease specialists (at $245,000) and emergency medicine specialists (at $354,000) remained basically unchanged from the prior year, and for pulmonologists, it was slightly down.

Emergency departments reported decreases in volume of 40% or more early in the pandemic, according to the American College of Emergency Physicians. It was reported that patients were avoiding EDs for fear of contracting COVID, and car accidents were down because people ventured out less.

In this year’s report, psychiatrists saw a modest rise in compensation, to $275,000. “There has been an increase in mental health visits in the pandemic,” Dr. Pearl says. In 2020, about 4 in 10 adults in the United States reported symptoms of anxiety or depressive disorder, up from 1 in 10 adults the prior year. In addition, psychiatrists were third on the list of Merritt Hawkins’ most requested recruiting engagements.

Oncologists saw a rise in compensation, from $377,000 to $403,000. “Volume likely did not fall because cancer patients would go through with their chemotherapy in spite of the pandemic,” Dr. Pearl says. “The increase in income might have to do with the usual inflation in the cost of chemotherapy drugs.” Dr. Pinto saw the same trend for retinal surgeons, whose care also cannot be delayed.

Medscape’s survey also reports increases in compensation for rheumatologists, endocrinologists, and neurologists, but it reports small declines among dermatologists, radiologists, and gastroenterologists.
 

Gender-based pay gap remains in place

The gender-based pay gap in this year’s report is similar to that seen in Medscape’s report for the prior year. Men earned 27% more than women in 2021, compared with 25% more the year before. Some physicians commented that more women physicians maintained flexible or shorter work schedules to help with children who could not go into school.

“Having to be a full-time physician, full-time mom, and full-time teacher during our surge was unbelievable,” a primary care pediatrician in group practice and mother of two reported in November. “I felt pulled in all directions and didn’t do anything well.”

In addition, “men dominate some specialties that seem to have seen a smaller drop in volume in the pandemic, such as emergency medicine, infectious disease, pulmonology, and oncology,” says Halee Fischer-Wright, MD, CEO of MGMA.
 

Employed physicians shared their employers’ pain

Employed physicians, who typically work at hospitals, shared the financial pains of their institutions, particularly in the early stages of the pandemic. In April, hospital admissions were 34.1% below prepandemic levels, according to a study published in Health Affairs. That figure had risen by June, but it was still 8.3% below prepandemic volume.

By the end of the year, many hospitals and hospital systems were in the black, thanks in large part to generous federal subsidies, but actual operations still lost money for the year. Altogether, 42% of them posted an operational loss in 2020, up from the 23% in 2019, according to a survey by Moody’s Investors Service.

Medscape’s report shows that many employed physicians lost pay in 2020, and for many, pay had not returned to pre-COVID levels. Only 28% of primary care physicians and 32% of specialists who lost pay have seen it restored, according to the report. In addition, 15% of surveyed physicians did not receive an annual raise.

Many employed doctors are paid on the basis of relative value units (RVUs), which is a measure of the value of their work. In many cases, there was not enough work to reach RVU thresholds. Would hospitals and other employers lower RVU targets to meet the problem? “I haven’t seen our clients make concessions to providers along those lines,” Mr. Belkin says.
 

Physicians had to work longer hours

The Medscape report also found that in 2020, physicians saw fewer patients because each visit took longer.

“With the threat of COVID, in-person visits take more time than before,” Mr. Belkin says. “Physicians and staff have to prepare the exam room after each visit, and doctors must spend more time answering patients’ questions about COVID.”

“The new protocols to keep everyone safe add time between patients, and physicians have to answer patients’ questions about the pandemic and vaccines,” Dr. Fischer-Wright says. “You might see a 20% increase in time spent just on these non–revenue-generating COVID activities.”
 

Physicians still like their specialty

Although 2020 was a challenging year for physicians, the percentage of those who were satisfied with their specialty choice generally did not slip from the year before. It actually rose for several specialties – most notably, rheumatology, pulmonology, physical medicine and rehabilitation, and nephrology.

One specialty saw a decline in satisfaction with their specialty choice, and that was public health and preventive medicine, which plummeted 16 percentage points to 67% – putting it at the bottom of the list.

Even before the pandemic, many public health departments were chronically underfunded. This problem was possibly exacerbated by the pressures to keep up with COVID reporting and testing responsibilities.
 

Conclusion

Although 2020 was a wild ride for many physicians, many came out of it with only minor reductions in overall compensation, and some saw increases. Still, some specialties and many individuals experienced terrible financial stress and had to make changes in their lives and their spending in order to stay afloat.

“The biggest inhibitor to getting back to normal had to do with doctors who did not want to return because they did not want to risk getting COVID,” Dr. Pinto reports. But he notes that by February 2021 most doctors were completely vaccinated and could feel safe again.

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

Physician compensation plummeted in the opening weeks of the COVID-19 pandemic in March and April 2020, but earnings had rebounded for many physicians by the end of the year, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Almost 18,000 physicians in more than 29 specialties told Medscape about their income, hours worked, greatest challenges, and the unexpected impact of COVID-19 on their compensation.
 

How many physicians avoided massive losses

When the pandemic started around March 2020, “a great many physicians saw reductions in volume at first,” says Robert Pearl, MD, former CEO of the Permanente Medical Group and a professor at Stanford (Calif.) University.

Medscape’s survey report shows that a staggering 44% saw a 1%-25% reduction in patient volume, and 9% saw a 26%-50% decline. “That is indeed breathtaking,” Dr. Pearl says.

Several key factors saved many practices from hemorrhaging money, says Michael Belkin, JD, divisional vice president at Merritt Hawkins and Associates in Dallas. “Many physicians used the federal Paycheck Protection Program [PPP] to help keep themselves afloat,” he says. “A large percentage reduced their staff, which reduced their expenses, and many got some of their volume back by transitioning to telemedicine.”

In a 2020 survey for the Physicians Foundation, conducted by Merritt Hawkins, 48% of physicians said their practice had received PPP support, and most of those said the support was enough to allow them to stay open without reducing staff. Only 6% of practices that received PPP support did not stay open.
 

Telemedicine helped many practices

Early in the pandemic, Medicare reimbursements for telemedicine were equal with those for face-to-face visits. “Since telemedicine takes a third less time than an inpatient visit, doctors could see more patients,” Dr. Pearl says.

The switch was almost instantaneous in some practices. Within 3 days, a 200-provider multispecialty practice in Wilmington, N.C., went from not using telehealth to its being used by all physicians, the Medical Group Management Association reported. By late April, the practice was already back up to about 70% of normal overall production.

However, telemedicine could not help every specialty equally. “Generally, allergists can’t do their allergy testing virtually, and patients with mild problems probably put off visits,” Dr. Pearl says. Allergists experienced a large percentage decline in compensation, according to Medscape’s survey. For some, income fell from $301,000 the prior year to $274,000 this year.
 

Primary care struggled

Primary care physicians posted lower compensation than they did the prior year, but most rebounded to some degree. A study released in June 2020 projected that, even with telemedicine, primary care physicians would lose an average of $67,774 for the year.

However, Medscape’s survey found that internists’ average compensation declined from $251,000 in the prior year to $248,000, and average family physicians’ compensation actually rose from $234,000.

Pediatricians had a harder slog. Their average compensation sank from $232,000 to $221,000, according to the report. Even with telemedicine, parents of young children were not contacting the doctor. In May 2020, visits by children aged 3-5 years were down by 56%.
 

Many proceduralists recovered

Procedure-oriented specialties were particularly hard-hit at first, because many hospitals and some states banned all elective surgeries at the beginning of the pandemic.

“In March and April, ophthalmology practices were virtually at a standstill,” says John B. Pinto, an ophthalmology practice management consultant in San Diego. “But by the fourth quarter, operations were back to normal. Practices were fully open, and patients were coming back in.”

Medscape’s survey shows that, by year’s end, compensation was about the same as the year before for orthopedic surgeons ($511,000 in both the 2020 and 2021 reports); cardiologists actually did better ($438,000 in our 2020 report and $459,000 in 2021); and ophthalmologists’ compensation was about the same ($378,000 in our prior report and $379,000 in 2021).

Some other proceduralists, however, did not do as well. Otolaryngologists’ compensation fell to $417,000, the second-biggest percentage drop. “This may be because otolaryngologists’ chief procedures are tonsillectomies, sinus surgery, and nasal surgery, which can be put off,” Dr. Pearl says.

Anesthesiologists, who depend on surgical volume, also did not earn as much in 2020. Their compensation declined from $398,000 in our 2020 report to $378,000 in Medscape’s 2021 report.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day,” an independent anesthesiology practice in Alabama told the MGMA early in the pandemic.
 

Plastic surgeons now the top earners

The biggest increase in compensation by far was made by plastic surgeons, whose income rose 9.8% over the year before, to $526,000. This put them at the top of the list

Dr. Pearl adds that plastic surgeons can perform their procedures in their offices, rather than in a hospital, where elective surgeries were often canceled.

Mr. Belkin says specialties other than plastic surgery had been offering more boutique cosmetic care even before the pandemic. In 2020, nonsurgical cosmetic procedures such as neurotoxin therapy, dermal filler procedures, chemical peels, and hair removal earned $3.1 billion in revenue, according to a survey by the Aesthetic Society.
 

Other specialties that earned more even during COVID

In Medscape’s survey, several specialties actually earned more during the pandemic than in 2019. Some specialties, such as critical care and public health, were integral in managing COVID patients and the pandemic.

However, some specialties involved in COVID care did not see an increase. Compensation for infectious disease specialists (at $245,000) and emergency medicine specialists (at $354,000) remained basically unchanged from the prior year, and for pulmonologists, it was slightly down.

Emergency departments reported decreases in volume of 40% or more early in the pandemic, according to the American College of Emergency Physicians. It was reported that patients were avoiding EDs for fear of contracting COVID, and car accidents were down because people ventured out less.

In this year’s report, psychiatrists saw a modest rise in compensation, to $275,000. “There has been an increase in mental health visits in the pandemic,” Dr. Pearl says. In 2020, about 4 in 10 adults in the United States reported symptoms of anxiety or depressive disorder, up from 1 in 10 adults the prior year. In addition, psychiatrists were third on the list of Merritt Hawkins’ most requested recruiting engagements.

Oncologists saw a rise in compensation, from $377,000 to $403,000. “Volume likely did not fall because cancer patients would go through with their chemotherapy in spite of the pandemic,” Dr. Pearl says. “The increase in income might have to do with the usual inflation in the cost of chemotherapy drugs.” Dr. Pinto saw the same trend for retinal surgeons, whose care also cannot be delayed.

Medscape’s survey also reports increases in compensation for rheumatologists, endocrinologists, and neurologists, but it reports small declines among dermatologists, radiologists, and gastroenterologists.
 

Gender-based pay gap remains in place

The gender-based pay gap in this year’s report is similar to that seen in Medscape’s report for the prior year. Men earned 27% more than women in 2021, compared with 25% more the year before. Some physicians commented that more women physicians maintained flexible or shorter work schedules to help with children who could not go into school.

“Having to be a full-time physician, full-time mom, and full-time teacher during our surge was unbelievable,” a primary care pediatrician in group practice and mother of two reported in November. “I felt pulled in all directions and didn’t do anything well.”

In addition, “men dominate some specialties that seem to have seen a smaller drop in volume in the pandemic, such as emergency medicine, infectious disease, pulmonology, and oncology,” says Halee Fischer-Wright, MD, CEO of MGMA.
 

Employed physicians shared their employers’ pain

Employed physicians, who typically work at hospitals, shared the financial pains of their institutions, particularly in the early stages of the pandemic. In April, hospital admissions were 34.1% below prepandemic levels, according to a study published in Health Affairs. That figure had risen by June, but it was still 8.3% below prepandemic volume.

By the end of the year, many hospitals and hospital systems were in the black, thanks in large part to generous federal subsidies, but actual operations still lost money for the year. Altogether, 42% of them posted an operational loss in 2020, up from the 23% in 2019, according to a survey by Moody’s Investors Service.

Medscape’s report shows that many employed physicians lost pay in 2020, and for many, pay had not returned to pre-COVID levels. Only 28% of primary care physicians and 32% of specialists who lost pay have seen it restored, according to the report. In addition, 15% of surveyed physicians did not receive an annual raise.

Many employed doctors are paid on the basis of relative value units (RVUs), which is a measure of the value of their work. In many cases, there was not enough work to reach RVU thresholds. Would hospitals and other employers lower RVU targets to meet the problem? “I haven’t seen our clients make concessions to providers along those lines,” Mr. Belkin says.
 

Physicians had to work longer hours

The Medscape report also found that in 2020, physicians saw fewer patients because each visit took longer.

“With the threat of COVID, in-person visits take more time than before,” Mr. Belkin says. “Physicians and staff have to prepare the exam room after each visit, and doctors must spend more time answering patients’ questions about COVID.”

“The new protocols to keep everyone safe add time between patients, and physicians have to answer patients’ questions about the pandemic and vaccines,” Dr. Fischer-Wright says. “You might see a 20% increase in time spent just on these non–revenue-generating COVID activities.”
 

Physicians still like their specialty

Although 2020 was a challenging year for physicians, the percentage of those who were satisfied with their specialty choice generally did not slip from the year before. It actually rose for several specialties – most notably, rheumatology, pulmonology, physical medicine and rehabilitation, and nephrology.

One specialty saw a decline in satisfaction with their specialty choice, and that was public health and preventive medicine, which plummeted 16 percentage points to 67% – putting it at the bottom of the list.

Even before the pandemic, many public health departments were chronically underfunded. This problem was possibly exacerbated by the pressures to keep up with COVID reporting and testing responsibilities.
 

Conclusion

Although 2020 was a wild ride for many physicians, many came out of it with only minor reductions in overall compensation, and some saw increases. Still, some specialties and many individuals experienced terrible financial stress and had to make changes in their lives and their spending in order to stay afloat.

“The biggest inhibitor to getting back to normal had to do with doctors who did not want to return because they did not want to risk getting COVID,” Dr. Pinto reports. But he notes that by February 2021 most doctors were completely vaccinated and could feel safe again.

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

Physician compensation plummeted in the opening weeks of the COVID-19 pandemic in March and April 2020, but earnings had rebounded for many physicians by the end of the year, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Almost 18,000 physicians in more than 29 specialties told Medscape about their income, hours worked, greatest challenges, and the unexpected impact of COVID-19 on their compensation.
 

How many physicians avoided massive losses

When the pandemic started around March 2020, “a great many physicians saw reductions in volume at first,” says Robert Pearl, MD, former CEO of the Permanente Medical Group and a professor at Stanford (Calif.) University.

Medscape’s survey report shows that a staggering 44% saw a 1%-25% reduction in patient volume, and 9% saw a 26%-50% decline. “That is indeed breathtaking,” Dr. Pearl says.

Several key factors saved many practices from hemorrhaging money, says Michael Belkin, JD, divisional vice president at Merritt Hawkins and Associates in Dallas. “Many physicians used the federal Paycheck Protection Program [PPP] to help keep themselves afloat,” he says. “A large percentage reduced their staff, which reduced their expenses, and many got some of their volume back by transitioning to telemedicine.”

In a 2020 survey for the Physicians Foundation, conducted by Merritt Hawkins, 48% of physicians said their practice had received PPP support, and most of those said the support was enough to allow them to stay open without reducing staff. Only 6% of practices that received PPP support did not stay open.
 

Telemedicine helped many practices

Early in the pandemic, Medicare reimbursements for telemedicine were equal with those for face-to-face visits. “Since telemedicine takes a third less time than an inpatient visit, doctors could see more patients,” Dr. Pearl says.

The switch was almost instantaneous in some practices. Within 3 days, a 200-provider multispecialty practice in Wilmington, N.C., went from not using telehealth to its being used by all physicians, the Medical Group Management Association reported. By late April, the practice was already back up to about 70% of normal overall production.

However, telemedicine could not help every specialty equally. “Generally, allergists can’t do their allergy testing virtually, and patients with mild problems probably put off visits,” Dr. Pearl says. Allergists experienced a large percentage decline in compensation, according to Medscape’s survey. For some, income fell from $301,000 the prior year to $274,000 this year.
 

Primary care struggled

Primary care physicians posted lower compensation than they did the prior year, but most rebounded to some degree. A study released in June 2020 projected that, even with telemedicine, primary care physicians would lose an average of $67,774 for the year.

However, Medscape’s survey found that internists’ average compensation declined from $251,000 in the prior year to $248,000, and average family physicians’ compensation actually rose from $234,000.

Pediatricians had a harder slog. Their average compensation sank from $232,000 to $221,000, according to the report. Even with telemedicine, parents of young children were not contacting the doctor. In May 2020, visits by children aged 3-5 years were down by 56%.
 

Many proceduralists recovered

Procedure-oriented specialties were particularly hard-hit at first, because many hospitals and some states banned all elective surgeries at the beginning of the pandemic.

“In March and April, ophthalmology practices were virtually at a standstill,” says John B. Pinto, an ophthalmology practice management consultant in San Diego. “But by the fourth quarter, operations were back to normal. Practices were fully open, and patients were coming back in.”

Medscape’s survey shows that, by year’s end, compensation was about the same as the year before for orthopedic surgeons ($511,000 in both the 2020 and 2021 reports); cardiologists actually did better ($438,000 in our 2020 report and $459,000 in 2021); and ophthalmologists’ compensation was about the same ($378,000 in our prior report and $379,000 in 2021).

Some other proceduralists, however, did not do as well. Otolaryngologists’ compensation fell to $417,000, the second-biggest percentage drop. “This may be because otolaryngologists’ chief procedures are tonsillectomies, sinus surgery, and nasal surgery, which can be put off,” Dr. Pearl says.

Anesthesiologists, who depend on surgical volume, also did not earn as much in 2020. Their compensation declined from $398,000 in our 2020 report to $378,000 in Medscape’s 2021 report.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day,” an independent anesthesiology practice in Alabama told the MGMA early in the pandemic.
 

Plastic surgeons now the top earners

The biggest increase in compensation by far was made by plastic surgeons, whose income rose 9.8% over the year before, to $526,000. This put them at the top of the list

Dr. Pearl adds that plastic surgeons can perform their procedures in their offices, rather than in a hospital, where elective surgeries were often canceled.

Mr. Belkin says specialties other than plastic surgery had been offering more boutique cosmetic care even before the pandemic. In 2020, nonsurgical cosmetic procedures such as neurotoxin therapy, dermal filler procedures, chemical peels, and hair removal earned $3.1 billion in revenue, according to a survey by the Aesthetic Society.
 

Other specialties that earned more even during COVID

In Medscape’s survey, several specialties actually earned more during the pandemic than in 2019. Some specialties, such as critical care and public health, were integral in managing COVID patients and the pandemic.

However, some specialties involved in COVID care did not see an increase. Compensation for infectious disease specialists (at $245,000) and emergency medicine specialists (at $354,000) remained basically unchanged from the prior year, and for pulmonologists, it was slightly down.

Emergency departments reported decreases in volume of 40% or more early in the pandemic, according to the American College of Emergency Physicians. It was reported that patients were avoiding EDs for fear of contracting COVID, and car accidents were down because people ventured out less.

In this year’s report, psychiatrists saw a modest rise in compensation, to $275,000. “There has been an increase in mental health visits in the pandemic,” Dr. Pearl says. In 2020, about 4 in 10 adults in the United States reported symptoms of anxiety or depressive disorder, up from 1 in 10 adults the prior year. In addition, psychiatrists were third on the list of Merritt Hawkins’ most requested recruiting engagements.

Oncologists saw a rise in compensation, from $377,000 to $403,000. “Volume likely did not fall because cancer patients would go through with their chemotherapy in spite of the pandemic,” Dr. Pearl says. “The increase in income might have to do with the usual inflation in the cost of chemotherapy drugs.” Dr. Pinto saw the same trend for retinal surgeons, whose care also cannot be delayed.

Medscape’s survey also reports increases in compensation for rheumatologists, endocrinologists, and neurologists, but it reports small declines among dermatologists, radiologists, and gastroenterologists.
 

Gender-based pay gap remains in place

The gender-based pay gap in this year’s report is similar to that seen in Medscape’s report for the prior year. Men earned 27% more than women in 2021, compared with 25% more the year before. Some physicians commented that more women physicians maintained flexible or shorter work schedules to help with children who could not go into school.

“Having to be a full-time physician, full-time mom, and full-time teacher during our surge was unbelievable,” a primary care pediatrician in group practice and mother of two reported in November. “I felt pulled in all directions and didn’t do anything well.”

In addition, “men dominate some specialties that seem to have seen a smaller drop in volume in the pandemic, such as emergency medicine, infectious disease, pulmonology, and oncology,” says Halee Fischer-Wright, MD, CEO of MGMA.
 

Employed physicians shared their employers’ pain

Employed physicians, who typically work at hospitals, shared the financial pains of their institutions, particularly in the early stages of the pandemic. In April, hospital admissions were 34.1% below prepandemic levels, according to a study published in Health Affairs. That figure had risen by June, but it was still 8.3% below prepandemic volume.

By the end of the year, many hospitals and hospital systems were in the black, thanks in large part to generous federal subsidies, but actual operations still lost money for the year. Altogether, 42% of them posted an operational loss in 2020, up from the 23% in 2019, according to a survey by Moody’s Investors Service.

Medscape’s report shows that many employed physicians lost pay in 2020, and for many, pay had not returned to pre-COVID levels. Only 28% of primary care physicians and 32% of specialists who lost pay have seen it restored, according to the report. In addition, 15% of surveyed physicians did not receive an annual raise.

Many employed doctors are paid on the basis of relative value units (RVUs), which is a measure of the value of their work. In many cases, there was not enough work to reach RVU thresholds. Would hospitals and other employers lower RVU targets to meet the problem? “I haven’t seen our clients make concessions to providers along those lines,” Mr. Belkin says.
 

Physicians had to work longer hours

The Medscape report also found that in 2020, physicians saw fewer patients because each visit took longer.

“With the threat of COVID, in-person visits take more time than before,” Mr. Belkin says. “Physicians and staff have to prepare the exam room after each visit, and doctors must spend more time answering patients’ questions about COVID.”

“The new protocols to keep everyone safe add time between patients, and physicians have to answer patients’ questions about the pandemic and vaccines,” Dr. Fischer-Wright says. “You might see a 20% increase in time spent just on these non–revenue-generating COVID activities.”
 

Physicians still like their specialty

Although 2020 was a challenging year for physicians, the percentage of those who were satisfied with their specialty choice generally did not slip from the year before. It actually rose for several specialties – most notably, rheumatology, pulmonology, physical medicine and rehabilitation, and nephrology.

One specialty saw a decline in satisfaction with their specialty choice, and that was public health and preventive medicine, which plummeted 16 percentage points to 67% – putting it at the bottom of the list.

Even before the pandemic, many public health departments were chronically underfunded. This problem was possibly exacerbated by the pressures to keep up with COVID reporting and testing responsibilities.
 

Conclusion

Although 2020 was a wild ride for many physicians, many came out of it with only minor reductions in overall compensation, and some saw increases. Still, some specialties and many individuals experienced terrible financial stress and had to make changes in their lives and their spending in order to stay afloat.

“The biggest inhibitor to getting back to normal had to do with doctors who did not want to return because they did not want to risk getting COVID,” Dr. Pinto reports. But he notes that by February 2021 most doctors were completely vaccinated and could feel safe again.

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

In April, federal rules implementing the bipartisan federal 21st Century Cures Act went into effect that allow patients to see their clinical notes. While some clinicians consider it an unwelcome intrusion, advocates say it will improve communication and compliance.

Patient access to notes is not new. In many states, patients already have the ability to request copies of their charts, or to access truncated information via clinic websites. The difference is that most patients will now be able to click on a patient portal – such as MyChart, or other similar apps – and gain instantaneous, unfettered access to everything in their records.

Clinicians have traditionally thought of medical notes as private journal entries; but in the last few decades they have become an important component of the documentation necessary for billing, as well as evidence in the event of litigation. Now, with the implementation of the Cures Act, medical notes have evolved into a tool to communicate with the patient, rather than just among health care providers, lawyers, and billing departments.

Supporters contend that this change will make a big difference, because patients will be able to see exactly what their doctors have written, rather than just a list of confusing test results and diagnosis lists in “medicalese.”

OpenNotes, a think tank that has promoted the sharing of clinical notes with patients for years, calls the Cures Act legislation a “new world” where shared notes are valuable tools to improve communication between patients and physicians while strengthening their relationship. They cite evidence indicating that “when health professionals offer patients and families ready access to clinical notes, the quality and safety of care improves.”

Not all doctors are as enthusiastic. Many are concerned that patients might misinterpret what they see in their doctors’ notes, including complex descriptions of clinical assessments and decisions.

Others worry about patients having immediate access to their records, perhaps even before their physicians. The American Academy of Dermatology is working with the American Medical Association and other groups to gather real-world instances where the release of lab results, reports, or notes directly to patients before their physician could review the information with them caused emotional harm or other adverse consequences.

Undoubtedly, there are scenarios where unrestricted display of clinical notes could be problematic. One example is the issue of adolescents and reproductive health. Since parents now have access to their children’s records, some teenagers might hesitate to confide in their physicians and deny themselves important medical care.

The new rules permit blocking access to records if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or third parties. Psychotherapy counseling notes, for example, are completely exempt from the new requirements.

There are also state-level laws that can supersede the new federal law and block access to notes. For example, California law forbids providers from posting cancer test results without discussing them with the patient first.

Research indicates that shared notes have benefits that should outweigh the concerns of most physicians. One study showed that about 70% of patients said reviewing their notes helped them understand why medications were prescribed, which improved their compliance. This was particularly true for patients whose primary language is not English. A British study found that patients felt empowered by shared notes, and thought they improved their relationship with their physicians.

Other advantages of sharing notes include the ability of family members to review what happened at visits, which can be particularly important when dementia or other disabilities are involved. Patients will also be able to share their medical records with physicians outside of their health network, thus avoiding unnecessary or repetitious workups.

OpenNotes contends that when patients review their doctors’ notes, they gain “a newfound, deeper respect for what physicians have to understand to do their jobs.” Other predicted advantages include improved medical record accuracy and less miscommunication. In a study published in 2019 that evaluated experiences of patients who read ambulatory visit notes, only 5% were more worried after reading the notes and 3% were confused.

Alleviating worry among clinicians may be a bigger problem; but as a general principle, you should avoid judgmental language, and never write anything in a chart that you wouldn’t want your patients or their family members – or lawyers – to see.

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 dermnews@mdedge.com.

In April, federal rules implementing the bipartisan federal 21st Century Cures Act went into effect that allow patients to see their clinical notes. While some clinicians consider it an unwelcome intrusion, advocates say it will improve communication and compliance.

Patient access to notes is not new. In many states, patients already have the ability to request copies of their charts, or to access truncated information via clinic websites. The difference is that most patients will now be able to click on a patient portal – such as MyChart, or other similar apps – and gain instantaneous, unfettered access to everything in their records.

Clinicians have traditionally thought of medical notes as private journal entries; but in the last few decades they have become an important component of the documentation necessary for billing, as well as evidence in the event of litigation. Now, with the implementation of the Cures Act, medical notes have evolved into a tool to communicate with the patient, rather than just among health care providers, lawyers, and billing departments.

Supporters contend that this change will make a big difference, because patients will be able to see exactly what their doctors have written, rather than just a list of confusing test results and diagnosis lists in “medicalese.”

OpenNotes, a think tank that has promoted the sharing of clinical notes with patients for years, calls the Cures Act legislation a “new world” where shared notes are valuable tools to improve communication between patients and physicians while strengthening their relationship. They cite evidence indicating that “when health professionals offer patients and families ready access to clinical notes, the quality and safety of care improves.”

Not all doctors are as enthusiastic. Many are concerned that patients might misinterpret what they see in their doctors’ notes, including complex descriptions of clinical assessments and decisions.

Others worry about patients having immediate access to their records, perhaps even before their physicians. The American Academy of Dermatology is working with the American Medical Association and other groups to gather real-world instances where the release of lab results, reports, or notes directly to patients before their physician could review the information with them caused emotional harm or other adverse consequences.

Undoubtedly, there are scenarios where unrestricted display of clinical notes could be problematic. One example is the issue of adolescents and reproductive health. Since parents now have access to their children’s records, some teenagers might hesitate to confide in their physicians and deny themselves important medical care.

The new rules permit blocking access to records if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or third parties. Psychotherapy counseling notes, for example, are completely exempt from the new requirements.

There are also state-level laws that can supersede the new federal law and block access to notes. For example, California law forbids providers from posting cancer test results without discussing them with the patient first.

Research indicates that shared notes have benefits that should outweigh the concerns of most physicians. One study showed that about 70% of patients said reviewing their notes helped them understand why medications were prescribed, which improved their compliance. This was particularly true for patients whose primary language is not English. A British study found that patients felt empowered by shared notes, and thought they improved their relationship with their physicians.

Other advantages of sharing notes include the ability of family members to review what happened at visits, which can be particularly important when dementia or other disabilities are involved. Patients will also be able to share their medical records with physicians outside of their health network, thus avoiding unnecessary or repetitious workups.

OpenNotes contends that when patients review their doctors’ notes, they gain “a newfound, deeper respect for what physicians have to understand to do their jobs.” Other predicted advantages include improved medical record accuracy and less miscommunication. In a study published in 2019 that evaluated experiences of patients who read ambulatory visit notes, only 5% were more worried after reading the notes and 3% were confused.

Alleviating worry among clinicians may be a bigger problem; but as a general principle, you should avoid judgmental language, and never write anything in a chart that you wouldn’t want your patients or their family members – or lawyers – to see.

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 dermnews@mdedge.com.

In April, federal rules implementing the bipartisan federal 21st Century Cures Act went into effect that allow patients to see their clinical notes. While some clinicians consider it an unwelcome intrusion, advocates say it will improve communication and compliance.

Patient access to notes is not new. In many states, patients already have the ability to request copies of their charts, or to access truncated information via clinic websites. The difference is that most patients will now be able to click on a patient portal – such as MyChart, or other similar apps – and gain instantaneous, unfettered access to everything in their records.

Clinicians have traditionally thought of medical notes as private journal entries; but in the last few decades they have become an important component of the documentation necessary for billing, as well as evidence in the event of litigation. Now, with the implementation of the Cures Act, medical notes have evolved into a tool to communicate with the patient, rather than just among health care providers, lawyers, and billing departments.

Supporters contend that this change will make a big difference, because patients will be able to see exactly what their doctors have written, rather than just a list of confusing test results and diagnosis lists in “medicalese.”

OpenNotes, a think tank that has promoted the sharing of clinical notes with patients for years, calls the Cures Act legislation a “new world” where shared notes are valuable tools to improve communication between patients and physicians while strengthening their relationship. They cite evidence indicating that “when health professionals offer patients and families ready access to clinical notes, the quality and safety of care improves.”

Not all doctors are as enthusiastic. Many are concerned that patients might misinterpret what they see in their doctors’ notes, including complex descriptions of clinical assessments and decisions.

Others worry about patients having immediate access to their records, perhaps even before their physicians. The American Academy of Dermatology is working with the American Medical Association and other groups to gather real-world instances where the release of lab results, reports, or notes directly to patients before their physician could review the information with them caused emotional harm or other adverse consequences.

Undoubtedly, there are scenarios where unrestricted display of clinical notes could be problematic. One example is the issue of adolescents and reproductive health. Since parents now have access to their children’s records, some teenagers might hesitate to confide in their physicians and deny themselves important medical care.

The new rules permit blocking access to records if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or third parties. Psychotherapy counseling notes, for example, are completely exempt from the new requirements.

There are also state-level laws that can supersede the new federal law and block access to notes. For example, California law forbids providers from posting cancer test results without discussing them with the patient first.

Research indicates that shared notes have benefits that should outweigh the concerns of most physicians. One study showed that about 70% of patients said reviewing their notes helped them understand why medications were prescribed, which improved their compliance. This was particularly true for patients whose primary language is not English. A British study found that patients felt empowered by shared notes, and thought they improved their relationship with their physicians.

Other advantages of sharing notes include the ability of family members to review what happened at visits, which can be particularly important when dementia or other disabilities are involved. Patients will also be able to share their medical records with physicians outside of their health network, thus avoiding unnecessary or repetitious workups.

OpenNotes contends that when patients review their doctors’ notes, they gain “a newfound, deeper respect for what physicians have to understand to do their jobs.” Other predicted advantages include improved medical record accuracy and less miscommunication. In a study published in 2019 that evaluated experiences of patients who read ambulatory visit notes, only 5% were more worried after reading the notes and 3% were confused.

Alleviating worry among clinicians may be a bigger problem; but as a general principle, you should avoid judgmental language, and never write anything in a chart that you wouldn’t want your patients or their family members – or lawyers – to see.

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 dermnews@mdedge.com.