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Humira topped drug-revenue list for 2019
Humira outsold all other drugs in 2019 in terms of revenue as cytokine inhibitor medications earned their way to three of the first four spots on the pharmaceutical best-seller list, according to a new analysis from the IQVIA Institute for Human Data Science.
Sales of Humira (adalimumab) amounted to $21.4 billion before discounting, Murray Aitken, the institute’s executive director, and associates wrote in their analysis. That’s more than double the total of the anticoagulant Eliquis (apixaban), which brought in $9.9 billion in its last year before generic forms became available.
The next two spots were filled by the tumor necrosis factor inhibitor Enbrel (etanercept) with $8.1 billion in sales and the interleukin 12/23 inhibitor Stelara (ustekinumab) with sales totaling $6.6 billion, followed by the chemotherapy drug Keytruda (pembrolizumab) close behind after racking up $6.5 billion in sales, the researchers reported.
Total nondiscounted spending on all drugs in the U.S. market came to $511 billion in 2019, an increase of 5.7% over the $484 billion spent in 2018, based on data from the July 2020 IQVIA National Sales Perspectives.
These figures are “not adjusted for estimates of off-invoice discounts and rebates,” the authors noted, but they include “prescription and insulin products sold into chain and independent pharmacies, food store pharmacies, mail service pharmacies, long-term care facilities, hospitals, clinics, and other institutional settings.”
Those “discounts and rebates” do exist, however, and they can add up. Drug sales for 2019, “after deducting negotiated rebates, discounts, and other forms of price concessions, such as patient coupons or vouchers that offset out-of-pocket costs,” were $235 billion less than overall nondiscounted spending, the report noted.
Now that we’ve shown you the money, let’s take a quick look at volume. The leading drugs by number of dispensed prescriptions in 2019 were, not surprisingly, quite different. First, with 118 million prescriptions, was atorvastatin, followed by levothyroxine (113 million), lisinopril (96), amlodipine (89), and metoprolol (85), Mr. Aitken and associates reported.
Altogether, over 4.2 billion prescriptions were dispensed last year, with a couple of caveats: 90-day and 30-day fills were both counted as one prescription, and OTC drugs were not included, they pointed out.
Humira outsold all other drugs in 2019 in terms of revenue as cytokine inhibitor medications earned their way to three of the first four spots on the pharmaceutical best-seller list, according to a new analysis from the IQVIA Institute for Human Data Science.
Sales of Humira (adalimumab) amounted to $21.4 billion before discounting, Murray Aitken, the institute’s executive director, and associates wrote in their analysis. That’s more than double the total of the anticoagulant Eliquis (apixaban), which brought in $9.9 billion in its last year before generic forms became available.
The next two spots were filled by the tumor necrosis factor inhibitor Enbrel (etanercept) with $8.1 billion in sales and the interleukin 12/23 inhibitor Stelara (ustekinumab) with sales totaling $6.6 billion, followed by the chemotherapy drug Keytruda (pembrolizumab) close behind after racking up $6.5 billion in sales, the researchers reported.
Total nondiscounted spending on all drugs in the U.S. market came to $511 billion in 2019, an increase of 5.7% over the $484 billion spent in 2018, based on data from the July 2020 IQVIA National Sales Perspectives.
These figures are “not adjusted for estimates of off-invoice discounts and rebates,” the authors noted, but they include “prescription and insulin products sold into chain and independent pharmacies, food store pharmacies, mail service pharmacies, long-term care facilities, hospitals, clinics, and other institutional settings.”
Those “discounts and rebates” do exist, however, and they can add up. Drug sales for 2019, “after deducting negotiated rebates, discounts, and other forms of price concessions, such as patient coupons or vouchers that offset out-of-pocket costs,” were $235 billion less than overall nondiscounted spending, the report noted.
Now that we’ve shown you the money, let’s take a quick look at volume. The leading drugs by number of dispensed prescriptions in 2019 were, not surprisingly, quite different. First, with 118 million prescriptions, was atorvastatin, followed by levothyroxine (113 million), lisinopril (96), amlodipine (89), and metoprolol (85), Mr. Aitken and associates reported.
Altogether, over 4.2 billion prescriptions were dispensed last year, with a couple of caveats: 90-day and 30-day fills were both counted as one prescription, and OTC drugs were not included, they pointed out.
Humira outsold all other drugs in 2019 in terms of revenue as cytokine inhibitor medications earned their way to three of the first four spots on the pharmaceutical best-seller list, according to a new analysis from the IQVIA Institute for Human Data Science.
Sales of Humira (adalimumab) amounted to $21.4 billion before discounting, Murray Aitken, the institute’s executive director, and associates wrote in their analysis. That’s more than double the total of the anticoagulant Eliquis (apixaban), which brought in $9.9 billion in its last year before generic forms became available.
The next two spots were filled by the tumor necrosis factor inhibitor Enbrel (etanercept) with $8.1 billion in sales and the interleukin 12/23 inhibitor Stelara (ustekinumab) with sales totaling $6.6 billion, followed by the chemotherapy drug Keytruda (pembrolizumab) close behind after racking up $6.5 billion in sales, the researchers reported.
Total nondiscounted spending on all drugs in the U.S. market came to $511 billion in 2019, an increase of 5.7% over the $484 billion spent in 2018, based on data from the July 2020 IQVIA National Sales Perspectives.
These figures are “not adjusted for estimates of off-invoice discounts and rebates,” the authors noted, but they include “prescription and insulin products sold into chain and independent pharmacies, food store pharmacies, mail service pharmacies, long-term care facilities, hospitals, clinics, and other institutional settings.”
Those “discounts and rebates” do exist, however, and they can add up. Drug sales for 2019, “after deducting negotiated rebates, discounts, and other forms of price concessions, such as patient coupons or vouchers that offset out-of-pocket costs,” were $235 billion less than overall nondiscounted spending, the report noted.
Now that we’ve shown you the money, let’s take a quick look at volume. The leading drugs by number of dispensed prescriptions in 2019 were, not surprisingly, quite different. First, with 118 million prescriptions, was atorvastatin, followed by levothyroxine (113 million), lisinopril (96), amlodipine (89), and metoprolol (85), Mr. Aitken and associates reported.
Altogether, over 4.2 billion prescriptions were dispensed last year, with a couple of caveats: 90-day and 30-day fills were both counted as one prescription, and OTC drugs were not included, they pointed out.
Oleander extract for COVID-19? That’s a hard ‘no’ experts say
“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.
Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.
The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.
After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.
Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.
Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.
Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
In vitro study
Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.
In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.
“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.
On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”
But it’s a far cry from test tube to human, one expert cautioned.
“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.
“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.
Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.
“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.
This article first appeared on Medscape.com.
“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.
Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.
The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.
After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.
Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.
Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.
Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
In vitro study
Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.
In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.
“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.
On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”
But it’s a far cry from test tube to human, one expert cautioned.
“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.
“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.
Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.
“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.
This article first appeared on Medscape.com.
“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.
Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.
The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.
After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.
Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.
Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.
Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
In vitro study
Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.
In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.
“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.
On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”
But it’s a far cry from test tube to human, one expert cautioned.
“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.
“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.
Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.
“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.
This article first appeared on Medscape.com.
SGLT2 inhibitors with metformin look safe for bone
The combination of sodium-glucose transporter-2 (SGLT-2) inhibitors and metformin is not associated with an increase in fracture risk among patients with type 2 diabetes (T2D), according to a new meta-analysis of 25 randomized, controlled trials.
Researchers at The Second Clinical College of Dalian Medical University in Jiangsu, China, compared fracture risk associated with the metformin/SLGT2 combination to metformin alone as well as other T2D therapeutics, and found no differences in risk. The study was published online Aug. 11 in Osteoporosis International.
T2D is associated with an increased risk of fracture, though causative mechanisms remain uncertain. Some lines of evidence suggest multiple factors may contribute to fractures, including hyperglycemia, oxidative stress, toxic effects of advanced glycosylation end-products, altered insulin levels, and treatment-induced hypoglycemia, as well as an association between T2D and increased risk of falls.
Antidiabetes drugs can have positive or negative effects on bone. thiazolidinediones, insulin, and sulfonylureas may increase risk of fractures, while dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-2 (GLP-2) receptor agonists may be protective. Metformin may also reduce fracture risk.
SGLT-2 inhibitors interrupt glucose reabsorption in the kidney, leading to improved glycemic control. Other benefits include improved renal and cardiovascular outcomes, weight loss, and reduced blood pressure, liver fat, and serum uric acid levels.
These properties have made SGLT-2 inhibitors combined with metformin an important therapy for patients at high risk of atherosclerotic disease, or who have heart failure or chronic kidney disease.
But SGLT-2 inhibition increases osmotic diuresis, and this could alter the mineral balance within bone. Some studies also showed that SGLT-2 inhibitors led to changes in bone turnover markers, bone mineral density, and bone microarchitecture. Observational studies of the SGLT-2 inhibitor canagliflozin found associations with a higher rate of fracture risk in patients taking the drug.
Such studies carry the risk of confounding factors, so the researchers took advantage of the fact that many recent clinical trials have examined the impact of SGLT-2 inhibitors on T2D. They pooled data from 25 clinical trials with a total of 19,500 participants, 9,662 of whom received SGLT-2 inhibitors plus metformin; 9,838 received other active comparators.
The fracture rate was 0.91% in the SGLT-2 inhibitors/metformin group, and 0.80% among controls (odds ratio, 0.97; 95% CI, 0.71-1.32), with no heterogeneity. Metformin alone was not associated with a change in fracture rate (OR, 0.95; 95% CI, 0.44-2.08), nor were other forms of diabetes control (OR, 0.95; 95% CI, 0.69-1.31).
There were some differences in fracture risk among SGLT-2 inhibitors when studied individually, though none differed significantly from controls. The highest risk was associated with the canagliflozin/metformin (OR, 2.19; 95% CI, 0.66-7.27), followed by dapagliflozin/metformin (OR, 0.91; 95% CI, 0.50-1.64), empagliflozin/metformin (OR, 0.94; 95% CI, 0.59-1.50), and ertugliflozin/metformin (OR, 0.76; 95% CI, 0.38-1.54).
There were no differences with respect to hip or lumbar spine fractures, or other fractures. The researchers found no differences in bone mineral density or bone turnover markers.
The meta-analysis is limited by the relatively short average follow-up in the included studies, which was 61 weeks. Bone damage may occur over longer time periods. Bone fractures were also not a prespecified adverse event in most included studies.
The studies also did not provide detailed information on the types of fractures experienced, such as whether they were result of a fall, or the location of the fracture, or bone health parameters. Although the results support a belief that SGLT-2 inhibitors do not adversely affect bone health, “given limited information on bone health outcomes, further work is needed to validate this conclusion,” the authors wrote.
The authors did not disclose any funding and had no relevant conflicts of interest.
SOURCE: B-B Qian et al. Osteoporosis Int. 2020 Aug 11. doi: 10.1007/s00198-020-05590-y.
The combination of sodium-glucose transporter-2 (SGLT-2) inhibitors and metformin is not associated with an increase in fracture risk among patients with type 2 diabetes (T2D), according to a new meta-analysis of 25 randomized, controlled trials.
Researchers at The Second Clinical College of Dalian Medical University in Jiangsu, China, compared fracture risk associated with the metformin/SLGT2 combination to metformin alone as well as other T2D therapeutics, and found no differences in risk. The study was published online Aug. 11 in Osteoporosis International.
T2D is associated with an increased risk of fracture, though causative mechanisms remain uncertain. Some lines of evidence suggest multiple factors may contribute to fractures, including hyperglycemia, oxidative stress, toxic effects of advanced glycosylation end-products, altered insulin levels, and treatment-induced hypoglycemia, as well as an association between T2D and increased risk of falls.
Antidiabetes drugs can have positive or negative effects on bone. thiazolidinediones, insulin, and sulfonylureas may increase risk of fractures, while dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-2 (GLP-2) receptor agonists may be protective. Metformin may also reduce fracture risk.
SGLT-2 inhibitors interrupt glucose reabsorption in the kidney, leading to improved glycemic control. Other benefits include improved renal and cardiovascular outcomes, weight loss, and reduced blood pressure, liver fat, and serum uric acid levels.
These properties have made SGLT-2 inhibitors combined with metformin an important therapy for patients at high risk of atherosclerotic disease, or who have heart failure or chronic kidney disease.
But SGLT-2 inhibition increases osmotic diuresis, and this could alter the mineral balance within bone. Some studies also showed that SGLT-2 inhibitors led to changes in bone turnover markers, bone mineral density, and bone microarchitecture. Observational studies of the SGLT-2 inhibitor canagliflozin found associations with a higher rate of fracture risk in patients taking the drug.
Such studies carry the risk of confounding factors, so the researchers took advantage of the fact that many recent clinical trials have examined the impact of SGLT-2 inhibitors on T2D. They pooled data from 25 clinical trials with a total of 19,500 participants, 9,662 of whom received SGLT-2 inhibitors plus metformin; 9,838 received other active comparators.
The fracture rate was 0.91% in the SGLT-2 inhibitors/metformin group, and 0.80% among controls (odds ratio, 0.97; 95% CI, 0.71-1.32), with no heterogeneity. Metformin alone was not associated with a change in fracture rate (OR, 0.95; 95% CI, 0.44-2.08), nor were other forms of diabetes control (OR, 0.95; 95% CI, 0.69-1.31).
There were some differences in fracture risk among SGLT-2 inhibitors when studied individually, though none differed significantly from controls. The highest risk was associated with the canagliflozin/metformin (OR, 2.19; 95% CI, 0.66-7.27), followed by dapagliflozin/metformin (OR, 0.91; 95% CI, 0.50-1.64), empagliflozin/metformin (OR, 0.94; 95% CI, 0.59-1.50), and ertugliflozin/metformin (OR, 0.76; 95% CI, 0.38-1.54).
There were no differences with respect to hip or lumbar spine fractures, or other fractures. The researchers found no differences in bone mineral density or bone turnover markers.
The meta-analysis is limited by the relatively short average follow-up in the included studies, which was 61 weeks. Bone damage may occur over longer time periods. Bone fractures were also not a prespecified adverse event in most included studies.
The studies also did not provide detailed information on the types of fractures experienced, such as whether they were result of a fall, or the location of the fracture, or bone health parameters. Although the results support a belief that SGLT-2 inhibitors do not adversely affect bone health, “given limited information on bone health outcomes, further work is needed to validate this conclusion,” the authors wrote.
The authors did not disclose any funding and had no relevant conflicts of interest.
SOURCE: B-B Qian et al. Osteoporosis Int. 2020 Aug 11. doi: 10.1007/s00198-020-05590-y.
The combination of sodium-glucose transporter-2 (SGLT-2) inhibitors and metformin is not associated with an increase in fracture risk among patients with type 2 diabetes (T2D), according to a new meta-analysis of 25 randomized, controlled trials.
Researchers at The Second Clinical College of Dalian Medical University in Jiangsu, China, compared fracture risk associated with the metformin/SLGT2 combination to metformin alone as well as other T2D therapeutics, and found no differences in risk. The study was published online Aug. 11 in Osteoporosis International.
T2D is associated with an increased risk of fracture, though causative mechanisms remain uncertain. Some lines of evidence suggest multiple factors may contribute to fractures, including hyperglycemia, oxidative stress, toxic effects of advanced glycosylation end-products, altered insulin levels, and treatment-induced hypoglycemia, as well as an association between T2D and increased risk of falls.
Antidiabetes drugs can have positive or negative effects on bone. thiazolidinediones, insulin, and sulfonylureas may increase risk of fractures, while dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-2 (GLP-2) receptor agonists may be protective. Metformin may also reduce fracture risk.
SGLT-2 inhibitors interrupt glucose reabsorption in the kidney, leading to improved glycemic control. Other benefits include improved renal and cardiovascular outcomes, weight loss, and reduced blood pressure, liver fat, and serum uric acid levels.
These properties have made SGLT-2 inhibitors combined with metformin an important therapy for patients at high risk of atherosclerotic disease, or who have heart failure or chronic kidney disease.
But SGLT-2 inhibition increases osmotic diuresis, and this could alter the mineral balance within bone. Some studies also showed that SGLT-2 inhibitors led to changes in bone turnover markers, bone mineral density, and bone microarchitecture. Observational studies of the SGLT-2 inhibitor canagliflozin found associations with a higher rate of fracture risk in patients taking the drug.
Such studies carry the risk of confounding factors, so the researchers took advantage of the fact that many recent clinical trials have examined the impact of SGLT-2 inhibitors on T2D. They pooled data from 25 clinical trials with a total of 19,500 participants, 9,662 of whom received SGLT-2 inhibitors plus metformin; 9,838 received other active comparators.
The fracture rate was 0.91% in the SGLT-2 inhibitors/metformin group, and 0.80% among controls (odds ratio, 0.97; 95% CI, 0.71-1.32), with no heterogeneity. Metformin alone was not associated with a change in fracture rate (OR, 0.95; 95% CI, 0.44-2.08), nor were other forms of diabetes control (OR, 0.95; 95% CI, 0.69-1.31).
There were some differences in fracture risk among SGLT-2 inhibitors when studied individually, though none differed significantly from controls. The highest risk was associated with the canagliflozin/metformin (OR, 2.19; 95% CI, 0.66-7.27), followed by dapagliflozin/metformin (OR, 0.91; 95% CI, 0.50-1.64), empagliflozin/metformin (OR, 0.94; 95% CI, 0.59-1.50), and ertugliflozin/metformin (OR, 0.76; 95% CI, 0.38-1.54).
There were no differences with respect to hip or lumbar spine fractures, or other fractures. The researchers found no differences in bone mineral density or bone turnover markers.
The meta-analysis is limited by the relatively short average follow-up in the included studies, which was 61 weeks. Bone damage may occur over longer time periods. Bone fractures were also not a prespecified adverse event in most included studies.
The studies also did not provide detailed information on the types of fractures experienced, such as whether they were result of a fall, or the location of the fracture, or bone health parameters. Although the results support a belief that SGLT-2 inhibitors do not adversely affect bone health, “given limited information on bone health outcomes, further work is needed to validate this conclusion,” the authors wrote.
The authors did not disclose any funding and had no relevant conflicts of interest.
SOURCE: B-B Qian et al. Osteoporosis Int. 2020 Aug 11. doi: 10.1007/s00198-020-05590-y.
FROM OSTEOPOROSIS INTERNATIONAL
Are aging physicians a burden?
The evaluation of physicians with alleged cognitive decline
As forensic evaluators, we are often asked to review and assess the cognition of aging colleagues. The premise often involves a minor mistake, a poor choice of words, or a lapse in judgment. A physician gets reported for having difficulty using a new electronic form, forgetting the dose of a brand new medication, or getting upset in a public setting. Those behaviors often lead to mandatory psychiatric evaluations. Those requirements are often perceived by the provider as an insult, and betrayal by peers despite many years of dedicated work.
Interestingly, we have noticed many independent evaluators and hospital administrators using this opportunity to send many of our colleagues to pasture. There seems to be an unspoken rule among some forensic evaluators that physicians should represent some form of apex of humanity, beyond reproach, and beyond any fault. Those evaluators will point to any mistake on cognitive scales as proof that the aging physician is no longer safe to practice.1 Forgetting that Jill is from Illinois in the Saint Louis University Mental Status Examination test or how to copy a three-dimensional cube on the Montreal Cognitive Assessment can cost someone their license.2 We are also aware of some evaluators even taking the step further and opining that physicians not only need to score adequately but also demonstrate cognition significantly above average to maintain their privileges.
There is certainly significant appeal in setting a high bar for physicians. In many ways, physicians are characterized in society by their astuteness, intelligence, and high ethical standards. Patients place their lives in the hands of physicians and should trust that those physicians have the cognitive tools to heal them. It could almost seem evident that physicians should have high IQs, score perfectly on screening tools for dementia, and complete a mandatory psychiatric evaluation without any reproach. Yet the reality is often more complex.
We have two main concerns about the idea that we should be intransigent with aging physicians. The first one is the vast differential diagnosis for minor mistakes. An aging physician refusing to comply with a new form or yelling at a clerk once when asked to learn a new electronic medical record are inappropriate though not specific assessments for dementia. Similarly, having significant difficulty learning a new electronic medical record system more often is a sign of ageism rather than cognitive impairment. Subsequently, when arriving for their evaluation, forgetting the date is a common sign of anxiety. A relatable analogy would be to compare the mistake with a medical student forgetting part of the anatomy while questioning by an attending during surgery. Imagine such medical students being referred to mandatory psychiatric evaluation when failing to answer a question during rounds.
In our practice, the most common reason for those minor mistakes during our clinical evaluation is anxiety. After all, patients who present for problems completely unrelated to cognitive decline make similar mistakes. Psychological stressors in physicians require no introduction. The concept is so prevalent and pervasive that it has its own name, “burnout.” Imagine having dedicated most of one’s life to a profession then being enumerated a list of complaints, having one’s privileges put on hold, then being told to complete an independent psychiatric evaluation. If burnout is in part caused by a lack of control, unclear job expectations, rapidly changing models of health care, and dysfunctional workplace dynamics, imagine the consequence of such a referral.
The militant evaluator will use jargon to vilify the reviewed physician. If the physician complains too voraciously, he will be described as having signs of frontotemporal dementia. If the physician comes with a written list of rebuttals, he will be described as having memory problems requiring aids. If the physician is demoralized and quiet, he will be described as being withdrawn and apathetic. If the physician refuses to use or has difficulty with new forms or electronic systems, he will be described as having “impaired executive function,” an ominous term that surely should not be associated with a practicing physician.
The second concern arises from problems with the validity and use of diagnoses like mild cognitive impairment (MCI). MCI is considered to be a transition stage when one maintains “normal activities of daily living, and normal general cognitive function.”3 The American Psychiatric Association Textbook of Psychiatry mentions that there are “however, many cases of nonprogressive MCI.” Should a disorder with generally normal cognition and unclear progression to a more severe disorder require one to be dispensed of their privileges? Should any disorder trump an assessment of functioning?
It is our experience that many if not most physicians’ practice of medicine is not a job but a profession that defines who they are. As such, their occupational habits are an overly repeated and ingrained series of maneuvers analogous to so-called muscle memory. This kind of ritualistic pattern is precisely the kind of cognition that may persist as one starts to have some deficits. This requires the evaluator to be particularly sensitive and cognizant that one may still be able to perform professionally despite some mild but notable deficits. While it is facile to diagnose someone with MCI and justify removing their license, a review of their actual clinical skills is, despite being more time consuming, more pertinent to the evaluation.
In practice, we find that many cases lie in a gray area, which is hard to define. Physicians may come to our office for an evaluation after having said something odd at work. Maybe they misdosed a medication on one occasion. Maybe they wrote the wrong year on a chart. However, if the physician was 30 years old, would we consider any one of those incidents significant? As a psychiatrist rather than a physician practicing the specialty in review, it is particularly hard and sometimes unwise to condone or sanction individual incidents.
Evaluators find solace in neuropsychological testing. However the relevance to the safety of patients is unclear. Many of those tests end up being a simple proxy for age. A physicians’ ability to sort words or cards at a certain speed might correlate to cognitive performance but has unclear significance to the ability to care for patients. Using such tests becomes a de facto age limit on the practice of medicine. It seems essential to expand and refine our repertoire of evaluation tools for the assessment of physicians. As when we perform capacity evaluation in the hospital, we enlist the assistance of the treating team in understanding the questions being asked for a patient, medical boards could consider creating independent multidisciplinary teams where psychiatry has a seat along with the relevant specialties of the evaluee. Likewise, the assessment would benefit from a broad review of the physicians’ general practice rather than the more typical review of one or two incidents.
We are promoting a more individualized approach by medical boards to the many issues of the aging physician. Retiring is no longer the dream of older physicians, but rather working in the suitable position where their contributions, clinical experience, and wisdom are positive contributions to patient care. Furthermore, we encourage medical boards to consider more nuanced decisions. A binary approach fits few cases that we see. Surgeons are a prime example of this. A surgeon in the early stages of Parkinsonism may be unfit to perform surgery but very capable of continuing to contribute to the well-being of patients in other forms of clinical work, including postsurgical care that doesn’t involve physical dexterity. Similarly, medical boards could consider other forms of partial restrictions, including a ban on procedures, a ban on hospital privileges, as well as required supervision or working in teams. Accumulated clinical wisdom allows older physicians to be excellent mentors and educators for younger doctors. There is no simple method to predict which physicians may have the early stages of a progressive dementia, and which may have a stable MCI. A yearly reevaluation if there are no further complaints, is the best approach to determine progression of cognitive problems.
Few crises like the current COVID-19 pandemic can better remind us of the importance of the place of medicine in society. Many states have encouraged retired physicians to contribute their knowledge and expertise, putting themselves in particular risk because of their age. It is a good time to be reminded that we owe them significant respect and care when deciding to remove their license. We are encouraged by the diligent efforts of medical boards in supervising our colleagues but warn against zealot evaluators who use this opportunity to force physicians into retirement. We also encourage medical boards to expand their tools and approaches when facing such cases, as mislabeled cognitive diagnoses can be an easy scapegoat of a poor understanding of the more important psychological and biological factors in the evaluation.
References
1. Tariq SH et al. Am J Geriatr Psychiatry. 2006;14:900-10.
2. Nasreddine Z. mocatest.org. Version 2004 Nov 7.
3. Hales RE et al. The American Psychiatric Publishing Textbook of Psychiatry. Washington: American Psychiatric Association Publishing, 2014.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings in chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.
Dr. Abrams is a forensic psychiatrist and attorney in San Diego. He is an expert in addictionology, behavioral toxicology, psychopharmacology and correctional mental health. He holds a teaching positions at the University of California, San Diego. Among his writings are chapters about competency in national textbooks. Dr. Abrams has no disclosures.
The evaluation of physicians with alleged cognitive decline
The evaluation of physicians with alleged cognitive decline
As forensic evaluators, we are often asked to review and assess the cognition of aging colleagues. The premise often involves a minor mistake, a poor choice of words, or a lapse in judgment. A physician gets reported for having difficulty using a new electronic form, forgetting the dose of a brand new medication, or getting upset in a public setting. Those behaviors often lead to mandatory psychiatric evaluations. Those requirements are often perceived by the provider as an insult, and betrayal by peers despite many years of dedicated work.
Interestingly, we have noticed many independent evaluators and hospital administrators using this opportunity to send many of our colleagues to pasture. There seems to be an unspoken rule among some forensic evaluators that physicians should represent some form of apex of humanity, beyond reproach, and beyond any fault. Those evaluators will point to any mistake on cognitive scales as proof that the aging physician is no longer safe to practice.1 Forgetting that Jill is from Illinois in the Saint Louis University Mental Status Examination test or how to copy a three-dimensional cube on the Montreal Cognitive Assessment can cost someone their license.2 We are also aware of some evaluators even taking the step further and opining that physicians not only need to score adequately but also demonstrate cognition significantly above average to maintain their privileges.
There is certainly significant appeal in setting a high bar for physicians. In many ways, physicians are characterized in society by their astuteness, intelligence, and high ethical standards. Patients place their lives in the hands of physicians and should trust that those physicians have the cognitive tools to heal them. It could almost seem evident that physicians should have high IQs, score perfectly on screening tools for dementia, and complete a mandatory psychiatric evaluation without any reproach. Yet the reality is often more complex.
We have two main concerns about the idea that we should be intransigent with aging physicians. The first one is the vast differential diagnosis for minor mistakes. An aging physician refusing to comply with a new form or yelling at a clerk once when asked to learn a new electronic medical record are inappropriate though not specific assessments for dementia. Similarly, having significant difficulty learning a new electronic medical record system more often is a sign of ageism rather than cognitive impairment. Subsequently, when arriving for their evaluation, forgetting the date is a common sign of anxiety. A relatable analogy would be to compare the mistake with a medical student forgetting part of the anatomy while questioning by an attending during surgery. Imagine such medical students being referred to mandatory psychiatric evaluation when failing to answer a question during rounds.
In our practice, the most common reason for those minor mistakes during our clinical evaluation is anxiety. After all, patients who present for problems completely unrelated to cognitive decline make similar mistakes. Psychological stressors in physicians require no introduction. The concept is so prevalent and pervasive that it has its own name, “burnout.” Imagine having dedicated most of one’s life to a profession then being enumerated a list of complaints, having one’s privileges put on hold, then being told to complete an independent psychiatric evaluation. If burnout is in part caused by a lack of control, unclear job expectations, rapidly changing models of health care, and dysfunctional workplace dynamics, imagine the consequence of such a referral.
The militant evaluator will use jargon to vilify the reviewed physician. If the physician complains too voraciously, he will be described as having signs of frontotemporal dementia. If the physician comes with a written list of rebuttals, he will be described as having memory problems requiring aids. If the physician is demoralized and quiet, he will be described as being withdrawn and apathetic. If the physician refuses to use or has difficulty with new forms or electronic systems, he will be described as having “impaired executive function,” an ominous term that surely should not be associated with a practicing physician.
The second concern arises from problems with the validity and use of diagnoses like mild cognitive impairment (MCI). MCI is considered to be a transition stage when one maintains “normal activities of daily living, and normal general cognitive function.”3 The American Psychiatric Association Textbook of Psychiatry mentions that there are “however, many cases of nonprogressive MCI.” Should a disorder with generally normal cognition and unclear progression to a more severe disorder require one to be dispensed of their privileges? Should any disorder trump an assessment of functioning?
It is our experience that many if not most physicians’ practice of medicine is not a job but a profession that defines who they are. As such, their occupational habits are an overly repeated and ingrained series of maneuvers analogous to so-called muscle memory. This kind of ritualistic pattern is precisely the kind of cognition that may persist as one starts to have some deficits. This requires the evaluator to be particularly sensitive and cognizant that one may still be able to perform professionally despite some mild but notable deficits. While it is facile to diagnose someone with MCI and justify removing their license, a review of their actual clinical skills is, despite being more time consuming, more pertinent to the evaluation.
In practice, we find that many cases lie in a gray area, which is hard to define. Physicians may come to our office for an evaluation after having said something odd at work. Maybe they misdosed a medication on one occasion. Maybe they wrote the wrong year on a chart. However, if the physician was 30 years old, would we consider any one of those incidents significant? As a psychiatrist rather than a physician practicing the specialty in review, it is particularly hard and sometimes unwise to condone or sanction individual incidents.
Evaluators find solace in neuropsychological testing. However the relevance to the safety of patients is unclear. Many of those tests end up being a simple proxy for age. A physicians’ ability to sort words or cards at a certain speed might correlate to cognitive performance but has unclear significance to the ability to care for patients. Using such tests becomes a de facto age limit on the practice of medicine. It seems essential to expand and refine our repertoire of evaluation tools for the assessment of physicians. As when we perform capacity evaluation in the hospital, we enlist the assistance of the treating team in understanding the questions being asked for a patient, medical boards could consider creating independent multidisciplinary teams where psychiatry has a seat along with the relevant specialties of the evaluee. Likewise, the assessment would benefit from a broad review of the physicians’ general practice rather than the more typical review of one or two incidents.
We are promoting a more individualized approach by medical boards to the many issues of the aging physician. Retiring is no longer the dream of older physicians, but rather working in the suitable position where their contributions, clinical experience, and wisdom are positive contributions to patient care. Furthermore, we encourage medical boards to consider more nuanced decisions. A binary approach fits few cases that we see. Surgeons are a prime example of this. A surgeon in the early stages of Parkinsonism may be unfit to perform surgery but very capable of continuing to contribute to the well-being of patients in other forms of clinical work, including postsurgical care that doesn’t involve physical dexterity. Similarly, medical boards could consider other forms of partial restrictions, including a ban on procedures, a ban on hospital privileges, as well as required supervision or working in teams. Accumulated clinical wisdom allows older physicians to be excellent mentors and educators for younger doctors. There is no simple method to predict which physicians may have the early stages of a progressive dementia, and which may have a stable MCI. A yearly reevaluation if there are no further complaints, is the best approach to determine progression of cognitive problems.
Few crises like the current COVID-19 pandemic can better remind us of the importance of the place of medicine in society. Many states have encouraged retired physicians to contribute their knowledge and expertise, putting themselves in particular risk because of their age. It is a good time to be reminded that we owe them significant respect and care when deciding to remove their license. We are encouraged by the diligent efforts of medical boards in supervising our colleagues but warn against zealot evaluators who use this opportunity to force physicians into retirement. We also encourage medical boards to expand their tools and approaches when facing such cases, as mislabeled cognitive diagnoses can be an easy scapegoat of a poor understanding of the more important psychological and biological factors in the evaluation.
References
1. Tariq SH et al. Am J Geriatr Psychiatry. 2006;14:900-10.
2. Nasreddine Z. mocatest.org. Version 2004 Nov 7.
3. Hales RE et al. The American Psychiatric Publishing Textbook of Psychiatry. Washington: American Psychiatric Association Publishing, 2014.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings in chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.
Dr. Abrams is a forensic psychiatrist and attorney in San Diego. He is an expert in addictionology, behavioral toxicology, psychopharmacology and correctional mental health. He holds a teaching positions at the University of California, San Diego. Among his writings are chapters about competency in national textbooks. Dr. Abrams has no disclosures.
As forensic evaluators, we are often asked to review and assess the cognition of aging colleagues. The premise often involves a minor mistake, a poor choice of words, or a lapse in judgment. A physician gets reported for having difficulty using a new electronic form, forgetting the dose of a brand new medication, or getting upset in a public setting. Those behaviors often lead to mandatory psychiatric evaluations. Those requirements are often perceived by the provider as an insult, and betrayal by peers despite many years of dedicated work.
Interestingly, we have noticed many independent evaluators and hospital administrators using this opportunity to send many of our colleagues to pasture. There seems to be an unspoken rule among some forensic evaluators that physicians should represent some form of apex of humanity, beyond reproach, and beyond any fault. Those evaluators will point to any mistake on cognitive scales as proof that the aging physician is no longer safe to practice.1 Forgetting that Jill is from Illinois in the Saint Louis University Mental Status Examination test or how to copy a three-dimensional cube on the Montreal Cognitive Assessment can cost someone their license.2 We are also aware of some evaluators even taking the step further and opining that physicians not only need to score adequately but also demonstrate cognition significantly above average to maintain their privileges.
There is certainly significant appeal in setting a high bar for physicians. In many ways, physicians are characterized in society by their astuteness, intelligence, and high ethical standards. Patients place their lives in the hands of physicians and should trust that those physicians have the cognitive tools to heal them. It could almost seem evident that physicians should have high IQs, score perfectly on screening tools for dementia, and complete a mandatory psychiatric evaluation without any reproach. Yet the reality is often more complex.
We have two main concerns about the idea that we should be intransigent with aging physicians. The first one is the vast differential diagnosis for minor mistakes. An aging physician refusing to comply with a new form or yelling at a clerk once when asked to learn a new electronic medical record are inappropriate though not specific assessments for dementia. Similarly, having significant difficulty learning a new electronic medical record system more often is a sign of ageism rather than cognitive impairment. Subsequently, when arriving for their evaluation, forgetting the date is a common sign of anxiety. A relatable analogy would be to compare the mistake with a medical student forgetting part of the anatomy while questioning by an attending during surgery. Imagine such medical students being referred to mandatory psychiatric evaluation when failing to answer a question during rounds.
In our practice, the most common reason for those minor mistakes during our clinical evaluation is anxiety. After all, patients who present for problems completely unrelated to cognitive decline make similar mistakes. Psychological stressors in physicians require no introduction. The concept is so prevalent and pervasive that it has its own name, “burnout.” Imagine having dedicated most of one’s life to a profession then being enumerated a list of complaints, having one’s privileges put on hold, then being told to complete an independent psychiatric evaluation. If burnout is in part caused by a lack of control, unclear job expectations, rapidly changing models of health care, and dysfunctional workplace dynamics, imagine the consequence of such a referral.
The militant evaluator will use jargon to vilify the reviewed physician. If the physician complains too voraciously, he will be described as having signs of frontotemporal dementia. If the physician comes with a written list of rebuttals, he will be described as having memory problems requiring aids. If the physician is demoralized and quiet, he will be described as being withdrawn and apathetic. If the physician refuses to use or has difficulty with new forms or electronic systems, he will be described as having “impaired executive function,” an ominous term that surely should not be associated with a practicing physician.
The second concern arises from problems with the validity and use of diagnoses like mild cognitive impairment (MCI). MCI is considered to be a transition stage when one maintains “normal activities of daily living, and normal general cognitive function.”3 The American Psychiatric Association Textbook of Psychiatry mentions that there are “however, many cases of nonprogressive MCI.” Should a disorder with generally normal cognition and unclear progression to a more severe disorder require one to be dispensed of their privileges? Should any disorder trump an assessment of functioning?
It is our experience that many if not most physicians’ practice of medicine is not a job but a profession that defines who they are. As such, their occupational habits are an overly repeated and ingrained series of maneuvers analogous to so-called muscle memory. This kind of ritualistic pattern is precisely the kind of cognition that may persist as one starts to have some deficits. This requires the evaluator to be particularly sensitive and cognizant that one may still be able to perform professionally despite some mild but notable deficits. While it is facile to diagnose someone with MCI and justify removing their license, a review of their actual clinical skills is, despite being more time consuming, more pertinent to the evaluation.
In practice, we find that many cases lie in a gray area, which is hard to define. Physicians may come to our office for an evaluation after having said something odd at work. Maybe they misdosed a medication on one occasion. Maybe they wrote the wrong year on a chart. However, if the physician was 30 years old, would we consider any one of those incidents significant? As a psychiatrist rather than a physician practicing the specialty in review, it is particularly hard and sometimes unwise to condone or sanction individual incidents.
Evaluators find solace in neuropsychological testing. However the relevance to the safety of patients is unclear. Many of those tests end up being a simple proxy for age. A physicians’ ability to sort words or cards at a certain speed might correlate to cognitive performance but has unclear significance to the ability to care for patients. Using such tests becomes a de facto age limit on the practice of medicine. It seems essential to expand and refine our repertoire of evaluation tools for the assessment of physicians. As when we perform capacity evaluation in the hospital, we enlist the assistance of the treating team in understanding the questions being asked for a patient, medical boards could consider creating independent multidisciplinary teams where psychiatry has a seat along with the relevant specialties of the evaluee. Likewise, the assessment would benefit from a broad review of the physicians’ general practice rather than the more typical review of one or two incidents.
We are promoting a more individualized approach by medical boards to the many issues of the aging physician. Retiring is no longer the dream of older physicians, but rather working in the suitable position where their contributions, clinical experience, and wisdom are positive contributions to patient care. Furthermore, we encourage medical boards to consider more nuanced decisions. A binary approach fits few cases that we see. Surgeons are a prime example of this. A surgeon in the early stages of Parkinsonism may be unfit to perform surgery but very capable of continuing to contribute to the well-being of patients in other forms of clinical work, including postsurgical care that doesn’t involve physical dexterity. Similarly, medical boards could consider other forms of partial restrictions, including a ban on procedures, a ban on hospital privileges, as well as required supervision or working in teams. Accumulated clinical wisdom allows older physicians to be excellent mentors and educators for younger doctors. There is no simple method to predict which physicians may have the early stages of a progressive dementia, and which may have a stable MCI. A yearly reevaluation if there are no further complaints, is the best approach to determine progression of cognitive problems.
Few crises like the current COVID-19 pandemic can better remind us of the importance of the place of medicine in society. Many states have encouraged retired physicians to contribute their knowledge and expertise, putting themselves in particular risk because of their age. It is a good time to be reminded that we owe them significant respect and care when deciding to remove their license. We are encouraged by the diligent efforts of medical boards in supervising our colleagues but warn against zealot evaluators who use this opportunity to force physicians into retirement. We also encourage medical boards to expand their tools and approaches when facing such cases, as mislabeled cognitive diagnoses can be an easy scapegoat of a poor understanding of the more important psychological and biological factors in the evaluation.
References
1. Tariq SH et al. Am J Geriatr Psychiatry. 2006;14:900-10.
2. Nasreddine Z. mocatest.org. Version 2004 Nov 7.
3. Hales RE et al. The American Psychiatric Publishing Textbook of Psychiatry. Washington: American Psychiatric Association Publishing, 2014.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings in chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.
Dr. Abrams is a forensic psychiatrist and attorney in San Diego. He is an expert in addictionology, behavioral toxicology, psychopharmacology and correctional mental health. He holds a teaching positions at the University of California, San Diego. Among his writings are chapters about competency in national textbooks. Dr. Abrams has no disclosures.
Diabetes plus weight loss equals increased risk of pancreatic cancer
A new study has linked recent-onset diabetes and subsequent weight loss to an increased risk of pancreatic cancer, indicating a distinct group of individuals to screen early for this deadly disease.
“The likelihood of a pancreatic cancer diagnosis was even further elevated among individuals with older age, healthy weight before weight loss, and unintentional weight loss,” wrote Chen Yuan, ScD, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston. The study was published in JAMA Oncology.
To determine whether an association exists between diabetes plus weight change and pancreatic cancer, the researchers analyzed decades of medical history data from the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS). The study population from the NHS included 112,818 women with a mean age of 59 years; the population from the HPFS included 46,207 men with a mean age of 65 years. Since enrollment – the baseline was 1978 for the NHS and 1988 for the HPFS – participants have provided follow-up information via biennial questionnaires.
Recent diabetes onset, weight loss boost cancer risk
From those combined groups, 1,116 incident cases of pancreatic cancer (0.7%) were identified. Compared with patients with no diabetes, patients with recent-onset diabetes had triple the risk of pancreatic cancer (age-adjusted hazard ratio, 2.97; 95% confidence interval, 2.31-3.82) and patients with longstanding diabetes had more than double the risk (HR, 2.16; 95% CI, 1.78-2.60). Patients with longer disease duration also had more than twice the risk of pancreatic cancer, with HRs of 2.25 for those with diabetes for 4-10 years (95% CI, 1.74-2.92) and 2.07 for more than 10 years (95% CI, 1.61-2.66).
Compared with patients who hadn’t lost any weight, patients who reported a 1- to 4-pound weight loss (HR, 1.25; 95% CI, 1.03-1.52), a 5- to 8-pound weight loss (HR, 1.33; 95% CI, 1.06-1.66), and a more than 8-pound weight loss (HR, 1.92; 95% CI, 1.58-2.32) had higher risks of pancreatic cancer. Patients with recent-onset diabetes and a 1- to 8-pound weight loss (91 incident cases per 100,000 person-years; 95% CI, 55-151) or a weight loss of more than 8 pounds (164 incident cases per 100,000 person years; 95% CI, 114-238) had a much higher incidence of pancreatic cancer, compared with patients with neither (16 incident cases per 100,000 person-years; 95% CI, 14-17).
After stratified analyses of patients with both recent-onset diabetes and weight loss, rates of pancreatic cancer were also notably high in those 70 years or older (234 cases per 100,000 person years), those with a body mass index of less than 25 kg/m2 before weight loss (400 cases per 100,000 person years), and those with a low likelihood of intentional weight loss (334 cases per 100,000 person years).
“I like the study because it reminds us of the importance of not thinking everyone that presents with type 2 diabetes necessarily has garden-variety diabetes,” Paul Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said in an interview. “I have always been concerned when a new-onset diabetic individual presents with no family history of diabetes or prediabetes, especially if they’re neither overweight nor obese. I have sometimes screened those individuals for pancreatic abnormalities.”
A call for screening
“This study highlights the consideration for further screening to those with weight loss at the time of diabetes diagnosis, which is very sensible given how unusual weight loss is as a presenting symptom at the time of diagnosis of typical type 2 diabetes,” Dr. Jellinger added. “The combination of weight loss and no family history of diabetes at the time of diagnosis should be an even stronger signal for pancreatic cancer screening and potential detection at a much earlier stage.”
The authors acknowledged their study’s limitations, including some patients with pancreatic cancer not returning their questionnaires and the timing of the questionnaires meaning that patients could’ve developed diabetes after returning it. In addition, they recognized that the participants were “predominantly White health professionals” and recommended a study of “additional patient populations” in the future.
The authors noted numerous potential conflicts of interest, including receiving grants and personal fees from various initiatives, organizations, and pharmaceutical companies.
SOURCE: Yuan C et al. JAMA Oncol. 2020 Aug 13. doi: 10.1001/jamaoncol.2020.2948.
A new study has linked recent-onset diabetes and subsequent weight loss to an increased risk of pancreatic cancer, indicating a distinct group of individuals to screen early for this deadly disease.
“The likelihood of a pancreatic cancer diagnosis was even further elevated among individuals with older age, healthy weight before weight loss, and unintentional weight loss,” wrote Chen Yuan, ScD, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston. The study was published in JAMA Oncology.
To determine whether an association exists between diabetes plus weight change and pancreatic cancer, the researchers analyzed decades of medical history data from the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS). The study population from the NHS included 112,818 women with a mean age of 59 years; the population from the HPFS included 46,207 men with a mean age of 65 years. Since enrollment – the baseline was 1978 for the NHS and 1988 for the HPFS – participants have provided follow-up information via biennial questionnaires.
Recent diabetes onset, weight loss boost cancer risk
From those combined groups, 1,116 incident cases of pancreatic cancer (0.7%) were identified. Compared with patients with no diabetes, patients with recent-onset diabetes had triple the risk of pancreatic cancer (age-adjusted hazard ratio, 2.97; 95% confidence interval, 2.31-3.82) and patients with longstanding diabetes had more than double the risk (HR, 2.16; 95% CI, 1.78-2.60). Patients with longer disease duration also had more than twice the risk of pancreatic cancer, with HRs of 2.25 for those with diabetes for 4-10 years (95% CI, 1.74-2.92) and 2.07 for more than 10 years (95% CI, 1.61-2.66).
Compared with patients who hadn’t lost any weight, patients who reported a 1- to 4-pound weight loss (HR, 1.25; 95% CI, 1.03-1.52), a 5- to 8-pound weight loss (HR, 1.33; 95% CI, 1.06-1.66), and a more than 8-pound weight loss (HR, 1.92; 95% CI, 1.58-2.32) had higher risks of pancreatic cancer. Patients with recent-onset diabetes and a 1- to 8-pound weight loss (91 incident cases per 100,000 person-years; 95% CI, 55-151) or a weight loss of more than 8 pounds (164 incident cases per 100,000 person years; 95% CI, 114-238) had a much higher incidence of pancreatic cancer, compared with patients with neither (16 incident cases per 100,000 person-years; 95% CI, 14-17).
After stratified analyses of patients with both recent-onset diabetes and weight loss, rates of pancreatic cancer were also notably high in those 70 years or older (234 cases per 100,000 person years), those with a body mass index of less than 25 kg/m2 before weight loss (400 cases per 100,000 person years), and those with a low likelihood of intentional weight loss (334 cases per 100,000 person years).
“I like the study because it reminds us of the importance of not thinking everyone that presents with type 2 diabetes necessarily has garden-variety diabetes,” Paul Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said in an interview. “I have always been concerned when a new-onset diabetic individual presents with no family history of diabetes or prediabetes, especially if they’re neither overweight nor obese. I have sometimes screened those individuals for pancreatic abnormalities.”
A call for screening
“This study highlights the consideration for further screening to those with weight loss at the time of diabetes diagnosis, which is very sensible given how unusual weight loss is as a presenting symptom at the time of diagnosis of typical type 2 diabetes,” Dr. Jellinger added. “The combination of weight loss and no family history of diabetes at the time of diagnosis should be an even stronger signal for pancreatic cancer screening and potential detection at a much earlier stage.”
The authors acknowledged their study’s limitations, including some patients with pancreatic cancer not returning their questionnaires and the timing of the questionnaires meaning that patients could’ve developed diabetes after returning it. In addition, they recognized that the participants were “predominantly White health professionals” and recommended a study of “additional patient populations” in the future.
The authors noted numerous potential conflicts of interest, including receiving grants and personal fees from various initiatives, organizations, and pharmaceutical companies.
SOURCE: Yuan C et al. JAMA Oncol. 2020 Aug 13. doi: 10.1001/jamaoncol.2020.2948.
A new study has linked recent-onset diabetes and subsequent weight loss to an increased risk of pancreatic cancer, indicating a distinct group of individuals to screen early for this deadly disease.
“The likelihood of a pancreatic cancer diagnosis was even further elevated among individuals with older age, healthy weight before weight loss, and unintentional weight loss,” wrote Chen Yuan, ScD, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston. The study was published in JAMA Oncology.
To determine whether an association exists between diabetes plus weight change and pancreatic cancer, the researchers analyzed decades of medical history data from the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS). The study population from the NHS included 112,818 women with a mean age of 59 years; the population from the HPFS included 46,207 men with a mean age of 65 years. Since enrollment – the baseline was 1978 for the NHS and 1988 for the HPFS – participants have provided follow-up information via biennial questionnaires.
Recent diabetes onset, weight loss boost cancer risk
From those combined groups, 1,116 incident cases of pancreatic cancer (0.7%) were identified. Compared with patients with no diabetes, patients with recent-onset diabetes had triple the risk of pancreatic cancer (age-adjusted hazard ratio, 2.97; 95% confidence interval, 2.31-3.82) and patients with longstanding diabetes had more than double the risk (HR, 2.16; 95% CI, 1.78-2.60). Patients with longer disease duration also had more than twice the risk of pancreatic cancer, with HRs of 2.25 for those with diabetes for 4-10 years (95% CI, 1.74-2.92) and 2.07 for more than 10 years (95% CI, 1.61-2.66).
Compared with patients who hadn’t lost any weight, patients who reported a 1- to 4-pound weight loss (HR, 1.25; 95% CI, 1.03-1.52), a 5- to 8-pound weight loss (HR, 1.33; 95% CI, 1.06-1.66), and a more than 8-pound weight loss (HR, 1.92; 95% CI, 1.58-2.32) had higher risks of pancreatic cancer. Patients with recent-onset diabetes and a 1- to 8-pound weight loss (91 incident cases per 100,000 person-years; 95% CI, 55-151) or a weight loss of more than 8 pounds (164 incident cases per 100,000 person years; 95% CI, 114-238) had a much higher incidence of pancreatic cancer, compared with patients with neither (16 incident cases per 100,000 person-years; 95% CI, 14-17).
After stratified analyses of patients with both recent-onset diabetes and weight loss, rates of pancreatic cancer were also notably high in those 70 years or older (234 cases per 100,000 person years), those with a body mass index of less than 25 kg/m2 before weight loss (400 cases per 100,000 person years), and those with a low likelihood of intentional weight loss (334 cases per 100,000 person years).
“I like the study because it reminds us of the importance of not thinking everyone that presents with type 2 diabetes necessarily has garden-variety diabetes,” Paul Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said in an interview. “I have always been concerned when a new-onset diabetic individual presents with no family history of diabetes or prediabetes, especially if they’re neither overweight nor obese. I have sometimes screened those individuals for pancreatic abnormalities.”
A call for screening
“This study highlights the consideration for further screening to those with weight loss at the time of diabetes diagnosis, which is very sensible given how unusual weight loss is as a presenting symptom at the time of diagnosis of typical type 2 diabetes,” Dr. Jellinger added. “The combination of weight loss and no family history of diabetes at the time of diagnosis should be an even stronger signal for pancreatic cancer screening and potential detection at a much earlier stage.”
The authors acknowledged their study’s limitations, including some patients with pancreatic cancer not returning their questionnaires and the timing of the questionnaires meaning that patients could’ve developed diabetes after returning it. In addition, they recognized that the participants were “predominantly White health professionals” and recommended a study of “additional patient populations” in the future.
The authors noted numerous potential conflicts of interest, including receiving grants and personal fees from various initiatives, organizations, and pharmaceutical companies.
SOURCE: Yuan C et al. JAMA Oncol. 2020 Aug 13. doi: 10.1001/jamaoncol.2020.2948.
FROM JAMA ONCOLOGY
Evidence mounts for COVID-19 effects on thyroid gland
Rates of thyrotoxicosis are significantly higher among patients who are critically ill with COVID-19 than among patients who are critically ill but who do not not have COVID-19, suggesting an atypical form of thyroiditis related to the novel coronavirus infection, according to new research.
“We suggest routine assessment of thyroid function in patients with COVID-19 requiring high-intensity care because they frequently present with thyrotoxicosis due to a form of subacute thyroiditis related to SARS-CoV-2,” the authors wrote in correspondence published online in The Lancet Diabetes and Endocrinology.
However, notably, the study – which compared critically ill ICU patients who had COVID-19 with those who did not have COVID-19 or who had milder cases of COVID-19 – indicates that thyroid disorders do not appear to increase the risk of developing COVID-19, first author Ilaria Muller, MD, PhD, of the department of endocrinology, IRCCS Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Milan, said in an interview.
“It is important to highlight that we did not find an increased prevalence of preexisting thyroid disorders in COVID-19 patients (contrary to early media reports),” she said. “So far, clinical observations do not support this fear, and we need to reassure people with thyroid disorders, since such disorders are very common among the general population.”
Yet the findings add to emerging evidence of a COVID-19/thyroid relationship, Angela M. Leung, MD, said in an interview.
“Given the health care impacts of the current COVID-19 pandemic worldwide, this study provides some insight on the potential systemic inflammation, as well as thyroid-specific inflammation, of the SARS-Cov-2 virus that is described in some emerging reports,” she said.
“This study joins at least six others that have reported a clinical presentation resembling subacute thyroiditis in critically ill patients with COVID-19,” noted Dr. Leung, of the division of endocrinology, diabetes, and metabolism in the department of medicine at the University of California, Los Angeles.
Thyroid function analysis in those with severe COVID-19
Dr. Muller explained that preliminary data from her institution showed thyroid abnormalities in patients who were severely ill with COVID-19. She and her team extended the evaluation to include thyroid data and other data on 93 patients with COVID-19 who were admitted to high-intensity care units (HICUs) in Italy during the 2020 pandemic.
Those data were compared with data on 101 critically ill patients admitted to the same HICUs in 2019 who did not have COVID-19. A third group of 52 patients with COVID-19 who were admitted to low-intensity care units (LICUs) in Italy in 2020 were also included in the analysis.
The mean age of the patients in the HICU 2020 group was 65.3 years; in the HICU 2019 group, it was 73 years; and in the LICU group, it was 70 years (P = .001). In addition, the HICU 2020 group included more men than the other two groups (69% vs. 56% and 48%; P = .03).
Of note, only 9% of patients in the HICU 2020 group had preexisting thyroid disorders, compared with 21% in the LICU group and 23% in the HICU 2019 group (P = .017).
These findings suggest that “such conditions are not a risk factor for SARS-CoV-2 infection or severity of COVID-19,” the authors wrote.
The patients with the preexisting thyroid conditions were excluded from the thyroid function analysis.
A significantly higher proportion of patients in the HICU 2020 group (13; 15%) were thyrotoxic upon admission, compared with just 1 (1%) of 78 patients in the HICU 2019 group (P = .002) and one (2%) of 41 patients in the LICU group (P = .025).
Among the 14 patients in the two COVID-19 groups who had thyrotoxicosis, the majority were male (9; 64%)
Among those in the HICU 2020 group, serum thyroid-stimulating hormone concentrations were lower than in either of the other two groups (P = .018), and serum free thyroxine (free T4) concentrations were higher than in the LICU group (P = .016) but not the HICU 2019 group.
Differences compared with other infection-related thyroiditis
Although thyrotoxicosis relating to subacute viral thyroiditis can result from a wide variety of viral infections, there are some key differences with COVID-19, Dr. Muller said.
“Thyroid dysfunction related to SARS-CoV-2 seems to be milder than that of classic subacute thyroiditis due to other viruses,” she explained. Furthermore, thyroid dysfunction associated with other viral infections is more common in women, whereas there were more male patients with the COVID-19–related atypical thyroiditis.
In addition, the thyroid effects developed early with COVID-19, whereas they usually emerge after the infections by other viruses.
Patients did not demonstrate the neck pain that is common with classic viral thyroiditis, and the thyroid abnormalities appear to correlate with the severity of COVID-19, whereas they are seen even in patients with mild symptoms when other viral infections are the cause.
In addition to the risk for subacute viral thyroiditis, critically ill patients in general are at risk of developing nonthyroidal illness syndrome, with alterations in thyroid function. However, thyroid hormone measures in the patients severely ill with COVID-19 were not consistent with that syndrome.
A subanalysis of eight HICU 2020 patients with thyroid dysfunction who were followed for 55 days after discharge showed that two experienced hyperthyroidism but likely not from COVID-19; in the remaining six, thyroid function normalized.
Muller speculated that, when ill with COVID-19, the patients likely had a combination of SARS-CoV-2–related atypical thyroiditis and nonthyroidal illness syndrome, known as T4 toxicosis.
Will there be any long-term effects?
Importantly, it remains unknown whether the novel coronavirus has longer-term effects on the thyroid, Dr. Muller said.
“We cannot predict what will be the long-lasting thyroid effects after COVID-19,” she said.
With classic subacute viral thyroiditis, “After a few years ... 5%-20% of patients develop permanent hypothyroidism, [and] the same might happen in COVID-19 patients,” she hypothesized. “We will follow our patients long term to answer this question – this study is already ongoing.”
In the meantime, diagnosis of thyroid dysfunction in patients with COVID-19 is important, inasmuch as it could worsen the already critical conditions of patients, Muller stressed.
“The gold-standard treatment for thyroiditis is steroids, so the presence of thyroid dysfunction might represent an additional indication to such treatment in COVID-19 patients, to be verified in properly designed clinical trials,” she advised.
ACE2 cell receptors highly expressed in thyroid
Dr. Muller and colleagues also noted recent research showing that ACE2 – demonstrated to be a key host-cell entry receptor for both SARS-CoV and SARS-CoV-2 – is expressed in even higher levels in the thyroid than the lungs, where it causes COVID-19’s notorious pulmonary effects.
Dr. Muller said the implications of ACE2 expression in the thyroid remain to be elucidated.
“If ACE2 is confirmed to be expressed at higher levels, compared with the lungs in the thyroid gland and other tissues, i.e., small intestine, testis, kidney, heart, etc, dedicated studies will be needed to correlate ACE2 expression with the organs’ susceptibility to SARS-CoV-2 reflected by clinical presentation,” she said.
Dr. Leung added that, as a take-home message from these and the other thyroid/COVID-19 studies, “data are starting to show us that COVID-19 infection may cause thyrotoxicosis that is possibly related to thyroid and systemic inflammation. However, the serum thyroid function test abnormalities seen in COVID-19 patients with subacute thyroiditis are also likely exacerbated to a substantial extent by nonthyroidal illness physiology.”
The authors have disclosed no relevant financial relationships. Dr. Leung is on the advisory board of Medscape Diabetes and Endocrinology.
A version of this article originally appeared on Medscape.com.
Rates of thyrotoxicosis are significantly higher among patients who are critically ill with COVID-19 than among patients who are critically ill but who do not not have COVID-19, suggesting an atypical form of thyroiditis related to the novel coronavirus infection, according to new research.
“We suggest routine assessment of thyroid function in patients with COVID-19 requiring high-intensity care because they frequently present with thyrotoxicosis due to a form of subacute thyroiditis related to SARS-CoV-2,” the authors wrote in correspondence published online in The Lancet Diabetes and Endocrinology.
However, notably, the study – which compared critically ill ICU patients who had COVID-19 with those who did not have COVID-19 or who had milder cases of COVID-19 – indicates that thyroid disorders do not appear to increase the risk of developing COVID-19, first author Ilaria Muller, MD, PhD, of the department of endocrinology, IRCCS Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Milan, said in an interview.
“It is important to highlight that we did not find an increased prevalence of preexisting thyroid disorders in COVID-19 patients (contrary to early media reports),” she said. “So far, clinical observations do not support this fear, and we need to reassure people with thyroid disorders, since such disorders are very common among the general population.”
Yet the findings add to emerging evidence of a COVID-19/thyroid relationship, Angela M. Leung, MD, said in an interview.
“Given the health care impacts of the current COVID-19 pandemic worldwide, this study provides some insight on the potential systemic inflammation, as well as thyroid-specific inflammation, of the SARS-Cov-2 virus that is described in some emerging reports,” she said.
“This study joins at least six others that have reported a clinical presentation resembling subacute thyroiditis in critically ill patients with COVID-19,” noted Dr. Leung, of the division of endocrinology, diabetes, and metabolism in the department of medicine at the University of California, Los Angeles.
Thyroid function analysis in those with severe COVID-19
Dr. Muller explained that preliminary data from her institution showed thyroid abnormalities in patients who were severely ill with COVID-19. She and her team extended the evaluation to include thyroid data and other data on 93 patients with COVID-19 who were admitted to high-intensity care units (HICUs) in Italy during the 2020 pandemic.
Those data were compared with data on 101 critically ill patients admitted to the same HICUs in 2019 who did not have COVID-19. A third group of 52 patients with COVID-19 who were admitted to low-intensity care units (LICUs) in Italy in 2020 were also included in the analysis.
The mean age of the patients in the HICU 2020 group was 65.3 years; in the HICU 2019 group, it was 73 years; and in the LICU group, it was 70 years (P = .001). In addition, the HICU 2020 group included more men than the other two groups (69% vs. 56% and 48%; P = .03).
Of note, only 9% of patients in the HICU 2020 group had preexisting thyroid disorders, compared with 21% in the LICU group and 23% in the HICU 2019 group (P = .017).
These findings suggest that “such conditions are not a risk factor for SARS-CoV-2 infection or severity of COVID-19,” the authors wrote.
The patients with the preexisting thyroid conditions were excluded from the thyroid function analysis.
A significantly higher proportion of patients in the HICU 2020 group (13; 15%) were thyrotoxic upon admission, compared with just 1 (1%) of 78 patients in the HICU 2019 group (P = .002) and one (2%) of 41 patients in the LICU group (P = .025).
Among the 14 patients in the two COVID-19 groups who had thyrotoxicosis, the majority were male (9; 64%)
Among those in the HICU 2020 group, serum thyroid-stimulating hormone concentrations were lower than in either of the other two groups (P = .018), and serum free thyroxine (free T4) concentrations were higher than in the LICU group (P = .016) but not the HICU 2019 group.
Differences compared with other infection-related thyroiditis
Although thyrotoxicosis relating to subacute viral thyroiditis can result from a wide variety of viral infections, there are some key differences with COVID-19, Dr. Muller said.
“Thyroid dysfunction related to SARS-CoV-2 seems to be milder than that of classic subacute thyroiditis due to other viruses,” she explained. Furthermore, thyroid dysfunction associated with other viral infections is more common in women, whereas there were more male patients with the COVID-19–related atypical thyroiditis.
In addition, the thyroid effects developed early with COVID-19, whereas they usually emerge after the infections by other viruses.
Patients did not demonstrate the neck pain that is common with classic viral thyroiditis, and the thyroid abnormalities appear to correlate with the severity of COVID-19, whereas they are seen even in patients with mild symptoms when other viral infections are the cause.
In addition to the risk for subacute viral thyroiditis, critically ill patients in general are at risk of developing nonthyroidal illness syndrome, with alterations in thyroid function. However, thyroid hormone measures in the patients severely ill with COVID-19 were not consistent with that syndrome.
A subanalysis of eight HICU 2020 patients with thyroid dysfunction who were followed for 55 days after discharge showed that two experienced hyperthyroidism but likely not from COVID-19; in the remaining six, thyroid function normalized.
Muller speculated that, when ill with COVID-19, the patients likely had a combination of SARS-CoV-2–related atypical thyroiditis and nonthyroidal illness syndrome, known as T4 toxicosis.
Will there be any long-term effects?
Importantly, it remains unknown whether the novel coronavirus has longer-term effects on the thyroid, Dr. Muller said.
“We cannot predict what will be the long-lasting thyroid effects after COVID-19,” she said.
With classic subacute viral thyroiditis, “After a few years ... 5%-20% of patients develop permanent hypothyroidism, [and] the same might happen in COVID-19 patients,” she hypothesized. “We will follow our patients long term to answer this question – this study is already ongoing.”
In the meantime, diagnosis of thyroid dysfunction in patients with COVID-19 is important, inasmuch as it could worsen the already critical conditions of patients, Muller stressed.
“The gold-standard treatment for thyroiditis is steroids, so the presence of thyroid dysfunction might represent an additional indication to such treatment in COVID-19 patients, to be verified in properly designed clinical trials,” she advised.
ACE2 cell receptors highly expressed in thyroid
Dr. Muller and colleagues also noted recent research showing that ACE2 – demonstrated to be a key host-cell entry receptor for both SARS-CoV and SARS-CoV-2 – is expressed in even higher levels in the thyroid than the lungs, where it causes COVID-19’s notorious pulmonary effects.
Dr. Muller said the implications of ACE2 expression in the thyroid remain to be elucidated.
“If ACE2 is confirmed to be expressed at higher levels, compared with the lungs in the thyroid gland and other tissues, i.e., small intestine, testis, kidney, heart, etc, dedicated studies will be needed to correlate ACE2 expression with the organs’ susceptibility to SARS-CoV-2 reflected by clinical presentation,” she said.
Dr. Leung added that, as a take-home message from these and the other thyroid/COVID-19 studies, “data are starting to show us that COVID-19 infection may cause thyrotoxicosis that is possibly related to thyroid and systemic inflammation. However, the serum thyroid function test abnormalities seen in COVID-19 patients with subacute thyroiditis are also likely exacerbated to a substantial extent by nonthyroidal illness physiology.”
The authors have disclosed no relevant financial relationships. Dr. Leung is on the advisory board of Medscape Diabetes and Endocrinology.
A version of this article originally appeared on Medscape.com.
Rates of thyrotoxicosis are significantly higher among patients who are critically ill with COVID-19 than among patients who are critically ill but who do not not have COVID-19, suggesting an atypical form of thyroiditis related to the novel coronavirus infection, according to new research.
“We suggest routine assessment of thyroid function in patients with COVID-19 requiring high-intensity care because they frequently present with thyrotoxicosis due to a form of subacute thyroiditis related to SARS-CoV-2,” the authors wrote in correspondence published online in The Lancet Diabetes and Endocrinology.
However, notably, the study – which compared critically ill ICU patients who had COVID-19 with those who did not have COVID-19 or who had milder cases of COVID-19 – indicates that thyroid disorders do not appear to increase the risk of developing COVID-19, first author Ilaria Muller, MD, PhD, of the department of endocrinology, IRCCS Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Milan, said in an interview.
“It is important to highlight that we did not find an increased prevalence of preexisting thyroid disorders in COVID-19 patients (contrary to early media reports),” she said. “So far, clinical observations do not support this fear, and we need to reassure people with thyroid disorders, since such disorders are very common among the general population.”
Yet the findings add to emerging evidence of a COVID-19/thyroid relationship, Angela M. Leung, MD, said in an interview.
“Given the health care impacts of the current COVID-19 pandemic worldwide, this study provides some insight on the potential systemic inflammation, as well as thyroid-specific inflammation, of the SARS-Cov-2 virus that is described in some emerging reports,” she said.
“This study joins at least six others that have reported a clinical presentation resembling subacute thyroiditis in critically ill patients with COVID-19,” noted Dr. Leung, of the division of endocrinology, diabetes, and metabolism in the department of medicine at the University of California, Los Angeles.
Thyroid function analysis in those with severe COVID-19
Dr. Muller explained that preliminary data from her institution showed thyroid abnormalities in patients who were severely ill with COVID-19. She and her team extended the evaluation to include thyroid data and other data on 93 patients with COVID-19 who were admitted to high-intensity care units (HICUs) in Italy during the 2020 pandemic.
Those data were compared with data on 101 critically ill patients admitted to the same HICUs in 2019 who did not have COVID-19. A third group of 52 patients with COVID-19 who were admitted to low-intensity care units (LICUs) in Italy in 2020 were also included in the analysis.
The mean age of the patients in the HICU 2020 group was 65.3 years; in the HICU 2019 group, it was 73 years; and in the LICU group, it was 70 years (P = .001). In addition, the HICU 2020 group included more men than the other two groups (69% vs. 56% and 48%; P = .03).
Of note, only 9% of patients in the HICU 2020 group had preexisting thyroid disorders, compared with 21% in the LICU group and 23% in the HICU 2019 group (P = .017).
These findings suggest that “such conditions are not a risk factor for SARS-CoV-2 infection or severity of COVID-19,” the authors wrote.
The patients with the preexisting thyroid conditions were excluded from the thyroid function analysis.
A significantly higher proportion of patients in the HICU 2020 group (13; 15%) were thyrotoxic upon admission, compared with just 1 (1%) of 78 patients in the HICU 2019 group (P = .002) and one (2%) of 41 patients in the LICU group (P = .025).
Among the 14 patients in the two COVID-19 groups who had thyrotoxicosis, the majority were male (9; 64%)
Among those in the HICU 2020 group, serum thyroid-stimulating hormone concentrations were lower than in either of the other two groups (P = .018), and serum free thyroxine (free T4) concentrations were higher than in the LICU group (P = .016) but not the HICU 2019 group.
Differences compared with other infection-related thyroiditis
Although thyrotoxicosis relating to subacute viral thyroiditis can result from a wide variety of viral infections, there are some key differences with COVID-19, Dr. Muller said.
“Thyroid dysfunction related to SARS-CoV-2 seems to be milder than that of classic subacute thyroiditis due to other viruses,” she explained. Furthermore, thyroid dysfunction associated with other viral infections is more common in women, whereas there were more male patients with the COVID-19–related atypical thyroiditis.
In addition, the thyroid effects developed early with COVID-19, whereas they usually emerge after the infections by other viruses.
Patients did not demonstrate the neck pain that is common with classic viral thyroiditis, and the thyroid abnormalities appear to correlate with the severity of COVID-19, whereas they are seen even in patients with mild symptoms when other viral infections are the cause.
In addition to the risk for subacute viral thyroiditis, critically ill patients in general are at risk of developing nonthyroidal illness syndrome, with alterations in thyroid function. However, thyroid hormone measures in the patients severely ill with COVID-19 were not consistent with that syndrome.
A subanalysis of eight HICU 2020 patients with thyroid dysfunction who were followed for 55 days after discharge showed that two experienced hyperthyroidism but likely not from COVID-19; in the remaining six, thyroid function normalized.
Muller speculated that, when ill with COVID-19, the patients likely had a combination of SARS-CoV-2–related atypical thyroiditis and nonthyroidal illness syndrome, known as T4 toxicosis.
Will there be any long-term effects?
Importantly, it remains unknown whether the novel coronavirus has longer-term effects on the thyroid, Dr. Muller said.
“We cannot predict what will be the long-lasting thyroid effects after COVID-19,” she said.
With classic subacute viral thyroiditis, “After a few years ... 5%-20% of patients develop permanent hypothyroidism, [and] the same might happen in COVID-19 patients,” she hypothesized. “We will follow our patients long term to answer this question – this study is already ongoing.”
In the meantime, diagnosis of thyroid dysfunction in patients with COVID-19 is important, inasmuch as it could worsen the already critical conditions of patients, Muller stressed.
“The gold-standard treatment for thyroiditis is steroids, so the presence of thyroid dysfunction might represent an additional indication to such treatment in COVID-19 patients, to be verified in properly designed clinical trials,” she advised.
ACE2 cell receptors highly expressed in thyroid
Dr. Muller and colleagues also noted recent research showing that ACE2 – demonstrated to be a key host-cell entry receptor for both SARS-CoV and SARS-CoV-2 – is expressed in even higher levels in the thyroid than the lungs, where it causes COVID-19’s notorious pulmonary effects.
Dr. Muller said the implications of ACE2 expression in the thyroid remain to be elucidated.
“If ACE2 is confirmed to be expressed at higher levels, compared with the lungs in the thyroid gland and other tissues, i.e., small intestine, testis, kidney, heart, etc, dedicated studies will be needed to correlate ACE2 expression with the organs’ susceptibility to SARS-CoV-2 reflected by clinical presentation,” she said.
Dr. Leung added that, as a take-home message from these and the other thyroid/COVID-19 studies, “data are starting to show us that COVID-19 infection may cause thyrotoxicosis that is possibly related to thyroid and systemic inflammation. However, the serum thyroid function test abnormalities seen in COVID-19 patients with subacute thyroiditis are also likely exacerbated to a substantial extent by nonthyroidal illness physiology.”
The authors have disclosed no relevant financial relationships. Dr. Leung is on the advisory board of Medscape Diabetes and Endocrinology.
A version of this article originally appeared on Medscape.com.
Non-COVID-19 clinical trials grind to a halt during pandemic
The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.
A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.
“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.
The analysis was published online July 31 in the Journal of the American College of Cardiology.
The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”
The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).
Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”
He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.
“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”
As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”
He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.
The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.
Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.
“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.
“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
Stopped for lack of funding
Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.
The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.
Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.
The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.
Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.
“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.
In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.
At what cost? It will take years to sort that out, he said.
This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.
A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.
“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.
The analysis was published online July 31 in the Journal of the American College of Cardiology.
The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”
The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).
Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”
He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.
“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”
As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”
He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.
The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.
Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.
“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.
“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
Stopped for lack of funding
Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.
The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.
Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.
The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.
Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.
“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.
In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.
At what cost? It will take years to sort that out, he said.
This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.
A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.
“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.
The analysis was published online July 31 in the Journal of the American College of Cardiology.
The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”
The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).
Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”
He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.
“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”
As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”
He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.
The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.
Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.
“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.
“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
Stopped for lack of funding
Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.
The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.
Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.
The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.
Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.
“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.
In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.
At what cost? It will take years to sort that out, he said.
This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
A version of this article originally appeared on Medscape.com.
Send kids to school safely if possible, supplement virtually
The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.
“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.
“Importantly, K-12 virtual schooling is not suited for all students or all families.”
In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
Not all virtual schools are equal
Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.
“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.
Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).
“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
Schools may be able to open safely
Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.
Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.
The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.
“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.
“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”
The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”
“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
Schools opening is a regional decision
“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”
“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.
“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”
In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.
“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.
Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”
The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”
“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.
“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
It’s not just about education
“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.
“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.
However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”
“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.
“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.
“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”
“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”
“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”
The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”
Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.
The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.
SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.
“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.
“Importantly, K-12 virtual schooling is not suited for all students or all families.”
In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
Not all virtual schools are equal
Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.
“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.
Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).
“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
Schools may be able to open safely
Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.
Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.
The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.
“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.
“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”
The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”
“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
Schools opening is a regional decision
“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”
“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.
“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”
In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.
“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.
Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”
The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”
“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.
“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
It’s not just about education
“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.
“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.
However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”
“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.
“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.
“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”
“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”
“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”
The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”
Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.
The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.
SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.
“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.
“Importantly, K-12 virtual schooling is not suited for all students or all families.”
In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
Not all virtual schools are equal
Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.
“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.
Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).
“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
Schools may be able to open safely
Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.
Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.
The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.
“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.
“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”
The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”
“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
Schools opening is a regional decision
“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”
“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.
“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”
In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.
“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.
Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”
The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”
“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.
“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
It’s not just about education
“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.
“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.
However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”
“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.
“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.
“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”
“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”
“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”
The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”
Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.
The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.
SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
FROM JAMA PEDIATRICS
Severe obesity ups risk for death in younger men with COVID-19
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
Only 40% of residents said training prepped them for COVID-19
Most residents who were asked whether their training prepared them for COVID-19 in a Medscape survey said it had not or they weren’t sure.
Whereas 40% said they felt prepared, 30% said they did not feel prepared and 31% answered they were unsure. (Numbers were rounded, so some answers pushed above 100%.)
One quarter have $300,000 or more in student debt
The Medscape Residents Salary & Debt Report 2020, with data collected April 3 to June 1, found that nearly one in four residents (24%) had medical school debt of more than $300,000. Half (49%) had more than $200,000.
The data include answers from 1,659 U.S. medical residents.
For the sixth straight year, female residents were more satisfied with their pay than were their male colleagues. This year the satisfaction gap was 45% female compared with 42% male. That imbalance came despite their making nearly the same pay overall ($63,700 for men and $63,000 for women).
Among practicing physicians, the pay gap is much wider: Men make 25% more in primary care and 31% more in specialties.
Ten percent thought they should earn 76%-100% more.
For those not satisfied with pay, the top reasons were feeling the pay was too low for the hours worked (81%) or too low compared with other medical staff, such as physician assistants (PAs) or nurses (77% chose that answer).
As for hours worked, 31% of residents reported they spend more than 60 hours/week seeing patients.
The top-paying specialties, averaging $69,500, were allergy and immunology, hematology, plastic surgery, aesthetic medicine, rheumatology, and specialized surgery. The lowest paid were family medicine residents at $58,500.
In primary care, overall, most residents said they planned to specialize. Only 47% planned to continue to work in primary care. Male residents were much more likely to say they will subspecialize than were their female colleagues (52% vs. 35%).
More than 90% of residents say future pay has influenced their choice of specialty, though more men than women felt that way (93% vs. 86%).
Good relationships with others
Overall, residents reported good relationships with attending physicians and nurses.
Most (88%) said they had good or very good relationships with attending physicians, 10% said the relationships were fair, and 2% said they were poor.
In addition, 89% of residents said the amount of supervision was appropriate, 4% said there was too much, and 7% said there was too little.
Relationships with nurses/PAs were slightly less positive overall: Eighty-two percent reported good or very good relationships with nurses/PAs, 15% said those relationships were fair, and 3% said they were poor.
One respondent said: “Our relationships could be better, but I think everyone is just overwhelmed with COVID-19, so emotions are heightened.”
Another said: “It takes time to earn the respect from nurses.”
Seventy-seven percent said they were satisfied with their learning experience overall, 12% were neutral on the question, and 11% said they were dissatisfied or very dissatisfied.
Work-life balance is the top concern
Work-life balance continues to be the top concern for residents. More than one-quarter (27%) in residency years 1 through 4 listed that as the top concern, and even more (32%) of those in years 5 through 8 agreed.
That was followed by demands on time and fear of failure or making a serious mistake.
The survey indicates that benefit packages for residents have stayed much the same over the past 2 years with health insurance and paid time off for sick leave, vacation, and personal time most commonly reported at 89% and 87%, respectively.
Much less common were benefits including commuter assistance (parking, public transportation) at 24%, housing allowance (8%), and child care (4%).
The vast majority of residents reported doing scut work (unskilled tasks): More than half (54%) reported doing 1-10 hours/week and 22% did 11-20 hours/week. Regardless of the number of hours, however, 62% said the time spent performing these tasks was appropriate.
A version of this article originally appeared on Medscape.com.
Most residents who were asked whether their training prepared them for COVID-19 in a Medscape survey said it had not or they weren’t sure.
Whereas 40% said they felt prepared, 30% said they did not feel prepared and 31% answered they were unsure. (Numbers were rounded, so some answers pushed above 100%.)
One quarter have $300,000 or more in student debt
The Medscape Residents Salary & Debt Report 2020, with data collected April 3 to June 1, found that nearly one in four residents (24%) had medical school debt of more than $300,000. Half (49%) had more than $200,000.
The data include answers from 1,659 U.S. medical residents.
For the sixth straight year, female residents were more satisfied with their pay than were their male colleagues. This year the satisfaction gap was 45% female compared with 42% male. That imbalance came despite their making nearly the same pay overall ($63,700 for men and $63,000 for women).
Among practicing physicians, the pay gap is much wider: Men make 25% more in primary care and 31% more in specialties.
Ten percent thought they should earn 76%-100% more.
For those not satisfied with pay, the top reasons were feeling the pay was too low for the hours worked (81%) or too low compared with other medical staff, such as physician assistants (PAs) or nurses (77% chose that answer).
As for hours worked, 31% of residents reported they spend more than 60 hours/week seeing patients.
The top-paying specialties, averaging $69,500, were allergy and immunology, hematology, plastic surgery, aesthetic medicine, rheumatology, and specialized surgery. The lowest paid were family medicine residents at $58,500.
In primary care, overall, most residents said they planned to specialize. Only 47% planned to continue to work in primary care. Male residents were much more likely to say they will subspecialize than were their female colleagues (52% vs. 35%).
More than 90% of residents say future pay has influenced their choice of specialty, though more men than women felt that way (93% vs. 86%).
Good relationships with others
Overall, residents reported good relationships with attending physicians and nurses.
Most (88%) said they had good or very good relationships with attending physicians, 10% said the relationships were fair, and 2% said they were poor.
In addition, 89% of residents said the amount of supervision was appropriate, 4% said there was too much, and 7% said there was too little.
Relationships with nurses/PAs were slightly less positive overall: Eighty-two percent reported good or very good relationships with nurses/PAs, 15% said those relationships were fair, and 3% said they were poor.
One respondent said: “Our relationships could be better, but I think everyone is just overwhelmed with COVID-19, so emotions are heightened.”
Another said: “It takes time to earn the respect from nurses.”
Seventy-seven percent said they were satisfied with their learning experience overall, 12% were neutral on the question, and 11% said they were dissatisfied or very dissatisfied.
Work-life balance is the top concern
Work-life balance continues to be the top concern for residents. More than one-quarter (27%) in residency years 1 through 4 listed that as the top concern, and even more (32%) of those in years 5 through 8 agreed.
That was followed by demands on time and fear of failure or making a serious mistake.
The survey indicates that benefit packages for residents have stayed much the same over the past 2 years with health insurance and paid time off for sick leave, vacation, and personal time most commonly reported at 89% and 87%, respectively.
Much less common were benefits including commuter assistance (parking, public transportation) at 24%, housing allowance (8%), and child care (4%).
The vast majority of residents reported doing scut work (unskilled tasks): More than half (54%) reported doing 1-10 hours/week and 22% did 11-20 hours/week. Regardless of the number of hours, however, 62% said the time spent performing these tasks was appropriate.
A version of this article originally appeared on Medscape.com.
Most residents who were asked whether their training prepared them for COVID-19 in a Medscape survey said it had not or they weren’t sure.
Whereas 40% said they felt prepared, 30% said they did not feel prepared and 31% answered they were unsure. (Numbers were rounded, so some answers pushed above 100%.)
One quarter have $300,000 or more in student debt
The Medscape Residents Salary & Debt Report 2020, with data collected April 3 to June 1, found that nearly one in four residents (24%) had medical school debt of more than $300,000. Half (49%) had more than $200,000.
The data include answers from 1,659 U.S. medical residents.
For the sixth straight year, female residents were more satisfied with their pay than were their male colleagues. This year the satisfaction gap was 45% female compared with 42% male. That imbalance came despite their making nearly the same pay overall ($63,700 for men and $63,000 for women).
Among practicing physicians, the pay gap is much wider: Men make 25% more in primary care and 31% more in specialties.
Ten percent thought they should earn 76%-100% more.
For those not satisfied with pay, the top reasons were feeling the pay was too low for the hours worked (81%) or too low compared with other medical staff, such as physician assistants (PAs) or nurses (77% chose that answer).
As for hours worked, 31% of residents reported they spend more than 60 hours/week seeing patients.
The top-paying specialties, averaging $69,500, were allergy and immunology, hematology, plastic surgery, aesthetic medicine, rheumatology, and specialized surgery. The lowest paid were family medicine residents at $58,500.
In primary care, overall, most residents said they planned to specialize. Only 47% planned to continue to work in primary care. Male residents were much more likely to say they will subspecialize than were their female colleagues (52% vs. 35%).
More than 90% of residents say future pay has influenced their choice of specialty, though more men than women felt that way (93% vs. 86%).
Good relationships with others
Overall, residents reported good relationships with attending physicians and nurses.
Most (88%) said they had good or very good relationships with attending physicians, 10% said the relationships were fair, and 2% said they were poor.
In addition, 89% of residents said the amount of supervision was appropriate, 4% said there was too much, and 7% said there was too little.
Relationships with nurses/PAs were slightly less positive overall: Eighty-two percent reported good or very good relationships with nurses/PAs, 15% said those relationships were fair, and 3% said they were poor.
One respondent said: “Our relationships could be better, but I think everyone is just overwhelmed with COVID-19, so emotions are heightened.”
Another said: “It takes time to earn the respect from nurses.”
Seventy-seven percent said they were satisfied with their learning experience overall, 12% were neutral on the question, and 11% said they were dissatisfied or very dissatisfied.
Work-life balance is the top concern
Work-life balance continues to be the top concern for residents. More than one-quarter (27%) in residency years 1 through 4 listed that as the top concern, and even more (32%) of those in years 5 through 8 agreed.
That was followed by demands on time and fear of failure or making a serious mistake.
The survey indicates that benefit packages for residents have stayed much the same over the past 2 years with health insurance and paid time off for sick leave, vacation, and personal time most commonly reported at 89% and 87%, respectively.
Much less common were benefits including commuter assistance (parking, public transportation) at 24%, housing allowance (8%), and child care (4%).
The vast majority of residents reported doing scut work (unskilled tasks): More than half (54%) reported doing 1-10 hours/week and 22% did 11-20 hours/week. Regardless of the number of hours, however, 62% said the time spent performing these tasks was appropriate.
A version of this article originally appeared on Medscape.com.