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Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.

“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.

Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible – an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.

The cost of joint replacement surgery varies widely – though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.

The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.

Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March – and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.

“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.

It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.

But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.

That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.

If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.

The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.

Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.

At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.

At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May – cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.

In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.

The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.

In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.

The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.

It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers – especially on younger, healthier patients who don’t require hospitalization.

The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.

“[G]enerally the savings should be very good – but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money – $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.

Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.

“That was key to me – avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”

Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.

However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.

“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”

McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’ ”

This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation.

Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.

“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.

Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible – an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.

The cost of joint replacement surgery varies widely – though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.

The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.

Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March – and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.

“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.

It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.

But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.

That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.

If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.

The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.

Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.

At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.

At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May – cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.

In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.

The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.

In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.

The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.

It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers – especially on younger, healthier patients who don’t require hospitalization.

The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.

“[G]enerally the savings should be very good – but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money – $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.

Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.

“That was key to me – avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”

Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.

However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.

“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”

McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’ ”

This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation.

Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.

“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.

Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible – an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.

The cost of joint replacement surgery varies widely – though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.

The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.

Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March – and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.

“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.

It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.

But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.

That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.

If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.

The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.

Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.

At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.

At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May – cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.

In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.

The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.

In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.

The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.

It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers – especially on younger, healthier patients who don’t require hospitalization.

The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.

“[G]enerally the savings should be very good – but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money – $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.

Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.

“That was key to me – avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”

Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.

However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.

“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”

McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’ ”

This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation.

Findings from a large randomized, controlled trial do not support the use of vitamin D3 supplementation for adults for the sole purpose of preventing depression.

Among adults aged 50 years or older who were without clinically relevant depressive symptoms at baseline, vitamin D3 supplementation taken over 5 years did not reduce the risk for depression or make a difference in the quality of mood.

“The study is among the largest of its kind ever, and it was able to address whether vitamin D3 supplementation is useful for what we call ‘universal prevention’ of depression,” Olivia Okereke, MD, Massachusetts General Hospital, Boston, said in an interview.

“These results tell us that there is no benefit to using vitamin D3 supplements for the sole purpose of preventing depression in the general population of middle-aged and older adults,” said Dr. Okereke.

“Because of the high dose and long duration of treatment and the randomized placebo-controlled design, we can have high confidence in results,” she added.

The study was published online August 4 in JAMA.
 

The VITAL-DEP trial

The findings are based on 18,353 older adults (mean age, 67.5 years; 49% women) in the VITAL-DEP study; 16,657 were at risk for incident depression (ie, had no history of depression), and 1696 were at risk for recurrent depression (i.e., had a history of depression but had not undergone treatment for depression within the past 2 years).

Roughly half were randomly allocated to receive vitamin D3 (2000 IU/d of cholecalciferol) and half to receive matching placebo for a median of 5.3 years. The participants’ mean level of 25-hydroxyvitamin D was 31.1 ng/mL; for about 12%, levels were lower than 20 ng/mL.

The risk for depression or clinically relevant depressive symptoms (total of incident and recurrent cases) was not significantly different between the vitamin D3 group (609 depression or clinically relevant depressive symptom events; 12.9/1000 person-years) and the placebo group (625 depression or clinically relevant depressive symptom events; 13.3/1000 person-years). The hazard ratio was 0.97 (95% confidence interval, 0.87-1.09; P = .62).

“Cumulative incidence curves showed lack of separation between treatment groups over the entire follow-up,” the researchers report.

There was also no significant between-group difference in the other primary outcome – the mean difference in mood scores on the eight-item Patient Health Questionnaire depression scale (PHQ-8).

The mean difference for change between treatment groups in PHQ-8 scores was not significantly different from 0 over the entire follow-up (0.01 points; 95% CI, −0.04 to 0.05 points) or at any point during follow-up.

To date, 13 randomized clinical trials have examined the effects of vitamin D3 supplementation on depression or mood during middle age or in older adults, and all except one reported null findings, Dr. Okereke and colleagues noted in their article.

The current study is the only one large enough to examine vitamin D3 supplementation for the universal prevention of depression, they point out.

Although the findings do not support vitamin D3 supplementation for depression prevention, Dr. Okereke said, “we cannot yet exclude the possibility of benefit of vitamin D3 for preventing depression among subgroups with certain health risk factors. We also know that vitamin D is essential for bone health, and this study does not tell us whether vitamin D3 is useful for prevention of other health outcomes.”

VITAL-DEP was supported by a grant from the National Institute of Mental Health. Pharmavite donated the vitamin D3, matching placebos, and packaging in the form of calendar packs. Dr. Okereke reported receiving royalties from Springer Publishing for a book on the prevention of late-life depression.

This article first appeared on Medscape.com.

Findings from a large randomized, controlled trial do not support the use of vitamin D3 supplementation for adults for the sole purpose of preventing depression.

Among adults aged 50 years or older who were without clinically relevant depressive symptoms at baseline, vitamin D3 supplementation taken over 5 years did not reduce the risk for depression or make a difference in the quality of mood.

“The study is among the largest of its kind ever, and it was able to address whether vitamin D3 supplementation is useful for what we call ‘universal prevention’ of depression,” Olivia Okereke, MD, Massachusetts General Hospital, Boston, said in an interview.

“These results tell us that there is no benefit to using vitamin D3 supplements for the sole purpose of preventing depression in the general population of middle-aged and older adults,” said Dr. Okereke.

“Because of the high dose and long duration of treatment and the randomized placebo-controlled design, we can have high confidence in results,” she added.

The study was published online August 4 in JAMA.
 

The VITAL-DEP trial

The findings are based on 18,353 older adults (mean age, 67.5 years; 49% women) in the VITAL-DEP study; 16,657 were at risk for incident depression (ie, had no history of depression), and 1696 were at risk for recurrent depression (i.e., had a history of depression but had not undergone treatment for depression within the past 2 years).

Roughly half were randomly allocated to receive vitamin D3 (2000 IU/d of cholecalciferol) and half to receive matching placebo for a median of 5.3 years. The participants’ mean level of 25-hydroxyvitamin D was 31.1 ng/mL; for about 12%, levels were lower than 20 ng/mL.

The risk for depression or clinically relevant depressive symptoms (total of incident and recurrent cases) was not significantly different between the vitamin D3 group (609 depression or clinically relevant depressive symptom events; 12.9/1000 person-years) and the placebo group (625 depression or clinically relevant depressive symptom events; 13.3/1000 person-years). The hazard ratio was 0.97 (95% confidence interval, 0.87-1.09; P = .62).

“Cumulative incidence curves showed lack of separation between treatment groups over the entire follow-up,” the researchers report.

There was also no significant between-group difference in the other primary outcome – the mean difference in mood scores on the eight-item Patient Health Questionnaire depression scale (PHQ-8).

The mean difference for change between treatment groups in PHQ-8 scores was not significantly different from 0 over the entire follow-up (0.01 points; 95% CI, −0.04 to 0.05 points) or at any point during follow-up.

To date, 13 randomized clinical trials have examined the effects of vitamin D3 supplementation on depression or mood during middle age or in older adults, and all except one reported null findings, Dr. Okereke and colleagues noted in their article.

The current study is the only one large enough to examine vitamin D3 supplementation for the universal prevention of depression, they point out.

Although the findings do not support vitamin D3 supplementation for depression prevention, Dr. Okereke said, “we cannot yet exclude the possibility of benefit of vitamin D3 for preventing depression among subgroups with certain health risk factors. We also know that vitamin D is essential for bone health, and this study does not tell us whether vitamin D3 is useful for prevention of other health outcomes.”

VITAL-DEP was supported by a grant from the National Institute of Mental Health. Pharmavite donated the vitamin D3, matching placebos, and packaging in the form of calendar packs. Dr. Okereke reported receiving royalties from Springer Publishing for a book on the prevention of late-life depression.

This article first appeared on Medscape.com.

Findings from a large randomized, controlled trial do not support the use of vitamin D3 supplementation for adults for the sole purpose of preventing depression.

Among adults aged 50 years or older who were without clinically relevant depressive symptoms at baseline, vitamin D3 supplementation taken over 5 years did not reduce the risk for depression or make a difference in the quality of mood.

“The study is among the largest of its kind ever, and it was able to address whether vitamin D3 supplementation is useful for what we call ‘universal prevention’ of depression,” Olivia Okereke, MD, Massachusetts General Hospital, Boston, said in an interview.

“These results tell us that there is no benefit to using vitamin D3 supplements for the sole purpose of preventing depression in the general population of middle-aged and older adults,” said Dr. Okereke.

“Because of the high dose and long duration of treatment and the randomized placebo-controlled design, we can have high confidence in results,” she added.

The study was published online August 4 in JAMA.
 

The VITAL-DEP trial

The findings are based on 18,353 older adults (mean age, 67.5 years; 49% women) in the VITAL-DEP study; 16,657 were at risk for incident depression (ie, had no history of depression), and 1696 were at risk for recurrent depression (i.e., had a history of depression but had not undergone treatment for depression within the past 2 years).

Roughly half were randomly allocated to receive vitamin D3 (2000 IU/d of cholecalciferol) and half to receive matching placebo for a median of 5.3 years. The participants’ mean level of 25-hydroxyvitamin D was 31.1 ng/mL; for about 12%, levels were lower than 20 ng/mL.

The risk for depression or clinically relevant depressive symptoms (total of incident and recurrent cases) was not significantly different between the vitamin D3 group (609 depression or clinically relevant depressive symptom events; 12.9/1000 person-years) and the placebo group (625 depression or clinically relevant depressive symptom events; 13.3/1000 person-years). The hazard ratio was 0.97 (95% confidence interval, 0.87-1.09; P = .62).

“Cumulative incidence curves showed lack of separation between treatment groups over the entire follow-up,” the researchers report.

There was also no significant between-group difference in the other primary outcome – the mean difference in mood scores on the eight-item Patient Health Questionnaire depression scale (PHQ-8).

The mean difference for change between treatment groups in PHQ-8 scores was not significantly different from 0 over the entire follow-up (0.01 points; 95% CI, −0.04 to 0.05 points) or at any point during follow-up.

To date, 13 randomized clinical trials have examined the effects of vitamin D3 supplementation on depression or mood during middle age or in older adults, and all except one reported null findings, Dr. Okereke and colleagues noted in their article.

The current study is the only one large enough to examine vitamin D3 supplementation for the universal prevention of depression, they point out.

Although the findings do not support vitamin D3 supplementation for depression prevention, Dr. Okereke said, “we cannot yet exclude the possibility of benefit of vitamin D3 for preventing depression among subgroups with certain health risk factors. We also know that vitamin D is essential for bone health, and this study does not tell us whether vitamin D3 is useful for prevention of other health outcomes.”

VITAL-DEP was supported by a grant from the National Institute of Mental Health. Pharmavite donated the vitamin D3, matching placebos, and packaging in the form of calendar packs. Dr. Okereke reported receiving royalties from Springer Publishing for a book on the prevention of late-life depression.

This article first appeared on Medscape.com.

When officials closed U.S. schools in March to limit the spread of COVID-19, they may have prevented more than 1 million cases over a 26-day period, a new estimate published online July 29 in JAMA suggests.

But school closures also left blind spots in understanding how children and schools affect disease transmission.

“School closures early in pandemic responses thwarted larger-scale investigations of schools as a source of community transmission,” researchers noted in a separate study, published online July 30 in JAMA Pediatrics, that examined levels of viral RNA in children and adults with COVID-19.

“Our analyses suggest children younger than 5 years with mild to moderate COVID-19 have high amounts of SARS-CoV-2 viral RNA in their nasopharynx, compared with older children and adults,” reported Taylor Heald-Sargent, MD, PhD, and colleagues. “Thus, young children can potentially be important drivers of SARS-CoV-2 spread in the general population, as has been demonstrated with respiratory syncytial virus, where children with high viral loads are more likely to transmit.”

Although the study “was not designed to prove that younger children spread COVID-19 as much as adults,” it is a possibility, Dr. Heald-Sargent, a pediatric infectious diseases specialist at Ann and Robert H. Lurie Children’s Hospital and assistant professor of pediatrics at Northwestern University, Chicago, said in a related news release. “We need to take that into account in efforts to reduce transmission as we continue to learn more about this virus.”.

The study included 145 patients with mild or moderate illness who were within 1 week of symptom onset. The researchers used reverse transcriptase–polymerase chain reaction (rt-PCR) on nasopharyngeal swabs collected at inpatient, outpatient, emergency department, or drive-through testing sites to measure SARS-CoV-2 levels. The investigators compared PCR amplification cycle threshold (CT) values for children younger than 5 years (n = 46), children aged 5-17 years (n = 51), and adults aged 18-65 years (n = 48); lower CT values indicate higher amounts of viral nucleic acid.

Median CT values for older children and adults were similar (about 11), whereas the median CT value for young children was significantly lower (6.5). The differences between young children and adults “approximate a 10-fold to 100-fold greater amount of SARS-CoV-2 in the upper respiratory tract of young children,” the researchers wrote.

“Behavioral habits of young children and close quarters in school and day care settings raise concern for SARS-CoV-2 amplification in this population as public health restrictions are eased,” they write.
 

Modeling the impact of school closures

In the JAMA study, Katherine A. Auger, MD, of Cincinnati Children’s Hospital Medical Center, and colleagues examined at the U.S. population level whether closing schools, as all 50 states did in March, was associated with relative decreases in COVID-19 incidence and mortality.

To isolate the effect of school closures, the researchers used an interrupted time series analysis and included other state-level nonpharmaceutical interventions and variables in their regression models.

“Per week, the incidence was estimated to have been 39% of what it would have been had schools remained open,” Dr. Auger and colleagues wrote. “Extrapolating the absolute differences of 423.9 cases and 12.6 deaths per 100,000 to 322.2 million residents nationally suggests that school closure may have been associated with approximately 1.37 million fewer cases of COVID-19 over a 26-day period and 40,600 fewer deaths over a 16-day period; however, these figures do not account for uncertainty in the model assumptions and the resulting estimates.”

Relative reductions in incidence and mortality were largest in states that closed schools when the incidence of COVID-19 was low, the authors found.
 

Decisions with high stakes

In an accompanying editorial, Julie M. Donohue, PhD, and Elizabeth Miller, MD, PhD, both affiliated with the University of Pittsburgh, emphasized that the results are estimates. “School closures were enacted in close proximity ... to other physical distancing measures, such as nonessential business closures and stay-at-home orders, making it difficult to disentangle the potential effect of each intervention.”

Although the findings “suggest a role for school closures in virus mitigation, school and health officials must balance this with academic, health, and economic consequences,” Dr. Donohue and Dr. Miller added. “Given the strong connection between education, income, and life expectancy, school closures could have long-term deleterious consequences for child health, likely reaching into adulthood.” Schools provide “meals and nutrition, health care including behavioral health supports, physical activity, social interaction, supports for students with special education needs and disabilities, and other vital resources for healthy development.”

In a viewpoint article also published in JAMA, authors involved in the creation of a National Academies of Sciences, Engineering, and Medicine reported on the reopening of schools recommend that districts “make every effort to prioritize reopening with an emphasis on providing in-person instruction for students in kindergarten through grade 5 as well as those students with special needs who might be best served by in-person instruction.

“To reopen safely, school districts are encouraged to ensure ventilation and air filtration, clean surfaces frequently, provide facilities for regular handwashing, and provide space for physical distancing,” write Kenne A. Dibner, PhD, of the NASEM in Washington, D.C., and coauthors.

Furthermore, districts “need to consider transparent communication of the reality that while measures can be implemented to lower the risk of transmitting COVID-19 when schools reopen, there is no way to eliminate that risk entirely. It is critical to share both the risks and benefits of different scenarios,” they wrote.

The JAMA modeling study received funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. The NASEM report was funded by the Brady Education Foundation and the Spencer Foundation. The authors disclosed no relevant financial relationships.

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

When officials closed U.S. schools in March to limit the spread of COVID-19, they may have prevented more than 1 million cases over a 26-day period, a new estimate published online July 29 in JAMA suggests.

But school closures also left blind spots in understanding how children and schools affect disease transmission.

“School closures early in pandemic responses thwarted larger-scale investigations of schools as a source of community transmission,” researchers noted in a separate study, published online July 30 in JAMA Pediatrics, that examined levels of viral RNA in children and adults with COVID-19.

“Our analyses suggest children younger than 5 years with mild to moderate COVID-19 have high amounts of SARS-CoV-2 viral RNA in their nasopharynx, compared with older children and adults,” reported Taylor Heald-Sargent, MD, PhD, and colleagues. “Thus, young children can potentially be important drivers of SARS-CoV-2 spread in the general population, as has been demonstrated with respiratory syncytial virus, where children with high viral loads are more likely to transmit.”

Although the study “was not designed to prove that younger children spread COVID-19 as much as adults,” it is a possibility, Dr. Heald-Sargent, a pediatric infectious diseases specialist at Ann and Robert H. Lurie Children’s Hospital and assistant professor of pediatrics at Northwestern University, Chicago, said in a related news release. “We need to take that into account in efforts to reduce transmission as we continue to learn more about this virus.”.

The study included 145 patients with mild or moderate illness who were within 1 week of symptom onset. The researchers used reverse transcriptase–polymerase chain reaction (rt-PCR) on nasopharyngeal swabs collected at inpatient, outpatient, emergency department, or drive-through testing sites to measure SARS-CoV-2 levels. The investigators compared PCR amplification cycle threshold (CT) values for children younger than 5 years (n = 46), children aged 5-17 years (n = 51), and adults aged 18-65 years (n = 48); lower CT values indicate higher amounts of viral nucleic acid.

Median CT values for older children and adults were similar (about 11), whereas the median CT value for young children was significantly lower (6.5). The differences between young children and adults “approximate a 10-fold to 100-fold greater amount of SARS-CoV-2 in the upper respiratory tract of young children,” the researchers wrote.

“Behavioral habits of young children and close quarters in school and day care settings raise concern for SARS-CoV-2 amplification in this population as public health restrictions are eased,” they write.
 

Modeling the impact of school closures

In the JAMA study, Katherine A. Auger, MD, of Cincinnati Children’s Hospital Medical Center, and colleagues examined at the U.S. population level whether closing schools, as all 50 states did in March, was associated with relative decreases in COVID-19 incidence and mortality.

To isolate the effect of school closures, the researchers used an interrupted time series analysis and included other state-level nonpharmaceutical interventions and variables in their regression models.

“Per week, the incidence was estimated to have been 39% of what it would have been had schools remained open,” Dr. Auger and colleagues wrote. “Extrapolating the absolute differences of 423.9 cases and 12.6 deaths per 100,000 to 322.2 million residents nationally suggests that school closure may have been associated with approximately 1.37 million fewer cases of COVID-19 over a 26-day period and 40,600 fewer deaths over a 16-day period; however, these figures do not account for uncertainty in the model assumptions and the resulting estimates.”

Relative reductions in incidence and mortality were largest in states that closed schools when the incidence of COVID-19 was low, the authors found.
 

Decisions with high stakes

In an accompanying editorial, Julie M. Donohue, PhD, and Elizabeth Miller, MD, PhD, both affiliated with the University of Pittsburgh, emphasized that the results are estimates. “School closures were enacted in close proximity ... to other physical distancing measures, such as nonessential business closures and stay-at-home orders, making it difficult to disentangle the potential effect of each intervention.”

Although the findings “suggest a role for school closures in virus mitigation, school and health officials must balance this with academic, health, and economic consequences,” Dr. Donohue and Dr. Miller added. “Given the strong connection between education, income, and life expectancy, school closures could have long-term deleterious consequences for child health, likely reaching into adulthood.” Schools provide “meals and nutrition, health care including behavioral health supports, physical activity, social interaction, supports for students with special education needs and disabilities, and other vital resources for healthy development.”

In a viewpoint article also published in JAMA, authors involved in the creation of a National Academies of Sciences, Engineering, and Medicine reported on the reopening of schools recommend that districts “make every effort to prioritize reopening with an emphasis on providing in-person instruction for students in kindergarten through grade 5 as well as those students with special needs who might be best served by in-person instruction.

“To reopen safely, school districts are encouraged to ensure ventilation and air filtration, clean surfaces frequently, provide facilities for regular handwashing, and provide space for physical distancing,” write Kenne A. Dibner, PhD, of the NASEM in Washington, D.C., and coauthors.

Furthermore, districts “need to consider transparent communication of the reality that while measures can be implemented to lower the risk of transmitting COVID-19 when schools reopen, there is no way to eliminate that risk entirely. It is critical to share both the risks and benefits of different scenarios,” they wrote.

The JAMA modeling study received funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. The NASEM report was funded by the Brady Education Foundation and the Spencer Foundation. The authors disclosed no relevant financial relationships.

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

When officials closed U.S. schools in March to limit the spread of COVID-19, they may have prevented more than 1 million cases over a 26-day period, a new estimate published online July 29 in JAMA suggests.

But school closures also left blind spots in understanding how children and schools affect disease transmission.

“School closures early in pandemic responses thwarted larger-scale investigations of schools as a source of community transmission,” researchers noted in a separate study, published online July 30 in JAMA Pediatrics, that examined levels of viral RNA in children and adults with COVID-19.

“Our analyses suggest children younger than 5 years with mild to moderate COVID-19 have high amounts of SARS-CoV-2 viral RNA in their nasopharynx, compared with older children and adults,” reported Taylor Heald-Sargent, MD, PhD, and colleagues. “Thus, young children can potentially be important drivers of SARS-CoV-2 spread in the general population, as has been demonstrated with respiratory syncytial virus, where children with high viral loads are more likely to transmit.”

Although the study “was not designed to prove that younger children spread COVID-19 as much as adults,” it is a possibility, Dr. Heald-Sargent, a pediatric infectious diseases specialist at Ann and Robert H. Lurie Children’s Hospital and assistant professor of pediatrics at Northwestern University, Chicago, said in a related news release. “We need to take that into account in efforts to reduce transmission as we continue to learn more about this virus.”.

The study included 145 patients with mild or moderate illness who were within 1 week of symptom onset. The researchers used reverse transcriptase–polymerase chain reaction (rt-PCR) on nasopharyngeal swabs collected at inpatient, outpatient, emergency department, or drive-through testing sites to measure SARS-CoV-2 levels. The investigators compared PCR amplification cycle threshold (CT) values for children younger than 5 years (n = 46), children aged 5-17 years (n = 51), and adults aged 18-65 years (n = 48); lower CT values indicate higher amounts of viral nucleic acid.

Median CT values for older children and adults were similar (about 11), whereas the median CT value for young children was significantly lower (6.5). The differences between young children and adults “approximate a 10-fold to 100-fold greater amount of SARS-CoV-2 in the upper respiratory tract of young children,” the researchers wrote.

“Behavioral habits of young children and close quarters in school and day care settings raise concern for SARS-CoV-2 amplification in this population as public health restrictions are eased,” they write.
 

Modeling the impact of school closures

In the JAMA study, Katherine A. Auger, MD, of Cincinnati Children’s Hospital Medical Center, and colleagues examined at the U.S. population level whether closing schools, as all 50 states did in March, was associated with relative decreases in COVID-19 incidence and mortality.

To isolate the effect of school closures, the researchers used an interrupted time series analysis and included other state-level nonpharmaceutical interventions and variables in their regression models.

“Per week, the incidence was estimated to have been 39% of what it would have been had schools remained open,” Dr. Auger and colleagues wrote. “Extrapolating the absolute differences of 423.9 cases and 12.6 deaths per 100,000 to 322.2 million residents nationally suggests that school closure may have been associated with approximately 1.37 million fewer cases of COVID-19 over a 26-day period and 40,600 fewer deaths over a 16-day period; however, these figures do not account for uncertainty in the model assumptions and the resulting estimates.”

Relative reductions in incidence and mortality were largest in states that closed schools when the incidence of COVID-19 was low, the authors found.
 

Decisions with high stakes

In an accompanying editorial, Julie M. Donohue, PhD, and Elizabeth Miller, MD, PhD, both affiliated with the University of Pittsburgh, emphasized that the results are estimates. “School closures were enacted in close proximity ... to other physical distancing measures, such as nonessential business closures and stay-at-home orders, making it difficult to disentangle the potential effect of each intervention.”

Although the findings “suggest a role for school closures in virus mitigation, school and health officials must balance this with academic, health, and economic consequences,” Dr. Donohue and Dr. Miller added. “Given the strong connection between education, income, and life expectancy, school closures could have long-term deleterious consequences for child health, likely reaching into adulthood.” Schools provide “meals and nutrition, health care including behavioral health supports, physical activity, social interaction, supports for students with special education needs and disabilities, and other vital resources for healthy development.”

In a viewpoint article also published in JAMA, authors involved in the creation of a National Academies of Sciences, Engineering, and Medicine reported on the reopening of schools recommend that districts “make every effort to prioritize reopening with an emphasis on providing in-person instruction for students in kindergarten through grade 5 as well as those students with special needs who might be best served by in-person instruction.

“To reopen safely, school districts are encouraged to ensure ventilation and air filtration, clean surfaces frequently, provide facilities for regular handwashing, and provide space for physical distancing,” write Kenne A. Dibner, PhD, of the NASEM in Washington, D.C., and coauthors.

Furthermore, districts “need to consider transparent communication of the reality that while measures can be implemented to lower the risk of transmitting COVID-19 when schools reopen, there is no way to eliminate that risk entirely. It is critical to share both the risks and benefits of different scenarios,” they wrote.

The JAMA modeling study received funding from the Agency for Healthcare Research and Quality and the National Institutes of Health. The NASEM report was funded by the Brady Education Foundation and the Spencer Foundation. The authors disclosed no relevant financial relationships.

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

Less than half of internal medicine residency program directors report formal curricula on the topic of health disparities, according to findings of a survey of medical directors and residents across the United States.

Despite recommendations from the Institute of Medicine going back to 2002 calling for increased education on the topic for health care providers, data from a 2012 survey showed that only 17% of internal medicine programs had a health disparities curriculum, wrote Denise M. Dupras, MD, of the Mayo Medical School, Rochester, Minn., and colleagues.

To describe internal medicine residency training programs’ curricula and educational experiences on health disparities and to determine residents’ perceptions of training, the researchers designed a cross-sectional survey study including 227 program directors and 22,723 internal medicine residents. The survey was conducted from August to November 2015.

Overall, 91 program directors (40%) reported a curriculum in health disparities, but only 16 of them described the quality of their education as very good or excellent. In 56% of the programs, outcomes of the curriculum were not measured.

A majority (90%) of the programs included racial/ethnic diversity and socioeconomic status in their curricula, 58% included information about limited English proficiency, and 53% included information about gender identity and sexual orientation.

Reported barriers to curriculum development in 132 programs that did not have a health disparities curriculum included lack of time in the current curriculum, insufficient faculty skill to teach the topic, lack of institutional support, and lack of faculty interest, the researchers noted.

A total of 13,251 residents (70%) reported receiving some training in caring for patients at risk for health disparities over 3 years of training, and 10,494 (80%) of these rated the quality as very good or excellent. “Residents who cared for a larger proportion of underserved patients perceived that they received health disparities training at a higher rate,” the researchers wrote. However, increased care of at-risk populations does not necessarily translate into increased knowledge and skills. “Our finding that residents’ rating of the quality of their training was not associated with the presence of a curriculum in health disparities in their program also raises a concern that perceptions may overestimate the acquisition of needed skills,” they added.

The major limitation of the study was “that residents were not asked directly if they were exposed to a curriculum in health disparities but rather if they received training in the care of patients who would be at risk, which raises the concern that we cannot distinguish between their recognition of a formal and informal curriculum,” the researchers noted. In addition, the survey could not confirm that program directors were aware of all training. “Furthermore, because the survey items were embedded in larger program director survey, we were limited in the ability to ask them to define more specifically the components of their health disparities curricula,” they wrote.

However, the results were strengthened by the large and comprehensive study population, and highlight not only the need for standardized health disparities curricula, but also the need for research to determine the most effective domains for such curricula in graduate medical education, they emphasized.

“There are opportunities to explore partnerships among residencies, institutional clinical practices, and communities for productive collaborations around disparities-related quality improvement projects to address gaps in health care that are specific to the populations they serve,” they concluded.

The surveys were conducted in 2015 and the comparative work in 2018, prior to the COVID-19 pandemic and the subsequent increased concerns about disparities in health care, Dr. Dupras said in an interview.

“We conducted the survey because we recognized that health disparities were still prevalent in our society despite calls to improve the education of our learners to address them. We wanted to determine what our programs were providing for educational curriculum and what our learners were experiencing,” she said.

“We did not know what the surveys would show, so I cannot say that we were surprised by the findings,” said Dr. Dupras. “One of the challenges in interpreting our results is inherent in studies that rely on surveys. We cannot know how those filling out the surveys interpret the questions.” The study results yield several messages.

“First, residency training programs have opportunities to do a better job in developing educational opportunities related to health disparities; second, residents learn in the context of care and we must optimize education around these experiences; third, every patient is different. It is time to move towards cultural humility, since the risk for disparities is not associated with one patient characteristic, but composed of multiple factors,” she said.

“Given that 5 years has passed since our original survey, it would be important to repeat the survey and consider expanding it to include other training programs that provide frontline care, such as family medicine and pediatrics,” Dr. Dupras noted.

Dr. Dupras and colleagues had no financial conflicts to disclose.

SOURCE: Dupras DM et al. JAMA Netw Open. 2020 Aug 10. doi: 10.1001/jamanetworkopen.2020.12757.

Less than half of internal medicine residency program directors report formal curricula on the topic of health disparities, according to findings of a survey of medical directors and residents across the United States.

Despite recommendations from the Institute of Medicine going back to 2002 calling for increased education on the topic for health care providers, data from a 2012 survey showed that only 17% of internal medicine programs had a health disparities curriculum, wrote Denise M. Dupras, MD, of the Mayo Medical School, Rochester, Minn., and colleagues.

To describe internal medicine residency training programs’ curricula and educational experiences on health disparities and to determine residents’ perceptions of training, the researchers designed a cross-sectional survey study including 227 program directors and 22,723 internal medicine residents. The survey was conducted from August to November 2015.

Overall, 91 program directors (40%) reported a curriculum in health disparities, but only 16 of them described the quality of their education as very good or excellent. In 56% of the programs, outcomes of the curriculum were not measured.

A majority (90%) of the programs included racial/ethnic diversity and socioeconomic status in their curricula, 58% included information about limited English proficiency, and 53% included information about gender identity and sexual orientation.

Reported barriers to curriculum development in 132 programs that did not have a health disparities curriculum included lack of time in the current curriculum, insufficient faculty skill to teach the topic, lack of institutional support, and lack of faculty interest, the researchers noted.

A total of 13,251 residents (70%) reported receiving some training in caring for patients at risk for health disparities over 3 years of training, and 10,494 (80%) of these rated the quality as very good or excellent. “Residents who cared for a larger proportion of underserved patients perceived that they received health disparities training at a higher rate,” the researchers wrote. However, increased care of at-risk populations does not necessarily translate into increased knowledge and skills. “Our finding that residents’ rating of the quality of their training was not associated with the presence of a curriculum in health disparities in their program also raises a concern that perceptions may overestimate the acquisition of needed skills,” they added.

The major limitation of the study was “that residents were not asked directly if they were exposed to a curriculum in health disparities but rather if they received training in the care of patients who would be at risk, which raises the concern that we cannot distinguish between their recognition of a formal and informal curriculum,” the researchers noted. In addition, the survey could not confirm that program directors were aware of all training. “Furthermore, because the survey items were embedded in larger program director survey, we were limited in the ability to ask them to define more specifically the components of their health disparities curricula,” they wrote.

However, the results were strengthened by the large and comprehensive study population, and highlight not only the need for standardized health disparities curricula, but also the need for research to determine the most effective domains for such curricula in graduate medical education, they emphasized.

“There are opportunities to explore partnerships among residencies, institutional clinical practices, and communities for productive collaborations around disparities-related quality improvement projects to address gaps in health care that are specific to the populations they serve,” they concluded.

The surveys were conducted in 2015 and the comparative work in 2018, prior to the COVID-19 pandemic and the subsequent increased concerns about disparities in health care, Dr. Dupras said in an interview.

“We conducted the survey because we recognized that health disparities were still prevalent in our society despite calls to improve the education of our learners to address them. We wanted to determine what our programs were providing for educational curriculum and what our learners were experiencing,” she said.

“We did not know what the surveys would show, so I cannot say that we were surprised by the findings,” said Dr. Dupras. “One of the challenges in interpreting our results is inherent in studies that rely on surveys. We cannot know how those filling out the surveys interpret the questions.” The study results yield several messages.

“First, residency training programs have opportunities to do a better job in developing educational opportunities related to health disparities; second, residents learn in the context of care and we must optimize education around these experiences; third, every patient is different. It is time to move towards cultural humility, since the risk for disparities is not associated with one patient characteristic, but composed of multiple factors,” she said.

“Given that 5 years has passed since our original survey, it would be important to repeat the survey and consider expanding it to include other training programs that provide frontline care, such as family medicine and pediatrics,” Dr. Dupras noted.

Dr. Dupras and colleagues had no financial conflicts to disclose.

SOURCE: Dupras DM et al. JAMA Netw Open. 2020 Aug 10. doi: 10.1001/jamanetworkopen.2020.12757.

Less than half of internal medicine residency program directors report formal curricula on the topic of health disparities, according to findings of a survey of medical directors and residents across the United States.

Despite recommendations from the Institute of Medicine going back to 2002 calling for increased education on the topic for health care providers, data from a 2012 survey showed that only 17% of internal medicine programs had a health disparities curriculum, wrote Denise M. Dupras, MD, of the Mayo Medical School, Rochester, Minn., and colleagues.

To describe internal medicine residency training programs’ curricula and educational experiences on health disparities and to determine residents’ perceptions of training, the researchers designed a cross-sectional survey study including 227 program directors and 22,723 internal medicine residents. The survey was conducted from August to November 2015.

Overall, 91 program directors (40%) reported a curriculum in health disparities, but only 16 of them described the quality of their education as very good or excellent. In 56% of the programs, outcomes of the curriculum were not measured.

A majority (90%) of the programs included racial/ethnic diversity and socioeconomic status in their curricula, 58% included information about limited English proficiency, and 53% included information about gender identity and sexual orientation.

Reported barriers to curriculum development in 132 programs that did not have a health disparities curriculum included lack of time in the current curriculum, insufficient faculty skill to teach the topic, lack of institutional support, and lack of faculty interest, the researchers noted.

A total of 13,251 residents (70%) reported receiving some training in caring for patients at risk for health disparities over 3 years of training, and 10,494 (80%) of these rated the quality as very good or excellent. “Residents who cared for a larger proportion of underserved patients perceived that they received health disparities training at a higher rate,” the researchers wrote. However, increased care of at-risk populations does not necessarily translate into increased knowledge and skills. “Our finding that residents’ rating of the quality of their training was not associated with the presence of a curriculum in health disparities in their program also raises a concern that perceptions may overestimate the acquisition of needed skills,” they added.

The major limitation of the study was “that residents were not asked directly if they were exposed to a curriculum in health disparities but rather if they received training in the care of patients who would be at risk, which raises the concern that we cannot distinguish between their recognition of a formal and informal curriculum,” the researchers noted. In addition, the survey could not confirm that program directors were aware of all training. “Furthermore, because the survey items were embedded in larger program director survey, we were limited in the ability to ask them to define more specifically the components of their health disparities curricula,” they wrote.

However, the results were strengthened by the large and comprehensive study population, and highlight not only the need for standardized health disparities curricula, but also the need for research to determine the most effective domains for such curricula in graduate medical education, they emphasized.

“There are opportunities to explore partnerships among residencies, institutional clinical practices, and communities for productive collaborations around disparities-related quality improvement projects to address gaps in health care that are specific to the populations they serve,” they concluded.

The surveys were conducted in 2015 and the comparative work in 2018, prior to the COVID-19 pandemic and the subsequent increased concerns about disparities in health care, Dr. Dupras said in an interview.

“We conducted the survey because we recognized that health disparities were still prevalent in our society despite calls to improve the education of our learners to address them. We wanted to determine what our programs were providing for educational curriculum and what our learners were experiencing,” she said.

“We did not know what the surveys would show, so I cannot say that we were surprised by the findings,” said Dr. Dupras. “One of the challenges in interpreting our results is inherent in studies that rely on surveys. We cannot know how those filling out the surveys interpret the questions.” The study results yield several messages.

“First, residency training programs have opportunities to do a better job in developing educational opportunities related to health disparities; second, residents learn in the context of care and we must optimize education around these experiences; third, every patient is different. It is time to move towards cultural humility, since the risk for disparities is not associated with one patient characteristic, but composed of multiple factors,” she said.

“Given that 5 years has passed since our original survey, it would be important to repeat the survey and consider expanding it to include other training programs that provide frontline care, such as family medicine and pediatrics,” Dr. Dupras noted.

Dr. Dupras and colleagues had no financial conflicts to disclose.

SOURCE: Dupras DM et al. JAMA Netw Open. 2020 Aug 10. doi: 10.1001/jamanetworkopen.2020.12757.

New guidance from the U.K. National Diabetes COVID-19 Response Group addresses glucose management in patients with COVID-19 who are receiving dexamethasone therapy.

Although there are already guidelines that address inpatient management of steroid-induced hyperglycemia, the authors of the new document wrote that this new expert opinion paper was needed “given the ‘triple insult’ of dexamethasone-induced–impaired glucose metabolism, COVID-19–induced insulin resistance, and COVID-19–impaired insulin production.”

RECOVERY trial spurs response

The document, which is the latest in a series from the Association of British Clinical Diabetologists, was published online Aug. 2 in Diabetic Medicine. The group is chaired by Gerry Rayman, MD, consultant physician at the diabetes centre and diabetes research unit, East Suffolk (England) and North East NHS Foundation Trust.

The guidance was developed in response to the recent “breakthrough” Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, which showed that dexamethasone reduced deaths in patients with COVID-19 on ventilators or receiving oxygen therapy. The advice is not intended for critical care units but can be adapted for that use.

The dose used in RECOVERY – 6 mg daily for 10 days – is 400%-500% greater than the therapeutic glucocorticoid replacement dose. High glucocorticoid doses can exacerbate hyperglycemia in people with established diabetes, unmask undiagnosed diabetes, precipitate hyperglycemia or new-onset diabetes, and can also cause hyperglycemic hyperosmolar state (HHS), the authors explained.

They recommended a target glucose of 6.0-10.0 mmol/L (108-180 mg/dL), although they say up to 12 mmol/L (216 mg/dL) is “acceptable.” They then gave advice on frequency of monitoring for people with and without known diabetes, exclusion of diabetic ketoacidosis and HHS, correction of initial hyperglycemia and maintenance of glycemic control using subcutaneous insulin, and prevention of hypoglycemia at the end of dexamethasone therapy (day 10) with insulin down-titration, discharge, and follow-up.

The detailed insulin guidance covers dose escalation for both insulin-treated and insulin-naive patients. A table suggests increasing correction doses of rapid-acting insulin based on prior total daily dose or weight.

Use of once- or twice-daily NPH insulin is recommended for patients whose glucose has risen above 12 mmol/L, in some cases with the addition of a long-acting analog. A second chart gives dose adjustments for those insulins. Additional guidance addresses patients on insulin pumps.

Guidance useful for U.S. physicians

Francisco Pasquel, MD, assistant professor of medicine in the division of endocrinology at Emory University, Atlanta, said in an interview that he believes the guidance is “acceptable” for worldwide use, and that “it’s coherent and consistent with what we typically do.”

However, Dr. Pasquel, who founded COVID-in-Diabetes, an online repository of published guidance and shared experience – to which this new document has now been added – did take issue with one piece of advice. The guidance says that patients already taking premixed insulin formulations can continue using them while increasing the dose by 20%-40%. Given the risk of hypoglycemia associated with those formulations, Dr. Pasquel said he would switch those patients to NPH during the time that they’re on dexamethasone.

He also noted that the rapid-acting insulin dose range of 2-10 units provided in the first table, for correction of initial hyperglycemia, are more conservative than those used at his hospital, where correction doses of up to 14-16 units are sometimes necessary.

But Dr. Pasquel praised the group’s overall efforts since the pandemic began, noting that “they’re very organized and constantly updating their recommendations. They have a unified system in the [National Health Service], so it’s easier to standardize. They have a unique [electronic health record] which is far superior to what we do from a public health perspective.”

Dr. Rayman reported no relevant financial relationships. Dr. Pasquel reported receiving research funding from Dexcom, Merck, and the National Institutes of Health, and consulting for AstraZeneca, Eli Lilly, Merck, and Boehringer Ingelheim.

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

New guidance from the U.K. National Diabetes COVID-19 Response Group addresses glucose management in patients with COVID-19 who are receiving dexamethasone therapy.

Although there are already guidelines that address inpatient management of steroid-induced hyperglycemia, the authors of the new document wrote that this new expert opinion paper was needed “given the ‘triple insult’ of dexamethasone-induced–impaired glucose metabolism, COVID-19–induced insulin resistance, and COVID-19–impaired insulin production.”

RECOVERY trial spurs response

The document, which is the latest in a series from the Association of British Clinical Diabetologists, was published online Aug. 2 in Diabetic Medicine. The group is chaired by Gerry Rayman, MD, consultant physician at the diabetes centre and diabetes research unit, East Suffolk (England) and North East NHS Foundation Trust.

The guidance was developed in response to the recent “breakthrough” Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, which showed that dexamethasone reduced deaths in patients with COVID-19 on ventilators or receiving oxygen therapy. The advice is not intended for critical care units but can be adapted for that use.

The dose used in RECOVERY – 6 mg daily for 10 days – is 400%-500% greater than the therapeutic glucocorticoid replacement dose. High glucocorticoid doses can exacerbate hyperglycemia in people with established diabetes, unmask undiagnosed diabetes, precipitate hyperglycemia or new-onset diabetes, and can also cause hyperglycemic hyperosmolar state (HHS), the authors explained.

They recommended a target glucose of 6.0-10.0 mmol/L (108-180 mg/dL), although they say up to 12 mmol/L (216 mg/dL) is “acceptable.” They then gave advice on frequency of monitoring for people with and without known diabetes, exclusion of diabetic ketoacidosis and HHS, correction of initial hyperglycemia and maintenance of glycemic control using subcutaneous insulin, and prevention of hypoglycemia at the end of dexamethasone therapy (day 10) with insulin down-titration, discharge, and follow-up.

The detailed insulin guidance covers dose escalation for both insulin-treated and insulin-naive patients. A table suggests increasing correction doses of rapid-acting insulin based on prior total daily dose or weight.

Use of once- or twice-daily NPH insulin is recommended for patients whose glucose has risen above 12 mmol/L, in some cases with the addition of a long-acting analog. A second chart gives dose adjustments for those insulins. Additional guidance addresses patients on insulin pumps.

Guidance useful for U.S. physicians

Francisco Pasquel, MD, assistant professor of medicine in the division of endocrinology at Emory University, Atlanta, said in an interview that he believes the guidance is “acceptable” for worldwide use, and that “it’s coherent and consistent with what we typically do.”

However, Dr. Pasquel, who founded COVID-in-Diabetes, an online repository of published guidance and shared experience – to which this new document has now been added – did take issue with one piece of advice. The guidance says that patients already taking premixed insulin formulations can continue using them while increasing the dose by 20%-40%. Given the risk of hypoglycemia associated with those formulations, Dr. Pasquel said he would switch those patients to NPH during the time that they’re on dexamethasone.

He also noted that the rapid-acting insulin dose range of 2-10 units provided in the first table, for correction of initial hyperglycemia, are more conservative than those used at his hospital, where correction doses of up to 14-16 units are sometimes necessary.

But Dr. Pasquel praised the group’s overall efforts since the pandemic began, noting that “they’re very organized and constantly updating their recommendations. They have a unified system in the [National Health Service], so it’s easier to standardize. They have a unique [electronic health record] which is far superior to what we do from a public health perspective.”

Dr. Rayman reported no relevant financial relationships. Dr. Pasquel reported receiving research funding from Dexcom, Merck, and the National Institutes of Health, and consulting for AstraZeneca, Eli Lilly, Merck, and Boehringer Ingelheim.

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

New guidance from the U.K. National Diabetes COVID-19 Response Group addresses glucose management in patients with COVID-19 who are receiving dexamethasone therapy.

Although there are already guidelines that address inpatient management of steroid-induced hyperglycemia, the authors of the new document wrote that this new expert opinion paper was needed “given the ‘triple insult’ of dexamethasone-induced–impaired glucose metabolism, COVID-19–induced insulin resistance, and COVID-19–impaired insulin production.”

RECOVERY trial spurs response

The document, which is the latest in a series from the Association of British Clinical Diabetologists, was published online Aug. 2 in Diabetic Medicine. The group is chaired by Gerry Rayman, MD, consultant physician at the diabetes centre and diabetes research unit, East Suffolk (England) and North East NHS Foundation Trust.

The guidance was developed in response to the recent “breakthrough” Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, which showed that dexamethasone reduced deaths in patients with COVID-19 on ventilators or receiving oxygen therapy. The advice is not intended for critical care units but can be adapted for that use.

The dose used in RECOVERY – 6 mg daily for 10 days – is 400%-500% greater than the therapeutic glucocorticoid replacement dose. High glucocorticoid doses can exacerbate hyperglycemia in people with established diabetes, unmask undiagnosed diabetes, precipitate hyperglycemia or new-onset diabetes, and can also cause hyperglycemic hyperosmolar state (HHS), the authors explained.

They recommended a target glucose of 6.0-10.0 mmol/L (108-180 mg/dL), although they say up to 12 mmol/L (216 mg/dL) is “acceptable.” They then gave advice on frequency of monitoring for people with and without known diabetes, exclusion of diabetic ketoacidosis and HHS, correction of initial hyperglycemia and maintenance of glycemic control using subcutaneous insulin, and prevention of hypoglycemia at the end of dexamethasone therapy (day 10) with insulin down-titration, discharge, and follow-up.

The detailed insulin guidance covers dose escalation for both insulin-treated and insulin-naive patients. A table suggests increasing correction doses of rapid-acting insulin based on prior total daily dose or weight.

Use of once- or twice-daily NPH insulin is recommended for patients whose glucose has risen above 12 mmol/L, in some cases with the addition of a long-acting analog. A second chart gives dose adjustments for those insulins. Additional guidance addresses patients on insulin pumps.

Guidance useful for U.S. physicians

Francisco Pasquel, MD, assistant professor of medicine in the division of endocrinology at Emory University, Atlanta, said in an interview that he believes the guidance is “acceptable” for worldwide use, and that “it’s coherent and consistent with what we typically do.”

However, Dr. Pasquel, who founded COVID-in-Diabetes, an online repository of published guidance and shared experience – to which this new document has now been added – did take issue with one piece of advice. The guidance says that patients already taking premixed insulin formulations can continue using them while increasing the dose by 20%-40%. Given the risk of hypoglycemia associated with those formulations, Dr. Pasquel said he would switch those patients to NPH during the time that they’re on dexamethasone.

He also noted that the rapid-acting insulin dose range of 2-10 units provided in the first table, for correction of initial hyperglycemia, are more conservative than those used at his hospital, where correction doses of up to 14-16 units are sometimes necessary.

But Dr. Pasquel praised the group’s overall efforts since the pandemic began, noting that “they’re very organized and constantly updating their recommendations. They have a unified system in the [National Health Service], so it’s easier to standardize. They have a unique [electronic health record] which is far superior to what we do from a public health perspective.”

Dr. Rayman reported no relevant financial relationships. Dr. Pasquel reported receiving research funding from Dexcom, Merck, and the National Institutes of Health, and consulting for AstraZeneca, Eli Lilly, Merck, and Boehringer Ingelheim.

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

An article published in March in the Journal of the American Heart Association that raised a ruckus on #medtwitter this week has now been retracted.   

It’s unclear what prompted the public explosion of anger, sadness, and recrimination that ultimately led to the retraction of this article – which flew almost completely under the radar when it first appeared online and in print – but it’s crystal clear why it might offend.

To many readers, the paper, written by Norman C. Wang, MD, MSc, an electrophysiologist at the University of Pittsburgh Medical Center, is a “racist” rant that relies on half-truths (J Am Heart Assoc. 2020 Mar 24. doi: 10.1161/JAHA.120.015959).

Officially, the article, “Diversity, Inclusion, and Equity: Evolution of Race and Ethnicity Considerations for the Cardiology Workforce in the United States of America From 1969 to 2019,” was retracted after the American Heart Association “became aware of serious concerns after publication. The author’s institution, the University of Pittsburgh Medical Center, has notified the Editor‐in‐Chief that the article contains many misconceptions and misquotes and that together those inaccuracies, misstatements, and selective misreading of source materials strip the paper of its scientific validity,” the retraction reads (J Am Heart Assoc. 2020 Aug 6. doi: 10.1161/JAHA.119.014602).

The journal will be publishing a detailed rebuttal, the notice adds: “This retraction notice will be updated with a link to the rebuttal when it publishes.”

“The Editor‐in‐Chief deeply regrets publishing the article and offers his apologies,” it further reads. “The American Heart Association and the Editor‐in‐Chief have determined that the best interest of the public and the research community will be served by issuing this notice of retraction. The author does not agree to the retraction.”

In the paper, Dr. Wang argues that affirmative action policies designed to increase minority representation in medical schools and cardiovascular training programs result in unqualified applicants being admitted, where they will struggle to succeed.

The article itself is a dense review of the topic of diversity, inclusion, and equity, aiming to “critically assess current paradigms, and to consider potential solutions to anticipated challenges,” according to its author. Supported by 108 references, Dr. Wang concludes with a lengthy quote from tennis great Arthur Ashe, an opponent of affirmative action who died in 1993.

Affirmative action, said Mr. Ashe, is “an insult to the people it intended to help.” Dr. Wang suggests that “racial and ethnic preferences for undergraduate and medical school admissions should be gradually rolled back with a target end year of 2028.”

He cites the $16 billion in federal funding that cardiovascular disease training programs receive every year to support graduate medical education in support of this contention.
 

#Medtwitter explodes

“My entire lived experience contradicts everything in that racist @JAHA_AHA article, as does the experience of so many others. So, I know it’s just a bad opinion piece passed off as ‘research’ that shouldn’t have been published. Still the damage has been done. We MUST do better,” tweeted Bryan A. Smith, MD, University of Chicago Medicine.

According to its Altmetric score, the article received very little attention back in March and April. There were three tweets referencing it, including one from JAHA announcing its publication. Since Aug. 2, an additional 390-odd Tweets from 347 Twitter users have been registered. None appear to be complimentary. Several days into the Twitter storm, the article was officially retracted.

“This article is shocking and makes me sad,” Martha Gulati, MD, University of Arizona, Phoenix, said in an interview. “We are all working so hard to make cardiology more inclusive and diverse, and this takes us like 1,000 steps backwards.”

For her part, Dr. Gulati would have liked a retraction earlier in the week. “The analysis was selective and incorrect, and the statements made intimate that minority trainees were selected based on affirmative action rather than their merits,” she said. It also suggested that their presence was representative of a decline in standards in cardiology programs that take underrepresented minorities (URMs).   
 

Standard arguments against affirmative action

According to Dr. Wang, who did not respond to a request to comment for this article, allowing minority students into medical school with academic records that are weaker than their classmates sets them up for failure.

“Many do not complete their intended programs or do not attain academic success to be attractive candidates for subsequent educational programs or employment,” he wrote.

This is a standard argument of opponents to affirmative action, said Quinn Capers IV, MD. Dr. Capers, a longtime advocate for diversity in medicine, acknowledges that, “on average,” test scores for Blacks, Hispanics, and Native Americans tend to be lower than for White applicants for a wide range of reasons, many of which are related to systemic racism.

“This is the strongest weapon opponents to affirmative action have, and they keep coming back to it, but it’s out of step with how many in academic medicine feel,” said Dr. Capers, who is an interventional cardiologist and the vice dean for faculty affairs at Ohio State University, Columbus.

This is why, he added, most medical schools have embraced the Association of American Medical Colleges’ concept of “holistic review,” which judges potential physicians on their academic records, their personal experiences, and their individual attributes.

“Standardized tests and academic records are important, but so are the experiences one has gone through and the individual attributes they may have. How resilient are you? How compassionate? Our embrace of this more holistic approach, I believe, is helping many medical schools move toward having a more diverse class that is closer to reflecting the needs of our multicultural and multiracial society,” Dr. Capers said. 

To be clear, Dr. Capers is not afraid of having a discussion on this topic and denies that the uproar against this article represents “cancel culture.”

“Hey, I love to debate and I’m not against hearing divisive voices, but then let’s have a debate and hear both sides. But there are several problems with the way they did this. No. 1, they called it a ‘white paper,’ which to most people means it reflects the views of the organization, not a specific individual, and, secondly, it’s more than an opinion piece in that he manipulates facts to make his points, with no chance for rebuttal.”

Several have also questioned how this paper, which is written by a nonexpert in the field, passed peer review.

The article contains some accurate historical references, said Dr. Capers, but intertwined with this history the author editorializes in a fashion that is “charged with racism.” In other places, Dr. Wang is just outright wrong, he added. 

“I can also tell you that, in one place where he quotes me specifically, what he says is quite damaging and completely wrong. He quotes something we wrote but cuts off the final sentence, making it seem as though we acknowledged that we had to artificially rank minority applicants high, just so we could say we have a diverse fellowship program.

“It’s frankly very hard to believe that was an accident,” Dr. Capers added.
 

AHA backs away, promises investigation

The article has been disowned by all levels of the AHA leadership – past, present, and future.

In an Editor’s Note, Barry London, MD, PhD, the Editor in chief of the Journal of the American Heart Association, apologized for his role and the role of his staff in publishing the article.

“JAHA will support all efforts to correct this error, including but not limited to the publication of alternate viewpoints, which we solicited at the time of publication but have not yet been submitted to the journal. In addition, we will work to improve our peer review system to prevent future missteps of this type,” Dr. London wrote. “I can only hope that igniting a discussion around diversity in cardiology will ultimately fuel new ideas and lead to real advances.”

“I want to emphasize in the strongest possible terms that this paper does not represent the views of the AHA as an organization or its leadership. This paper should never have been published. A thorough investigation is rightly being conducted,” tweeted Mitchell S.V. Elkind, MD, MPhil, who took over the AHA presidency last month.

“Author’s views are racist and not consistent with my values nor AHA,” tweeted Robert Harrington, MD, immediate past president of the AHA. ‘Investigation is underway into how it made it through the editorial process. Like you, I want to know what happened. I am angry, frustrated and disappointed that this piece was published; expect review soon.’

“Agree with @HeartBobH. It is impossible not to hear and feel the hurt and pain out there on a very personal level, especially among our young colleagues. You are valued, and worthy. Please stay tuned and then help all of us work to be better,” tweeted Donald Lloyd-Jones, MD, president-elect of AHA.

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

An article published in March in the Journal of the American Heart Association that raised a ruckus on #medtwitter this week has now been retracted.   

It’s unclear what prompted the public explosion of anger, sadness, and recrimination that ultimately led to the retraction of this article – which flew almost completely under the radar when it first appeared online and in print – but it’s crystal clear why it might offend.

To many readers, the paper, written by Norman C. Wang, MD, MSc, an electrophysiologist at the University of Pittsburgh Medical Center, is a “racist” rant that relies on half-truths (J Am Heart Assoc. 2020 Mar 24. doi: 10.1161/JAHA.120.015959).

Officially, the article, “Diversity, Inclusion, and Equity: Evolution of Race and Ethnicity Considerations for the Cardiology Workforce in the United States of America From 1969 to 2019,” was retracted after the American Heart Association “became aware of serious concerns after publication. The author’s institution, the University of Pittsburgh Medical Center, has notified the Editor‐in‐Chief that the article contains many misconceptions and misquotes and that together those inaccuracies, misstatements, and selective misreading of source materials strip the paper of its scientific validity,” the retraction reads (J Am Heart Assoc. 2020 Aug 6. doi: 10.1161/JAHA.119.014602).

The journal will be publishing a detailed rebuttal, the notice adds: “This retraction notice will be updated with a link to the rebuttal when it publishes.”

“The Editor‐in‐Chief deeply regrets publishing the article and offers his apologies,” it further reads. “The American Heart Association and the Editor‐in‐Chief have determined that the best interest of the public and the research community will be served by issuing this notice of retraction. The author does not agree to the retraction.”

In the paper, Dr. Wang argues that affirmative action policies designed to increase minority representation in medical schools and cardiovascular training programs result in unqualified applicants being admitted, where they will struggle to succeed.

The article itself is a dense review of the topic of diversity, inclusion, and equity, aiming to “critically assess current paradigms, and to consider potential solutions to anticipated challenges,” according to its author. Supported by 108 references, Dr. Wang concludes with a lengthy quote from tennis great Arthur Ashe, an opponent of affirmative action who died in 1993.

Affirmative action, said Mr. Ashe, is “an insult to the people it intended to help.” Dr. Wang suggests that “racial and ethnic preferences for undergraduate and medical school admissions should be gradually rolled back with a target end year of 2028.”

He cites the $16 billion in federal funding that cardiovascular disease training programs receive every year to support graduate medical education in support of this contention.
 

#Medtwitter explodes

“My entire lived experience contradicts everything in that racist @JAHA_AHA article, as does the experience of so many others. So, I know it’s just a bad opinion piece passed off as ‘research’ that shouldn’t have been published. Still the damage has been done. We MUST do better,” tweeted Bryan A. Smith, MD, University of Chicago Medicine.

According to its Altmetric score, the article received very little attention back in March and April. There were three tweets referencing it, including one from JAHA announcing its publication. Since Aug. 2, an additional 390-odd Tweets from 347 Twitter users have been registered. None appear to be complimentary. Several days into the Twitter storm, the article was officially retracted.

“This article is shocking and makes me sad,” Martha Gulati, MD, University of Arizona, Phoenix, said in an interview. “We are all working so hard to make cardiology more inclusive and diverse, and this takes us like 1,000 steps backwards.”

For her part, Dr. Gulati would have liked a retraction earlier in the week. “The analysis was selective and incorrect, and the statements made intimate that minority trainees were selected based on affirmative action rather than their merits,” she said. It also suggested that their presence was representative of a decline in standards in cardiology programs that take underrepresented minorities (URMs).   
 

Standard arguments against affirmative action

According to Dr. Wang, who did not respond to a request to comment for this article, allowing minority students into medical school with academic records that are weaker than their classmates sets them up for failure.

“Many do not complete their intended programs or do not attain academic success to be attractive candidates for subsequent educational programs or employment,” he wrote.

This is a standard argument of opponents to affirmative action, said Quinn Capers IV, MD. Dr. Capers, a longtime advocate for diversity in medicine, acknowledges that, “on average,” test scores for Blacks, Hispanics, and Native Americans tend to be lower than for White applicants for a wide range of reasons, many of which are related to systemic racism.

“This is the strongest weapon opponents to affirmative action have, and they keep coming back to it, but it’s out of step with how many in academic medicine feel,” said Dr. Capers, who is an interventional cardiologist and the vice dean for faculty affairs at Ohio State University, Columbus.

This is why, he added, most medical schools have embraced the Association of American Medical Colleges’ concept of “holistic review,” which judges potential physicians on their academic records, their personal experiences, and their individual attributes.

“Standardized tests and academic records are important, but so are the experiences one has gone through and the individual attributes they may have. How resilient are you? How compassionate? Our embrace of this more holistic approach, I believe, is helping many medical schools move toward having a more diverse class that is closer to reflecting the needs of our multicultural and multiracial society,” Dr. Capers said. 

To be clear, Dr. Capers is not afraid of having a discussion on this topic and denies that the uproar against this article represents “cancel culture.”

“Hey, I love to debate and I’m not against hearing divisive voices, but then let’s have a debate and hear both sides. But there are several problems with the way they did this. No. 1, they called it a ‘white paper,’ which to most people means it reflects the views of the organization, not a specific individual, and, secondly, it’s more than an opinion piece in that he manipulates facts to make his points, with no chance for rebuttal.”

Several have also questioned how this paper, which is written by a nonexpert in the field, passed peer review.

The article contains some accurate historical references, said Dr. Capers, but intertwined with this history the author editorializes in a fashion that is “charged with racism.” In other places, Dr. Wang is just outright wrong, he added. 

“I can also tell you that, in one place where he quotes me specifically, what he says is quite damaging and completely wrong. He quotes something we wrote but cuts off the final sentence, making it seem as though we acknowledged that we had to artificially rank minority applicants high, just so we could say we have a diverse fellowship program.

“It’s frankly very hard to believe that was an accident,” Dr. Capers added.
 

AHA backs away, promises investigation

The article has been disowned by all levels of the AHA leadership – past, present, and future.

In an Editor’s Note, Barry London, MD, PhD, the Editor in chief of the Journal of the American Heart Association, apologized for his role and the role of his staff in publishing the article.

“JAHA will support all efforts to correct this error, including but not limited to the publication of alternate viewpoints, which we solicited at the time of publication but have not yet been submitted to the journal. In addition, we will work to improve our peer review system to prevent future missteps of this type,” Dr. London wrote. “I can only hope that igniting a discussion around diversity in cardiology will ultimately fuel new ideas and lead to real advances.”

“I want to emphasize in the strongest possible terms that this paper does not represent the views of the AHA as an organization or its leadership. This paper should never have been published. A thorough investigation is rightly being conducted,” tweeted Mitchell S.V. Elkind, MD, MPhil, who took over the AHA presidency last month.

“Author’s views are racist and not consistent with my values nor AHA,” tweeted Robert Harrington, MD, immediate past president of the AHA. ‘Investigation is underway into how it made it through the editorial process. Like you, I want to know what happened. I am angry, frustrated and disappointed that this piece was published; expect review soon.’

“Agree with @HeartBobH. It is impossible not to hear and feel the hurt and pain out there on a very personal level, especially among our young colleagues. You are valued, and worthy. Please stay tuned and then help all of us work to be better,” tweeted Donald Lloyd-Jones, MD, president-elect of AHA.

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

An article published in March in the Journal of the American Heart Association that raised a ruckus on #medtwitter this week has now been retracted.   

It’s unclear what prompted the public explosion of anger, sadness, and recrimination that ultimately led to the retraction of this article – which flew almost completely under the radar when it first appeared online and in print – but it’s crystal clear why it might offend.

To many readers, the paper, written by Norman C. Wang, MD, MSc, an electrophysiologist at the University of Pittsburgh Medical Center, is a “racist” rant that relies on half-truths (J Am Heart Assoc. 2020 Mar 24. doi: 10.1161/JAHA.120.015959).

Officially, the article, “Diversity, Inclusion, and Equity: Evolution of Race and Ethnicity Considerations for the Cardiology Workforce in the United States of America From 1969 to 2019,” was retracted after the American Heart Association “became aware of serious concerns after publication. The author’s institution, the University of Pittsburgh Medical Center, has notified the Editor‐in‐Chief that the article contains many misconceptions and misquotes and that together those inaccuracies, misstatements, and selective misreading of source materials strip the paper of its scientific validity,” the retraction reads (J Am Heart Assoc. 2020 Aug 6. doi: 10.1161/JAHA.119.014602).

The journal will be publishing a detailed rebuttal, the notice adds: “This retraction notice will be updated with a link to the rebuttal when it publishes.”

“The Editor‐in‐Chief deeply regrets publishing the article and offers his apologies,” it further reads. “The American Heart Association and the Editor‐in‐Chief have determined that the best interest of the public and the research community will be served by issuing this notice of retraction. The author does not agree to the retraction.”

In the paper, Dr. Wang argues that affirmative action policies designed to increase minority representation in medical schools and cardiovascular training programs result in unqualified applicants being admitted, where they will struggle to succeed.

The article itself is a dense review of the topic of diversity, inclusion, and equity, aiming to “critically assess current paradigms, and to consider potential solutions to anticipated challenges,” according to its author. Supported by 108 references, Dr. Wang concludes with a lengthy quote from tennis great Arthur Ashe, an opponent of affirmative action who died in 1993.

Affirmative action, said Mr. Ashe, is “an insult to the people it intended to help.” Dr. Wang suggests that “racial and ethnic preferences for undergraduate and medical school admissions should be gradually rolled back with a target end year of 2028.”

He cites the $16 billion in federal funding that cardiovascular disease training programs receive every year to support graduate medical education in support of this contention.
 

#Medtwitter explodes

“My entire lived experience contradicts everything in that racist @JAHA_AHA article, as does the experience of so many others. So, I know it’s just a bad opinion piece passed off as ‘research’ that shouldn’t have been published. Still the damage has been done. We MUST do better,” tweeted Bryan A. Smith, MD, University of Chicago Medicine.

According to its Altmetric score, the article received very little attention back in March and April. There were three tweets referencing it, including one from JAHA announcing its publication. Since Aug. 2, an additional 390-odd Tweets from 347 Twitter users have been registered. None appear to be complimentary. Several days into the Twitter storm, the article was officially retracted.

“This article is shocking and makes me sad,” Martha Gulati, MD, University of Arizona, Phoenix, said in an interview. “We are all working so hard to make cardiology more inclusive and diverse, and this takes us like 1,000 steps backwards.”

For her part, Dr. Gulati would have liked a retraction earlier in the week. “The analysis was selective and incorrect, and the statements made intimate that minority trainees were selected based on affirmative action rather than their merits,” she said. It also suggested that their presence was representative of a decline in standards in cardiology programs that take underrepresented minorities (URMs).   
 

Standard arguments against affirmative action

According to Dr. Wang, who did not respond to a request to comment for this article, allowing minority students into medical school with academic records that are weaker than their classmates sets them up for failure.

“Many do not complete their intended programs or do not attain academic success to be attractive candidates for subsequent educational programs or employment,” he wrote.

This is a standard argument of opponents to affirmative action, said Quinn Capers IV, MD. Dr. Capers, a longtime advocate for diversity in medicine, acknowledges that, “on average,” test scores for Blacks, Hispanics, and Native Americans tend to be lower than for White applicants for a wide range of reasons, many of which are related to systemic racism.

“This is the strongest weapon opponents to affirmative action have, and they keep coming back to it, but it’s out of step with how many in academic medicine feel,” said Dr. Capers, who is an interventional cardiologist and the vice dean for faculty affairs at Ohio State University, Columbus.

This is why, he added, most medical schools have embraced the Association of American Medical Colleges’ concept of “holistic review,” which judges potential physicians on their academic records, their personal experiences, and their individual attributes.

“Standardized tests and academic records are important, but so are the experiences one has gone through and the individual attributes they may have. How resilient are you? How compassionate? Our embrace of this more holistic approach, I believe, is helping many medical schools move toward having a more diverse class that is closer to reflecting the needs of our multicultural and multiracial society,” Dr. Capers said. 

To be clear, Dr. Capers is not afraid of having a discussion on this topic and denies that the uproar against this article represents “cancel culture.”

“Hey, I love to debate and I’m not against hearing divisive voices, but then let’s have a debate and hear both sides. But there are several problems with the way they did this. No. 1, they called it a ‘white paper,’ which to most people means it reflects the views of the organization, not a specific individual, and, secondly, it’s more than an opinion piece in that he manipulates facts to make his points, with no chance for rebuttal.”

Several have also questioned how this paper, which is written by a nonexpert in the field, passed peer review.

The article contains some accurate historical references, said Dr. Capers, but intertwined with this history the author editorializes in a fashion that is “charged with racism.” In other places, Dr. Wang is just outright wrong, he added. 

“I can also tell you that, in one place where he quotes me specifically, what he says is quite damaging and completely wrong. He quotes something we wrote but cuts off the final sentence, making it seem as though we acknowledged that we had to artificially rank minority applicants high, just so we could say we have a diverse fellowship program.

“It’s frankly very hard to believe that was an accident,” Dr. Capers added.
 

AHA backs away, promises investigation

The article has been disowned by all levels of the AHA leadership – past, present, and future.

In an Editor’s Note, Barry London, MD, PhD, the Editor in chief of the Journal of the American Heart Association, apologized for his role and the role of his staff in publishing the article.

“JAHA will support all efforts to correct this error, including but not limited to the publication of alternate viewpoints, which we solicited at the time of publication but have not yet been submitted to the journal. In addition, we will work to improve our peer review system to prevent future missteps of this type,” Dr. London wrote. “I can only hope that igniting a discussion around diversity in cardiology will ultimately fuel new ideas and lead to real advances.”

“I want to emphasize in the strongest possible terms that this paper does not represent the views of the AHA as an organization or its leadership. This paper should never have been published. A thorough investigation is rightly being conducted,” tweeted Mitchell S.V. Elkind, MD, MPhil, who took over the AHA presidency last month.

“Author’s views are racist and not consistent with my values nor AHA,” tweeted Robert Harrington, MD, immediate past president of the AHA. ‘Investigation is underway into how it made it through the editorial process. Like you, I want to know what happened. I am angry, frustrated and disappointed that this piece was published; expect review soon.’

“Agree with @HeartBobH. It is impossible not to hear and feel the hurt and pain out there on a very personal level, especially among our young colleagues. You are valued, and worthy. Please stay tuned and then help all of us work to be better,” tweeted Donald Lloyd-Jones, MD, president-elect of AHA.

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

Italian patients with diabetic foot ulceration (DFUs) suffered mightily during the height of the coronavirus pandemic in that country, according to a newly published study.

Phalinn Ooi/CC-BY-2.0

Amid a mandatory national lockdown, the rates of amputations skyrocketed at a hospital far from the hardest-hit region as many patients developed gangrene.

The findings offer critical lessons for the United States, said wound care specialist William H. Tettelbach, MD, of Western Peaks Specialty Hospital near Salt Lake City. “It’s become more obvious that outpatient wound care is a critical care need for the community because of the risk of ignoring these chronic wounds and letting them remain open. We cannot let these services be closed down like some were when the pandemic started.”

The study, led by Paola Caruso, MD, of the University of Campania Luigi Vanvitelli in Naples, appeared in Diabetes Care.

The researchers launched the study to understand how patients with diabetes and DFU fared during the height of the pandemic in Italy, where tens of thousands of people died, mainly in the northern region of the country. They focused on patients in the southern region who were admitted to the division of endocrinology and metabolic diseases at the Teaching Hospital at the University of Campania Luigi Vanvitelli.

The study compared 25 patients who were admitted from March 9 to May 18, 2020, with 38 patients who were admitted from a longer period between January and May 2019. The demographics of the groups are similar, with average ages in the early 60s and more men than women (21:4, respectively, in 2020 and 23:15, respectively, in 2019.)

The results reveal high numbers of emergent and serious cases in 2020. Compared with 2019, fewer were outpatients (16% vs. 45%, P = .028) and more were emergency patients (76% vs. 26%, P < .001).

Clinically, gangrene was much more common in the 2020 group, compared with the 2019 group (64% vs. 29%, P = .009), as was amputation (60% vs. 18%, P = .001).

The researchers determined that amputation was more than three times more likely in the 2020 versus the 2019 group (relative risk, 3.26; 95% confidence interval, 1.55-6.84) even though the 2019 period was longer. After adjustment for gender, the heightened risk in 2020 was 2.50 (95% CI, 1.18-5.29).

There was no statistically significant increase in the risk of revascularization.

“The COVID-19 lockdown may have had a detrimental impact on amputation risk because of the sudden interruption of DFU care and lower-limb preservation pathways, resulting in delayed diagnosis and treatment,” the researchers wrote. “DFU is often characterized by progressive clinical course, which can rapidly lead patients to critical worsening of their ulcers.”

They added that “the higher risk of amputation observed during COVID-19 lockdown confirms the need for proper and timely management of DFU patients to prevent dramatic outcomes responsible for a reduction of quality of life and increased morbidity and mortality.”

The study authors didn’t discuss why more patients seemed to have stayed home and not gotten proper care. It’s not clear if they were scared to get treatment or couldn’t obtain it because of the national shutdown.

Both have been factors affecting diabetic foot care in the United States during the pandemic, said Dr. Tettelbach. He called the study “timely and pertinent,” and said it highlights how wound care is “a critical need” that must remain available even when other medical services such as elective surgeries are shut down.

Infection-control protocols such as allowing patients to wait for appointments in their cars instead of waiting rooms will alleviate the fears of certain patients about seeking in-person care during the pandemic, he said. But some patients will be afraid to come in no matter what, he said, and home health may be the best solution for their care.

Several of the study authors reported various disclosures. Dr. Tettelbach reported no relevant disclosures.

SOURCE: Caruso P et al. Diabetes Care. 2020 Jul 23. doi:10.2337/dc20-1347.

Italian patients with diabetic foot ulceration (DFUs) suffered mightily during the height of the coronavirus pandemic in that country, according to a newly published study.

Phalinn Ooi/CC-BY-2.0

Amid a mandatory national lockdown, the rates of amputations skyrocketed at a hospital far from the hardest-hit region as many patients developed gangrene.

The findings offer critical lessons for the United States, said wound care specialist William H. Tettelbach, MD, of Western Peaks Specialty Hospital near Salt Lake City. “It’s become more obvious that outpatient wound care is a critical care need for the community because of the risk of ignoring these chronic wounds and letting them remain open. We cannot let these services be closed down like some were when the pandemic started.”

The study, led by Paola Caruso, MD, of the University of Campania Luigi Vanvitelli in Naples, appeared in Diabetes Care.

The researchers launched the study to understand how patients with diabetes and DFU fared during the height of the pandemic in Italy, where tens of thousands of people died, mainly in the northern region of the country. They focused on patients in the southern region who were admitted to the division of endocrinology and metabolic diseases at the Teaching Hospital at the University of Campania Luigi Vanvitelli.

The study compared 25 patients who were admitted from March 9 to May 18, 2020, with 38 patients who were admitted from a longer period between January and May 2019. The demographics of the groups are similar, with average ages in the early 60s and more men than women (21:4, respectively, in 2020 and 23:15, respectively, in 2019.)

The results reveal high numbers of emergent and serious cases in 2020. Compared with 2019, fewer were outpatients (16% vs. 45%, P = .028) and more were emergency patients (76% vs. 26%, P < .001).

Clinically, gangrene was much more common in the 2020 group, compared with the 2019 group (64% vs. 29%, P = .009), as was amputation (60% vs. 18%, P = .001).

The researchers determined that amputation was more than three times more likely in the 2020 versus the 2019 group (relative risk, 3.26; 95% confidence interval, 1.55-6.84) even though the 2019 period was longer. After adjustment for gender, the heightened risk in 2020 was 2.50 (95% CI, 1.18-5.29).

There was no statistically significant increase in the risk of revascularization.

“The COVID-19 lockdown may have had a detrimental impact on amputation risk because of the sudden interruption of DFU care and lower-limb preservation pathways, resulting in delayed diagnosis and treatment,” the researchers wrote. “DFU is often characterized by progressive clinical course, which can rapidly lead patients to critical worsening of their ulcers.”

They added that “the higher risk of amputation observed during COVID-19 lockdown confirms the need for proper and timely management of DFU patients to prevent dramatic outcomes responsible for a reduction of quality of life and increased morbidity and mortality.”

The study authors didn’t discuss why more patients seemed to have stayed home and not gotten proper care. It’s not clear if they were scared to get treatment or couldn’t obtain it because of the national shutdown.

Both have been factors affecting diabetic foot care in the United States during the pandemic, said Dr. Tettelbach. He called the study “timely and pertinent,” and said it highlights how wound care is “a critical need” that must remain available even when other medical services such as elective surgeries are shut down.

Infection-control protocols such as allowing patients to wait for appointments in their cars instead of waiting rooms will alleviate the fears of certain patients about seeking in-person care during the pandemic, he said. But some patients will be afraid to come in no matter what, he said, and home health may be the best solution for their care.

Several of the study authors reported various disclosures. Dr. Tettelbach reported no relevant disclosures.

SOURCE: Caruso P et al. Diabetes Care. 2020 Jul 23. doi:10.2337/dc20-1347.

Italian patients with diabetic foot ulceration (DFUs) suffered mightily during the height of the coronavirus pandemic in that country, according to a newly published study.

Phalinn Ooi/CC-BY-2.0

Amid a mandatory national lockdown, the rates of amputations skyrocketed at a hospital far from the hardest-hit region as many patients developed gangrene.

The findings offer critical lessons for the United States, said wound care specialist William H. Tettelbach, MD, of Western Peaks Specialty Hospital near Salt Lake City. “It’s become more obvious that outpatient wound care is a critical care need for the community because of the risk of ignoring these chronic wounds and letting them remain open. We cannot let these services be closed down like some were when the pandemic started.”

The study, led by Paola Caruso, MD, of the University of Campania Luigi Vanvitelli in Naples, appeared in Diabetes Care.

The researchers launched the study to understand how patients with diabetes and DFU fared during the height of the pandemic in Italy, where tens of thousands of people died, mainly in the northern region of the country. They focused on patients in the southern region who were admitted to the division of endocrinology and metabolic diseases at the Teaching Hospital at the University of Campania Luigi Vanvitelli.

The study compared 25 patients who were admitted from March 9 to May 18, 2020, with 38 patients who were admitted from a longer period between January and May 2019. The demographics of the groups are similar, with average ages in the early 60s and more men than women (21:4, respectively, in 2020 and 23:15, respectively, in 2019.)

The results reveal high numbers of emergent and serious cases in 2020. Compared with 2019, fewer were outpatients (16% vs. 45%, P = .028) and more were emergency patients (76% vs. 26%, P < .001).

Clinically, gangrene was much more common in the 2020 group, compared with the 2019 group (64% vs. 29%, P = .009), as was amputation (60% vs. 18%, P = .001).

The researchers determined that amputation was more than three times more likely in the 2020 versus the 2019 group (relative risk, 3.26; 95% confidence interval, 1.55-6.84) even though the 2019 period was longer. After adjustment for gender, the heightened risk in 2020 was 2.50 (95% CI, 1.18-5.29).

There was no statistically significant increase in the risk of revascularization.

“The COVID-19 lockdown may have had a detrimental impact on amputation risk because of the sudden interruption of DFU care and lower-limb preservation pathways, resulting in delayed diagnosis and treatment,” the researchers wrote. “DFU is often characterized by progressive clinical course, which can rapidly lead patients to critical worsening of their ulcers.”

They added that “the higher risk of amputation observed during COVID-19 lockdown confirms the need for proper and timely management of DFU patients to prevent dramatic outcomes responsible for a reduction of quality of life and increased morbidity and mortality.”

The study authors didn’t discuss why more patients seemed to have stayed home and not gotten proper care. It’s not clear if they were scared to get treatment or couldn’t obtain it because of the national shutdown.

Both have been factors affecting diabetic foot care in the United States during the pandemic, said Dr. Tettelbach. He called the study “timely and pertinent,” and said it highlights how wound care is “a critical need” that must remain available even when other medical services such as elective surgeries are shut down.

Infection-control protocols such as allowing patients to wait for appointments in their cars instead of waiting rooms will alleviate the fears of certain patients about seeking in-person care during the pandemic, he said. But some patients will be afraid to come in no matter what, he said, and home health may be the best solution for their care.

Several of the study authors reported various disclosures. Dr. Tettelbach reported no relevant disclosures.

SOURCE: Caruso P et al. Diabetes Care. 2020 Jul 23. doi:10.2337/dc20-1347.

Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Information about COVID has evolved so quickly that it can be difficult for clinicians to feel confident that they are staying current. These summaries include links to our reference article on diagnosis of COVID-19, which is constantly updated to make sure you have the latest information.

Diagnostic testing for COVID-19 is critical. No one disputes that. But what is in dispute is whom to test, when to test, how to test, what to do while waiting for results, and how accurate those results are when you finally get them.

Here are the answers to those questions, based on the current information.

Whom to test. This is the (relatively) easy part. The ideal answer is that everyone should be tested. The Infectious Diseases Society of America issued tier-based recommendations way back in March, and they still apply. First priority continues to be patients who are ill, healthcare workers, and those with known exposure. But to truly figure out the amount of community spread in a given area, we need to test people who do not have a clear indication for testing. That is particularly true as more people return to work and the Centers for Disease Control and Prevention (CDC) has issued guidelines for workplaces to establish testing programs. Universal testing is recommended for some high-risk settings, such as nursing homes.

One key change: CDC no longer recommends testing to determine whether someone with a known infection is still infectious.

When to test. People with any symptoms suggestive of COVID should be tested, ideally as soon as feasible. But given the ongoing shortages of tests, that may not be possible, particularly for those requiring only symptomatic care. Rather, these patients should be treated as probable cases, with appropriate instructions regarding quarantine. Testing of those with known exposures ideally should be done about 5 days after exposure.

How to test. Only viral nucleic acid or antigen tests should be used to diagnose acute illness. CDC does not currently recommend using serologic assays, now broadly available, for diagnosis of acute infection, though they obviously play an important role in understanding the transmission dynamic of the virus in the general population.

Testing strategies vary from state to state and even within communities in a single state. It is recommended that clinicians check with their own local or state health department for specifics on tests available, indications for testing, and processing details. While often forgotten, it is worth emphasizing that no diagnostic tests have been approved by the US Food and Drug Administration (FDA). Rather, they are available under emergency use authorization (EUA), meaning that they have not been fully vetted by the FDA.

In late July, the FDA expanded authorization for real-time reverse transcription–polymerase chain reaction (rRT-PCR) molecular assays, utilizing nasal or nasopharyngeal swabs, to permit testing of all persons, regardless of exposure history or symptoms. The FDA maintains a list of all approved diagnostic tests and corresponding labs. Current evidence suggests that no one test is better than any other — and most clinicians won›t have a choice anyway. Patients will have to get what is available via their health department or insurance plan.

Two point-of-care antigen tests using nasopharyngeal or nasal samples have been issued an EUA. These tests can be used only in settings with a valid CLIA certificate.

Several commercial laboratories have received approval to process diagnostic tests using patients’ self-collected saliva rather than swabs. One lab has now received authorization for in-home testing without any input from a clinician. These testing options can be a boon for patients who have symptoms or exposure and for whatever reason are unable to get to a diagnostic site. These samples are collected at home and mailed to a lab. Note that these tests are not yet widely available.

Waiting for results. If waiting for results meant a day or even a couple of days, the answer to this one would be easier. But if the wait extends to 1 and even sometimes 2 weeks, then the test is not able to meaningfully guide clinical decisions. The latest guidance from the CDC is that individuals with symptoms suggestive of COVID who do not require hospitalization should remain at home in self-quarantine for at least 10 days from symptom onset. Asymptomatic individuals with a known exposure to someone else with COVID, or participation in a high-risk event like an indoor gathering involving more than 10 persons, should self-quarantine either until they receive a negative test result or 14 days after the exposure.

Accuracy of results. A positive rRT-PCR antigen test is highly accurate, indicating presence of SARS-CoV-2 RNA. There appears to be no significant cross-reactivity with other respiratory viruses or even other coronaviruses. A small study conducted in Korea suggests that patients with persistent positive tests who are beyond 10 days from the initial positive test and are now symptom free are no longer infectious.

For patients with a high suspicion of COVID-19, a negative test should not rule out the infection. The number of false-negative results is not well known, though the resultant risk is “substantial.” A number of factors affect the likelihood of a false-negative test, including when the sample was collected relative to the timing of illness and the type of specimen collected; for example, nasopharyngeal swabs are more likely to be accurate vs nasal or throat specimens. Repeat or serial testing increases the sensitivity but may not always be available. Although rRT-PCR is the current criterion standard, more inclusive consensus-based criteria are likely to emerge because of the concern about these false-negative results.
 

This article first appeared on Medscape.com.

Information about COVID has evolved so quickly that it can be difficult for clinicians to feel confident that they are staying current. These summaries include links to our reference article on diagnosis of COVID-19, which is constantly updated to make sure you have the latest information.

Diagnostic testing for COVID-19 is critical. No one disputes that. But what is in dispute is whom to test, when to test, how to test, what to do while waiting for results, and how accurate those results are when you finally get them.

Here are the answers to those questions, based on the current information.

Whom to test. This is the (relatively) easy part. The ideal answer is that everyone should be tested. The Infectious Diseases Society of America issued tier-based recommendations way back in March, and they still apply. First priority continues to be patients who are ill, healthcare workers, and those with known exposure. But to truly figure out the amount of community spread in a given area, we need to test people who do not have a clear indication for testing. That is particularly true as more people return to work and the Centers for Disease Control and Prevention (CDC) has issued guidelines for workplaces to establish testing programs. Universal testing is recommended for some high-risk settings, such as nursing homes.

One key change: CDC no longer recommends testing to determine whether someone with a known infection is still infectious.

When to test. People with any symptoms suggestive of COVID should be tested, ideally as soon as feasible. But given the ongoing shortages of tests, that may not be possible, particularly for those requiring only symptomatic care. Rather, these patients should be treated as probable cases, with appropriate instructions regarding quarantine. Testing of those with known exposures ideally should be done about 5 days after exposure.

How to test. Only viral nucleic acid or antigen tests should be used to diagnose acute illness. CDC does not currently recommend using serologic assays, now broadly available, for diagnosis of acute infection, though they obviously play an important role in understanding the transmission dynamic of the virus in the general population.

Testing strategies vary from state to state and even within communities in a single state. It is recommended that clinicians check with their own local or state health department for specifics on tests available, indications for testing, and processing details. While often forgotten, it is worth emphasizing that no diagnostic tests have been approved by the US Food and Drug Administration (FDA). Rather, they are available under emergency use authorization (EUA), meaning that they have not been fully vetted by the FDA.

In late July, the FDA expanded authorization for real-time reverse transcription–polymerase chain reaction (rRT-PCR) molecular assays, utilizing nasal or nasopharyngeal swabs, to permit testing of all persons, regardless of exposure history or symptoms. The FDA maintains a list of all approved diagnostic tests and corresponding labs. Current evidence suggests that no one test is better than any other — and most clinicians won›t have a choice anyway. Patients will have to get what is available via their health department or insurance plan.

Two point-of-care antigen tests using nasopharyngeal or nasal samples have been issued an EUA. These tests can be used only in settings with a valid CLIA certificate.

Several commercial laboratories have received approval to process diagnostic tests using patients’ self-collected saliva rather than swabs. One lab has now received authorization for in-home testing without any input from a clinician. These testing options can be a boon for patients who have symptoms or exposure and for whatever reason are unable to get to a diagnostic site. These samples are collected at home and mailed to a lab. Note that these tests are not yet widely available.

Waiting for results. If waiting for results meant a day or even a couple of days, the answer to this one would be easier. But if the wait extends to 1 and even sometimes 2 weeks, then the test is not able to meaningfully guide clinical decisions. The latest guidance from the CDC is that individuals with symptoms suggestive of COVID who do not require hospitalization should remain at home in self-quarantine for at least 10 days from symptom onset. Asymptomatic individuals with a known exposure to someone else with COVID, or participation in a high-risk event like an indoor gathering involving more than 10 persons, should self-quarantine either until they receive a negative test result or 14 days after the exposure.

Accuracy of results. A positive rRT-PCR antigen test is highly accurate, indicating presence of SARS-CoV-2 RNA. There appears to be no significant cross-reactivity with other respiratory viruses or even other coronaviruses. A small study conducted in Korea suggests that patients with persistent positive tests who are beyond 10 days from the initial positive test and are now symptom free are no longer infectious.

For patients with a high suspicion of COVID-19, a negative test should not rule out the infection. The number of false-negative results is not well known, though the resultant risk is “substantial.” A number of factors affect the likelihood of a false-negative test, including when the sample was collected relative to the timing of illness and the type of specimen collected; for example, nasopharyngeal swabs are more likely to be accurate vs nasal or throat specimens. Repeat or serial testing increases the sensitivity but may not always be available. Although rRT-PCR is the current criterion standard, more inclusive consensus-based criteria are likely to emerge because of the concern about these false-negative results.
 

This article first appeared on Medscape.com.

Information about COVID has evolved so quickly that it can be difficult for clinicians to feel confident that they are staying current. These summaries include links to our reference article on diagnosis of COVID-19, which is constantly updated to make sure you have the latest information.

Diagnostic testing for COVID-19 is critical. No one disputes that. But what is in dispute is whom to test, when to test, how to test, what to do while waiting for results, and how accurate those results are when you finally get them.

Here are the answers to those questions, based on the current information.

Whom to test. This is the (relatively) easy part. The ideal answer is that everyone should be tested. The Infectious Diseases Society of America issued tier-based recommendations way back in March, and they still apply. First priority continues to be patients who are ill, healthcare workers, and those with known exposure. But to truly figure out the amount of community spread in a given area, we need to test people who do not have a clear indication for testing. That is particularly true as more people return to work and the Centers for Disease Control and Prevention (CDC) has issued guidelines for workplaces to establish testing programs. Universal testing is recommended for some high-risk settings, such as nursing homes.

One key change: CDC no longer recommends testing to determine whether someone with a known infection is still infectious.

When to test. People with any symptoms suggestive of COVID should be tested, ideally as soon as feasible. But given the ongoing shortages of tests, that may not be possible, particularly for those requiring only symptomatic care. Rather, these patients should be treated as probable cases, with appropriate instructions regarding quarantine. Testing of those with known exposures ideally should be done about 5 days after exposure.

How to test. Only viral nucleic acid or antigen tests should be used to diagnose acute illness. CDC does not currently recommend using serologic assays, now broadly available, for diagnosis of acute infection, though they obviously play an important role in understanding the transmission dynamic of the virus in the general population.

Testing strategies vary from state to state and even within communities in a single state. It is recommended that clinicians check with their own local or state health department for specifics on tests available, indications for testing, and processing details. While often forgotten, it is worth emphasizing that no diagnostic tests have been approved by the US Food and Drug Administration (FDA). Rather, they are available under emergency use authorization (EUA), meaning that they have not been fully vetted by the FDA.

In late July, the FDA expanded authorization for real-time reverse transcription–polymerase chain reaction (rRT-PCR) molecular assays, utilizing nasal or nasopharyngeal swabs, to permit testing of all persons, regardless of exposure history or symptoms. The FDA maintains a list of all approved diagnostic tests and corresponding labs. Current evidence suggests that no one test is better than any other — and most clinicians won›t have a choice anyway. Patients will have to get what is available via their health department or insurance plan.

Two point-of-care antigen tests using nasopharyngeal or nasal samples have been issued an EUA. These tests can be used only in settings with a valid CLIA certificate.

Several commercial laboratories have received approval to process diagnostic tests using patients’ self-collected saliva rather than swabs. One lab has now received authorization for in-home testing without any input from a clinician. These testing options can be a boon for patients who have symptoms or exposure and for whatever reason are unable to get to a diagnostic site. These samples are collected at home and mailed to a lab. Note that these tests are not yet widely available.

Waiting for results. If waiting for results meant a day or even a couple of days, the answer to this one would be easier. But if the wait extends to 1 and even sometimes 2 weeks, then the test is not able to meaningfully guide clinical decisions. The latest guidance from the CDC is that individuals with symptoms suggestive of COVID who do not require hospitalization should remain at home in self-quarantine for at least 10 days from symptom onset. Asymptomatic individuals with a known exposure to someone else with COVID, or participation in a high-risk event like an indoor gathering involving more than 10 persons, should self-quarantine either until they receive a negative test result or 14 days after the exposure.

Accuracy of results. A positive rRT-PCR antigen test is highly accurate, indicating presence of SARS-CoV-2 RNA. There appears to be no significant cross-reactivity with other respiratory viruses or even other coronaviruses. A small study conducted in Korea suggests that patients with persistent positive tests who are beyond 10 days from the initial positive test and are now symptom free are no longer infectious.

For patients with a high suspicion of COVID-19, a negative test should not rule out the infection. The number of false-negative results is not well known, though the resultant risk is “substantial.” A number of factors affect the likelihood of a false-negative test, including when the sample was collected relative to the timing of illness and the type of specimen collected; for example, nasopharyngeal swabs are more likely to be accurate vs nasal or throat specimens. Repeat or serial testing increases the sensitivity but may not always be available. Although rRT-PCR is the current criterion standard, more inclusive consensus-based criteria are likely to emerge because of the concern about these false-negative results.
 

This article first appeared on Medscape.com.

Among women who have a coincidental appendectomy during surgery for chronic pelvic pain or endometriosis, about 15% have appendiceal endometriosis confirmed by pathological examination, according to a study.

“In the women with appendiceal endometriosis, only 26% had an appendix that looked abnormal,” said Whitney T. Ross, MD, of the department of obstetrics and gynecology at Penn State Health, Hershey.

The results, presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons, indicate that “appendiceal endometriosis is common in women receiving surgery for chronic pelvic pain or endometriosis,” she said. “This study and multiple other studies have also demonstrated that coincidental appendectomy is safe.”

The long-term impact of coincidental appendectomy and its effect on quality of life are not known, however, which may make it difficult to weigh the costs and benefits of the procedure, Dr. Ross said. “It is important to talk to patients about this procedure and determine which approach is the right approach for your institution.”

The study of 609 coincidental appendectomies did not include patients with retrocecal appendices, which may confound the true rate of appendiceal endometriosis, commented Saifuddin T. Mama, MD, MPH, of Rowan University, Camden, N.J.

When the investigators started the study, they were not sure of the risks and benefits of the procedure in patients with retrocecal appendices. An anecdotal report from another research group suggests that outcomes with retrocecal appendices may not be significantly different. “But that is certainly an important question and one that we would like to address in a future prospective study,” Dr. Ross said.

Surgeons have debated the role of coincidental appendectomy during gynecologic surgery. Concerns about safety and questions about the prevalence of appendiceal pathology are reasons that coincidental appendectomy has not been more widely adopted. On the other hand, the procedure may benefit patients and aid diagnosis.

To evaluate the role of coincidental appendectomy in the surgical excision of endometriosis, Dr. Ross and colleagues analyzed data from consecutive coincidental appendectomies performed at one institution between 2013 and 2019. They identified cases in a prospectively maintained surgical database to assess safety and the prevalence of appendiceal pathology.

iStockphoto.com

The indication for surgery was chronic pelvic pain but no visualized endometriosis for 42 patients, stage I-II endometriosis for 388 patients, and stage III-IV endometriosis for 179 patients.

Surgeries included laparoscopic hysterectomy (77.5%), operative laparoscopy (19.9%), and laparoscopic trachelectomy (2.6%). Pathological analysis of the appendices identified endometriosis in 14.9%, malignancy in 0.7%, polyps in 0.5%, and appendicitis in 0.3%.

Among women with chronic pelvic pain but no visualized endometriosis, 2.4% had appendiceal endometriosis. Among those with stage I-II endometriosis, 7% had appendiceal endometriosis, and in patients with stage III-IV endometriosis, the rate of appendiceal endometriosis was 35.2%.

In about 6% of patients with appendiceal endometriosis, the appendix was the only site of pathologically confirmed endometriosis.

Compared with chronic pelvic pain, stage III-IV endometriosis was associated with a significantly increased risk of appendiceal endometriosis (odds ratio, 22.2). The likelihood of appendiceal endometriosis also increased when the appendix looked abnormal (odds ratio, 6.5).

The probability of diagnosing appendiceal endometriosis also increases with the number of other locations of confirmed endometriosis.

“Our surgical decision making is based off of intraoperative findings. However, the final gold-standard diagnosis can’t take place until the pathologic specimen is analyzed,” she said. “We also know that there is a significant discordance, as high as 50%, in early-stage endometriosis between visual inspection and pathology findings.”

There were no complications related to the performance of a coincidental appendectomy during surgery or in the 12 weeks after.

Dr. Ross outlined surgeons’ three main options for performing coincidental appendectomy in patients undergoing surgery for chronic pelvic pain or endometriosis: universal coincidental appendectomy, targeted appendectomy based on operative findings, and performing the procedure based on the appearance of the appendix.

Basing the decision on appearance “is going to miss a lot of appendiceal endometriosis,” Dr. Ross said. In the present study, 67 of the 91 cases, about 74%, would have been missed.

Dr. Ross and Dr. Mama had no relevant financial disclosures. The study coauthors disclosed ties to Titan Medical, Merck, and AbbVie.

jremaly@mdedge.com

SOURCE: Ross WT et al. SGS 2020, Abstract 14.

Among women who have a coincidental appendectomy during surgery for chronic pelvic pain or endometriosis, about 15% have appendiceal endometriosis confirmed by pathological examination, according to a study.

“In the women with appendiceal endometriosis, only 26% had an appendix that looked abnormal,” said Whitney T. Ross, MD, of the department of obstetrics and gynecology at Penn State Health, Hershey.

The results, presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons, indicate that “appendiceal endometriosis is common in women receiving surgery for chronic pelvic pain or endometriosis,” she said. “This study and multiple other studies have also demonstrated that coincidental appendectomy is safe.”

The long-term impact of coincidental appendectomy and its effect on quality of life are not known, however, which may make it difficult to weigh the costs and benefits of the procedure, Dr. Ross said. “It is important to talk to patients about this procedure and determine which approach is the right approach for your institution.”

The study of 609 coincidental appendectomies did not include patients with retrocecal appendices, which may confound the true rate of appendiceal endometriosis, commented Saifuddin T. Mama, MD, MPH, of Rowan University, Camden, N.J.

When the investigators started the study, they were not sure of the risks and benefits of the procedure in patients with retrocecal appendices. An anecdotal report from another research group suggests that outcomes with retrocecal appendices may not be significantly different. “But that is certainly an important question and one that we would like to address in a future prospective study,” Dr. Ross said.

Surgeons have debated the role of coincidental appendectomy during gynecologic surgery. Concerns about safety and questions about the prevalence of appendiceal pathology are reasons that coincidental appendectomy has not been more widely adopted. On the other hand, the procedure may benefit patients and aid diagnosis.

To evaluate the role of coincidental appendectomy in the surgical excision of endometriosis, Dr. Ross and colleagues analyzed data from consecutive coincidental appendectomies performed at one institution between 2013 and 2019. They identified cases in a prospectively maintained surgical database to assess safety and the prevalence of appendiceal pathology.

iStockphoto.com

The indication for surgery was chronic pelvic pain but no visualized endometriosis for 42 patients, stage I-II endometriosis for 388 patients, and stage III-IV endometriosis for 179 patients.

Surgeries included laparoscopic hysterectomy (77.5%), operative laparoscopy (19.9%), and laparoscopic trachelectomy (2.6%). Pathological analysis of the appendices identified endometriosis in 14.9%, malignancy in 0.7%, polyps in 0.5%, and appendicitis in 0.3%.

Among women with chronic pelvic pain but no visualized endometriosis, 2.4% had appendiceal endometriosis. Among those with stage I-II endometriosis, 7% had appendiceal endometriosis, and in patients with stage III-IV endometriosis, the rate of appendiceal endometriosis was 35.2%.

In about 6% of patients with appendiceal endometriosis, the appendix was the only site of pathologically confirmed endometriosis.

Compared with chronic pelvic pain, stage III-IV endometriosis was associated with a significantly increased risk of appendiceal endometriosis (odds ratio, 22.2). The likelihood of appendiceal endometriosis also increased when the appendix looked abnormal (odds ratio, 6.5).

The probability of diagnosing appendiceal endometriosis also increases with the number of other locations of confirmed endometriosis.

“Our surgical decision making is based off of intraoperative findings. However, the final gold-standard diagnosis can’t take place until the pathologic specimen is analyzed,” she said. “We also know that there is a significant discordance, as high as 50%, in early-stage endometriosis between visual inspection and pathology findings.”

There were no complications related to the performance of a coincidental appendectomy during surgery or in the 12 weeks after.

Dr. Ross outlined surgeons’ three main options for performing coincidental appendectomy in patients undergoing surgery for chronic pelvic pain or endometriosis: universal coincidental appendectomy, targeted appendectomy based on operative findings, and performing the procedure based on the appearance of the appendix.

Basing the decision on appearance “is going to miss a lot of appendiceal endometriosis,” Dr. Ross said. In the present study, 67 of the 91 cases, about 74%, would have been missed.

Dr. Ross and Dr. Mama had no relevant financial disclosures. The study coauthors disclosed ties to Titan Medical, Merck, and AbbVie.

jremaly@mdedge.com

SOURCE: Ross WT et al. SGS 2020, Abstract 14.

Among women who have a coincidental appendectomy during surgery for chronic pelvic pain or endometriosis, about 15% have appendiceal endometriosis confirmed by pathological examination, according to a study.

“In the women with appendiceal endometriosis, only 26% had an appendix that looked abnormal,” said Whitney T. Ross, MD, of the department of obstetrics and gynecology at Penn State Health, Hershey.

The results, presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons, indicate that “appendiceal endometriosis is common in women receiving surgery for chronic pelvic pain or endometriosis,” she said. “This study and multiple other studies have also demonstrated that coincidental appendectomy is safe.”

The long-term impact of coincidental appendectomy and its effect on quality of life are not known, however, which may make it difficult to weigh the costs and benefits of the procedure, Dr. Ross said. “It is important to talk to patients about this procedure and determine which approach is the right approach for your institution.”

The study of 609 coincidental appendectomies did not include patients with retrocecal appendices, which may confound the true rate of appendiceal endometriosis, commented Saifuddin T. Mama, MD, MPH, of Rowan University, Camden, N.J.

When the investigators started the study, they were not sure of the risks and benefits of the procedure in patients with retrocecal appendices. An anecdotal report from another research group suggests that outcomes with retrocecal appendices may not be significantly different. “But that is certainly an important question and one that we would like to address in a future prospective study,” Dr. Ross said.

Surgeons have debated the role of coincidental appendectomy during gynecologic surgery. Concerns about safety and questions about the prevalence of appendiceal pathology are reasons that coincidental appendectomy has not been more widely adopted. On the other hand, the procedure may benefit patients and aid diagnosis.

To evaluate the role of coincidental appendectomy in the surgical excision of endometriosis, Dr. Ross and colleagues analyzed data from consecutive coincidental appendectomies performed at one institution between 2013 and 2019. They identified cases in a prospectively maintained surgical database to assess safety and the prevalence of appendiceal pathology.

iStockphoto.com

The indication for surgery was chronic pelvic pain but no visualized endometriosis for 42 patients, stage I-II endometriosis for 388 patients, and stage III-IV endometriosis for 179 patients.

Surgeries included laparoscopic hysterectomy (77.5%), operative laparoscopy (19.9%), and laparoscopic trachelectomy (2.6%). Pathological analysis of the appendices identified endometriosis in 14.9%, malignancy in 0.7%, polyps in 0.5%, and appendicitis in 0.3%.

Among women with chronic pelvic pain but no visualized endometriosis, 2.4% had appendiceal endometriosis. Among those with stage I-II endometriosis, 7% had appendiceal endometriosis, and in patients with stage III-IV endometriosis, the rate of appendiceal endometriosis was 35.2%.

In about 6% of patients with appendiceal endometriosis, the appendix was the only site of pathologically confirmed endometriosis.

Compared with chronic pelvic pain, stage III-IV endometriosis was associated with a significantly increased risk of appendiceal endometriosis (odds ratio, 22.2). The likelihood of appendiceal endometriosis also increased when the appendix looked abnormal (odds ratio, 6.5).

The probability of diagnosing appendiceal endometriosis also increases with the number of other locations of confirmed endometriosis.

“Our surgical decision making is based off of intraoperative findings. However, the final gold-standard diagnosis can’t take place until the pathologic specimen is analyzed,” she said. “We also know that there is a significant discordance, as high as 50%, in early-stage endometriosis between visual inspection and pathology findings.”

There were no complications related to the performance of a coincidental appendectomy during surgery or in the 12 weeks after.

Dr. Ross outlined surgeons’ three main options for performing coincidental appendectomy in patients undergoing surgery for chronic pelvic pain or endometriosis: universal coincidental appendectomy, targeted appendectomy based on operative findings, and performing the procedure based on the appearance of the appendix.

Basing the decision on appearance “is going to miss a lot of appendiceal endometriosis,” Dr. Ross said. In the present study, 67 of the 91 cases, about 74%, would have been missed.

Dr. Ross and Dr. Mama had no relevant financial disclosures. The study coauthors disclosed ties to Titan Medical, Merck, and AbbVie.

jremaly@mdedge.com

SOURCE: Ross WT et al. SGS 2020, Abstract 14.