Clinical Endocrinology News

The incidence of autoimmune hepatitis (AIH) may be rising, according to a prospective population-based study conducted in New Zealand.

From 2008 to 2016, the rising incidence of AIH led to a 40% increase in point prevalence, reported lead author Mehul Lamba, MD, of Christchurch (New Zealand) Hospital and colleagues.

The present study, which also assessed rates of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), adds data to an area of inquiry historically characterized by limited and inconsistent results, the investigators wrote in Clinical Gastroenterology and Hepatology. They suggested that mixed findings from previous studies may be because of differences in population and environmental factors, but also varying diagnostic criteria.

“The epidemiological trends of these autoimmune liver diseases therefore remain incompletely understood,” wrote Dr. Lamba and colleagues.

Their study evaluated trends in autoimmune liver diseases over a 9-year time frame in Canterbury, New Zealand. According to the investigators, this region is well suited to an epidemiological investigation because it is a clearly defined geographic area with approximately 600,000 people, most of whom rely on one tertiary care center: Christchurch Hospital. The bulk of the data therefore came from this center, while a minority of cases were gathered from local private gastroenterology practices, “making complete case ascertainment possible.”

Incidence of AIH, PBC, and PSC was assessed at three time points: 2008-2010, 2011-2013, and 2014-2016. AIH had the highest overall incidence, at 1.93 cases per 100,000 people, followed by PSC (0.92) and PBC (0.51).

While the rates of PBC and PSC did not change significantly over time, the incidence of AIH rose from 1.37 cases per 100,000 people in the period from 2008-2010 to 2.39 per 100,000 in 2014-2016 (P = .04), which computes to an incidence rate ratio of 1.69 (95% confidence interval, 1.02-2.84). Point prevalence was also significantly higher in 2016, compared with 2008, at 27.5 per 100,000 versus 19.7 per 100,000 (P < .01). The investigators described a bimodal age of presentation, with the first peak among patients younger than 20 years, and a second, larger peak among individuals aged 50-69 years.

According to the investigators, these findings “are concordant with the results observed in the European cohort,” citing a Danish study spanning 1994-2012 and a Dutch study spanning 2000-2010. They noted that the Danish study also reported a bimodal distribution of age incidence, as did a Swedish study, and another study from New Zealand. The stable levels of PBC and PSC align with two recent retrospective studies conducted in the United States and, they added.

“We believe that the observed differential trends in the incidence of these autoimmune liver diseases truly reflects their contemporary epidemiology,” the investigators wrote. They went on to suggest that the findings did not stem from an increase in diagnostic scrutiny because the study period did not include any significant changes in gastroenterology service, coding, or diagnostic criteria in the region studied.

“The increased incidence of AIH parallels rising incidence and prevalence of other autoimmune disorders such as [inflammatory bowel disease], type 1 diabetes, and multiple sclerosis in New Zealand, and it is unclear whether these autoimmune conditions share a common local environmental trigger,” they wrote. “Environmental factors likely play a central role augmenting phenotypic expression in genetically predisposed individuals.”

While Dr. Lamba and colleagues proposed several possible factors, such as increased exposure to pharmaceuticals, definitive factors remain elusive, which the authors cited as one limitation of their study. Another limitation they cited is the possibility that other etiologies were mistakenly classified as “probable” AIH; however, the chances of that are small, and the proportion of probable versus definitive AIH noted in this study do reflect those seen in other epidemiological studies.

“The reason for observed differential change in incidence of these autoimmune liver diseases is unclear,” they wrote, “and future collaborative prospective epidemiological study would be required to assess this further.”

The investigators reported no conflicts of interest.

The incidence of autoimmune hepatitis (AIH) may be rising, according to a prospective population-based study conducted in New Zealand.

From 2008 to 2016, the rising incidence of AIH led to a 40% increase in point prevalence, reported lead author Mehul Lamba, MD, of Christchurch (New Zealand) Hospital and colleagues.

The present study, which also assessed rates of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), adds data to an area of inquiry historically characterized by limited and inconsistent results, the investigators wrote in Clinical Gastroenterology and Hepatology. They suggested that mixed findings from previous studies may be because of differences in population and environmental factors, but also varying diagnostic criteria.

“The epidemiological trends of these autoimmune liver diseases therefore remain incompletely understood,” wrote Dr. Lamba and colleagues.

Their study evaluated trends in autoimmune liver diseases over a 9-year time frame in Canterbury, New Zealand. According to the investigators, this region is well suited to an epidemiological investigation because it is a clearly defined geographic area with approximately 600,000 people, most of whom rely on one tertiary care center: Christchurch Hospital. The bulk of the data therefore came from this center, while a minority of cases were gathered from local private gastroenterology practices, “making complete case ascertainment possible.”

Incidence of AIH, PBC, and PSC was assessed at three time points: 2008-2010, 2011-2013, and 2014-2016. AIH had the highest overall incidence, at 1.93 cases per 100,000 people, followed by PSC (0.92) and PBC (0.51).

While the rates of PBC and PSC did not change significantly over time, the incidence of AIH rose from 1.37 cases per 100,000 people in the period from 2008-2010 to 2.39 per 100,000 in 2014-2016 (P = .04), which computes to an incidence rate ratio of 1.69 (95% confidence interval, 1.02-2.84). Point prevalence was also significantly higher in 2016, compared with 2008, at 27.5 per 100,000 versus 19.7 per 100,000 (P < .01). The investigators described a bimodal age of presentation, with the first peak among patients younger than 20 years, and a second, larger peak among individuals aged 50-69 years.

According to the investigators, these findings “are concordant with the results observed in the European cohort,” citing a Danish study spanning 1994-2012 and a Dutch study spanning 2000-2010. They noted that the Danish study also reported a bimodal distribution of age incidence, as did a Swedish study, and another study from New Zealand. The stable levels of PBC and PSC align with two recent retrospective studies conducted in the United States and, they added.

“We believe that the observed differential trends in the incidence of these autoimmune liver diseases truly reflects their contemporary epidemiology,” the investigators wrote. They went on to suggest that the findings did not stem from an increase in diagnostic scrutiny because the study period did not include any significant changes in gastroenterology service, coding, or diagnostic criteria in the region studied.

“The increased incidence of AIH parallels rising incidence and prevalence of other autoimmune disorders such as [inflammatory bowel disease], type 1 diabetes, and multiple sclerosis in New Zealand, and it is unclear whether these autoimmune conditions share a common local environmental trigger,” they wrote. “Environmental factors likely play a central role augmenting phenotypic expression in genetically predisposed individuals.”

While Dr. Lamba and colleagues proposed several possible factors, such as increased exposure to pharmaceuticals, definitive factors remain elusive, which the authors cited as one limitation of their study. Another limitation they cited is the possibility that other etiologies were mistakenly classified as “probable” AIH; however, the chances of that are small, and the proportion of probable versus definitive AIH noted in this study do reflect those seen in other epidemiological studies.

“The reason for observed differential change in incidence of these autoimmune liver diseases is unclear,” they wrote, “and future collaborative prospective epidemiological study would be required to assess this further.”

The investigators reported no conflicts of interest.

The incidence of autoimmune hepatitis (AIH) may be rising, according to a prospective population-based study conducted in New Zealand.

From 2008 to 2016, the rising incidence of AIH led to a 40% increase in point prevalence, reported lead author Mehul Lamba, MD, of Christchurch (New Zealand) Hospital and colleagues.

The present study, which also assessed rates of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), adds data to an area of inquiry historically characterized by limited and inconsistent results, the investigators wrote in Clinical Gastroenterology and Hepatology. They suggested that mixed findings from previous studies may be because of differences in population and environmental factors, but also varying diagnostic criteria.

“The epidemiological trends of these autoimmune liver diseases therefore remain incompletely understood,” wrote Dr. Lamba and colleagues.

Their study evaluated trends in autoimmune liver diseases over a 9-year time frame in Canterbury, New Zealand. According to the investigators, this region is well suited to an epidemiological investigation because it is a clearly defined geographic area with approximately 600,000 people, most of whom rely on one tertiary care center: Christchurch Hospital. The bulk of the data therefore came from this center, while a minority of cases were gathered from local private gastroenterology practices, “making complete case ascertainment possible.”

Incidence of AIH, PBC, and PSC was assessed at three time points: 2008-2010, 2011-2013, and 2014-2016. AIH had the highest overall incidence, at 1.93 cases per 100,000 people, followed by PSC (0.92) and PBC (0.51).

While the rates of PBC and PSC did not change significantly over time, the incidence of AIH rose from 1.37 cases per 100,000 people in the period from 2008-2010 to 2.39 per 100,000 in 2014-2016 (P = .04), which computes to an incidence rate ratio of 1.69 (95% confidence interval, 1.02-2.84). Point prevalence was also significantly higher in 2016, compared with 2008, at 27.5 per 100,000 versus 19.7 per 100,000 (P < .01). The investigators described a bimodal age of presentation, with the first peak among patients younger than 20 years, and a second, larger peak among individuals aged 50-69 years.

According to the investigators, these findings “are concordant with the results observed in the European cohort,” citing a Danish study spanning 1994-2012 and a Dutch study spanning 2000-2010. They noted that the Danish study also reported a bimodal distribution of age incidence, as did a Swedish study, and another study from New Zealand. The stable levels of PBC and PSC align with two recent retrospective studies conducted in the United States and, they added.

“We believe that the observed differential trends in the incidence of these autoimmune liver diseases truly reflects their contemporary epidemiology,” the investigators wrote. They went on to suggest that the findings did not stem from an increase in diagnostic scrutiny because the study period did not include any significant changes in gastroenterology service, coding, or diagnostic criteria in the region studied.

“The increased incidence of AIH parallels rising incidence and prevalence of other autoimmune disorders such as [inflammatory bowel disease], type 1 diabetes, and multiple sclerosis in New Zealand, and it is unclear whether these autoimmune conditions share a common local environmental trigger,” they wrote. “Environmental factors likely play a central role augmenting phenotypic expression in genetically predisposed individuals.”

While Dr. Lamba and colleagues proposed several possible factors, such as increased exposure to pharmaceuticals, definitive factors remain elusive, which the authors cited as one limitation of their study. Another limitation they cited is the possibility that other etiologies were mistakenly classified as “probable” AIH; however, the chances of that are small, and the proportion of probable versus definitive AIH noted in this study do reflect those seen in other epidemiological studies.

“The reason for observed differential change in incidence of these autoimmune liver diseases is unclear,” they wrote, “and future collaborative prospective epidemiological study would be required to assess this further.”

The investigators reported no conflicts of interest.

Experts discuss how to best protect people with diabetes from serious COVID-19 outcomes in a newly published article that summarizes in-depth discussions on the topic from a conference held online last year.

Lead author and Diabetes Technology Society founder and director David C. Klonoff, MD, said in an interview: “To my knowledge this is the largest article or learning that has been written anywhere ever about the co-occurrence of COVID-19 and diabetes and how COVID-19 affects diabetes ... There are a lot of different dimensions.” 

The 37-page report covers all sessions from the Virtual International COVID-19 and Diabetes Summit, held Aug. 26-27, 2020, which had 800 attendees from six continents, on topics including pathophysiology and COVID-19 risk factors, the impact of social determinants of health on diabetes and COVID-19, and psychological aspects of the COVID-19 pandemic for people with diabetes.

The freely available report was published online Jan. 21 in the Journal of Diabetes Science and Technology by Jennifer Y. Zhang of the Diabetes Technology Society, Burlingame, Calif., and colleagues.

Other topics include medications and vaccines, outpatient diabetes management during the COVID-19 pandemic and the growth of telehealth, inpatient management of diabetes in patients with or without COVID-19, ethical considerations, children, pregnancy, economics of care for COVID-19, government policy, regulation of tests and treatments, patient surveillance/privacy, and research gaps and opportunities.

“A comprehensive report like this is so important because it covers such a wide range of topics that are all relevant when it comes to protecting patients with diabetes during a pandemic. Our report aims to bring together all these different aspects of policy during the pandemic, patient physiology, and patient psychology, so I hope it will be widely read and widely appreciated,” Ms. Zhang said in an interview.

Two important clinical trends arising as a result of the pandemic – the advent of telehealth in diabetes management and the use of continuous glucose monitoring (CGM) in hospital – are expected to continue even after COVID-19 abates, said Dr. Klonoff, medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center, San Mateo, Calif.


 

Telehealth in diabetes here to stay, in U.S. at least  

Dr. Klonoff noted that with diabetes telehealth, or “telediabetes” as it’s been dubbed, by using downloaded device data patients don’t have to travel, pay for parking, or take as much time off work. “There are advantages ... patients really like it,” he said.

And for health care providers, an advantage of remote visits is that the clinician can look at the patient while reviewing the patient’s data. “With telehealth for diabetes, the patient’s face and the software data are right next to each other on the same screen. Even as I’m typing I’m looking at the patient ... I consider that a huge advantage,” Dr. Klonoff said.

Rule changes early in the pandemic made the shift to telehealth in the United States possible, he said.

“Fortunately, Medicare and other payers are covering telehealth. It used to be there was no coverage, so that was a damper. Now that it’s covered I don’t think that’s going to go back. Everybody likes it,” he said. 
 

CGM in hospitals helps detect hypoglycemia on wards

Regarding the increase of inpatient CGM (continuous glucose monitoring) prompted by the need to minimize patient exposure of nursing staff during the pandemic and the relaxing of Food and Drug Administration rules about its use, Dr. Klonoff said this phenomenon has led to two other positive developments.

“For FDA, it’s actually an opportunity to see some data collected. To do a clinical trial [prior to] March 2020 you had to go through a lot of processes to do a study. Once it becomes part of clinical care, then you can collect a lot of data,” he noted.   

Moreover, Dr. Klonoff said there’s an important new area where hospital use of CGM is emerging: detection of hypoglycemia on wards.

“When a patient is in the ICU, if they become hypoglycemic or hyperglycemic it will likely be detected. But on the wards, they simply don’t get the same attention. Just about every doctor has had a case where somebody drifted into hypoglycemia that wasn’t recognized and maybe even died,” he explained.

If, however, “patients treated with insulin could all have CGMs that would be so useful. It would send out an alarm. A lot of times people don’t eat when you think they will. Suddenly the insulin dose is inappropriate and the nurse didn’t realize. Or, if IV nutrition stops and the insulin is given [it can be harmful].”

Another example, he said, is a common scenario when insulin is used in patients who are treated with steroids. “They need insulin, but then the steroid is decreased and the insulin dose isn’t decreased fast enough. All those situations can be helped with CGM.”

Overall, he concluded, COVID-19 has provided many lessons, which are “expanding our horizons.”

Ms. Zhang has reported no relevant financial relationships. Dr. Klonoff has reported being a consultant for Dexcom, EOFlow, Fractyl, Lifecare, Novo Nordisk, Roche Diagnostics, Samsung, and Thirdwayv.

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

Experts discuss how to best protect people with diabetes from serious COVID-19 outcomes in a newly published article that summarizes in-depth discussions on the topic from a conference held online last year.

Lead author and Diabetes Technology Society founder and director David C. Klonoff, MD, said in an interview: “To my knowledge this is the largest article or learning that has been written anywhere ever about the co-occurrence of COVID-19 and diabetes and how COVID-19 affects diabetes ... There are a lot of different dimensions.” 

The 37-page report covers all sessions from the Virtual International COVID-19 and Diabetes Summit, held Aug. 26-27, 2020, which had 800 attendees from six continents, on topics including pathophysiology and COVID-19 risk factors, the impact of social determinants of health on diabetes and COVID-19, and psychological aspects of the COVID-19 pandemic for people with diabetes.

The freely available report was published online Jan. 21 in the Journal of Diabetes Science and Technology by Jennifer Y. Zhang of the Diabetes Technology Society, Burlingame, Calif., and colleagues.

Other topics include medications and vaccines, outpatient diabetes management during the COVID-19 pandemic and the growth of telehealth, inpatient management of diabetes in patients with or without COVID-19, ethical considerations, children, pregnancy, economics of care for COVID-19, government policy, regulation of tests and treatments, patient surveillance/privacy, and research gaps and opportunities.

“A comprehensive report like this is so important because it covers such a wide range of topics that are all relevant when it comes to protecting patients with diabetes during a pandemic. Our report aims to bring together all these different aspects of policy during the pandemic, patient physiology, and patient psychology, so I hope it will be widely read and widely appreciated,” Ms. Zhang said in an interview.

Two important clinical trends arising as a result of the pandemic – the advent of telehealth in diabetes management and the use of continuous glucose monitoring (CGM) in hospital – are expected to continue even after COVID-19 abates, said Dr. Klonoff, medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center, San Mateo, Calif.


 

Telehealth in diabetes here to stay, in U.S. at least  

Dr. Klonoff noted that with diabetes telehealth, or “telediabetes” as it’s been dubbed, by using downloaded device data patients don’t have to travel, pay for parking, or take as much time off work. “There are advantages ... patients really like it,” he said.

And for health care providers, an advantage of remote visits is that the clinician can look at the patient while reviewing the patient’s data. “With telehealth for diabetes, the patient’s face and the software data are right next to each other on the same screen. Even as I’m typing I’m looking at the patient ... I consider that a huge advantage,” Dr. Klonoff said.

Rule changes early in the pandemic made the shift to telehealth in the United States possible, he said.

“Fortunately, Medicare and other payers are covering telehealth. It used to be there was no coverage, so that was a damper. Now that it’s covered I don’t think that’s going to go back. Everybody likes it,” he said. 
 

CGM in hospitals helps detect hypoglycemia on wards

Regarding the increase of inpatient CGM (continuous glucose monitoring) prompted by the need to minimize patient exposure of nursing staff during the pandemic and the relaxing of Food and Drug Administration rules about its use, Dr. Klonoff said this phenomenon has led to two other positive developments.

“For FDA, it’s actually an opportunity to see some data collected. To do a clinical trial [prior to] March 2020 you had to go through a lot of processes to do a study. Once it becomes part of clinical care, then you can collect a lot of data,” he noted.   

Moreover, Dr. Klonoff said there’s an important new area where hospital use of CGM is emerging: detection of hypoglycemia on wards.

“When a patient is in the ICU, if they become hypoglycemic or hyperglycemic it will likely be detected. But on the wards, they simply don’t get the same attention. Just about every doctor has had a case where somebody drifted into hypoglycemia that wasn’t recognized and maybe even died,” he explained.

If, however, “patients treated with insulin could all have CGMs that would be so useful. It would send out an alarm. A lot of times people don’t eat when you think they will. Suddenly the insulin dose is inappropriate and the nurse didn’t realize. Or, if IV nutrition stops and the insulin is given [it can be harmful].”

Another example, he said, is a common scenario when insulin is used in patients who are treated with steroids. “They need insulin, but then the steroid is decreased and the insulin dose isn’t decreased fast enough. All those situations can be helped with CGM.”

Overall, he concluded, COVID-19 has provided many lessons, which are “expanding our horizons.”

Ms. Zhang has reported no relevant financial relationships. Dr. Klonoff has reported being a consultant for Dexcom, EOFlow, Fractyl, Lifecare, Novo Nordisk, Roche Diagnostics, Samsung, and Thirdwayv.

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

Experts discuss how to best protect people with diabetes from serious COVID-19 outcomes in a newly published article that summarizes in-depth discussions on the topic from a conference held online last year.

Lead author and Diabetes Technology Society founder and director David C. Klonoff, MD, said in an interview: “To my knowledge this is the largest article or learning that has been written anywhere ever about the co-occurrence of COVID-19 and diabetes and how COVID-19 affects diabetes ... There are a lot of different dimensions.” 

The 37-page report covers all sessions from the Virtual International COVID-19 and Diabetes Summit, held Aug. 26-27, 2020, which had 800 attendees from six continents, on topics including pathophysiology and COVID-19 risk factors, the impact of social determinants of health on diabetes and COVID-19, and psychological aspects of the COVID-19 pandemic for people with diabetes.

The freely available report was published online Jan. 21 in the Journal of Diabetes Science and Technology by Jennifer Y. Zhang of the Diabetes Technology Society, Burlingame, Calif., and colleagues.

Other topics include medications and vaccines, outpatient diabetes management during the COVID-19 pandemic and the growth of telehealth, inpatient management of diabetes in patients with or without COVID-19, ethical considerations, children, pregnancy, economics of care for COVID-19, government policy, regulation of tests and treatments, patient surveillance/privacy, and research gaps and opportunities.

“A comprehensive report like this is so important because it covers such a wide range of topics that are all relevant when it comes to protecting patients with diabetes during a pandemic. Our report aims to bring together all these different aspects of policy during the pandemic, patient physiology, and patient psychology, so I hope it will be widely read and widely appreciated,” Ms. Zhang said in an interview.

Two important clinical trends arising as a result of the pandemic – the advent of telehealth in diabetes management and the use of continuous glucose monitoring (CGM) in hospital – are expected to continue even after COVID-19 abates, said Dr. Klonoff, medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center, San Mateo, Calif.


 

Telehealth in diabetes here to stay, in U.S. at least  

Dr. Klonoff noted that with diabetes telehealth, or “telediabetes” as it’s been dubbed, by using downloaded device data patients don’t have to travel, pay for parking, or take as much time off work. “There are advantages ... patients really like it,” he said.

And for health care providers, an advantage of remote visits is that the clinician can look at the patient while reviewing the patient’s data. “With telehealth for diabetes, the patient’s face and the software data are right next to each other on the same screen. Even as I’m typing I’m looking at the patient ... I consider that a huge advantage,” Dr. Klonoff said.

Rule changes early in the pandemic made the shift to telehealth in the United States possible, he said.

“Fortunately, Medicare and other payers are covering telehealth. It used to be there was no coverage, so that was a damper. Now that it’s covered I don’t think that’s going to go back. Everybody likes it,” he said. 
 

CGM in hospitals helps detect hypoglycemia on wards

Regarding the increase of inpatient CGM (continuous glucose monitoring) prompted by the need to minimize patient exposure of nursing staff during the pandemic and the relaxing of Food and Drug Administration rules about its use, Dr. Klonoff said this phenomenon has led to two other positive developments.

“For FDA, it’s actually an opportunity to see some data collected. To do a clinical trial [prior to] March 2020 you had to go through a lot of processes to do a study. Once it becomes part of clinical care, then you can collect a lot of data,” he noted.   

Moreover, Dr. Klonoff said there’s an important new area where hospital use of CGM is emerging: detection of hypoglycemia on wards.

“When a patient is in the ICU, if they become hypoglycemic or hyperglycemic it will likely be detected. But on the wards, they simply don’t get the same attention. Just about every doctor has had a case where somebody drifted into hypoglycemia that wasn’t recognized and maybe even died,” he explained.

If, however, “patients treated with insulin could all have CGMs that would be so useful. It would send out an alarm. A lot of times people don’t eat when you think they will. Suddenly the insulin dose is inappropriate and the nurse didn’t realize. Or, if IV nutrition stops and the insulin is given [it can be harmful].”

Another example, he said, is a common scenario when insulin is used in patients who are treated with steroids. “They need insulin, but then the steroid is decreased and the insulin dose isn’t decreased fast enough. All those situations can be helped with CGM.”

Overall, he concluded, COVID-19 has provided many lessons, which are “expanding our horizons.”

Ms. Zhang has reported no relevant financial relationships. Dr. Klonoff has reported being a consultant for Dexcom, EOFlow, Fractyl, Lifecare, Novo Nordisk, Roche Diagnostics, Samsung, and Thirdwayv.

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

The incidence of idiopathic intracranial hypertension (IIH) – characterized by increased cerebrospinal fluid (CSF) pressure – is rising considerably, corresponding to population increases in body mass index (BMI), a new study has shown. “The condition is associated with a high rate of health care utilization, so the increasing incidence has important implications for health care professionals and policy makers in addressing the associated comorbidities,” said senior author William Owen Pickrell, PhD, Swansea University (Wales).

The study was published online Jan. 20 in Neurology.

IIH is a condition of unknown etiology that is strongly associated with obesity, the researchers noted. Predominantly affecting women of childbearing age, it causes chronic disabling headaches, visual disturbance, and in a minority of patients, permanent visual loss. The definitive management is weight loss, but a minority of patients require surgery to preserve vision.

People with IIH potentially have high rates of health care utilization, multiple specialist consultations, diagnostic tests, CSF diversion procedures, and complications related to CSF diversion surgery.  
 

Population study in Wales

Given that there is a paucity of data regarding the epidemiology, health care utilization, and outcomes of people with IIH, Dr. Pickrell and colleagues conducted the current retrospective cohort study, which aimed to determine the temporal trends of IIH incidence and prevalence in Wales and health care utilization associated with IIH. They also investigated the effects of socioeconomic deprivation and obesity on IIH epidemiology.

For the study, they used and validated primary and secondary care IIH diagnostic codes within the Secure Anonymised Information Linkage data bank, which is part of the national e-health records research infrastructure for Wales, to ascertain IIH cases and controls between 2003 and 2017. In total, 35 million patient-years of data were analyzed. Information was recorded on body mass index, deprivation quintile, CSF diversion surgery, and unscheduled hospital admissions in case and control cohorts.

“This is the first time the diagnostic codes for this condition have been validated. This is important as it is critical if we are studying a condition to know that the individuals we are studying actually have that condition,” Dr. Pickrell commented. “We were able to establish that the diagnostic codes were 92% sensitive and 87% specific – that’s pretty good.”

Results showed a significant increase in IIH incidence and prevalence in Wales. The prevalence of IIH in Wales increased sixfold from 12/100,000 in 2003 to 76/100,000 in 2017, and the incidence of IIH increased threefold from 2.3/100,000 per year in 2003 to 7.8/100,000 per year in 2017. This corresponded with increases in obesity rates: 29% of the population was obese in 2003, compared with 40% in 2017.
 

Reasons for the increase

“The considerable increase in IIH incidence is multifactorial but likely predominately due to rising obesity rates,” the authors noted. “The worldwide prevalence of obesity nearly tripled between 1975 and 2016 and therefore these results also have global relevance.”

The increase in IIH incidence may also be attributable to increased IIH diagnosis rates because of raised awareness of the condition and greater use of digital fundoscopy at routine optometry appointments, they suggested.

“We found a strong association between increasing BMI, sex (being female), and IIH. Around 85% of our IIH cohort were female, similar to other studies, and we also found a significant association with increased deprivation and IIH, particularly in women,” the authors reported.

IIH is associated with increasing deprivation in women even after adjusting for obesity suggesting additional etiologic factors associated with deprivation apart from BMI; this effect was not seen in men, pointing to sex-specific drivers for IIH, they added.

The results also show that individuals with IIH have increased rates of unscheduled health care utilization compared with a matched-control cohort. The rate ratio for unscheduled hospital admissions in the IIH cohort, compared with controls was 5.28.

“A considerable proportion of this excess in unscheduled hospital admissions occurs at the time of diagnosis and can be explained by the need for urgent investigation of papilloedema with brain imaging and spinal fluid analysis. However, there is also a considerable excess in unscheduled hospital admissions up to 2 years after diagnosis,” the authors reported.

They suggested that these admissions are likely to be for severe headache, and they say there is some scope to reduce emergency admissions through better management of headache, patient education, and rapid access to outpatient specialist advice.

They also pointed out that the rate of unscheduled admissions is higher in the IIH cohort in the 3 years leading up to diagnosis, suggesting an opportunity for earlier diagnosis and earlier intervention.

In their study population, 8% of patients with IIH received CSF diversion procedures a mean of 1.3 years after diagnosis, and these patients showed significantly increased unscheduled health care admission rates, compared with IIH patients who had not undergone such procedures.

“There are frequent complications with the shunts after surgery, which causes a high revision rate,” Dr. Pickrell commented. In this study, 40% of patients undergoing CSF diversion needed at least one CSF shunt revision procedure.

The study was supported by the Brain Repair and Intracranial Neurotherapeutics unit, Wales Gene Park, Health Data Research UK, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Wales), Public Health Agency (Northern Ireland), British Heart Foundation, and Wellcome Trust. The authors reported no relevant financial relationships.

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

The incidence of idiopathic intracranial hypertension (IIH) – characterized by increased cerebrospinal fluid (CSF) pressure – is rising considerably, corresponding to population increases in body mass index (BMI), a new study has shown. “The condition is associated with a high rate of health care utilization, so the increasing incidence has important implications for health care professionals and policy makers in addressing the associated comorbidities,” said senior author William Owen Pickrell, PhD, Swansea University (Wales).

The study was published online Jan. 20 in Neurology.

IIH is a condition of unknown etiology that is strongly associated with obesity, the researchers noted. Predominantly affecting women of childbearing age, it causes chronic disabling headaches, visual disturbance, and in a minority of patients, permanent visual loss. The definitive management is weight loss, but a minority of patients require surgery to preserve vision.

People with IIH potentially have high rates of health care utilization, multiple specialist consultations, diagnostic tests, CSF diversion procedures, and complications related to CSF diversion surgery.  
 

Population study in Wales

Given that there is a paucity of data regarding the epidemiology, health care utilization, and outcomes of people with IIH, Dr. Pickrell and colleagues conducted the current retrospective cohort study, which aimed to determine the temporal trends of IIH incidence and prevalence in Wales and health care utilization associated with IIH. They also investigated the effects of socioeconomic deprivation and obesity on IIH epidemiology.

For the study, they used and validated primary and secondary care IIH diagnostic codes within the Secure Anonymised Information Linkage data bank, which is part of the national e-health records research infrastructure for Wales, to ascertain IIH cases and controls between 2003 and 2017. In total, 35 million patient-years of data were analyzed. Information was recorded on body mass index, deprivation quintile, CSF diversion surgery, and unscheduled hospital admissions in case and control cohorts.

“This is the first time the diagnostic codes for this condition have been validated. This is important as it is critical if we are studying a condition to know that the individuals we are studying actually have that condition,” Dr. Pickrell commented. “We were able to establish that the diagnostic codes were 92% sensitive and 87% specific – that’s pretty good.”

Results showed a significant increase in IIH incidence and prevalence in Wales. The prevalence of IIH in Wales increased sixfold from 12/100,000 in 2003 to 76/100,000 in 2017, and the incidence of IIH increased threefold from 2.3/100,000 per year in 2003 to 7.8/100,000 per year in 2017. This corresponded with increases in obesity rates: 29% of the population was obese in 2003, compared with 40% in 2017.
 

Reasons for the increase

“The considerable increase in IIH incidence is multifactorial but likely predominately due to rising obesity rates,” the authors noted. “The worldwide prevalence of obesity nearly tripled between 1975 and 2016 and therefore these results also have global relevance.”

The increase in IIH incidence may also be attributable to increased IIH diagnosis rates because of raised awareness of the condition and greater use of digital fundoscopy at routine optometry appointments, they suggested.

“We found a strong association between increasing BMI, sex (being female), and IIH. Around 85% of our IIH cohort were female, similar to other studies, and we also found a significant association with increased deprivation and IIH, particularly in women,” the authors reported.

IIH is associated with increasing deprivation in women even after adjusting for obesity suggesting additional etiologic factors associated with deprivation apart from BMI; this effect was not seen in men, pointing to sex-specific drivers for IIH, they added.

The results also show that individuals with IIH have increased rates of unscheduled health care utilization compared with a matched-control cohort. The rate ratio for unscheduled hospital admissions in the IIH cohort, compared with controls was 5.28.

“A considerable proportion of this excess in unscheduled hospital admissions occurs at the time of diagnosis and can be explained by the need for urgent investigation of papilloedema with brain imaging and spinal fluid analysis. However, there is also a considerable excess in unscheduled hospital admissions up to 2 years after diagnosis,” the authors reported.

They suggested that these admissions are likely to be for severe headache, and they say there is some scope to reduce emergency admissions through better management of headache, patient education, and rapid access to outpatient specialist advice.

They also pointed out that the rate of unscheduled admissions is higher in the IIH cohort in the 3 years leading up to diagnosis, suggesting an opportunity for earlier diagnosis and earlier intervention.

In their study population, 8% of patients with IIH received CSF diversion procedures a mean of 1.3 years after diagnosis, and these patients showed significantly increased unscheduled health care admission rates, compared with IIH patients who had not undergone such procedures.

“There are frequent complications with the shunts after surgery, which causes a high revision rate,” Dr. Pickrell commented. In this study, 40% of patients undergoing CSF diversion needed at least one CSF shunt revision procedure.

The study was supported by the Brain Repair and Intracranial Neurotherapeutics unit, Wales Gene Park, Health Data Research UK, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Wales), Public Health Agency (Northern Ireland), British Heart Foundation, and Wellcome Trust. The authors reported no relevant financial relationships.

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

The incidence of idiopathic intracranial hypertension (IIH) – characterized by increased cerebrospinal fluid (CSF) pressure – is rising considerably, corresponding to population increases in body mass index (BMI), a new study has shown. “The condition is associated with a high rate of health care utilization, so the increasing incidence has important implications for health care professionals and policy makers in addressing the associated comorbidities,” said senior author William Owen Pickrell, PhD, Swansea University (Wales).

The study was published online Jan. 20 in Neurology.

IIH is a condition of unknown etiology that is strongly associated with obesity, the researchers noted. Predominantly affecting women of childbearing age, it causes chronic disabling headaches, visual disturbance, and in a minority of patients, permanent visual loss. The definitive management is weight loss, but a minority of patients require surgery to preserve vision.

People with IIH potentially have high rates of health care utilization, multiple specialist consultations, diagnostic tests, CSF diversion procedures, and complications related to CSF diversion surgery.  
 

Population study in Wales

Given that there is a paucity of data regarding the epidemiology, health care utilization, and outcomes of people with IIH, Dr. Pickrell and colleagues conducted the current retrospective cohort study, which aimed to determine the temporal trends of IIH incidence and prevalence in Wales and health care utilization associated with IIH. They also investigated the effects of socioeconomic deprivation and obesity on IIH epidemiology.

For the study, they used and validated primary and secondary care IIH diagnostic codes within the Secure Anonymised Information Linkage data bank, which is part of the national e-health records research infrastructure for Wales, to ascertain IIH cases and controls between 2003 and 2017. In total, 35 million patient-years of data were analyzed. Information was recorded on body mass index, deprivation quintile, CSF diversion surgery, and unscheduled hospital admissions in case and control cohorts.

“This is the first time the diagnostic codes for this condition have been validated. This is important as it is critical if we are studying a condition to know that the individuals we are studying actually have that condition,” Dr. Pickrell commented. “We were able to establish that the diagnostic codes were 92% sensitive and 87% specific – that’s pretty good.”

Results showed a significant increase in IIH incidence and prevalence in Wales. The prevalence of IIH in Wales increased sixfold from 12/100,000 in 2003 to 76/100,000 in 2017, and the incidence of IIH increased threefold from 2.3/100,000 per year in 2003 to 7.8/100,000 per year in 2017. This corresponded with increases in obesity rates: 29% of the population was obese in 2003, compared with 40% in 2017.
 

Reasons for the increase

“The considerable increase in IIH incidence is multifactorial but likely predominately due to rising obesity rates,” the authors noted. “The worldwide prevalence of obesity nearly tripled between 1975 and 2016 and therefore these results also have global relevance.”

The increase in IIH incidence may also be attributable to increased IIH diagnosis rates because of raised awareness of the condition and greater use of digital fundoscopy at routine optometry appointments, they suggested.

“We found a strong association between increasing BMI, sex (being female), and IIH. Around 85% of our IIH cohort were female, similar to other studies, and we also found a significant association with increased deprivation and IIH, particularly in women,” the authors reported.

IIH is associated with increasing deprivation in women even after adjusting for obesity suggesting additional etiologic factors associated with deprivation apart from BMI; this effect was not seen in men, pointing to sex-specific drivers for IIH, they added.

The results also show that individuals with IIH have increased rates of unscheduled health care utilization compared with a matched-control cohort. The rate ratio for unscheduled hospital admissions in the IIH cohort, compared with controls was 5.28.

“A considerable proportion of this excess in unscheduled hospital admissions occurs at the time of diagnosis and can be explained by the need for urgent investigation of papilloedema with brain imaging and spinal fluid analysis. However, there is also a considerable excess in unscheduled hospital admissions up to 2 years after diagnosis,” the authors reported.

They suggested that these admissions are likely to be for severe headache, and they say there is some scope to reduce emergency admissions through better management of headache, patient education, and rapid access to outpatient specialist advice.

They also pointed out that the rate of unscheduled admissions is higher in the IIH cohort in the 3 years leading up to diagnosis, suggesting an opportunity for earlier diagnosis and earlier intervention.

In their study population, 8% of patients with IIH received CSF diversion procedures a mean of 1.3 years after diagnosis, and these patients showed significantly increased unscheduled health care admission rates, compared with IIH patients who had not undergone such procedures.

“There are frequent complications with the shunts after surgery, which causes a high revision rate,” Dr. Pickrell commented. In this study, 40% of patients undergoing CSF diversion needed at least one CSF shunt revision procedure.

The study was supported by the Brain Repair and Intracranial Neurotherapeutics unit, Wales Gene Park, Health Data Research UK, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Wales), Public Health Agency (Northern Ireland), British Heart Foundation, and Wellcome Trust. The authors reported no relevant financial relationships.

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

Marius Pharmaceuticals has submitted a new drug application (NDA) to the Food and Drug Administration for Kyzatrex, an oral testosterone replacement therapy (TRT).

With this NDA, the company is seeking approval for Kyzatrex as a treatment for adult men with primary and secondary hypogonadism, also known as testosterone deficiency. Marius has requested a priority review that, if accepted, would result in an anticipated 6-month review period.

Current treatment options for hypogonadal men consist of therapies with safety concerns, such as cardiovascular and metabolic risks, that make patient adherence to treatment very low.

Kyzatrex is a novel oral formulation of testosterone undecanoate administered twice daily in a soft gelatin capsule.

“TRT remains a therapeutic challenge because there are worrisome and conflicting data related to increased cardiovascular disease risk, which has special relevance to high-risk diabetic populations,” Paul S. Jellinger, MD, professor of clinical medicine at the University of Miami, told this news organization. Furthermore, “injectable depot testosterone may be associated with peak supraphysiological levels and a substantial increase in hemoglobin. Topical testosterone offers more stable levels without a peak and trough, but in some men achieving physiologic levels may be difficult.”

The NDA is supported by results from a 6-month treatment extension of the pivotal phase 3 MRS-TU-2019 study (NCT04467697). Final results from this study have not been presented, but the company wrote in a press release that the results will be published some time in 2021.

They further reported that Kyzatrex was well tolerated by patients, with more than 96% of study participants completing 90 days of treatment in the pivotal phase 3 study. Study patients achieved average testosterone levels in the normal range.

Across the pooled phase 3 trials, the most frequent treatment-related treatment-emergent adverse event (TEAE) was hypertension, and no serious TEAEs were considered treatment related.

“We are extremely proud to have generated compelling efficacy and safety data in our phase 3 trials,” said Om Dhingra, PhD, cofounder and CEO of Marius. “We look forward to continuing to work collaboratively with the FDA on the review of our application, and if approved, Kyzatrex has the potential to become the standard of care for the treatment of primary and secondary hypogonadism globally.”

“An oral [testosterone] preparation with steady state physiologic levels would be a welcome addition to our choices for therapy assuming, of course, the absence of adverse effects,” explained Dr. Jellinger. “However, the greater challenge of testosterone therapy is the appropriate selection of those suited for testosterone replacement therapy.”

The company also plans to submit a marketing authorization application with the European Medicines Agency in the first half of 2022.

Marius Pharmaceuticals has submitted a new drug application (NDA) to the Food and Drug Administration for Kyzatrex, an oral testosterone replacement therapy (TRT).

With this NDA, the company is seeking approval for Kyzatrex as a treatment for adult men with primary and secondary hypogonadism, also known as testosterone deficiency. Marius has requested a priority review that, if accepted, would result in an anticipated 6-month review period.

Current treatment options for hypogonadal men consist of therapies with safety concerns, such as cardiovascular and metabolic risks, that make patient adherence to treatment very low.

Kyzatrex is a novel oral formulation of testosterone undecanoate administered twice daily in a soft gelatin capsule.

“TRT remains a therapeutic challenge because there are worrisome and conflicting data related to increased cardiovascular disease risk, which has special relevance to high-risk diabetic populations,” Paul S. Jellinger, MD, professor of clinical medicine at the University of Miami, told this news organization. Furthermore, “injectable depot testosterone may be associated with peak supraphysiological levels and a substantial increase in hemoglobin. Topical testosterone offers more stable levels without a peak and trough, but in some men achieving physiologic levels may be difficult.”

The NDA is supported by results from a 6-month treatment extension of the pivotal phase 3 MRS-TU-2019 study (NCT04467697). Final results from this study have not been presented, but the company wrote in a press release that the results will be published some time in 2021.

They further reported that Kyzatrex was well tolerated by patients, with more than 96% of study participants completing 90 days of treatment in the pivotal phase 3 study. Study patients achieved average testosterone levels in the normal range.

Across the pooled phase 3 trials, the most frequent treatment-related treatment-emergent adverse event (TEAE) was hypertension, and no serious TEAEs were considered treatment related.

“We are extremely proud to have generated compelling efficacy and safety data in our phase 3 trials,” said Om Dhingra, PhD, cofounder and CEO of Marius. “We look forward to continuing to work collaboratively with the FDA on the review of our application, and if approved, Kyzatrex has the potential to become the standard of care for the treatment of primary and secondary hypogonadism globally.”

“An oral [testosterone] preparation with steady state physiologic levels would be a welcome addition to our choices for therapy assuming, of course, the absence of adverse effects,” explained Dr. Jellinger. “However, the greater challenge of testosterone therapy is the appropriate selection of those suited for testosterone replacement therapy.”

The company also plans to submit a marketing authorization application with the European Medicines Agency in the first half of 2022.

Marius Pharmaceuticals has submitted a new drug application (NDA) to the Food and Drug Administration for Kyzatrex, an oral testosterone replacement therapy (TRT).

With this NDA, the company is seeking approval for Kyzatrex as a treatment for adult men with primary and secondary hypogonadism, also known as testosterone deficiency. Marius has requested a priority review that, if accepted, would result in an anticipated 6-month review period.

Current treatment options for hypogonadal men consist of therapies with safety concerns, such as cardiovascular and metabolic risks, that make patient adherence to treatment very low.

Kyzatrex is a novel oral formulation of testosterone undecanoate administered twice daily in a soft gelatin capsule.

“TRT remains a therapeutic challenge because there are worrisome and conflicting data related to increased cardiovascular disease risk, which has special relevance to high-risk diabetic populations,” Paul S. Jellinger, MD, professor of clinical medicine at the University of Miami, told this news organization. Furthermore, “injectable depot testosterone may be associated with peak supraphysiological levels and a substantial increase in hemoglobin. Topical testosterone offers more stable levels without a peak and trough, but in some men achieving physiologic levels may be difficult.”

The NDA is supported by results from a 6-month treatment extension of the pivotal phase 3 MRS-TU-2019 study (NCT04467697). Final results from this study have not been presented, but the company wrote in a press release that the results will be published some time in 2021.

They further reported that Kyzatrex was well tolerated by patients, with more than 96% of study participants completing 90 days of treatment in the pivotal phase 3 study. Study patients achieved average testosterone levels in the normal range.

Across the pooled phase 3 trials, the most frequent treatment-related treatment-emergent adverse event (TEAE) was hypertension, and no serious TEAEs were considered treatment related.

“We are extremely proud to have generated compelling efficacy and safety data in our phase 3 trials,” said Om Dhingra, PhD, cofounder and CEO of Marius. “We look forward to continuing to work collaboratively with the FDA on the review of our application, and if approved, Kyzatrex has the potential to become the standard of care for the treatment of primary and secondary hypogonadism globally.”

“An oral [testosterone] preparation with steady state physiologic levels would be a welcome addition to our choices for therapy assuming, of course, the absence of adverse effects,” explained Dr. Jellinger. “However, the greater challenge of testosterone therapy is the appropriate selection of those suited for testosterone replacement therapy.”

The company also plans to submit a marketing authorization application with the European Medicines Agency in the first half of 2022.

Women who experienced severe complications during pregnancy were more than twice as likely to die at any time after their last pregnancy, including post partum and beyond, based on data from more than 1 million women.

“Current data suggest that up to 88% of maternal deaths are preceded by severe maternal morbidity,” but the long-term risk of mortality and the effect of severe maternal morbidity has not been well studied, wrote U. Vivian Ukah, MPH, PhD, of McGill University, Montreal, and colleagues.

In a longitudinal cohort study published in Obstetrics & Gynecology, the researchers identified 1,229,306 pregnant women who delivered in Quebec between 1989 and 2016.

The primary outcome of in-hospital mortality after the last pregnancy, either post partum (within 42 days of delivery) or long term (43 days to 29 years after delivery).

Overall, 2.9% of the study population experienced severe maternal morbidity, with an associated mortality rate of 0.86 per 1,000 person-years versus 0.41 per 1,000 person-years in women without severe maternal morbidity. The median time to death for women with severe maternal mortality was 6.8 years, compared with 151 years for those without severe maternal morbidity.

The death rate at any time after delivery, post partum and beyond, was twice as high among women with severe maternal morbidity. The morbidities most often associated with long-term mortality after 42 days were severe cardiac complications (hazard ratio, 7.00), acute renal failure (HR, 4.35), and cerebrovascular accidents (HR, 4.03).

However, the mortality risk following severe maternal morbidity decreased over time, the researchers noted. Severe maternal morbidity was associated with 6.73 times the mortality risk, compared with no morbidity, during the period from 43 days to 11 months, but this difference dropped to 1.91, 1.77, and 1.18 times the risk, compared with no comorbidity, at 1-4 years, 5-9 years, and 10-29 years, respectively.

The study findings were limited by several factors, including the inability to prove causality, the use of only in-hospital mortality data, and the potential for missed cases that fell outside the Canadian Perinatal Surveillance System definition of severe maternal morbidity, the researchers noted.

However, the results suggest that identifying severe maternal morbidity may help identify women at risk for postpartum and long-term premature mortality. “Women with severe maternal morbidity may benefit from continued surveillance and preventative interventions to reduce the risk of premature mortality,” they concluded.

Increased morbidity rates drive need for research

“In this retrospective longitudinal cohort study of over 1.2 million women delivering in Quebec between 1989 and 2016, Dr. Ukah and her colleagues demonstrated the association between severe maternal morbidity [SMM] and an accelerated risk of mortality beyond the postpartum period, compared with women who do not experience SMM,” Rachel Humphrey, MD, a maternal-fetal medicine specialist at Advent Health in Orlando, said in an interview. “This study is important as there has been a steady increase in SMM in recent years. In the United States, the CDC reports that SMM affected more than 50,000 women in 2014 alone. Across multiple countries the decline in overall health of women giving birth is felt to contribute to SMM. As the rates of preexisting conditions such as maternal obesity, hypertension, diabetes, and advanced age increases, we can assume that SMM will increase as well. This study clearly depicts the association between SMM and maternal death at 43 days to years after the complicated delivery. We can assume that, as SMM increases, so will the risk of mortality beyond the postpartum period for these women who initially survive their serious pregnancy complication.”

Dr. Humphrey said that, in some respects, the study results are to be expected. “It is logical to assume that a patient with a life-threatening issue at delivery such as severe cardiac complications, acute renal failure and cerebrovascular accident would be at higher risk for long-term morbidity and mortality. This study also adds to the large body of evidence linking socioeconomic deprivation with SMM. But there were unexpected findings in this study. I did not expect certain types of SMM to be associated with an increased risk of death years after the event.For example, hysterectomy at delivery carried a hazard ratio of 3.54 for death at 5-9 years after the event. The association between severe hemorrhage and fully adjusted hazard ratio was similarly increased at 2.96 [2.37-3.71].”

 

More screening and prospective studies needed

“Recognizing the association between SMM and accelerated long-term risk of mortality is a first step in determining what interventions might improve health and longevity in women who experience SMM,” said Dr. Humphrey. “With the absence of prospective studies, it still is logical to assume that close medical follow-up and lifestyle interventions are appropriate in this population. Screening for and actively managing chronic conditions such as diabetes, dyslipidemia, and hypertension seems appropriate for these patients.”

As for further research, “I am interested to know through prospective clinical trials if specific health maintenance screens and interventions would have a positive impact on the life expectancy of survivors of SMM,” said Dr. Humphrey. “I applaud this team for providing data up to 27 years after an obstetric complication, and I am interested to see if Dr. Ukah and her team will continue their research to determine if there is a ‘second peak’ in mortality in the survivors of SMM when they are elderly. Finally, I would be interested to see more detailed data from this team on the associations between socioeconomic deprivation and short- and long-term mortality for women in their study. This information may help further fuel the movement toward social changes to maximize the health of the women and families we serve.”

The study was supported by the Heart & Stroke Foundation of Canada and awards to the lead author and others from the Fonds de recherche du Québec-Santé. The researchers and Dr. Humphrey had no financial conflicts to disclose.

Women who experienced severe complications during pregnancy were more than twice as likely to die at any time after their last pregnancy, including post partum and beyond, based on data from more than 1 million women.

“Current data suggest that up to 88% of maternal deaths are preceded by severe maternal morbidity,” but the long-term risk of mortality and the effect of severe maternal morbidity has not been well studied, wrote U. Vivian Ukah, MPH, PhD, of McGill University, Montreal, and colleagues.

In a longitudinal cohort study published in Obstetrics & Gynecology, the researchers identified 1,229,306 pregnant women who delivered in Quebec between 1989 and 2016.

The primary outcome of in-hospital mortality after the last pregnancy, either post partum (within 42 days of delivery) or long term (43 days to 29 years after delivery).

Overall, 2.9% of the study population experienced severe maternal morbidity, with an associated mortality rate of 0.86 per 1,000 person-years versus 0.41 per 1,000 person-years in women without severe maternal morbidity. The median time to death for women with severe maternal mortality was 6.8 years, compared with 151 years for those without severe maternal morbidity.

The death rate at any time after delivery, post partum and beyond, was twice as high among women with severe maternal morbidity. The morbidities most often associated with long-term mortality after 42 days were severe cardiac complications (hazard ratio, 7.00), acute renal failure (HR, 4.35), and cerebrovascular accidents (HR, 4.03).

However, the mortality risk following severe maternal morbidity decreased over time, the researchers noted. Severe maternal morbidity was associated with 6.73 times the mortality risk, compared with no morbidity, during the period from 43 days to 11 months, but this difference dropped to 1.91, 1.77, and 1.18 times the risk, compared with no comorbidity, at 1-4 years, 5-9 years, and 10-29 years, respectively.

The study findings were limited by several factors, including the inability to prove causality, the use of only in-hospital mortality data, and the potential for missed cases that fell outside the Canadian Perinatal Surveillance System definition of severe maternal morbidity, the researchers noted.

However, the results suggest that identifying severe maternal morbidity may help identify women at risk for postpartum and long-term premature mortality. “Women with severe maternal morbidity may benefit from continued surveillance and preventative interventions to reduce the risk of premature mortality,” they concluded.

Increased morbidity rates drive need for research

“In this retrospective longitudinal cohort study of over 1.2 million women delivering in Quebec between 1989 and 2016, Dr. Ukah and her colleagues demonstrated the association between severe maternal morbidity [SMM] and an accelerated risk of mortality beyond the postpartum period, compared with women who do not experience SMM,” Rachel Humphrey, MD, a maternal-fetal medicine specialist at Advent Health in Orlando, said in an interview. “This study is important as there has been a steady increase in SMM in recent years. In the United States, the CDC reports that SMM affected more than 50,000 women in 2014 alone. Across multiple countries the decline in overall health of women giving birth is felt to contribute to SMM. As the rates of preexisting conditions such as maternal obesity, hypertension, diabetes, and advanced age increases, we can assume that SMM will increase as well. This study clearly depicts the association between SMM and maternal death at 43 days to years after the complicated delivery. We can assume that, as SMM increases, so will the risk of mortality beyond the postpartum period for these women who initially survive their serious pregnancy complication.”

Dr. Humphrey said that, in some respects, the study results are to be expected. “It is logical to assume that a patient with a life-threatening issue at delivery such as severe cardiac complications, acute renal failure and cerebrovascular accident would be at higher risk for long-term morbidity and mortality. This study also adds to the large body of evidence linking socioeconomic deprivation with SMM. But there were unexpected findings in this study. I did not expect certain types of SMM to be associated with an increased risk of death years after the event.For example, hysterectomy at delivery carried a hazard ratio of 3.54 for death at 5-9 years after the event. The association between severe hemorrhage and fully adjusted hazard ratio was similarly increased at 2.96 [2.37-3.71].”

 

More screening and prospective studies needed

“Recognizing the association between SMM and accelerated long-term risk of mortality is a first step in determining what interventions might improve health and longevity in women who experience SMM,” said Dr. Humphrey. “With the absence of prospective studies, it still is logical to assume that close medical follow-up and lifestyle interventions are appropriate in this population. Screening for and actively managing chronic conditions such as diabetes, dyslipidemia, and hypertension seems appropriate for these patients.”

As for further research, “I am interested to know through prospective clinical trials if specific health maintenance screens and interventions would have a positive impact on the life expectancy of survivors of SMM,” said Dr. Humphrey. “I applaud this team for providing data up to 27 years after an obstetric complication, and I am interested to see if Dr. Ukah and her team will continue their research to determine if there is a ‘second peak’ in mortality in the survivors of SMM when they are elderly. Finally, I would be interested to see more detailed data from this team on the associations between socioeconomic deprivation and short- and long-term mortality for women in their study. This information may help further fuel the movement toward social changes to maximize the health of the women and families we serve.”

The study was supported by the Heart & Stroke Foundation of Canada and awards to the lead author and others from the Fonds de recherche du Québec-Santé. The researchers and Dr. Humphrey had no financial conflicts to disclose.

Women who experienced severe complications during pregnancy were more than twice as likely to die at any time after their last pregnancy, including post partum and beyond, based on data from more than 1 million women.

“Current data suggest that up to 88% of maternal deaths are preceded by severe maternal morbidity,” but the long-term risk of mortality and the effect of severe maternal morbidity has not been well studied, wrote U. Vivian Ukah, MPH, PhD, of McGill University, Montreal, and colleagues.

In a longitudinal cohort study published in Obstetrics & Gynecology, the researchers identified 1,229,306 pregnant women who delivered in Quebec between 1989 and 2016.

The primary outcome of in-hospital mortality after the last pregnancy, either post partum (within 42 days of delivery) or long term (43 days to 29 years after delivery).

Overall, 2.9% of the study population experienced severe maternal morbidity, with an associated mortality rate of 0.86 per 1,000 person-years versus 0.41 per 1,000 person-years in women without severe maternal morbidity. The median time to death for women with severe maternal mortality was 6.8 years, compared with 151 years for those without severe maternal morbidity.

The death rate at any time after delivery, post partum and beyond, was twice as high among women with severe maternal morbidity. The morbidities most often associated with long-term mortality after 42 days were severe cardiac complications (hazard ratio, 7.00), acute renal failure (HR, 4.35), and cerebrovascular accidents (HR, 4.03).

However, the mortality risk following severe maternal morbidity decreased over time, the researchers noted. Severe maternal morbidity was associated with 6.73 times the mortality risk, compared with no morbidity, during the period from 43 days to 11 months, but this difference dropped to 1.91, 1.77, and 1.18 times the risk, compared with no comorbidity, at 1-4 years, 5-9 years, and 10-29 years, respectively.

The study findings were limited by several factors, including the inability to prove causality, the use of only in-hospital mortality data, and the potential for missed cases that fell outside the Canadian Perinatal Surveillance System definition of severe maternal morbidity, the researchers noted.

However, the results suggest that identifying severe maternal morbidity may help identify women at risk for postpartum and long-term premature mortality. “Women with severe maternal morbidity may benefit from continued surveillance and preventative interventions to reduce the risk of premature mortality,” they concluded.

Increased morbidity rates drive need for research

“In this retrospective longitudinal cohort study of over 1.2 million women delivering in Quebec between 1989 and 2016, Dr. Ukah and her colleagues demonstrated the association between severe maternal morbidity [SMM] and an accelerated risk of mortality beyond the postpartum period, compared with women who do not experience SMM,” Rachel Humphrey, MD, a maternal-fetal medicine specialist at Advent Health in Orlando, said in an interview. “This study is important as there has been a steady increase in SMM in recent years. In the United States, the CDC reports that SMM affected more than 50,000 women in 2014 alone. Across multiple countries the decline in overall health of women giving birth is felt to contribute to SMM. As the rates of preexisting conditions such as maternal obesity, hypertension, diabetes, and advanced age increases, we can assume that SMM will increase as well. This study clearly depicts the association between SMM and maternal death at 43 days to years after the complicated delivery. We can assume that, as SMM increases, so will the risk of mortality beyond the postpartum period for these women who initially survive their serious pregnancy complication.”

Dr. Humphrey said that, in some respects, the study results are to be expected. “It is logical to assume that a patient with a life-threatening issue at delivery such as severe cardiac complications, acute renal failure and cerebrovascular accident would be at higher risk for long-term morbidity and mortality. This study also adds to the large body of evidence linking socioeconomic deprivation with SMM. But there were unexpected findings in this study. I did not expect certain types of SMM to be associated with an increased risk of death years after the event.For example, hysterectomy at delivery carried a hazard ratio of 3.54 for death at 5-9 years after the event. The association between severe hemorrhage and fully adjusted hazard ratio was similarly increased at 2.96 [2.37-3.71].”

 

More screening and prospective studies needed

“Recognizing the association between SMM and accelerated long-term risk of mortality is a first step in determining what interventions might improve health and longevity in women who experience SMM,” said Dr. Humphrey. “With the absence of prospective studies, it still is logical to assume that close medical follow-up and lifestyle interventions are appropriate in this population. Screening for and actively managing chronic conditions such as diabetes, dyslipidemia, and hypertension seems appropriate for these patients.”

As for further research, “I am interested to know through prospective clinical trials if specific health maintenance screens and interventions would have a positive impact on the life expectancy of survivors of SMM,” said Dr. Humphrey. “I applaud this team for providing data up to 27 years after an obstetric complication, and I am interested to see if Dr. Ukah and her team will continue their research to determine if there is a ‘second peak’ in mortality in the survivors of SMM when they are elderly. Finally, I would be interested to see more detailed data from this team on the associations between socioeconomic deprivation and short- and long-term mortality for women in their study. This information may help further fuel the movement toward social changes to maximize the health of the women and families we serve.”

The study was supported by the Heart & Stroke Foundation of Canada and awards to the lead author and others from the Fonds de recherche du Québec-Santé. The researchers and Dr. Humphrey had no financial conflicts to disclose.

The United States is nearly 6 weeks into its historic campaign to vaccinate Americans against the virus that causes COVID-19, and so far, the two vaccines in use look remarkably low risk, according to new data presented today at a meeting of vaccine experts that advise the Centers for Disease Control and Prevention.

With 23.5 million doses of the Pfizer and Moderna vaccines now given, there have been very few serious side effects. In addition, deaths reported after people got the vaccine do not seem to be related to it.

The most common symptoms reported after vaccination were pain where people got the shot, fatigue, headache, and muscle soreness. These were more common after the second dose. In addition, about one in four people reported fever and chills after the second shot.

“On the whole, I thought it was very reassuring,” said William Schaffner, MD, an infectious disease expert with Vanderbilt University, Nashville, Tenn., who listened to the presentations.

The CDC is collecting safety information through multiple channels. These include a new smartphone-based app called V-Safe, which collects daily information from people who’ve been vaccinated; the federal Vaccine Adverse Event Reporting System, which accepts reports from anyone; and the Vaccine Safety Datalink, which is a collaboration between the CDC and nine major hospital systems. There’s also the Clinical Immunization Safety Assessment Project, a collaboration between the CDC and vaccine safety experts.

After surveying these systems, experts heading the safety committee for the CDC’s Advisory Committee on Immunization Practices said there have been few serious side effects reported.

Very rarely, severe allergic reactions – called anaphylaxis – have occurred after vaccination. There have been 50 of these cases reported after the Pfizer vaccine and 21 cases reported after the Moderna vaccine to date. Nearly all of them – 94% of the anaphylaxis cases after Pfizer vaccines and 100% of those after Moderna’s vaccine – have been in women, though it’s not clear why.

That translates to a rate of about five cases of anaphylaxis for every million doses of the Pfizer vaccine and about three for every million doses of the Moderna vaccine. Most of these occur within 15 minutes after getting a vaccine dose, with one reported as long as 20 hours after the shot.

The CDC suspects these may be related to an ingredient called polyethylene glycol (PEG). PEG is a part of the particles that slip the vaccines’ mRNA into cells with instructions to make the spike protein of the virus. Cells then express these spikes on their surfaces so the immune system can learn to recognize them and make defenses against them. PEG is a common ingredient in many drugs and occasionally triggers anaphylaxis.
 

Reported deaths seem unrelated to vaccines

Through Jan. 18, 196 people have died after getting a vaccine.

Most of these deaths (129) were in patients in long term care facilities. These deaths are still being investigated, but when they were compared with the number of deaths that might be expected over the same period because of natural causes, they seemed to be coincidental and not caused by the vaccine, said Tom Shimabukuro, MD, deputy director of the Immunization Safety Office at the CDC, who studied the data.

In fact, death rates were lower among vaccinated nursing home residents, compared with those who had not been vaccinated.

“These findings suggest that short-term mortality rates appear unrelated to vaccination for COVID-19,” Dr. Shimabukuro said.

This also appeared to be true for younger adults who died after their shots.

There were 28 people aged under 65 years who died after being vaccinated. Most of these deaths were heart related, according to autopsy reports. When investigators compared the number of sudden cardiac deaths expected to occur in this population naturally, they found people who were vaccinated had a lower rate than would have been expected without vaccination. This suggests that these deaths were also unrelated to the vaccine.
 

More vaccines on the horizon

The panel also heard an update from drug company AstraZeneca on its vaccine. It’s being used in 18 countries but has not yet been authorized in the United States.

That vaccine is currently in phase 3 of its U.S. clinical trials, and more than 26,000 people who have volunteered to get the shot had received their second dose as of Jan. 21, the company said.

The Food and Drug Administration requires at least 2 months of follow-up before it will evaluate a vaccine for an emergency-use authorization, which means the company would be ready to submit by the end of March, with a possible approval by April.

The AstraZeneca vaccine uses a more traditional method to create immunity, slipping a key part of the virus that causes COVID-19 into the shell of an adenovirus – a virus that causes cold-like symptoms – that normally infects monkeys. When the immune system sees the virus, it generates protective defenses against it.

The two-dose vaccine can be stored in a regular refrigerator for up to 6 months, which makes it easier to handle than the mRNA vaccines, which require much colder storage. Another advantage appears to be that it’s less likely to trigger severe allergic reactions. So far, there have been no cases of anaphylaxis reported after this shot.

In total, four serious side effects have been reported with the AstraZeneca vaccine, including two cases of transverse myelitis, a serious condition that causes swelling of the spinal cord, leading to pain, muscle weakness, and paralysis. One of these was in the group that got the placebo. The reports paused the trial, but it was allowed to continue after a safety review.

This vaccine also appears to be less effective than the mRNA shots. Data presented to the panel show it appears to cut the risk of developing a COVID infection that has symptoms by 62%. That’s over the 50% threshold the FDA set for approval but less than seen with the mRNA vaccines, which are more than 90% effective at preventing infections.

“Is the average person going to want to take the AstraZeneca shot? What role is this going to play in our vaccination program?” Dr. Schaffner said.

Johnson & Johnson will have enough data from its clinical trials to submit it to the FDA within the next week, the company said in a call with shareholders on Tuesday. So far, its one-dose shots looks to be about as effective as both the Pfizer and Moderna vaccines.

“It could be that we wind up with four vaccines: Three that can run very fast, and one that’s not so fast,” Dr. Schaffner said.

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

The United States is nearly 6 weeks into its historic campaign to vaccinate Americans against the virus that causes COVID-19, and so far, the two vaccines in use look remarkably low risk, according to new data presented today at a meeting of vaccine experts that advise the Centers for Disease Control and Prevention.

With 23.5 million doses of the Pfizer and Moderna vaccines now given, there have been very few serious side effects. In addition, deaths reported after people got the vaccine do not seem to be related to it.

The most common symptoms reported after vaccination were pain where people got the shot, fatigue, headache, and muscle soreness. These were more common after the second dose. In addition, about one in four people reported fever and chills after the second shot.

“On the whole, I thought it was very reassuring,” said William Schaffner, MD, an infectious disease expert with Vanderbilt University, Nashville, Tenn., who listened to the presentations.

The CDC is collecting safety information through multiple channels. These include a new smartphone-based app called V-Safe, which collects daily information from people who’ve been vaccinated; the federal Vaccine Adverse Event Reporting System, which accepts reports from anyone; and the Vaccine Safety Datalink, which is a collaboration between the CDC and nine major hospital systems. There’s also the Clinical Immunization Safety Assessment Project, a collaboration between the CDC and vaccine safety experts.

After surveying these systems, experts heading the safety committee for the CDC’s Advisory Committee on Immunization Practices said there have been few serious side effects reported.

Very rarely, severe allergic reactions – called anaphylaxis – have occurred after vaccination. There have been 50 of these cases reported after the Pfizer vaccine and 21 cases reported after the Moderna vaccine to date. Nearly all of them – 94% of the anaphylaxis cases after Pfizer vaccines and 100% of those after Moderna’s vaccine – have been in women, though it’s not clear why.

That translates to a rate of about five cases of anaphylaxis for every million doses of the Pfizer vaccine and about three for every million doses of the Moderna vaccine. Most of these occur within 15 minutes after getting a vaccine dose, with one reported as long as 20 hours after the shot.

The CDC suspects these may be related to an ingredient called polyethylene glycol (PEG). PEG is a part of the particles that slip the vaccines’ mRNA into cells with instructions to make the spike protein of the virus. Cells then express these spikes on their surfaces so the immune system can learn to recognize them and make defenses against them. PEG is a common ingredient in many drugs and occasionally triggers anaphylaxis.
 

Reported deaths seem unrelated to vaccines

Through Jan. 18, 196 people have died after getting a vaccine.

Most of these deaths (129) were in patients in long term care facilities. These deaths are still being investigated, but when they were compared with the number of deaths that might be expected over the same period because of natural causes, they seemed to be coincidental and not caused by the vaccine, said Tom Shimabukuro, MD, deputy director of the Immunization Safety Office at the CDC, who studied the data.

In fact, death rates were lower among vaccinated nursing home residents, compared with those who had not been vaccinated.

“These findings suggest that short-term mortality rates appear unrelated to vaccination for COVID-19,” Dr. Shimabukuro said.

This also appeared to be true for younger adults who died after their shots.

There were 28 people aged under 65 years who died after being vaccinated. Most of these deaths were heart related, according to autopsy reports. When investigators compared the number of sudden cardiac deaths expected to occur in this population naturally, they found people who were vaccinated had a lower rate than would have been expected without vaccination. This suggests that these deaths were also unrelated to the vaccine.
 

More vaccines on the horizon

The panel also heard an update from drug company AstraZeneca on its vaccine. It’s being used in 18 countries but has not yet been authorized in the United States.

That vaccine is currently in phase 3 of its U.S. clinical trials, and more than 26,000 people who have volunteered to get the shot had received their second dose as of Jan. 21, the company said.

The Food and Drug Administration requires at least 2 months of follow-up before it will evaluate a vaccine for an emergency-use authorization, which means the company would be ready to submit by the end of March, with a possible approval by April.

The AstraZeneca vaccine uses a more traditional method to create immunity, slipping a key part of the virus that causes COVID-19 into the shell of an adenovirus – a virus that causes cold-like symptoms – that normally infects monkeys. When the immune system sees the virus, it generates protective defenses against it.

The two-dose vaccine can be stored in a regular refrigerator for up to 6 months, which makes it easier to handle than the mRNA vaccines, which require much colder storage. Another advantage appears to be that it’s less likely to trigger severe allergic reactions. So far, there have been no cases of anaphylaxis reported after this shot.

In total, four serious side effects have been reported with the AstraZeneca vaccine, including two cases of transverse myelitis, a serious condition that causes swelling of the spinal cord, leading to pain, muscle weakness, and paralysis. One of these was in the group that got the placebo. The reports paused the trial, but it was allowed to continue after a safety review.

This vaccine also appears to be less effective than the mRNA shots. Data presented to the panel show it appears to cut the risk of developing a COVID infection that has symptoms by 62%. That’s over the 50% threshold the FDA set for approval but less than seen with the mRNA vaccines, which are more than 90% effective at preventing infections.

“Is the average person going to want to take the AstraZeneca shot? What role is this going to play in our vaccination program?” Dr. Schaffner said.

Johnson & Johnson will have enough data from its clinical trials to submit it to the FDA within the next week, the company said in a call with shareholders on Tuesday. So far, its one-dose shots looks to be about as effective as both the Pfizer and Moderna vaccines.

“It could be that we wind up with four vaccines: Three that can run very fast, and one that’s not so fast,” Dr. Schaffner said.

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

The United States is nearly 6 weeks into its historic campaign to vaccinate Americans against the virus that causes COVID-19, and so far, the two vaccines in use look remarkably low risk, according to new data presented today at a meeting of vaccine experts that advise the Centers for Disease Control and Prevention.

With 23.5 million doses of the Pfizer and Moderna vaccines now given, there have been very few serious side effects. In addition, deaths reported after people got the vaccine do not seem to be related to it.

The most common symptoms reported after vaccination were pain where people got the shot, fatigue, headache, and muscle soreness. These were more common after the second dose. In addition, about one in four people reported fever and chills after the second shot.

“On the whole, I thought it was very reassuring,” said William Schaffner, MD, an infectious disease expert with Vanderbilt University, Nashville, Tenn., who listened to the presentations.

The CDC is collecting safety information through multiple channels. These include a new smartphone-based app called V-Safe, which collects daily information from people who’ve been vaccinated; the federal Vaccine Adverse Event Reporting System, which accepts reports from anyone; and the Vaccine Safety Datalink, which is a collaboration between the CDC and nine major hospital systems. There’s also the Clinical Immunization Safety Assessment Project, a collaboration between the CDC and vaccine safety experts.

After surveying these systems, experts heading the safety committee for the CDC’s Advisory Committee on Immunization Practices said there have been few serious side effects reported.

Very rarely, severe allergic reactions – called anaphylaxis – have occurred after vaccination. There have been 50 of these cases reported after the Pfizer vaccine and 21 cases reported after the Moderna vaccine to date. Nearly all of them – 94% of the anaphylaxis cases after Pfizer vaccines and 100% of those after Moderna’s vaccine – have been in women, though it’s not clear why.

That translates to a rate of about five cases of anaphylaxis for every million doses of the Pfizer vaccine and about three for every million doses of the Moderna vaccine. Most of these occur within 15 minutes after getting a vaccine dose, with one reported as long as 20 hours after the shot.

The CDC suspects these may be related to an ingredient called polyethylene glycol (PEG). PEG is a part of the particles that slip the vaccines’ mRNA into cells with instructions to make the spike protein of the virus. Cells then express these spikes on their surfaces so the immune system can learn to recognize them and make defenses against them. PEG is a common ingredient in many drugs and occasionally triggers anaphylaxis.
 

Reported deaths seem unrelated to vaccines

Through Jan. 18, 196 people have died after getting a vaccine.

Most of these deaths (129) were in patients in long term care facilities. These deaths are still being investigated, but when they were compared with the number of deaths that might be expected over the same period because of natural causes, they seemed to be coincidental and not caused by the vaccine, said Tom Shimabukuro, MD, deputy director of the Immunization Safety Office at the CDC, who studied the data.

In fact, death rates were lower among vaccinated nursing home residents, compared with those who had not been vaccinated.

“These findings suggest that short-term mortality rates appear unrelated to vaccination for COVID-19,” Dr. Shimabukuro said.

This also appeared to be true for younger adults who died after their shots.

There were 28 people aged under 65 years who died after being vaccinated. Most of these deaths were heart related, according to autopsy reports. When investigators compared the number of sudden cardiac deaths expected to occur in this population naturally, they found people who were vaccinated had a lower rate than would have been expected without vaccination. This suggests that these deaths were also unrelated to the vaccine.
 

More vaccines on the horizon

The panel also heard an update from drug company AstraZeneca on its vaccine. It’s being used in 18 countries but has not yet been authorized in the United States.

That vaccine is currently in phase 3 of its U.S. clinical trials, and more than 26,000 people who have volunteered to get the shot had received their second dose as of Jan. 21, the company said.

The Food and Drug Administration requires at least 2 months of follow-up before it will evaluate a vaccine for an emergency-use authorization, which means the company would be ready to submit by the end of March, with a possible approval by April.

The AstraZeneca vaccine uses a more traditional method to create immunity, slipping a key part of the virus that causes COVID-19 into the shell of an adenovirus – a virus that causes cold-like symptoms – that normally infects monkeys. When the immune system sees the virus, it generates protective defenses against it.

The two-dose vaccine can be stored in a regular refrigerator for up to 6 months, which makes it easier to handle than the mRNA vaccines, which require much colder storage. Another advantage appears to be that it’s less likely to trigger severe allergic reactions. So far, there have been no cases of anaphylaxis reported after this shot.

In total, four serious side effects have been reported with the AstraZeneca vaccine, including two cases of transverse myelitis, a serious condition that causes swelling of the spinal cord, leading to pain, muscle weakness, and paralysis. One of these was in the group that got the placebo. The reports paused the trial, but it was allowed to continue after a safety review.

This vaccine also appears to be less effective than the mRNA shots. Data presented to the panel show it appears to cut the risk of developing a COVID infection that has symptoms by 62%. That’s over the 50% threshold the FDA set for approval but less than seen with the mRNA vaccines, which are more than 90% effective at preventing infections.

“Is the average person going to want to take the AstraZeneca shot? What role is this going to play in our vaccination program?” Dr. Schaffner said.

Johnson & Johnson will have enough data from its clinical trials to submit it to the FDA within the next week, the company said in a call with shareholders on Tuesday. So far, its one-dose shots looks to be about as effective as both the Pfizer and Moderna vaccines.

“It could be that we wind up with four vaccines: Three that can run very fast, and one that’s not so fast,” Dr. Schaffner said.

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

A follow-up look at an international registry suggests that some people may have persistent, long-lasting dermatologic manifestations – especially so-called “COVID toes” – as a result of infection with or exposure to the SARS-CoV-2 virus, but some dermatologists question if the skin signs and symptoms are truly related.

In their commentary in the Lancet Infectious Diseases, Esther P. Freeman, MD, PhD, and colleagues who lead and participate in the American Academy of Dermatology’s international registry said their analysis “revealed a previously unreported subset of patients who experience long-haul symptoms in dermatology-dominant COVID-19.”

Some of the data was presented at the 29th European Academy of Dermatology and Venereology in late October 2020, but has since been updated with more cases.

Dermatologists who spoke with this news organization said it has not been settled that some skin manifestations – such as pernio/chilblains rashes, seen primarily in nonhospitalized patients, and described in the registry – are definitively caused by COVID. They also noted that in some cases, patients who initially test negative for COVID-19 by polymerase chain reaction (PCR) sometimes do not ever develop antibodies, which could mean they were never actually exposed to SARS-CoV-2.

M. Alexander Otto/MDedge News

“I still question whether the perniosis is directly related to infection with SARS-CoV-2 or not,” said Anthony Fernandez, MD, PhD, director of medical and inpatient dermatology and assistant professor of dermatopathology at the Cleveland Clinic. His uncertainty is driven by the lack of seroconversion and that few cases were seen over the summer in the United States – suggesting that it may still be a result of cold temperatures.

“I’m not sure there is a definitive correct answer, definitely not that everyone would agree on,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn.

Dr. Freeman, however, believed that pernio and especially persistent lesions are caused by an immune response to COVID.

In an interview, she noted the multiple cases of patients in the registry who did seroconvert and that, while a registry is not a perfect means of getting an answer, it is good for generating questions. Taken collectively, the cases in the registry can “tell a story for further hypotheses,” said Dr. Freeman, who is director of global health dermatology at Massachusetts General Hospital and assistant professor of dermatology at Harvard University, both in Boston.

“We were noticing this signal across the world” that patients “developed these toe lesions and they never got better,” said Dr. Freeman. Generally, people who experience pernio, also described as COVID toes or “COVID fingers,” recover in 4-8 weeks. But in the registry, “we did have this subset of patients who really were experiencing these very longstanding symptoms,” she added.

Two patients with lab-confirmed COVID have had long-lasting pernio of 133 days and 150 days. “I’m caring for a cohort in Boston who have had long COVID of the skin and symptoms for over 10 months,” Dr. Freeman said.
 

Pernio dominates

The registry – a collaboration between the AAD and the International League of Dermatological Societies – was launched in April 2020. Any medical professional can enter case information. From April to October, 1,030 total cases and 331 laboratory-confirmed or suspected COVID-19 cases with dermatological manifestations were entered from 41 countries.

Most of the cases were just recorded at a single time point, which is an acknowledged limitation of the study.

Dr. Freeman and colleagues reached out to registry participants in June and August to get updates on COVID lab test results and sign and symptom duration. Overall, 234 total and 96 lab-confirmed COVID infections had more lengthy data about sign and symptom duration.

Pernio lasted a median of 15 days in patients with suspected disease and 12 days for those with lab-confirmed COVID, compared with a median of 7 days for morbilliform eruptions, 4 days for urticarial eruptions, and 20 days for papulosquamous eruptions – all in patients with lab-confirmed disease.

Of the 103 cases of pernio, 7 had symptoms lasting more than 60 days. Only two of those seven patients had lab-confirmed COVID. Initially, the one patient tested negative with nasopharyngeal PCR, and serum IgM and IgG. Six weeks after pernio onset, the patient – still experiencing fatigue and pernio – seroconverted to anti–SARS-CoV-2 IgM positivity.

The other long-haul patient, after a negative PCR, tested positive for SARS-CoV-2 serum IgG 1 month after pernio onset.

Robust immune response?

Dr. Freeman said these patients might have a very high interferon response initially to the virus, which makes for a mild to nonexistent disease, but could create inflammation elsewhere. “I almost view the toes as an innocent bystander of a robust immune response to SARS-CoV-2.”

Although he has not seen extended pernio or other skin manifestations in his patients, Dr. Fernandez said the interferon hypothesis is “fair,” and “the best that’s out there.” Dr. Fernandez is currently studying cutaneous manifestations of COVID-19 as a principal investigator of a trial sponsored by the Clinical and Translational Science Collaborative of Cleveland.

Dr. Ko said in an interview that she has not observed long-haul skin issues in her patients, but Yale colleagues have.

In a study, she and Yale colleagues published in September, SARS-CoV-2 spike protein was detected in perniotic lesions, but not nuclear protein or viral RNA. The test they used – immunohistochemistry – can be nonspecific, which muddied results.

She does not think there is replicating virus in the skin or the lesions. Instead, said Dr. Ko, “either there is viral spike protein that has somehow become disassociated from actively replicating virus that somehow got deposited in endothelial cells,” or the staining “was spurious,” or some other protein is cross-reacting. “And the people who are unlucky enough to have that protein in their endothelial cells can manifest this COVID-toe, COVID-finger phenomenon.”

To her, it’s an unsolved mystery. “The weird thing is, we’ve never before had this much perniosis,” Dr. Ko said.

Dr. Fernandez is not convinced yet, noting that, in Cleveland, more pernio cases were observed in March and April than in the summer. “If it is a manifestation of the infection then you also need the right environment, the cold weather for this manifestation to present,” he said. “Or, it really isn’t a direct manifestation of COVID-19 but may be more related to other factors,” such as lifestyle changes related to limitations implemented to help mitigate the spread of the disease.

“To me the jury is still out whether or not the perniotic lesions really can tell us something about a patient’s exposure and infection with SARS-CoV-2,” he said.

Dr. Freeman reported receiving a grant from the International League of Dermatological Societies and nonfinancial support from the AAD for the study. Dr. Ko reported no conflicts. Dr. Fernadnez had no disclosures.

A follow-up look at an international registry suggests that some people may have persistent, long-lasting dermatologic manifestations – especially so-called “COVID toes” – as a result of infection with or exposure to the SARS-CoV-2 virus, but some dermatologists question if the skin signs and symptoms are truly related.

In their commentary in the Lancet Infectious Diseases, Esther P. Freeman, MD, PhD, and colleagues who lead and participate in the American Academy of Dermatology’s international registry said their analysis “revealed a previously unreported subset of patients who experience long-haul symptoms in dermatology-dominant COVID-19.”

Some of the data was presented at the 29th European Academy of Dermatology and Venereology in late October 2020, but has since been updated with more cases.

Dermatologists who spoke with this news organization said it has not been settled that some skin manifestations – such as pernio/chilblains rashes, seen primarily in nonhospitalized patients, and described in the registry – are definitively caused by COVID. They also noted that in some cases, patients who initially test negative for COVID-19 by polymerase chain reaction (PCR) sometimes do not ever develop antibodies, which could mean they were never actually exposed to SARS-CoV-2.

M. Alexander Otto/MDedge News

“I still question whether the perniosis is directly related to infection with SARS-CoV-2 or not,” said Anthony Fernandez, MD, PhD, director of medical and inpatient dermatology and assistant professor of dermatopathology at the Cleveland Clinic. His uncertainty is driven by the lack of seroconversion and that few cases were seen over the summer in the United States – suggesting that it may still be a result of cold temperatures.

“I’m not sure there is a definitive correct answer, definitely not that everyone would agree on,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn.

Dr. Freeman, however, believed that pernio and especially persistent lesions are caused by an immune response to COVID.

In an interview, she noted the multiple cases of patients in the registry who did seroconvert and that, while a registry is not a perfect means of getting an answer, it is good for generating questions. Taken collectively, the cases in the registry can “tell a story for further hypotheses,” said Dr. Freeman, who is director of global health dermatology at Massachusetts General Hospital and assistant professor of dermatology at Harvard University, both in Boston.

“We were noticing this signal across the world” that patients “developed these toe lesions and they never got better,” said Dr. Freeman. Generally, people who experience pernio, also described as COVID toes or “COVID fingers,” recover in 4-8 weeks. But in the registry, “we did have this subset of patients who really were experiencing these very longstanding symptoms,” she added.

Two patients with lab-confirmed COVID have had long-lasting pernio of 133 days and 150 days. “I’m caring for a cohort in Boston who have had long COVID of the skin and symptoms for over 10 months,” Dr. Freeman said.
 

Pernio dominates

The registry – a collaboration between the AAD and the International League of Dermatological Societies – was launched in April 2020. Any medical professional can enter case information. From April to October, 1,030 total cases and 331 laboratory-confirmed or suspected COVID-19 cases with dermatological manifestations were entered from 41 countries.

Most of the cases were just recorded at a single time point, which is an acknowledged limitation of the study.

Dr. Freeman and colleagues reached out to registry participants in June and August to get updates on COVID lab test results and sign and symptom duration. Overall, 234 total and 96 lab-confirmed COVID infections had more lengthy data about sign and symptom duration.

Pernio lasted a median of 15 days in patients with suspected disease and 12 days for those with lab-confirmed COVID, compared with a median of 7 days for morbilliform eruptions, 4 days for urticarial eruptions, and 20 days for papulosquamous eruptions – all in patients with lab-confirmed disease.

Of the 103 cases of pernio, 7 had symptoms lasting more than 60 days. Only two of those seven patients had lab-confirmed COVID. Initially, the one patient tested negative with nasopharyngeal PCR, and serum IgM and IgG. Six weeks after pernio onset, the patient – still experiencing fatigue and pernio – seroconverted to anti–SARS-CoV-2 IgM positivity.

The other long-haul patient, after a negative PCR, tested positive for SARS-CoV-2 serum IgG 1 month after pernio onset.

Robust immune response?

Dr. Freeman said these patients might have a very high interferon response initially to the virus, which makes for a mild to nonexistent disease, but could create inflammation elsewhere. “I almost view the toes as an innocent bystander of a robust immune response to SARS-CoV-2.”

Although he has not seen extended pernio or other skin manifestations in his patients, Dr. Fernandez said the interferon hypothesis is “fair,” and “the best that’s out there.” Dr. Fernandez is currently studying cutaneous manifestations of COVID-19 as a principal investigator of a trial sponsored by the Clinical and Translational Science Collaborative of Cleveland.

Dr. Ko said in an interview that she has not observed long-haul skin issues in her patients, but Yale colleagues have.

In a study, she and Yale colleagues published in September, SARS-CoV-2 spike protein was detected in perniotic lesions, but not nuclear protein or viral RNA. The test they used – immunohistochemistry – can be nonspecific, which muddied results.

She does not think there is replicating virus in the skin or the lesions. Instead, said Dr. Ko, “either there is viral spike protein that has somehow become disassociated from actively replicating virus that somehow got deposited in endothelial cells,” or the staining “was spurious,” or some other protein is cross-reacting. “And the people who are unlucky enough to have that protein in their endothelial cells can manifest this COVID-toe, COVID-finger phenomenon.”

To her, it’s an unsolved mystery. “The weird thing is, we’ve never before had this much perniosis,” Dr. Ko said.

Dr. Fernandez is not convinced yet, noting that, in Cleveland, more pernio cases were observed in March and April than in the summer. “If it is a manifestation of the infection then you also need the right environment, the cold weather for this manifestation to present,” he said. “Or, it really isn’t a direct manifestation of COVID-19 but may be more related to other factors,” such as lifestyle changes related to limitations implemented to help mitigate the spread of the disease.

“To me the jury is still out whether or not the perniotic lesions really can tell us something about a patient’s exposure and infection with SARS-CoV-2,” he said.

Dr. Freeman reported receiving a grant from the International League of Dermatological Societies and nonfinancial support from the AAD for the study. Dr. Ko reported no conflicts. Dr. Fernadnez had no disclosures.

A follow-up look at an international registry suggests that some people may have persistent, long-lasting dermatologic manifestations – especially so-called “COVID toes” – as a result of infection with or exposure to the SARS-CoV-2 virus, but some dermatologists question if the skin signs and symptoms are truly related.

In their commentary in the Lancet Infectious Diseases, Esther P. Freeman, MD, PhD, and colleagues who lead and participate in the American Academy of Dermatology’s international registry said their analysis “revealed a previously unreported subset of patients who experience long-haul symptoms in dermatology-dominant COVID-19.”

Some of the data was presented at the 29th European Academy of Dermatology and Venereology in late October 2020, but has since been updated with more cases.

Dermatologists who spoke with this news organization said it has not been settled that some skin manifestations – such as pernio/chilblains rashes, seen primarily in nonhospitalized patients, and described in the registry – are definitively caused by COVID. They also noted that in some cases, patients who initially test negative for COVID-19 by polymerase chain reaction (PCR) sometimes do not ever develop antibodies, which could mean they were never actually exposed to SARS-CoV-2.

M. Alexander Otto/MDedge News

“I still question whether the perniosis is directly related to infection with SARS-CoV-2 or not,” said Anthony Fernandez, MD, PhD, director of medical and inpatient dermatology and assistant professor of dermatopathology at the Cleveland Clinic. His uncertainty is driven by the lack of seroconversion and that few cases were seen over the summer in the United States – suggesting that it may still be a result of cold temperatures.

“I’m not sure there is a definitive correct answer, definitely not that everyone would agree on,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn.

Dr. Freeman, however, believed that pernio and especially persistent lesions are caused by an immune response to COVID.

In an interview, she noted the multiple cases of patients in the registry who did seroconvert and that, while a registry is not a perfect means of getting an answer, it is good for generating questions. Taken collectively, the cases in the registry can “tell a story for further hypotheses,” said Dr. Freeman, who is director of global health dermatology at Massachusetts General Hospital and assistant professor of dermatology at Harvard University, both in Boston.

“We were noticing this signal across the world” that patients “developed these toe lesions and they never got better,” said Dr. Freeman. Generally, people who experience pernio, also described as COVID toes or “COVID fingers,” recover in 4-8 weeks. But in the registry, “we did have this subset of patients who really were experiencing these very longstanding symptoms,” she added.

Two patients with lab-confirmed COVID have had long-lasting pernio of 133 days and 150 days. “I’m caring for a cohort in Boston who have had long COVID of the skin and symptoms for over 10 months,” Dr. Freeman said.
 

Pernio dominates

The registry – a collaboration between the AAD and the International League of Dermatological Societies – was launched in April 2020. Any medical professional can enter case information. From April to October, 1,030 total cases and 331 laboratory-confirmed or suspected COVID-19 cases with dermatological manifestations were entered from 41 countries.

Most of the cases were just recorded at a single time point, which is an acknowledged limitation of the study.

Dr. Freeman and colleagues reached out to registry participants in June and August to get updates on COVID lab test results and sign and symptom duration. Overall, 234 total and 96 lab-confirmed COVID infections had more lengthy data about sign and symptom duration.

Pernio lasted a median of 15 days in patients with suspected disease and 12 days for those with lab-confirmed COVID, compared with a median of 7 days for morbilliform eruptions, 4 days for urticarial eruptions, and 20 days for papulosquamous eruptions – all in patients with lab-confirmed disease.

Of the 103 cases of pernio, 7 had symptoms lasting more than 60 days. Only two of those seven patients had lab-confirmed COVID. Initially, the one patient tested negative with nasopharyngeal PCR, and serum IgM and IgG. Six weeks after pernio onset, the patient – still experiencing fatigue and pernio – seroconverted to anti–SARS-CoV-2 IgM positivity.

The other long-haul patient, after a negative PCR, tested positive for SARS-CoV-2 serum IgG 1 month after pernio onset.

Robust immune response?

Dr. Freeman said these patients might have a very high interferon response initially to the virus, which makes for a mild to nonexistent disease, but could create inflammation elsewhere. “I almost view the toes as an innocent bystander of a robust immune response to SARS-CoV-2.”

Although he has not seen extended pernio or other skin manifestations in his patients, Dr. Fernandez said the interferon hypothesis is “fair,” and “the best that’s out there.” Dr. Fernandez is currently studying cutaneous manifestations of COVID-19 as a principal investigator of a trial sponsored by the Clinical and Translational Science Collaborative of Cleveland.

Dr. Ko said in an interview that she has not observed long-haul skin issues in her patients, but Yale colleagues have.

In a study, she and Yale colleagues published in September, SARS-CoV-2 spike protein was detected in perniotic lesions, but not nuclear protein or viral RNA. The test they used – immunohistochemistry – can be nonspecific, which muddied results.

She does not think there is replicating virus in the skin or the lesions. Instead, said Dr. Ko, “either there is viral spike protein that has somehow become disassociated from actively replicating virus that somehow got deposited in endothelial cells,” or the staining “was spurious,” or some other protein is cross-reacting. “And the people who are unlucky enough to have that protein in their endothelial cells can manifest this COVID-toe, COVID-finger phenomenon.”

To her, it’s an unsolved mystery. “The weird thing is, we’ve never before had this much perniosis,” Dr. Ko said.

Dr. Fernandez is not convinced yet, noting that, in Cleveland, more pernio cases were observed in March and April than in the summer. “If it is a manifestation of the infection then you also need the right environment, the cold weather for this manifestation to present,” he said. “Or, it really isn’t a direct manifestation of COVID-19 but may be more related to other factors,” such as lifestyle changes related to limitations implemented to help mitigate the spread of the disease.

“To me the jury is still out whether or not the perniotic lesions really can tell us something about a patient’s exposure and infection with SARS-CoV-2,” he said.

Dr. Freeman reported receiving a grant from the International League of Dermatological Societies and nonfinancial support from the AAD for the study. Dr. Ko reported no conflicts. Dr. Fernadnez had no disclosures.

While many people were committing to their New Year’s resolutions to lose weight, in January 2020 Cosmopolitan UK magazine released covers portraying 11 women of different shapes and sizes, with the headline, “This is healthy!” Each version of the cover features one or more of the 11 women wearing athletic gear and makeup, some of whom are caught mid-action – boxing, doing yoga, or simply rejoicing in being who they are. Seeing these, I was reminded of a patient I cared for as an intern.

Janet Spears (not her real name) was thin. Standing barely 5 feet 3 inches, she weighed 110 pounds. For those out there who think of size in terms of body mass index (BMI), it was about 20 kg/m², solidly in the “normal” category. At the age of 62, despite this healthy BMI, she had so much plaque in her arteries that she needed surgery to improve blood flow to her foot.

Admittedly, whenever I had read about people with high cholesterol, type 2 diabetes, or atherosclerosis, I pictured bigger people. But when I met Ms. Spears, I realized that one’s health cannot necessarily be inferred from physical appearance.

As a bariatric surgeon board certified in obesity medicine, I’ve probably spent more time thinking and learning about obesity than most people – and yet I still didn’t know what to make of the Cosmopolitan covers.

I saw the reaction on Twitter before I saw the magazines themselves, and I quickly observed a number of people decrying the covers, suggesting that they promote obesity:

Multiple people suggested that this was inappropriate, especially in the context of the COVID-19 pandemic and the fact that people with obesity are at risk for worse outcomes, compared with those without obesity. (As an aside, these comments suggest that people did not read the associated article, which is about fitness and body image more than it is about obesity.)
 

Does size reflect health?

Putting the pandemic aside for a moment, the question the magazine covers raise is whether physical appearance reflects health. That’s what got me thinking about Ms. Spears, who, though appearing healthy, was sick enough that she needed to have major surgery. This whole conversation hinges, of course, on one’s definition of health.

A common knee-jerk response, especially from physicians, would be to say that obesity is by definition unhealthy. Some researchers have suggested though that a segment of people with obesity fall into a category called metabolically healthy obesity, which is typically characterized by a limited set of data such as cholesterol, blood sugar, and blood pressure. Indeed, some people with obesity have normal values in those categories.

Being metabolically healthy, however, does not preclude other medical problems associated with obesity, including joint pain, cancer, and mood disorders, among other issues. So even those who have metabolically healthy obesity are not necessarily immune to the many other obesity-related conditions.
 

What about body positivity?

As I delved further into the conversation about these covers, I saw people embracing the idea of promoting different-sized bodies. With almost two thirds of the U.S. population having overweight or obesity, one might argue that it’s high time magazine covers and the media reflect the reality in our hometowns. Unrealistic images in the media are associated with negative self-image and disordered eating, so perhaps embracing the shapes of real people may help us all have healthier attitudes toward our bodies.

That said, this idea can be taken too far. The Health at Every Size movement, which some might consider to be the ultimate body-positivity movement, espouses the idea that size and health are completely unrelated. That crosses a line between what we know to be true – that, at a population level, higher weight is associated with more medical problems – and fake news.

Another idea to consider is fitness, as opposed to health. Fitness can be defined multiple ways, but if we consider it to be measured exercise capacity, those who are more fit have a longer life expectancy than those with lower fitness levels at a given BMI. While some feel that the Cosmopolitan covers promote obesity and are therefore irresponsible, it’s at least as likely that highlighting people with obesity being active may inspire others with obesity to do the same.

Now let’s bring the pandemic back into the picture. As much as we all wish that it was over, with uncontrolled spread in every state and record numbers of people dying, COVID-19 is still very much a part of our reality. Having obesity increases the risk of having a severe case of COVID-19 if infected. Patients with obesity are also more likely than those without obesity to be hospitalized, require intensive care, and die with COVID-19.
 

Guiding the conversation

Pandemic or not, the truth is that obesity is related to multiple medical problems. That does not mean that every person with obesity has medical problems. The musician Lizzo, for example, is someone with obesity who considers herself to be healthy. She posts images and videos of working out and shares her personal fitness routine with her millions of fans. As a physician, I worry about the medical conditions – metabolic or otherwise – that someone like her may develop. But I love how she embraces who she is while striving to be healthier.

Most of the critical comments I have seen about the Cosmopolitan covers have, at best, bordered on fat shaming; others are solidly in that category. And the vitriol aimed at the larger models is despicable. It seems that conversations about obesity often vacillate from one extreme (fat shaming) to the other (extreme body positivity).

Although it may not sell magazines, I would love to see more nuanced, fact-based discussions, both in the media and in our clinics. We can start by acknowledging the fact that people of different sizes can be healthy. The truth is that we can’t tell very much about a person’s health from their outward appearance, and we should probably stop trying to make such inferences.

Assessment of health is most accurately judged by each person with their medical team, not by observers who use media images as part of their own propaganda machine, pushing one extreme view or another. As physicians, we have the opportunity and the responsibility to support our patients in the pursuit of health, without shame or judgment. Maybe that’s a New Year’s resolution worth committing to.

Arghavan Salles, MD, PhD, is a bariatric surgeon.

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

While many people were committing to their New Year’s resolutions to lose weight, in January 2020 Cosmopolitan UK magazine released covers portraying 11 women of different shapes and sizes, with the headline, “This is healthy!” Each version of the cover features one or more of the 11 women wearing athletic gear and makeup, some of whom are caught mid-action – boxing, doing yoga, or simply rejoicing in being who they are. Seeing these, I was reminded of a patient I cared for as an intern.

Janet Spears (not her real name) was thin. Standing barely 5 feet 3 inches, she weighed 110 pounds. For those out there who think of size in terms of body mass index (BMI), it was about 20 kg/m², solidly in the “normal” category. At the age of 62, despite this healthy BMI, she had so much plaque in her arteries that she needed surgery to improve blood flow to her foot.

Admittedly, whenever I had read about people with high cholesterol, type 2 diabetes, or atherosclerosis, I pictured bigger people. But when I met Ms. Spears, I realized that one’s health cannot necessarily be inferred from physical appearance.

As a bariatric surgeon board certified in obesity medicine, I’ve probably spent more time thinking and learning about obesity than most people – and yet I still didn’t know what to make of the Cosmopolitan covers.

I saw the reaction on Twitter before I saw the magazines themselves, and I quickly observed a number of people decrying the covers, suggesting that they promote obesity:

Multiple people suggested that this was inappropriate, especially in the context of the COVID-19 pandemic and the fact that people with obesity are at risk for worse outcomes, compared with those without obesity. (As an aside, these comments suggest that people did not read the associated article, which is about fitness and body image more than it is about obesity.)
 

Does size reflect health?

Putting the pandemic aside for a moment, the question the magazine covers raise is whether physical appearance reflects health. That’s what got me thinking about Ms. Spears, who, though appearing healthy, was sick enough that she needed to have major surgery. This whole conversation hinges, of course, on one’s definition of health.

A common knee-jerk response, especially from physicians, would be to say that obesity is by definition unhealthy. Some researchers have suggested though that a segment of people with obesity fall into a category called metabolically healthy obesity, which is typically characterized by a limited set of data such as cholesterol, blood sugar, and blood pressure. Indeed, some people with obesity have normal values in those categories.

Being metabolically healthy, however, does not preclude other medical problems associated with obesity, including joint pain, cancer, and mood disorders, among other issues. So even those who have metabolically healthy obesity are not necessarily immune to the many other obesity-related conditions.
 

What about body positivity?

As I delved further into the conversation about these covers, I saw people embracing the idea of promoting different-sized bodies. With almost two thirds of the U.S. population having overweight or obesity, one might argue that it’s high time magazine covers and the media reflect the reality in our hometowns. Unrealistic images in the media are associated with negative self-image and disordered eating, so perhaps embracing the shapes of real people may help us all have healthier attitudes toward our bodies.

That said, this idea can be taken too far. The Health at Every Size movement, which some might consider to be the ultimate body-positivity movement, espouses the idea that size and health are completely unrelated. That crosses a line between what we know to be true – that, at a population level, higher weight is associated with more medical problems – and fake news.

Another idea to consider is fitness, as opposed to health. Fitness can be defined multiple ways, but if we consider it to be measured exercise capacity, those who are more fit have a longer life expectancy than those with lower fitness levels at a given BMI. While some feel that the Cosmopolitan covers promote obesity and are therefore irresponsible, it’s at least as likely that highlighting people with obesity being active may inspire others with obesity to do the same.

Now let’s bring the pandemic back into the picture. As much as we all wish that it was over, with uncontrolled spread in every state and record numbers of people dying, COVID-19 is still very much a part of our reality. Having obesity increases the risk of having a severe case of COVID-19 if infected. Patients with obesity are also more likely than those without obesity to be hospitalized, require intensive care, and die with COVID-19.
 

Guiding the conversation

Pandemic or not, the truth is that obesity is related to multiple medical problems. That does not mean that every person with obesity has medical problems. The musician Lizzo, for example, is someone with obesity who considers herself to be healthy. She posts images and videos of working out and shares her personal fitness routine with her millions of fans. As a physician, I worry about the medical conditions – metabolic or otherwise – that someone like her may develop. But I love how she embraces who she is while striving to be healthier.

Most of the critical comments I have seen about the Cosmopolitan covers have, at best, bordered on fat shaming; others are solidly in that category. And the vitriol aimed at the larger models is despicable. It seems that conversations about obesity often vacillate from one extreme (fat shaming) to the other (extreme body positivity).

Although it may not sell magazines, I would love to see more nuanced, fact-based discussions, both in the media and in our clinics. We can start by acknowledging the fact that people of different sizes can be healthy. The truth is that we can’t tell very much about a person’s health from their outward appearance, and we should probably stop trying to make such inferences.

Assessment of health is most accurately judged by each person with their medical team, not by observers who use media images as part of their own propaganda machine, pushing one extreme view or another. As physicians, we have the opportunity and the responsibility to support our patients in the pursuit of health, without shame or judgment. Maybe that’s a New Year’s resolution worth committing to.

Arghavan Salles, MD, PhD, is a bariatric surgeon.

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

While many people were committing to their New Year’s resolutions to lose weight, in January 2020 Cosmopolitan UK magazine released covers portraying 11 women of different shapes and sizes, with the headline, “This is healthy!” Each version of the cover features one or more of the 11 women wearing athletic gear and makeup, some of whom are caught mid-action – boxing, doing yoga, or simply rejoicing in being who they are. Seeing these, I was reminded of a patient I cared for as an intern.

Janet Spears (not her real name) was thin. Standing barely 5 feet 3 inches, she weighed 110 pounds. For those out there who think of size in terms of body mass index (BMI), it was about 20 kg/m², solidly in the “normal” category. At the age of 62, despite this healthy BMI, she had so much plaque in her arteries that she needed surgery to improve blood flow to her foot.

Admittedly, whenever I had read about people with high cholesterol, type 2 diabetes, or atherosclerosis, I pictured bigger people. But when I met Ms. Spears, I realized that one’s health cannot necessarily be inferred from physical appearance.

As a bariatric surgeon board certified in obesity medicine, I’ve probably spent more time thinking and learning about obesity than most people – and yet I still didn’t know what to make of the Cosmopolitan covers.

I saw the reaction on Twitter before I saw the magazines themselves, and I quickly observed a number of people decrying the covers, suggesting that they promote obesity:

Multiple people suggested that this was inappropriate, especially in the context of the COVID-19 pandemic and the fact that people with obesity are at risk for worse outcomes, compared with those without obesity. (As an aside, these comments suggest that people did not read the associated article, which is about fitness and body image more than it is about obesity.)
 

Does size reflect health?

Putting the pandemic aside for a moment, the question the magazine covers raise is whether physical appearance reflects health. That’s what got me thinking about Ms. Spears, who, though appearing healthy, was sick enough that she needed to have major surgery. This whole conversation hinges, of course, on one’s definition of health.

A common knee-jerk response, especially from physicians, would be to say that obesity is by definition unhealthy. Some researchers have suggested though that a segment of people with obesity fall into a category called metabolically healthy obesity, which is typically characterized by a limited set of data such as cholesterol, blood sugar, and blood pressure. Indeed, some people with obesity have normal values in those categories.

Being metabolically healthy, however, does not preclude other medical problems associated with obesity, including joint pain, cancer, and mood disorders, among other issues. So even those who have metabolically healthy obesity are not necessarily immune to the many other obesity-related conditions.
 

What about body positivity?

As I delved further into the conversation about these covers, I saw people embracing the idea of promoting different-sized bodies. With almost two thirds of the U.S. population having overweight or obesity, one might argue that it’s high time magazine covers and the media reflect the reality in our hometowns. Unrealistic images in the media are associated with negative self-image and disordered eating, so perhaps embracing the shapes of real people may help us all have healthier attitudes toward our bodies.

That said, this idea can be taken too far. The Health at Every Size movement, which some might consider to be the ultimate body-positivity movement, espouses the idea that size and health are completely unrelated. That crosses a line between what we know to be true – that, at a population level, higher weight is associated with more medical problems – and fake news.

Another idea to consider is fitness, as opposed to health. Fitness can be defined multiple ways, but if we consider it to be measured exercise capacity, those who are more fit have a longer life expectancy than those with lower fitness levels at a given BMI. While some feel that the Cosmopolitan covers promote obesity and are therefore irresponsible, it’s at least as likely that highlighting people with obesity being active may inspire others with obesity to do the same.

Now let’s bring the pandemic back into the picture. As much as we all wish that it was over, with uncontrolled spread in every state and record numbers of people dying, COVID-19 is still very much a part of our reality. Having obesity increases the risk of having a severe case of COVID-19 if infected. Patients with obesity are also more likely than those without obesity to be hospitalized, require intensive care, and die with COVID-19.
 

Guiding the conversation

Pandemic or not, the truth is that obesity is related to multiple medical problems. That does not mean that every person with obesity has medical problems. The musician Lizzo, for example, is someone with obesity who considers herself to be healthy. She posts images and videos of working out and shares her personal fitness routine with her millions of fans. As a physician, I worry about the medical conditions – metabolic or otherwise – that someone like her may develop. But I love how she embraces who she is while striving to be healthier.

Most of the critical comments I have seen about the Cosmopolitan covers have, at best, bordered on fat shaming; others are solidly in that category. And the vitriol aimed at the larger models is despicable. It seems that conversations about obesity often vacillate from one extreme (fat shaming) to the other (extreme body positivity).

Although it may not sell magazines, I would love to see more nuanced, fact-based discussions, both in the media and in our clinics. We can start by acknowledging the fact that people of different sizes can be healthy. The truth is that we can’t tell very much about a person’s health from their outward appearance, and we should probably stop trying to make such inferences.

Assessment of health is most accurately judged by each person with their medical team, not by observers who use media images as part of their own propaganda machine, pushing one extreme view or another. As physicians, we have the opportunity and the responsibility to support our patients in the pursuit of health, without shame or judgment. Maybe that’s a New Year’s resolution worth committing to.

Arghavan Salles, MD, PhD, is a bariatric surgeon.

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

Two recent observational studies suggest that myocarditis, at least on cardiac magnetic resonance (CMR) imaging, might be far less common in elite-level athletes recovering from COVID-19 than suggested in influential earlier reports.

AlexLMX/Getty Images

Both new studies documented a rate less than one-quarter as high as those previously reported from smaller cohorts, raising questions about the diagnostic yield of CMR in highly conditioned athletes with recent COVID-19 absent other evidence, such as from biomarker assays or electrocardiography (ECG).

That could have implications for some top-tier university athletics programs that mandate CMR imaging, biomarker assays, and other evaluations for myocarditis on all their players who test positive for SARS-CoV-2 before they can return to play.

The findings collectively point to CMR imaging features that might be a hallmark of an athlete’s heart, characterized by normal myocardial remodeling brought on by elite-level exercise training, which in athletes with recent COVID-19 could be misinterpreted as evidence of myocarditis. That may have thrown off prevalence estimates in the literature, the studies’ investigators speculated.

The two studies were retrospective takes on university athletes who underwent CMR imaging while recovering from COVID-19, who were either asymptomatic or with only mild to moderate symptoms and were generally without ECG or troponin evidence of myocarditis.

One of them showed a less than 2% incidence of myocarditis by CMR among 145 such cases, a low yield for imaging that is “raising doubt regarding its utility to evaluate athletes without a clinical presentation or abnormal ancillary tests to support the diagnosis of myocarditis,” argues a report published Jan. 14 in JAMA Cardiology, with lead author Jitka Starekova, MD, University of Wisconsin – Madison.

“Part of the problem is that occult myocarditis is, at least with other viruses, a risk factor for sudden death in competitive athletes. So you don’t want to let one slip through the cracks,” senior author Scott B. Reeder, MD, PhD, from the same institution, said in an interview.

Whether a policy of routine CMR imaging in elite athletes who test positive for the new coronavirus is better than more selective use driven by symptoms or other screening tests is unknown. But the more pressing issue, Dr. Reeder said, “is if they have a normal electrocardiogram and troponins, do they still need cardiac magnetic resonance imaging?”

The current study, he said, “certainly provides helpful evidence that maybe we don’t need as many.”

The other study, which featured two control groups, saw a similarly low incidence of myocarditis by CMR in athletes with recent COVID-19. One of the control groups included university athletes imaged prior to the advent of SARS-CoV-2 in the university’s region of the country. The other consisted of apparently healthy adult nonathletes.

Armed with two non-COVID-19 cohorts and two athlete cohorts, the researchers found comparable rates of myocarditis by CMR in both the COVID-19 athletes and the healthy athletes. And only 3% of the COVID-19 athletes had the tell-tale CMR signs, notes the report, published Dec. 17 in Circulation, with lead author Daniel E. Clark, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn.
 

Reassurance and concern

“The incidence is much lower than we feared, and so that’s reassuring,” Clark said in an interview. Still, the athletes with myocarditis by CMR “would have been completely missed by a protocol that did not include cardiac MR, and that’s concerning,” he said. “Both had active myocarditis.”

The study’s two non-COVID-19 control groups – elite athletes in one and nonathletes in the other – allowed them to tease out the potential contribution of athletic myocardial remodeling to CMR features that could be interpreted as scar tissue, which are characterized by late gadolinium enhancement (LGE).

As it turned out, focal regions of LGE located in the right ventricular (RV) septum on the scans were often seen in both athlete cohorts. “This kind of trivial nonischemic fibrosis in the mid RV septal insertion site was common among athletic control subjects. It was seen in 24% of them, which is almost identical to the percentage that we saw in the COVID-19 athletes, 22%,” Dr. Clark said.

The LGE finding, wrote Dr. Clark and coauthors, “may represent remodeling from athletic training, and should not be conflated with myocarditis.”

Of note, the other study saw a comparable incidence of the same or a very similar CMR feature in its athletes; 26% of the Wisconsin COVID-19 athlete cohort showed limited focal LGE in the inferior RV insertion site.

“And you get a little bit in the mid-septum, as well,” Dr. Reeder said. But the sign, in the absence of any corresponding T2 abnormalities, was not judged to represent myocarditis. “We interpreted all of these studies with this potential confounder in mind.”

Conceivably, Dr. Reeder proposed, the earlier studies may have “over-called” the prevalence of myocarditis in their cohorts. “I haven’t seen their images, but it’s possible there could be false-positives.”

It’s noteworthy that the Vanderbilt and Wisconsin reports saw closely similar incidences of the tell-tale CMR sign in all the athlete cohorts whether or not COVID-19 was involved, Aaron L. Baggish, MD, Massachusetts General Hospital, Boston, said in an interview.

“It looks very much like just an unrecognized part of athletic remodeling and isn’t in any way, shape, or form implicated as being a COVID-related issue,” said Dr. Baggish, who directs the cardiovascular performance program at his center and is unaffiliated with either study.

Still, that connection remains unproven given how little is yet known about the prevalence of clinically important myocarditis in milder cases of COVID-19, according to an accompanying editorial from Jonathan H. Kim, MD, MSc.

Although isolated LGE at the interventricular RV insertion site is “more commonly described among masters-level endurance athletes, the clinical significance and prevalence of this finding in youthful athletes is uncertain and should not be assumed to be a normal consequence of intense athletic training in young competitive athletes,” argued Dr. Kim, of Emory University, Atlanta.

There’s probably little about being a young competitive athlete that would render a person any more or less prone to COVID-19 cardiac involvement, Dr. Baggish said. Rather, “I think what we’re seeing, as the studies continue to come out, is that prevalence estimates are getting into the low single digits.”

The estimates are similar to those associated with influenza before the COVID-19 age; about 2% of patients showed cardiac involvement, Dr. Baggish said. “So the degree to which COVID is a special virus from this perspective, I think, is still a topic of some debate.”

The two current studies have limitations and neither is positioned to change practice, he said. “I would say that they are both kind of important, reassuring pieces of an unfinished jigsaw puzzle. But we still don’t know what the picture on the puzzle is.”
 

Routine CMR for positive cases

The University of Wisconsin group looked at all of the institution’s competitive athletes who underwent gadolinium-enhanced CMR imaging and other tests during recovery from COVID-19 from the beginning of the pandemic to the end of November 2020.

The imaging was performed on average about 2 weeks after a first positive SARS-CoV-2 assay result. About one-half and one-fourth of the cohort had experienced mild and moderate symptoms, respectively, and about 17% were asymptomatic; none had been hospitalized.

All CMR scans were reviewed by two experienced radiologists for, among other things, evidence of myocarditis according to modified Lake Louise criteria, the group wrote. Those criteria are based on CMR markers of fibrosis and other characteristics of scarring from myocarditis.

Such evidence was seen in only two members of the cohort, or 1.4%, one with elevated troponins but normal with respect to other biomarkers, and the other negative for all assays. Both were asymptomatic at the time of imaging, the report noted.

The Vanderbilt analysis from Dr. Clark and associates centered on 59 university athletes recently with COVID-19 who underwent CMR imaging along with other tests about 3 weeks after confirmation of SARS-CoV-2 infection. Symptoms had been mild in 78% of the group, and the remainder were asymptomatic.

They were compared with 60 retrospectively identified college athletes and elite-conditioned military personnel who had undergone CMR imaging prior to the advent of COVID-19, and to 27 apparently healthy nonathlete adults in whom CMR had been previously performed to define normal CMR imaging criteria at that center.

The only two post-COVID-19 athletes who met modified Lake Louise criteria for myocarditis showed no abnormalities on ECG or myocardial strain echocardiography, and had normal troponins, the group reported.

The COVID-19 athletes showed increased cardiac chamber volumes and myocardial mass “consistent with athletic remodeling,” compared with the healthy control subjects, the group wrote. But “most standard CMR parameters were similar” between the COVID-19 athletes and the control athletes, consistent with the 22% and 24% rates, respectively, for the finding of focal late LGE isolated to the inferoseptal RV insertion site.

At the end of the day, all published experiences on athletes with recent COVID-19 “are descriptive studies, without any hint of follow-up,” Dr. Baggish noted, so their clinical implications are unknown.

“We need time to sit and watch to see what happens to these individuals,” he said. “And if the answer is nothing, then that’s a very reassuring story. If the answer is that we start to see events, then that’s really important for us to take stock of.”

Dr. Starekova had no disclosures. Dr. Reeder reports that the University of Wisconsin receives research support from GE Healthcare and Bracco Diagnostics; and that he has ownership interests in Calimetrix, Reveal Pharmaceuticals, Cellectar Biosciences, Elucent Medical, and HeartVista; and has received grant support from Bayer Healthcare. Disclosures for the other coauthors are in the report. Dr. Clark and coauthors had no disclosures. Dr. Baggish reported no conflicts. Kim discloses receiving funding from the National Heart, Lung, and Blood Institute; compensation as team cardiologist for the Atlanta Falcons; and research stipends from the Atlanta Track Club.

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

Two recent observational studies suggest that myocarditis, at least on cardiac magnetic resonance (CMR) imaging, might be far less common in elite-level athletes recovering from COVID-19 than suggested in influential earlier reports.

AlexLMX/Getty Images

Both new studies documented a rate less than one-quarter as high as those previously reported from smaller cohorts, raising questions about the diagnostic yield of CMR in highly conditioned athletes with recent COVID-19 absent other evidence, such as from biomarker assays or electrocardiography (ECG).

That could have implications for some top-tier university athletics programs that mandate CMR imaging, biomarker assays, and other evaluations for myocarditis on all their players who test positive for SARS-CoV-2 before they can return to play.

The findings collectively point to CMR imaging features that might be a hallmark of an athlete’s heart, characterized by normal myocardial remodeling brought on by elite-level exercise training, which in athletes with recent COVID-19 could be misinterpreted as evidence of myocarditis. That may have thrown off prevalence estimates in the literature, the studies’ investigators speculated.

The two studies were retrospective takes on university athletes who underwent CMR imaging while recovering from COVID-19, who were either asymptomatic or with only mild to moderate symptoms and were generally without ECG or troponin evidence of myocarditis.

One of them showed a less than 2% incidence of myocarditis by CMR among 145 such cases, a low yield for imaging that is “raising doubt regarding its utility to evaluate athletes without a clinical presentation or abnormal ancillary tests to support the diagnosis of myocarditis,” argues a report published Jan. 14 in JAMA Cardiology, with lead author Jitka Starekova, MD, University of Wisconsin – Madison.

“Part of the problem is that occult myocarditis is, at least with other viruses, a risk factor for sudden death in competitive athletes. So you don’t want to let one slip through the cracks,” senior author Scott B. Reeder, MD, PhD, from the same institution, said in an interview.

Whether a policy of routine CMR imaging in elite athletes who test positive for the new coronavirus is better than more selective use driven by symptoms or other screening tests is unknown. But the more pressing issue, Dr. Reeder said, “is if they have a normal electrocardiogram and troponins, do they still need cardiac magnetic resonance imaging?”

The current study, he said, “certainly provides helpful evidence that maybe we don’t need as many.”

The other study, which featured two control groups, saw a similarly low incidence of myocarditis by CMR in athletes with recent COVID-19. One of the control groups included university athletes imaged prior to the advent of SARS-CoV-2 in the university’s region of the country. The other consisted of apparently healthy adult nonathletes.

Armed with two non-COVID-19 cohorts and two athlete cohorts, the researchers found comparable rates of myocarditis by CMR in both the COVID-19 athletes and the healthy athletes. And only 3% of the COVID-19 athletes had the tell-tale CMR signs, notes the report, published Dec. 17 in Circulation, with lead author Daniel E. Clark, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn.
 

Reassurance and concern

“The incidence is much lower than we feared, and so that’s reassuring,” Clark said in an interview. Still, the athletes with myocarditis by CMR “would have been completely missed by a protocol that did not include cardiac MR, and that’s concerning,” he said. “Both had active myocarditis.”

The study’s two non-COVID-19 control groups – elite athletes in one and nonathletes in the other – allowed them to tease out the potential contribution of athletic myocardial remodeling to CMR features that could be interpreted as scar tissue, which are characterized by late gadolinium enhancement (LGE).

As it turned out, focal regions of LGE located in the right ventricular (RV) septum on the scans were often seen in both athlete cohorts. “This kind of trivial nonischemic fibrosis in the mid RV septal insertion site was common among athletic control subjects. It was seen in 24% of them, which is almost identical to the percentage that we saw in the COVID-19 athletes, 22%,” Dr. Clark said.

The LGE finding, wrote Dr. Clark and coauthors, “may represent remodeling from athletic training, and should not be conflated with myocarditis.”

Of note, the other study saw a comparable incidence of the same or a very similar CMR feature in its athletes; 26% of the Wisconsin COVID-19 athlete cohort showed limited focal LGE in the inferior RV insertion site.

“And you get a little bit in the mid-septum, as well,” Dr. Reeder said. But the sign, in the absence of any corresponding T2 abnormalities, was not judged to represent myocarditis. “We interpreted all of these studies with this potential confounder in mind.”

Conceivably, Dr. Reeder proposed, the earlier studies may have “over-called” the prevalence of myocarditis in their cohorts. “I haven’t seen their images, but it’s possible there could be false-positives.”

It’s noteworthy that the Vanderbilt and Wisconsin reports saw closely similar incidences of the tell-tale CMR sign in all the athlete cohorts whether or not COVID-19 was involved, Aaron L. Baggish, MD, Massachusetts General Hospital, Boston, said in an interview.

“It looks very much like just an unrecognized part of athletic remodeling and isn’t in any way, shape, or form implicated as being a COVID-related issue,” said Dr. Baggish, who directs the cardiovascular performance program at his center and is unaffiliated with either study.

Still, that connection remains unproven given how little is yet known about the prevalence of clinically important myocarditis in milder cases of COVID-19, according to an accompanying editorial from Jonathan H. Kim, MD, MSc.

Although isolated LGE at the interventricular RV insertion site is “more commonly described among masters-level endurance athletes, the clinical significance and prevalence of this finding in youthful athletes is uncertain and should not be assumed to be a normal consequence of intense athletic training in young competitive athletes,” argued Dr. Kim, of Emory University, Atlanta.

There’s probably little about being a young competitive athlete that would render a person any more or less prone to COVID-19 cardiac involvement, Dr. Baggish said. Rather, “I think what we’re seeing, as the studies continue to come out, is that prevalence estimates are getting into the low single digits.”

The estimates are similar to those associated with influenza before the COVID-19 age; about 2% of patients showed cardiac involvement, Dr. Baggish said. “So the degree to which COVID is a special virus from this perspective, I think, is still a topic of some debate.”

The two current studies have limitations and neither is positioned to change practice, he said. “I would say that they are both kind of important, reassuring pieces of an unfinished jigsaw puzzle. But we still don’t know what the picture on the puzzle is.”
 

Routine CMR for positive cases

The University of Wisconsin group looked at all of the institution’s competitive athletes who underwent gadolinium-enhanced CMR imaging and other tests during recovery from COVID-19 from the beginning of the pandemic to the end of November 2020.

The imaging was performed on average about 2 weeks after a first positive SARS-CoV-2 assay result. About one-half and one-fourth of the cohort had experienced mild and moderate symptoms, respectively, and about 17% were asymptomatic; none had been hospitalized.

All CMR scans were reviewed by two experienced radiologists for, among other things, evidence of myocarditis according to modified Lake Louise criteria, the group wrote. Those criteria are based on CMR markers of fibrosis and other characteristics of scarring from myocarditis.

Such evidence was seen in only two members of the cohort, or 1.4%, one with elevated troponins but normal with respect to other biomarkers, and the other negative for all assays. Both were asymptomatic at the time of imaging, the report noted.

The Vanderbilt analysis from Dr. Clark and associates centered on 59 university athletes recently with COVID-19 who underwent CMR imaging along with other tests about 3 weeks after confirmation of SARS-CoV-2 infection. Symptoms had been mild in 78% of the group, and the remainder were asymptomatic.

They were compared with 60 retrospectively identified college athletes and elite-conditioned military personnel who had undergone CMR imaging prior to the advent of COVID-19, and to 27 apparently healthy nonathlete adults in whom CMR had been previously performed to define normal CMR imaging criteria at that center.

The only two post-COVID-19 athletes who met modified Lake Louise criteria for myocarditis showed no abnormalities on ECG or myocardial strain echocardiography, and had normal troponins, the group reported.

The COVID-19 athletes showed increased cardiac chamber volumes and myocardial mass “consistent with athletic remodeling,” compared with the healthy control subjects, the group wrote. But “most standard CMR parameters were similar” between the COVID-19 athletes and the control athletes, consistent with the 22% and 24% rates, respectively, for the finding of focal late LGE isolated to the inferoseptal RV insertion site.

At the end of the day, all published experiences on athletes with recent COVID-19 “are descriptive studies, without any hint of follow-up,” Dr. Baggish noted, so their clinical implications are unknown.

“We need time to sit and watch to see what happens to these individuals,” he said. “And if the answer is nothing, then that’s a very reassuring story. If the answer is that we start to see events, then that’s really important for us to take stock of.”

Dr. Starekova had no disclosures. Dr. Reeder reports that the University of Wisconsin receives research support from GE Healthcare and Bracco Diagnostics; and that he has ownership interests in Calimetrix, Reveal Pharmaceuticals, Cellectar Biosciences, Elucent Medical, and HeartVista; and has received grant support from Bayer Healthcare. Disclosures for the other coauthors are in the report. Dr. Clark and coauthors had no disclosures. Dr. Baggish reported no conflicts. Kim discloses receiving funding from the National Heart, Lung, and Blood Institute; compensation as team cardiologist for the Atlanta Falcons; and research stipends from the Atlanta Track Club.

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

Two recent observational studies suggest that myocarditis, at least on cardiac magnetic resonance (CMR) imaging, might be far less common in elite-level athletes recovering from COVID-19 than suggested in influential earlier reports.

AlexLMX/Getty Images

Both new studies documented a rate less than one-quarter as high as those previously reported from smaller cohorts, raising questions about the diagnostic yield of CMR in highly conditioned athletes with recent COVID-19 absent other evidence, such as from biomarker assays or electrocardiography (ECG).

That could have implications for some top-tier university athletics programs that mandate CMR imaging, biomarker assays, and other evaluations for myocarditis on all their players who test positive for SARS-CoV-2 before they can return to play.

The findings collectively point to CMR imaging features that might be a hallmark of an athlete’s heart, characterized by normal myocardial remodeling brought on by elite-level exercise training, which in athletes with recent COVID-19 could be misinterpreted as evidence of myocarditis. That may have thrown off prevalence estimates in the literature, the studies’ investigators speculated.

The two studies were retrospective takes on university athletes who underwent CMR imaging while recovering from COVID-19, who were either asymptomatic or with only mild to moderate symptoms and were generally without ECG or troponin evidence of myocarditis.

One of them showed a less than 2% incidence of myocarditis by CMR among 145 such cases, a low yield for imaging that is “raising doubt regarding its utility to evaluate athletes without a clinical presentation or abnormal ancillary tests to support the diagnosis of myocarditis,” argues a report published Jan. 14 in JAMA Cardiology, with lead author Jitka Starekova, MD, University of Wisconsin – Madison.

“Part of the problem is that occult myocarditis is, at least with other viruses, a risk factor for sudden death in competitive athletes. So you don’t want to let one slip through the cracks,” senior author Scott B. Reeder, MD, PhD, from the same institution, said in an interview.

Whether a policy of routine CMR imaging in elite athletes who test positive for the new coronavirus is better than more selective use driven by symptoms or other screening tests is unknown. But the more pressing issue, Dr. Reeder said, “is if they have a normal electrocardiogram and troponins, do they still need cardiac magnetic resonance imaging?”

The current study, he said, “certainly provides helpful evidence that maybe we don’t need as many.”

The other study, which featured two control groups, saw a similarly low incidence of myocarditis by CMR in athletes with recent COVID-19. One of the control groups included university athletes imaged prior to the advent of SARS-CoV-2 in the university’s region of the country. The other consisted of apparently healthy adult nonathletes.

Armed with two non-COVID-19 cohorts and two athlete cohorts, the researchers found comparable rates of myocarditis by CMR in both the COVID-19 athletes and the healthy athletes. And only 3% of the COVID-19 athletes had the tell-tale CMR signs, notes the report, published Dec. 17 in Circulation, with lead author Daniel E. Clark, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn.
 

Reassurance and concern

“The incidence is much lower than we feared, and so that’s reassuring,” Clark said in an interview. Still, the athletes with myocarditis by CMR “would have been completely missed by a protocol that did not include cardiac MR, and that’s concerning,” he said. “Both had active myocarditis.”

The study’s two non-COVID-19 control groups – elite athletes in one and nonathletes in the other – allowed them to tease out the potential contribution of athletic myocardial remodeling to CMR features that could be interpreted as scar tissue, which are characterized by late gadolinium enhancement (LGE).

As it turned out, focal regions of LGE located in the right ventricular (RV) septum on the scans were often seen in both athlete cohorts. “This kind of trivial nonischemic fibrosis in the mid RV septal insertion site was common among athletic control subjects. It was seen in 24% of them, which is almost identical to the percentage that we saw in the COVID-19 athletes, 22%,” Dr. Clark said.

The LGE finding, wrote Dr. Clark and coauthors, “may represent remodeling from athletic training, and should not be conflated with myocarditis.”

Of note, the other study saw a comparable incidence of the same or a very similar CMR feature in its athletes; 26% of the Wisconsin COVID-19 athlete cohort showed limited focal LGE in the inferior RV insertion site.

“And you get a little bit in the mid-septum, as well,” Dr. Reeder said. But the sign, in the absence of any corresponding T2 abnormalities, was not judged to represent myocarditis. “We interpreted all of these studies with this potential confounder in mind.”

Conceivably, Dr. Reeder proposed, the earlier studies may have “over-called” the prevalence of myocarditis in their cohorts. “I haven’t seen their images, but it’s possible there could be false-positives.”

It’s noteworthy that the Vanderbilt and Wisconsin reports saw closely similar incidences of the tell-tale CMR sign in all the athlete cohorts whether or not COVID-19 was involved, Aaron L. Baggish, MD, Massachusetts General Hospital, Boston, said in an interview.

“It looks very much like just an unrecognized part of athletic remodeling and isn’t in any way, shape, or form implicated as being a COVID-related issue,” said Dr. Baggish, who directs the cardiovascular performance program at his center and is unaffiliated with either study.

Still, that connection remains unproven given how little is yet known about the prevalence of clinically important myocarditis in milder cases of COVID-19, according to an accompanying editorial from Jonathan H. Kim, MD, MSc.

Although isolated LGE at the interventricular RV insertion site is “more commonly described among masters-level endurance athletes, the clinical significance and prevalence of this finding in youthful athletes is uncertain and should not be assumed to be a normal consequence of intense athletic training in young competitive athletes,” argued Dr. Kim, of Emory University, Atlanta.

There’s probably little about being a young competitive athlete that would render a person any more or less prone to COVID-19 cardiac involvement, Dr. Baggish said. Rather, “I think what we’re seeing, as the studies continue to come out, is that prevalence estimates are getting into the low single digits.”

The estimates are similar to those associated with influenza before the COVID-19 age; about 2% of patients showed cardiac involvement, Dr. Baggish said. “So the degree to which COVID is a special virus from this perspective, I think, is still a topic of some debate.”

The two current studies have limitations and neither is positioned to change practice, he said. “I would say that they are both kind of important, reassuring pieces of an unfinished jigsaw puzzle. But we still don’t know what the picture on the puzzle is.”
 

Routine CMR for positive cases

The University of Wisconsin group looked at all of the institution’s competitive athletes who underwent gadolinium-enhanced CMR imaging and other tests during recovery from COVID-19 from the beginning of the pandemic to the end of November 2020.

The imaging was performed on average about 2 weeks after a first positive SARS-CoV-2 assay result. About one-half and one-fourth of the cohort had experienced mild and moderate symptoms, respectively, and about 17% were asymptomatic; none had been hospitalized.

All CMR scans were reviewed by two experienced radiologists for, among other things, evidence of myocarditis according to modified Lake Louise criteria, the group wrote. Those criteria are based on CMR markers of fibrosis and other characteristics of scarring from myocarditis.

Such evidence was seen in only two members of the cohort, or 1.4%, one with elevated troponins but normal with respect to other biomarkers, and the other negative for all assays. Both were asymptomatic at the time of imaging, the report noted.

The Vanderbilt analysis from Dr. Clark and associates centered on 59 university athletes recently with COVID-19 who underwent CMR imaging along with other tests about 3 weeks after confirmation of SARS-CoV-2 infection. Symptoms had been mild in 78% of the group, and the remainder were asymptomatic.

They were compared with 60 retrospectively identified college athletes and elite-conditioned military personnel who had undergone CMR imaging prior to the advent of COVID-19, and to 27 apparently healthy nonathlete adults in whom CMR had been previously performed to define normal CMR imaging criteria at that center.

The only two post-COVID-19 athletes who met modified Lake Louise criteria for myocarditis showed no abnormalities on ECG or myocardial strain echocardiography, and had normal troponins, the group reported.

The COVID-19 athletes showed increased cardiac chamber volumes and myocardial mass “consistent with athletic remodeling,” compared with the healthy control subjects, the group wrote. But “most standard CMR parameters were similar” between the COVID-19 athletes and the control athletes, consistent with the 22% and 24% rates, respectively, for the finding of focal late LGE isolated to the inferoseptal RV insertion site.

At the end of the day, all published experiences on athletes with recent COVID-19 “are descriptive studies, without any hint of follow-up,” Dr. Baggish noted, so their clinical implications are unknown.

“We need time to sit and watch to see what happens to these individuals,” he said. “And if the answer is nothing, then that’s a very reassuring story. If the answer is that we start to see events, then that’s really important for us to take stock of.”

Dr. Starekova had no disclosures. Dr. Reeder reports that the University of Wisconsin receives research support from GE Healthcare and Bracco Diagnostics; and that he has ownership interests in Calimetrix, Reveal Pharmaceuticals, Cellectar Biosciences, Elucent Medical, and HeartVista; and has received grant support from Bayer Healthcare. Disclosures for the other coauthors are in the report. Dr. Clark and coauthors had no disclosures. Dr. Baggish reported no conflicts. Kim discloses receiving funding from the National Heart, Lung, and Blood Institute; compensation as team cardiologist for the Atlanta Falcons; and research stipends from the Atlanta Track Club.

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

The Step 2 Clinical Skills (CS) test for medical school students and graduates has been permanently canceled, cosponsors of the U.S. Medical Licensing Examination (USMLE) announced in a press release this afternoon.

As previously reported by this news organization, the USMLE cosponsors, the Federation of State Medical Boards and the National Board of Medical Examiners, had announced in May that they would take the following 12-18 months to revamp the required test.

COVID-19 had forced a suspension of the all-day test, which requires test takers to have physical contact with standardized patients. It’s designed to gauge how soon-to-be doctors gather information from patients, perform physical exams, and communicate their findings to patients and colleagues.

However, the cosponsors said today, “we have no plans to bring back Step 2 CS, but we intend to take this opportunity to focus on working with our colleagues in medical education and at the state medical boards to determine innovative ways to assess clinical skills.”

David Johnson, FSMB’s chief assessment officer, said in an interview that, after months of study, “it became clear that the relaunch of a modified Step 2 CS exam would not meet our expectations to be appreciably better than the prior exam.”
 

Only weeks ago, NBME was hiring for the revamp

The news came as a huge surprise. Just weeks earlier, NBME was advertising for a position key to modifying the exam. The description for the position read: “This role will focus on operational planning and coordination both within the NBME and with ECFMG [Educational Commission for Foreign Medical Graduates] to effectively deliver a modified Step 2 Clinical Skills exam.”

Bryan Carmody, MD, MPH, an assistant professor at Eastern Virginia Medical School, Norfolk, noted in a Jan. 15 tweet that the position requires extensive information technology experience, “suggesting plans for a virtual test remain intact.”

Dr. Johnson said that, although the opportunities for helping lead the revamp of the test were posted until the announcement, no one had been hired for the position.

Today’s announcement stated that the USMLE still believes independent standardized tests for medical knowledge and clinical skills are important; however, it now feels clinical reasoning and communication skills will be able to be assessed in other steps.

“Computer-based case simulations in Step 3 and communication content recently bolstered in Step 1 are examples of these efforts that will continue,” the press release stated. “While not a replacement for Step 2 CS, these formats continue to contribute positively, e.g., measuring critical knowledge of medical communication.”

Critics ‘thrilled’ by test termination

Lydia Flier, MD, from the department of internal medicine at Harvard Medical School, Boston – who wrote an editorial for this news organization in August 2020 advocating that Step 2 CS be changed completely or ended entirely – said in an interview that she was “surprised and thrilled” by the announcement.

She said the cosponsors hadn’t initially appeared to agree with the growing sentiment that disruption from the pandemic had “proven the test was unnecessary and it looked like they really were going to try and keep it.”

“I’m thrilled for future generations,” she said. “It is proof of what many people have known all along, which is that the test is a no-value-add proposition that did not actually help determine people’s clinical skills.”

The test “met a breaking point” during the pandemic, she said, “from which CS could not recover.”

She noted in her editorial that the test costs $1,300 plus travel fees, as the test had been offered at only five sites. She agreed that the skills assessed by the Step 2 CS are already covered in medical school and through other Steps.

“It seems as though they could not justify it anymore. It’s the obvious right answer,” said Dr. Flier, who in 2016 cofounded #EndStep2CS, a nationwide movement demanding an end to the exam.

Another cofounder in that movement, Christopher Henderson, MD, a staff physician with Kaiser Permanente in Seattle, said in an interview that “this decision represents tremendous progress in the fight to reduce unnecessary costs in medical education, and is a win for future students. Credit goes to the many women and men who organized and voiced their desire for change.” He added that his views are his own and “do not reflect or imply the views of my organization.”

For the FSMB’s part, Dr. Johnson acknowledged that “the consideration of cost and value were two of many important factors for the Step 2 CS revitalization work.”

Dr. Johnson, Dr. Flier, and Dr. Henderson have declared no relevant financial relationships.

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

The Step 2 Clinical Skills (CS) test for medical school students and graduates has been permanently canceled, cosponsors of the U.S. Medical Licensing Examination (USMLE) announced in a press release this afternoon.

As previously reported by this news organization, the USMLE cosponsors, the Federation of State Medical Boards and the National Board of Medical Examiners, had announced in May that they would take the following 12-18 months to revamp the required test.

COVID-19 had forced a suspension of the all-day test, which requires test takers to have physical contact with standardized patients. It’s designed to gauge how soon-to-be doctors gather information from patients, perform physical exams, and communicate their findings to patients and colleagues.

However, the cosponsors said today, “we have no plans to bring back Step 2 CS, but we intend to take this opportunity to focus on working with our colleagues in medical education and at the state medical boards to determine innovative ways to assess clinical skills.”

David Johnson, FSMB’s chief assessment officer, said in an interview that, after months of study, “it became clear that the relaunch of a modified Step 2 CS exam would not meet our expectations to be appreciably better than the prior exam.”
 

Only weeks ago, NBME was hiring for the revamp

The news came as a huge surprise. Just weeks earlier, NBME was advertising for a position key to modifying the exam. The description for the position read: “This role will focus on operational planning and coordination both within the NBME and with ECFMG [Educational Commission for Foreign Medical Graduates] to effectively deliver a modified Step 2 Clinical Skills exam.”

Bryan Carmody, MD, MPH, an assistant professor at Eastern Virginia Medical School, Norfolk, noted in a Jan. 15 tweet that the position requires extensive information technology experience, “suggesting plans for a virtual test remain intact.”

Dr. Johnson said that, although the opportunities for helping lead the revamp of the test were posted until the announcement, no one had been hired for the position.

Today’s announcement stated that the USMLE still believes independent standardized tests for medical knowledge and clinical skills are important; however, it now feels clinical reasoning and communication skills will be able to be assessed in other steps.

“Computer-based case simulations in Step 3 and communication content recently bolstered in Step 1 are examples of these efforts that will continue,” the press release stated. “While not a replacement for Step 2 CS, these formats continue to contribute positively, e.g., measuring critical knowledge of medical communication.”

Critics ‘thrilled’ by test termination

Lydia Flier, MD, from the department of internal medicine at Harvard Medical School, Boston – who wrote an editorial for this news organization in August 2020 advocating that Step 2 CS be changed completely or ended entirely – said in an interview that she was “surprised and thrilled” by the announcement.

She said the cosponsors hadn’t initially appeared to agree with the growing sentiment that disruption from the pandemic had “proven the test was unnecessary and it looked like they really were going to try and keep it.”

“I’m thrilled for future generations,” she said. “It is proof of what many people have known all along, which is that the test is a no-value-add proposition that did not actually help determine people’s clinical skills.”

The test “met a breaking point” during the pandemic, she said, “from which CS could not recover.”

She noted in her editorial that the test costs $1,300 plus travel fees, as the test had been offered at only five sites. She agreed that the skills assessed by the Step 2 CS are already covered in medical school and through other Steps.

“It seems as though they could not justify it anymore. It’s the obvious right answer,” said Dr. Flier, who in 2016 cofounded #EndStep2CS, a nationwide movement demanding an end to the exam.

Another cofounder in that movement, Christopher Henderson, MD, a staff physician with Kaiser Permanente in Seattle, said in an interview that “this decision represents tremendous progress in the fight to reduce unnecessary costs in medical education, and is a win for future students. Credit goes to the many women and men who organized and voiced their desire for change.” He added that his views are his own and “do not reflect or imply the views of my organization.”

For the FSMB’s part, Dr. Johnson acknowledged that “the consideration of cost and value were two of many important factors for the Step 2 CS revitalization work.”

Dr. Johnson, Dr. Flier, and Dr. Henderson have declared no relevant financial relationships.

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

The Step 2 Clinical Skills (CS) test for medical school students and graduates has been permanently canceled, cosponsors of the U.S. Medical Licensing Examination (USMLE) announced in a press release this afternoon.

As previously reported by this news organization, the USMLE cosponsors, the Federation of State Medical Boards and the National Board of Medical Examiners, had announced in May that they would take the following 12-18 months to revamp the required test.

COVID-19 had forced a suspension of the all-day test, which requires test takers to have physical contact with standardized patients. It’s designed to gauge how soon-to-be doctors gather information from patients, perform physical exams, and communicate their findings to patients and colleagues.

However, the cosponsors said today, “we have no plans to bring back Step 2 CS, but we intend to take this opportunity to focus on working with our colleagues in medical education and at the state medical boards to determine innovative ways to assess clinical skills.”

David Johnson, FSMB’s chief assessment officer, said in an interview that, after months of study, “it became clear that the relaunch of a modified Step 2 CS exam would not meet our expectations to be appreciably better than the prior exam.”
 

Only weeks ago, NBME was hiring for the revamp

The news came as a huge surprise. Just weeks earlier, NBME was advertising for a position key to modifying the exam. The description for the position read: “This role will focus on operational planning and coordination both within the NBME and with ECFMG [Educational Commission for Foreign Medical Graduates] to effectively deliver a modified Step 2 Clinical Skills exam.”

Bryan Carmody, MD, MPH, an assistant professor at Eastern Virginia Medical School, Norfolk, noted in a Jan. 15 tweet that the position requires extensive information technology experience, “suggesting plans for a virtual test remain intact.”

Dr. Johnson said that, although the opportunities for helping lead the revamp of the test were posted until the announcement, no one had been hired for the position.

Today’s announcement stated that the USMLE still believes independent standardized tests for medical knowledge and clinical skills are important; however, it now feels clinical reasoning and communication skills will be able to be assessed in other steps.

“Computer-based case simulations in Step 3 and communication content recently bolstered in Step 1 are examples of these efforts that will continue,” the press release stated. “While not a replacement for Step 2 CS, these formats continue to contribute positively, e.g., measuring critical knowledge of medical communication.”

Critics ‘thrilled’ by test termination

Lydia Flier, MD, from the department of internal medicine at Harvard Medical School, Boston – who wrote an editorial for this news organization in August 2020 advocating that Step 2 CS be changed completely or ended entirely – said in an interview that she was “surprised and thrilled” by the announcement.

She said the cosponsors hadn’t initially appeared to agree with the growing sentiment that disruption from the pandemic had “proven the test was unnecessary and it looked like they really were going to try and keep it.”

“I’m thrilled for future generations,” she said. “It is proof of what many people have known all along, which is that the test is a no-value-add proposition that did not actually help determine people’s clinical skills.”

The test “met a breaking point” during the pandemic, she said, “from which CS could not recover.”

She noted in her editorial that the test costs $1,300 plus travel fees, as the test had been offered at only five sites. She agreed that the skills assessed by the Step 2 CS are already covered in medical school and through other Steps.

“It seems as though they could not justify it anymore. It’s the obvious right answer,” said Dr. Flier, who in 2016 cofounded #EndStep2CS, a nationwide movement demanding an end to the exam.

Another cofounder in that movement, Christopher Henderson, MD, a staff physician with Kaiser Permanente in Seattle, said in an interview that “this decision represents tremendous progress in the fight to reduce unnecessary costs in medical education, and is a win for future students. Credit goes to the many women and men who organized and voiced their desire for change.” He added that his views are his own and “do not reflect or imply the views of my organization.”

For the FSMB’s part, Dr. Johnson acknowledged that “the consideration of cost and value were two of many important factors for the Step 2 CS revitalization work.”

Dr. Johnson, Dr. Flier, and Dr. Henderson have declared no relevant financial relationships.

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