Clinical Endocrinology News

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

mlesney@mdedge.com

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

mlesney@mdedge.com

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

mlesney@mdedge.com

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.
 

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.
 

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.
 

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

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

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

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

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

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

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at pdnews@mdedge.com.

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at pdnews@mdedge.com.

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at pdnews@mdedge.com.

It was no surprise that updated guidelines recently published by the European Society of Cardiology for managing cardiovascular disease in patients with diabetes highlighted optimized treatment from a cardiovascular disease perspective, while a nearly concurrent update from two major diabetes societies saw the same issue from a more glycemic point of view.

This difference led to divergent approaches to managing hyperglycemia in patients with type 2 diabetes (T2D). The two diabetes societies that wrote one set of recommendations, the American Diabetes Association and the European Association for the Study of Diabetes, put metformin at the pinnacle of their drug hierarchy. Patients with T2D and established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure should all receive metformin first unless contraindicated or not tolerated, their updated consensus report said.

Once metformin is on board, a clinician can then add a second diabetes agent from among the two drug classes recently proven to also reduce cardiovascular and renal events, either the SGLT2 (sodium-glucose transporter 2) inhibitors, or GLP-1 (glucagonlike peptide–1) receptor agonists, they advised.
 

Cardiovascular disease focus represents a ‘major paradigm shift’

In contrast, the ESC guidelines called for upfront, systematic assessment of CVD risk in patients with T2D before treatment starts, and for patients in high- or very high–risk strata, the guidelines recommended starting the patient first on an SGLT2 inhibitor or a GLP-1 receptor agonist, and only adding metformin in patients who need additional glycemic control.

The guidelines also recommended starting treatment-naive patients with moderate CVD risk on metformin. For patients already on metformin, the new ESC guidelines called for adding an agent from at least one of these two drug classes with proven CVD benefits for those at high or very high CVD risk. The guidelines also note that the CVD benefits of the two newer drug classes differ and hence require further individualization depending on the risks faced by each patient, such as the risk for heart failure hospitalizations.

It’s an approach “driven by data from the cardiovascular outcome trials,” that showed several drugs from both the SGLT2 inhibitor and GLP-1 receptor agonist classes have substantial benefit for preventing cardiovascular events, renal events, hospitalizations for heart failure, and in some studies all-cause mortality, said Francesco Cosentino, MD, during a discussion of the guideline differences at the virtual annual meeting of the European Association for the Study of Diabetes.

The ESC approach also represents “a major paradigm shift,” a “change from a glucose-centric approach to an approach driven by cardiovascular disease events,” summed up Dr. Cosentino, professor of cardiology at the Karolinska Institute in Stockholm and chair of the task force that wrote the ESC’s 2019 updated guidelines. The ESC approach advocates initiating drugs for treating patients with T2D “based on cardiovascular disease risk classification,” he highlighted. Results from some SGLT2 inhibitor cardiovascular outcome trials showed that the CVD benefit was similar regardless of whether or not patients also received metformin.

ADA, EASD call for ‘a different emphasis’

“There is a different emphasis” in the statement issued by the diabetologists of the ADA and EASD, admitted Peter J. Grant, MD, a professor of diabetes and endocrinology at the University of Leeds (England) and cochair of the ESC guidelines task force. Dr. Grant represented the EASD on the task force, and the Association collaborated with the ESC in producing its guidelines.

“The ADA and EASD recommendations “look primarily at glucose control, with cardiovascular disease management as secondary.” In contrast, the ESC guidelines “are primarily cardiovascular disease risk guidelines, with a glucose interest,” Dr. Grant declared.

Despite his involvement in writing the ESC guidelines, Dr. Grant tilted toward the ADA/EASD statement as more globally relevant.

“There is much more to vasculopathy in diabetes than just macrovascular disease. Many patients with type 2 diabetes without macrovascular complications have microvascular disease,” including the potential for retinopathy, nephropathy, and neuropathy, he said. These complications can also have a strong impact on psychological well being and treatment satisfaction.

“It’s important that we’re not glucocentric any more, but it’s equally important that we treat glucose because it has such a benefit for microvascular disease.” Dr. Grant also cited metformin’s long history of safety and good tolerance, clinician comfort prescribing it, and its low price. Heavier reliance on SGLT2 inhibitors and GLP-1 receptor agonists will be expensive for the short term while the cost of these drugs remains high, which places a higher burden on “knowing we’re doing it right,” said Dr. Grant.

Dr. Cosentino pointed out that the higher cost of the drugs in the two classes shown to exert important cardiovascular and renal effects needs to be considered in a cost-effectiveness context, not just by cost alone.
 

‘Clinical inertia’ could be a danger

Dr. Cosentino played down a major disagreement between the two guidelines, suggesting that “focusing on the differences leads to clinical inertia” by the practicing community when they are unsure how to reconcile the two positions.

Dr. Grant agreed that adding a second drug to metformin right away made sense in at least selected patients. “Look at each patient and decide whether they need glycemic control. If so, and if they also have cardiovascular disease, use both drugs,” metformin, plus one agent from one of the two newer classes.

Something both experts agreed on is that it’s time to generally steer clear of sulfonylurea drugs. “We have evidence for harmful effects from sulfonylureas,” Dr. Cosentino said.

“I’d dump sulfonylureas,” was Dr. Grant’s assessment, but he added that they still have a role for patients who need additional glycemic control but can’t afford the newer drugs.

Dr. Cosentino has had financial relationships with Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Mundipharma, Novo Nordisk, and Pfizer, Dr. Grant has lectured on behalf of AstraZeneca, GlaxoSmithKline, Merck, Novo Nordisk, the Medicines Company, and Takeda, and he has been an adviser to Amgen, AstraZeneca, Novartis, Novo Nordisk, and Synexus.

mzoler@mdedge.com

It was no surprise that updated guidelines recently published by the European Society of Cardiology for managing cardiovascular disease in patients with diabetes highlighted optimized treatment from a cardiovascular disease perspective, while a nearly concurrent update from two major diabetes societies saw the same issue from a more glycemic point of view.

This difference led to divergent approaches to managing hyperglycemia in patients with type 2 diabetes (T2D). The two diabetes societies that wrote one set of recommendations, the American Diabetes Association and the European Association for the Study of Diabetes, put metformin at the pinnacle of their drug hierarchy. Patients with T2D and established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure should all receive metformin first unless contraindicated or not tolerated, their updated consensus report said.

Once metformin is on board, a clinician can then add a second diabetes agent from among the two drug classes recently proven to also reduce cardiovascular and renal events, either the SGLT2 (sodium-glucose transporter 2) inhibitors, or GLP-1 (glucagonlike peptide–1) receptor agonists, they advised.
 

Cardiovascular disease focus represents a ‘major paradigm shift’

In contrast, the ESC guidelines called for upfront, systematic assessment of CVD risk in patients with T2D before treatment starts, and for patients in high- or very high–risk strata, the guidelines recommended starting the patient first on an SGLT2 inhibitor or a GLP-1 receptor agonist, and only adding metformin in patients who need additional glycemic control.

The guidelines also recommended starting treatment-naive patients with moderate CVD risk on metformin. For patients already on metformin, the new ESC guidelines called for adding an agent from at least one of these two drug classes with proven CVD benefits for those at high or very high CVD risk. The guidelines also note that the CVD benefits of the two newer drug classes differ and hence require further individualization depending on the risks faced by each patient, such as the risk for heart failure hospitalizations.

It’s an approach “driven by data from the cardiovascular outcome trials,” that showed several drugs from both the SGLT2 inhibitor and GLP-1 receptor agonist classes have substantial benefit for preventing cardiovascular events, renal events, hospitalizations for heart failure, and in some studies all-cause mortality, said Francesco Cosentino, MD, during a discussion of the guideline differences at the virtual annual meeting of the European Association for the Study of Diabetes.

The ESC approach also represents “a major paradigm shift,” a “change from a glucose-centric approach to an approach driven by cardiovascular disease events,” summed up Dr. Cosentino, professor of cardiology at the Karolinska Institute in Stockholm and chair of the task force that wrote the ESC’s 2019 updated guidelines. The ESC approach advocates initiating drugs for treating patients with T2D “based on cardiovascular disease risk classification,” he highlighted. Results from some SGLT2 inhibitor cardiovascular outcome trials showed that the CVD benefit was similar regardless of whether or not patients also received metformin.

ADA, EASD call for ‘a different emphasis’

“There is a different emphasis” in the statement issued by the diabetologists of the ADA and EASD, admitted Peter J. Grant, MD, a professor of diabetes and endocrinology at the University of Leeds (England) and cochair of the ESC guidelines task force. Dr. Grant represented the EASD on the task force, and the Association collaborated with the ESC in producing its guidelines.

“The ADA and EASD recommendations “look primarily at glucose control, with cardiovascular disease management as secondary.” In contrast, the ESC guidelines “are primarily cardiovascular disease risk guidelines, with a glucose interest,” Dr. Grant declared.

Despite his involvement in writing the ESC guidelines, Dr. Grant tilted toward the ADA/EASD statement as more globally relevant.

“There is much more to vasculopathy in diabetes than just macrovascular disease. Many patients with type 2 diabetes without macrovascular complications have microvascular disease,” including the potential for retinopathy, nephropathy, and neuropathy, he said. These complications can also have a strong impact on psychological well being and treatment satisfaction.

“It’s important that we’re not glucocentric any more, but it’s equally important that we treat glucose because it has such a benefit for microvascular disease.” Dr. Grant also cited metformin’s long history of safety and good tolerance, clinician comfort prescribing it, and its low price. Heavier reliance on SGLT2 inhibitors and GLP-1 receptor agonists will be expensive for the short term while the cost of these drugs remains high, which places a higher burden on “knowing we’re doing it right,” said Dr. Grant.

Dr. Cosentino pointed out that the higher cost of the drugs in the two classes shown to exert important cardiovascular and renal effects needs to be considered in a cost-effectiveness context, not just by cost alone.
 

‘Clinical inertia’ could be a danger

Dr. Cosentino played down a major disagreement between the two guidelines, suggesting that “focusing on the differences leads to clinical inertia” by the practicing community when they are unsure how to reconcile the two positions.

Dr. Grant agreed that adding a second drug to metformin right away made sense in at least selected patients. “Look at each patient and decide whether they need glycemic control. If so, and if they also have cardiovascular disease, use both drugs,” metformin, plus one agent from one of the two newer classes.

Something both experts agreed on is that it’s time to generally steer clear of sulfonylurea drugs. “We have evidence for harmful effects from sulfonylureas,” Dr. Cosentino said.

“I’d dump sulfonylureas,” was Dr. Grant’s assessment, but he added that they still have a role for patients who need additional glycemic control but can’t afford the newer drugs.

Dr. Cosentino has had financial relationships with Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Mundipharma, Novo Nordisk, and Pfizer, Dr. Grant has lectured on behalf of AstraZeneca, GlaxoSmithKline, Merck, Novo Nordisk, the Medicines Company, and Takeda, and he has been an adviser to Amgen, AstraZeneca, Novartis, Novo Nordisk, and Synexus.

mzoler@mdedge.com

It was no surprise that updated guidelines recently published by the European Society of Cardiology for managing cardiovascular disease in patients with diabetes highlighted optimized treatment from a cardiovascular disease perspective, while a nearly concurrent update from two major diabetes societies saw the same issue from a more glycemic point of view.

This difference led to divergent approaches to managing hyperglycemia in patients with type 2 diabetes (T2D). The two diabetes societies that wrote one set of recommendations, the American Diabetes Association and the European Association for the Study of Diabetes, put metformin at the pinnacle of their drug hierarchy. Patients with T2D and established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure should all receive metformin first unless contraindicated or not tolerated, their updated consensus report said.

Once metformin is on board, a clinician can then add a second diabetes agent from among the two drug classes recently proven to also reduce cardiovascular and renal events, either the SGLT2 (sodium-glucose transporter 2) inhibitors, or GLP-1 (glucagonlike peptide–1) receptor agonists, they advised.
 

Cardiovascular disease focus represents a ‘major paradigm shift’

In contrast, the ESC guidelines called for upfront, systematic assessment of CVD risk in patients with T2D before treatment starts, and for patients in high- or very high–risk strata, the guidelines recommended starting the patient first on an SGLT2 inhibitor or a GLP-1 receptor agonist, and only adding metformin in patients who need additional glycemic control.

The guidelines also recommended starting treatment-naive patients with moderate CVD risk on metformin. For patients already on metformin, the new ESC guidelines called for adding an agent from at least one of these two drug classes with proven CVD benefits for those at high or very high CVD risk. The guidelines also note that the CVD benefits of the two newer drug classes differ and hence require further individualization depending on the risks faced by each patient, such as the risk for heart failure hospitalizations.

It’s an approach “driven by data from the cardiovascular outcome trials,” that showed several drugs from both the SGLT2 inhibitor and GLP-1 receptor agonist classes have substantial benefit for preventing cardiovascular events, renal events, hospitalizations for heart failure, and in some studies all-cause mortality, said Francesco Cosentino, MD, during a discussion of the guideline differences at the virtual annual meeting of the European Association for the Study of Diabetes.

The ESC approach also represents “a major paradigm shift,” a “change from a glucose-centric approach to an approach driven by cardiovascular disease events,” summed up Dr. Cosentino, professor of cardiology at the Karolinska Institute in Stockholm and chair of the task force that wrote the ESC’s 2019 updated guidelines. The ESC approach advocates initiating drugs for treating patients with T2D “based on cardiovascular disease risk classification,” he highlighted. Results from some SGLT2 inhibitor cardiovascular outcome trials showed that the CVD benefit was similar regardless of whether or not patients also received metformin.

ADA, EASD call for ‘a different emphasis’

“There is a different emphasis” in the statement issued by the diabetologists of the ADA and EASD, admitted Peter J. Grant, MD, a professor of diabetes and endocrinology at the University of Leeds (England) and cochair of the ESC guidelines task force. Dr. Grant represented the EASD on the task force, and the Association collaborated with the ESC in producing its guidelines.

“The ADA and EASD recommendations “look primarily at glucose control, with cardiovascular disease management as secondary.” In contrast, the ESC guidelines “are primarily cardiovascular disease risk guidelines, with a glucose interest,” Dr. Grant declared.

Despite his involvement in writing the ESC guidelines, Dr. Grant tilted toward the ADA/EASD statement as more globally relevant.

“There is much more to vasculopathy in diabetes than just macrovascular disease. Many patients with type 2 diabetes without macrovascular complications have microvascular disease,” including the potential for retinopathy, nephropathy, and neuropathy, he said. These complications can also have a strong impact on psychological well being and treatment satisfaction.

“It’s important that we’re not glucocentric any more, but it’s equally important that we treat glucose because it has such a benefit for microvascular disease.” Dr. Grant also cited metformin’s long history of safety and good tolerance, clinician comfort prescribing it, and its low price. Heavier reliance on SGLT2 inhibitors and GLP-1 receptor agonists will be expensive for the short term while the cost of these drugs remains high, which places a higher burden on “knowing we’re doing it right,” said Dr. Grant.

Dr. Cosentino pointed out that the higher cost of the drugs in the two classes shown to exert important cardiovascular and renal effects needs to be considered in a cost-effectiveness context, not just by cost alone.
 

‘Clinical inertia’ could be a danger

Dr. Cosentino played down a major disagreement between the two guidelines, suggesting that “focusing on the differences leads to clinical inertia” by the practicing community when they are unsure how to reconcile the two positions.

Dr. Grant agreed that adding a second drug to metformin right away made sense in at least selected patients. “Look at each patient and decide whether they need glycemic control. If so, and if they also have cardiovascular disease, use both drugs,” metformin, plus one agent from one of the two newer classes.

Something both experts agreed on is that it’s time to generally steer clear of sulfonylurea drugs. “We have evidence for harmful effects from sulfonylureas,” Dr. Cosentino said.

“I’d dump sulfonylureas,” was Dr. Grant’s assessment, but he added that they still have a role for patients who need additional glycemic control but can’t afford the newer drugs.

Dr. Cosentino has had financial relationships with Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Mundipharma, Novo Nordisk, and Pfizer, Dr. Grant has lectured on behalf of AstraZeneca, GlaxoSmithKline, Merck, Novo Nordisk, the Medicines Company, and Takeda, and he has been an adviser to Amgen, AstraZeneca, Novartis, Novo Nordisk, and Synexus.

mzoler@mdedge.com

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

At a time when new evidence strongly suggests that roughly a fifth of patents with hypertension have primary aldosteronism as the cause, other recent findings suggest that many of these possibly tens of millions of patients with aldosterone-driven high blood pressure may as a consequence need an expensive and not-widely-available diagnostic test – adrenal vein sampling – to determine whether they are candidates for a definitive surgical cure to their aldosteronism.

SciePro/Shutterstock

Some endocrinologists worry the worldwide infrastructure for running adrenal vein sampling (AVS) isn’t close to being in place to deliver on this looming need for patients with primary aldosteronism (PA), especially given the burgeoning numbers now being cited for PA prevalence.

“The system could be overwhelmed,” warned Robert M. Carey, MD, a cardiovascular endocrinologist and professor of medicine at the University of Virginia in Charlottesville. “Right now, adrenal vein sampling [AVS] is the gold standard,” for distinguishing unilateral and bilateral excess aldosterone secretion, “but not every radiologist can do AVS. Until we find a surrogate biomarker that can distinguish unilateral and bilateral PA” many patients will need AVS, Dr. Carey said in an interview.

“AVS is important for accurate lateralization of aldosterone excess in patients, but it may not be feasible for all patients with PA to undergo AVS. If the prevalence of PA truly is on the order of 15% [of all patients with hypertension] then health systems would be stretched to offer all of them AVS, which is technically challenging and requires dedicated training and is therefore limited to expert centers,” commented Jun Yang, MBBS, a cardiovascular endocrinologist at the Hudson Institute of Medical Research and a hypertension researcher at Monash University, both in Melbourne. “At Monash, our interventional radiologists have increased their [AVS] success rate from 40% to more than 90% during the past 10 years, and our waiting list for patients scheduled for AVS is now 3-4 months long,” Dr. Yang said in an interview.

Finding a unilateral adrenal nodule as the cause of PA means that surgical removal is an option, a step that often fully resolves the PA and normalizes blood pressure. Patients with a bilateral source of the aldosterone are not candidates for surgical cure and must be managed with medical treatment, usually a mineralocorticoid receptor antagonist such as spironolactone that can neutralize or at least reduce the impact of hyperaldosteronism.
 

AVS finds unilateral adenomas when imaging can’t

The evidence that raised concerns about the reliability of imaging as an easier and noninvasive means to identify hypertensive patients with PA and a unilateral adrenal nodule that makes them candidates for surgical removal to resolve their PA and hypertension came out in May 2020 in a review of 174 PA patients who underwent AVS at a single center in Calgary, Alta., during 2006-2018.

The review included 366 patients with PA referred to the University of Calgary for assessment, of whom 179 had no adrenal nodule visible with either CT or MRI imaging, with 174 of these patients also undergoing successful AVS. The procedure revealed 70 patients (40%) had unilateral aldosterone secretion (Can J Cardiol. 2020 May 16. doi: 10.1016/j.cjca.2020.05.013).

In an editorial about this report that appeared a few weeks later, Ross D. Feldman, MD, a hypertension-management researcher and professor of medicine at the University of Manitoba in Winnipeg, Man., said the finding was “amazing,” and “confirms that lateralization of aldosterone secretion in a patient with PA but without an identifiable mass on that side is not a zebra,” but instead a presentation that “occurs in almost half of patients with PA and no discernible adenoma on the side that lateralizes.” (Can J. Cardiol. 2020 Jul 3. doi: 10.1016/j.cjca.2020.06.022).

Although this was just one center’s experience, the authors are not alone in making this finding, although prior reports seem to have been largely forgotten or ignored until now.

“The discordance between AVS and adrenal imaging has been documented by numerous groups, and in our own experience [in Melbourne] around 40% of patients with unilateral aldosterone excess do not have a distinct unilateral adenoma on CT,” said Dr. Yang.

“Here’s the problem,” summed up Dr. Feldman in an interview. “Nearly half of patients with hyperaldosteronism don’t localize based on a CT or MRI, so you have to do AVS, but AVS is not generally available; it’s only at tertiary centers; and you have to do a lot of them,” to do them well. “It’s a half-day procedure, and you have to hit the correct adrenal vein.”
 

AVS for millions?

Compounding the challenge is the other bit of bombshell news recently dropped on the endocrinology and hypertension communities: PA may be much more prevalent that previously suspected, occurring in roughly 20% of patients with hypertension, according to study results that also came out in 2020 (Ann Int Med. 2020 Jul 7;173[1]:10-20).

The upshot, according to Dr. Feldman and others, is that researchers will need to find reliable criteria besides imaging for identifying PA patients with an increased likelihood of having a lateralized source for their excess aldosterone production. That’s “the only hope,” said Dr. Feldman, “so we won’t have to do AVS on 20 million Americans.”

Unfortunately, the path toward a successful screen to winnow down candidates for AVS has been long and not especially fruitful, with efforts dating back at least 50 years, and with one of the most recent efforts at stratifying PA patients by certain laboratory measures getting dismissed as producing a benefit that “might not be substantial,” wrote Michael Stowasser, MBBS, in a published commentary (J Hypertension. 2020 Jul;38[7]:1259-61).

In contrast to Dr. Feldman, Dr. Stowasser was more optimistic about the prospects for avoiding an immediate crisis in AVS assessment of PA patients, mostly because so few patients with PA are now identified by clinicians. Given the poor record clinicians have historically rung up diagnosing PA, “it would seem unlikely that we are going to be flooded with AVS requests any time soon,” he wrote. There is also reason to hope that increased demand for AVS will help broaden availability, and innovative testing methods promise to speed up the procedure, said Dr. Stowasser, a professor of medicine at the University of Queensland in Brisbane, Australia and director of the Endocrine Hypertension Research Centre at Greenslopes and Princess Alexandra Hospitals in Brisbane, in an interview.

But regardless of whether AVS testing becomes more available or streamlined, recent events suggest there will be little way to avoid eventually having to run millions of these diagnostic procedures.

Patients with PA “who decide they will not want surgery do not need AVS. For all other patients with PA, you need AVS. The medical system will just have to respond,” Dr. Carey concluded.

Dr. Carey, Dr. Yang, Dr. Feldman, and Dr. Stowasser had no relevant disclosures.

mzoler@mdedge.com

At a time when new evidence strongly suggests that roughly a fifth of patents with hypertension have primary aldosteronism as the cause, other recent findings suggest that many of these possibly tens of millions of patients with aldosterone-driven high blood pressure may as a consequence need an expensive and not-widely-available diagnostic test – adrenal vein sampling – to determine whether they are candidates for a definitive surgical cure to their aldosteronism.

SciePro/Shutterstock

Some endocrinologists worry the worldwide infrastructure for running adrenal vein sampling (AVS) isn’t close to being in place to deliver on this looming need for patients with primary aldosteronism (PA), especially given the burgeoning numbers now being cited for PA prevalence.

“The system could be overwhelmed,” warned Robert M. Carey, MD, a cardiovascular endocrinologist and professor of medicine at the University of Virginia in Charlottesville. “Right now, adrenal vein sampling [AVS] is the gold standard,” for distinguishing unilateral and bilateral excess aldosterone secretion, “but not every radiologist can do AVS. Until we find a surrogate biomarker that can distinguish unilateral and bilateral PA” many patients will need AVS, Dr. Carey said in an interview.

“AVS is important for accurate lateralization of aldosterone excess in patients, but it may not be feasible for all patients with PA to undergo AVS. If the prevalence of PA truly is on the order of 15% [of all patients with hypertension] then health systems would be stretched to offer all of them AVS, which is technically challenging and requires dedicated training and is therefore limited to expert centers,” commented Jun Yang, MBBS, a cardiovascular endocrinologist at the Hudson Institute of Medical Research and a hypertension researcher at Monash University, both in Melbourne. “At Monash, our interventional radiologists have increased their [AVS] success rate from 40% to more than 90% during the past 10 years, and our waiting list for patients scheduled for AVS is now 3-4 months long,” Dr. Yang said in an interview.

Finding a unilateral adrenal nodule as the cause of PA means that surgical removal is an option, a step that often fully resolves the PA and normalizes blood pressure. Patients with a bilateral source of the aldosterone are not candidates for surgical cure and must be managed with medical treatment, usually a mineralocorticoid receptor antagonist such as spironolactone that can neutralize or at least reduce the impact of hyperaldosteronism.
 

AVS finds unilateral adenomas when imaging can’t

The evidence that raised concerns about the reliability of imaging as an easier and noninvasive means to identify hypertensive patients with PA and a unilateral adrenal nodule that makes them candidates for surgical removal to resolve their PA and hypertension came out in May 2020 in a review of 174 PA patients who underwent AVS at a single center in Calgary, Alta., during 2006-2018.

The review included 366 patients with PA referred to the University of Calgary for assessment, of whom 179 had no adrenal nodule visible with either CT or MRI imaging, with 174 of these patients also undergoing successful AVS. The procedure revealed 70 patients (40%) had unilateral aldosterone secretion (Can J Cardiol. 2020 May 16. doi: 10.1016/j.cjca.2020.05.013).

In an editorial about this report that appeared a few weeks later, Ross D. Feldman, MD, a hypertension-management researcher and professor of medicine at the University of Manitoba in Winnipeg, Man., said the finding was “amazing,” and “confirms that lateralization of aldosterone secretion in a patient with PA but without an identifiable mass on that side is not a zebra,” but instead a presentation that “occurs in almost half of patients with PA and no discernible adenoma on the side that lateralizes.” (Can J. Cardiol. 2020 Jul 3. doi: 10.1016/j.cjca.2020.06.022).

Although this was just one center’s experience, the authors are not alone in making this finding, although prior reports seem to have been largely forgotten or ignored until now.

“The discordance between AVS and adrenal imaging has been documented by numerous groups, and in our own experience [in Melbourne] around 40% of patients with unilateral aldosterone excess do not have a distinct unilateral adenoma on CT,” said Dr. Yang.

“Here’s the problem,” summed up Dr. Feldman in an interview. “Nearly half of patients with hyperaldosteronism don’t localize based on a CT or MRI, so you have to do AVS, but AVS is not generally available; it’s only at tertiary centers; and you have to do a lot of them,” to do them well. “It’s a half-day procedure, and you have to hit the correct adrenal vein.”
 

AVS for millions?

Compounding the challenge is the other bit of bombshell news recently dropped on the endocrinology and hypertension communities: PA may be much more prevalent that previously suspected, occurring in roughly 20% of patients with hypertension, according to study results that also came out in 2020 (Ann Int Med. 2020 Jul 7;173[1]:10-20).

The upshot, according to Dr. Feldman and others, is that researchers will need to find reliable criteria besides imaging for identifying PA patients with an increased likelihood of having a lateralized source for their excess aldosterone production. That’s “the only hope,” said Dr. Feldman, “so we won’t have to do AVS on 20 million Americans.”

Unfortunately, the path toward a successful screen to winnow down candidates for AVS has been long and not especially fruitful, with efforts dating back at least 50 years, and with one of the most recent efforts at stratifying PA patients by certain laboratory measures getting dismissed as producing a benefit that “might not be substantial,” wrote Michael Stowasser, MBBS, in a published commentary (J Hypertension. 2020 Jul;38[7]:1259-61).

In contrast to Dr. Feldman, Dr. Stowasser was more optimistic about the prospects for avoiding an immediate crisis in AVS assessment of PA patients, mostly because so few patients with PA are now identified by clinicians. Given the poor record clinicians have historically rung up diagnosing PA, “it would seem unlikely that we are going to be flooded with AVS requests any time soon,” he wrote. There is also reason to hope that increased demand for AVS will help broaden availability, and innovative testing methods promise to speed up the procedure, said Dr. Stowasser, a professor of medicine at the University of Queensland in Brisbane, Australia and director of the Endocrine Hypertension Research Centre at Greenslopes and Princess Alexandra Hospitals in Brisbane, in an interview.

But regardless of whether AVS testing becomes more available or streamlined, recent events suggest there will be little way to avoid eventually having to run millions of these diagnostic procedures.

Patients with PA “who decide they will not want surgery do not need AVS. For all other patients with PA, you need AVS. The medical system will just have to respond,” Dr. Carey concluded.

Dr. Carey, Dr. Yang, Dr. Feldman, and Dr. Stowasser had no relevant disclosures.

mzoler@mdedge.com

At a time when new evidence strongly suggests that roughly a fifth of patents with hypertension have primary aldosteronism as the cause, other recent findings suggest that many of these possibly tens of millions of patients with aldosterone-driven high blood pressure may as a consequence need an expensive and not-widely-available diagnostic test – adrenal vein sampling – to determine whether they are candidates for a definitive surgical cure to their aldosteronism.

SciePro/Shutterstock

Some endocrinologists worry the worldwide infrastructure for running adrenal vein sampling (AVS) isn’t close to being in place to deliver on this looming need for patients with primary aldosteronism (PA), especially given the burgeoning numbers now being cited for PA prevalence.

“The system could be overwhelmed,” warned Robert M. Carey, MD, a cardiovascular endocrinologist and professor of medicine at the University of Virginia in Charlottesville. “Right now, adrenal vein sampling [AVS] is the gold standard,” for distinguishing unilateral and bilateral excess aldosterone secretion, “but not every radiologist can do AVS. Until we find a surrogate biomarker that can distinguish unilateral and bilateral PA” many patients will need AVS, Dr. Carey said in an interview.

“AVS is important for accurate lateralization of aldosterone excess in patients, but it may not be feasible for all patients with PA to undergo AVS. If the prevalence of PA truly is on the order of 15% [of all patients with hypertension] then health systems would be stretched to offer all of them AVS, which is technically challenging and requires dedicated training and is therefore limited to expert centers,” commented Jun Yang, MBBS, a cardiovascular endocrinologist at the Hudson Institute of Medical Research and a hypertension researcher at Monash University, both in Melbourne. “At Monash, our interventional radiologists have increased their [AVS] success rate from 40% to more than 90% during the past 10 years, and our waiting list for patients scheduled for AVS is now 3-4 months long,” Dr. Yang said in an interview.

Finding a unilateral adrenal nodule as the cause of PA means that surgical removal is an option, a step that often fully resolves the PA and normalizes blood pressure. Patients with a bilateral source of the aldosterone are not candidates for surgical cure and must be managed with medical treatment, usually a mineralocorticoid receptor antagonist such as spironolactone that can neutralize or at least reduce the impact of hyperaldosteronism.
 

AVS finds unilateral adenomas when imaging can’t

The evidence that raised concerns about the reliability of imaging as an easier and noninvasive means to identify hypertensive patients with PA and a unilateral adrenal nodule that makes them candidates for surgical removal to resolve their PA and hypertension came out in May 2020 in a review of 174 PA patients who underwent AVS at a single center in Calgary, Alta., during 2006-2018.

The review included 366 patients with PA referred to the University of Calgary for assessment, of whom 179 had no adrenal nodule visible with either CT or MRI imaging, with 174 of these patients also undergoing successful AVS. The procedure revealed 70 patients (40%) had unilateral aldosterone secretion (Can J Cardiol. 2020 May 16. doi: 10.1016/j.cjca.2020.05.013).

In an editorial about this report that appeared a few weeks later, Ross D. Feldman, MD, a hypertension-management researcher and professor of medicine at the University of Manitoba in Winnipeg, Man., said the finding was “amazing,” and “confirms that lateralization of aldosterone secretion in a patient with PA but without an identifiable mass on that side is not a zebra,” but instead a presentation that “occurs in almost half of patients with PA and no discernible adenoma on the side that lateralizes.” (Can J. Cardiol. 2020 Jul 3. doi: 10.1016/j.cjca.2020.06.022).

Although this was just one center’s experience, the authors are not alone in making this finding, although prior reports seem to have been largely forgotten or ignored until now.

“The discordance between AVS and adrenal imaging has been documented by numerous groups, and in our own experience [in Melbourne] around 40% of patients with unilateral aldosterone excess do not have a distinct unilateral adenoma on CT,” said Dr. Yang.

“Here’s the problem,” summed up Dr. Feldman in an interview. “Nearly half of patients with hyperaldosteronism don’t localize based on a CT or MRI, so you have to do AVS, but AVS is not generally available; it’s only at tertiary centers; and you have to do a lot of them,” to do them well. “It’s a half-day procedure, and you have to hit the correct adrenal vein.”
 

AVS for millions?

Compounding the challenge is the other bit of bombshell news recently dropped on the endocrinology and hypertension communities: PA may be much more prevalent that previously suspected, occurring in roughly 20% of patients with hypertension, according to study results that also came out in 2020 (Ann Int Med. 2020 Jul 7;173[1]:10-20).

The upshot, according to Dr. Feldman and others, is that researchers will need to find reliable criteria besides imaging for identifying PA patients with an increased likelihood of having a lateralized source for their excess aldosterone production. That’s “the only hope,” said Dr. Feldman, “so we won’t have to do AVS on 20 million Americans.”

Unfortunately, the path toward a successful screen to winnow down candidates for AVS has been long and not especially fruitful, with efforts dating back at least 50 years, and with one of the most recent efforts at stratifying PA patients by certain laboratory measures getting dismissed as producing a benefit that “might not be substantial,” wrote Michael Stowasser, MBBS, in a published commentary (J Hypertension. 2020 Jul;38[7]:1259-61).

In contrast to Dr. Feldman, Dr. Stowasser was more optimistic about the prospects for avoiding an immediate crisis in AVS assessment of PA patients, mostly because so few patients with PA are now identified by clinicians. Given the poor record clinicians have historically rung up diagnosing PA, “it would seem unlikely that we are going to be flooded with AVS requests any time soon,” he wrote. There is also reason to hope that increased demand for AVS will help broaden availability, and innovative testing methods promise to speed up the procedure, said Dr. Stowasser, a professor of medicine at the University of Queensland in Brisbane, Australia and director of the Endocrine Hypertension Research Centre at Greenslopes and Princess Alexandra Hospitals in Brisbane, in an interview.

But regardless of whether AVS testing becomes more available or streamlined, recent events suggest there will be little way to avoid eventually having to run millions of these diagnostic procedures.

Patients with PA “who decide they will not want surgery do not need AVS. For all other patients with PA, you need AVS. The medical system will just have to respond,” Dr. Carey concluded.

Dr. Carey, Dr. Yang, Dr. Feldman, and Dr. Stowasser had no relevant disclosures.

mzoler@mdedge.com