CHEST Physician

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.

A new test, the first to combine liquid biopsy and next-generation sequencing (NGS), has been approved by the US Food and Drug Administration (FDA) for use in patients with metastatic non–small cell lung cancer (NSCLC) to identify tumors with specific mutation types of the epidermal growth factor receptor (EGFR) gene.

The Guardant360 CDx assay (Guardant Health) is the first to combine the two technologies into a diagnostic test to guide treatment decisions.

Liquid biopsy offers the advantage of obtaining genetic information on a tumor from a simple blood draw instead of a tissue biopsy, which requires fine-needle aspiration of the lung. “ It is less invasive and more easily repeatable in comparison to standard tissue biopsies ... and can be used in cases in which standard tissue biopsies are not feasible, for instance, due to the location of the tumor,” the FDA commented.

NGS offers the advantage of simultaneously detecting mutations in 55 tumor genes, as opposed to conducting a separate test for each gene.

However, although the assay can provide information on multiple solid tumor biomarkers, the approval is specific only to identifying EGFR mutations in patients who will benefit from treatment with osimertinib (Tagrisso, AstraZeneca).

The approval does not validate the test for use in detecting other biomarkers, the FDA noted.

As previously reported, the assay has a comprehensive NGS panel that identifies seven guideline-recommended predictive biomarkers (EGFR, ALK, ROS1, BRAF, RET, MET, ERBB2) — known as the G7 biomarkers — and one prognostic marker (KRAS).

But the FDA noted that “genomic findings for other biomarkers evaluated are not validated for choosing a particular corresponding treatment with this approval.

“If the specific NSCLC mutations associated with today’s approval are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present,” the agency emphasized.

Nevertheless, the FDA announcement highlights the potential of the test to identify these other biomarkers.

“Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, commented in a statement. 

“In addition to benefiting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms,” he noted.

The manufacturer also highlighted this potential. “We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx,” Helmy Eltoukhy, PhD, CEO of Guardant Health, said in a statement.

NILE Study

The FDA did not cite any specific trial of the assay in its announcement of the approval, but Medscape Medical News has previously reported results from the NILE study presented at the 2019 Annual Meeting of the American Association for Cancer Research (AACR).

The NILE trial was conducted in 282 patients with untreated nonsquamous NSCLC who underwent standard-of-care tissue genotyping and had a pretreatment blood sample for cell-free DNA (cfDNA) analysis.

Results showed that a G7 biomarker was identified in a significantly higher proportion of liquid biopsies compared with tissue genotyping (27.3% vs 21.3%; P < .0001).

The lower frequency of G7 biomarkers in tissue genotyping was due to insufficient tissue for sequential sequencing, the authors reported at that time.

Liquid biopsy improved G7 detection frequency by 48%, from 60 to 89 patients, which included samples that were negative by tissue testing (7), not tested (16), or lacked sufficient sample for a tissue-based test (6).

Of 193 patients without a G7 biomarker by tissue or cfDNA, 24 patients (12.4%) had an activating KRAS mutation identified in the tissue alone, and with cfDNA, KRAS-positivity increased from 24 to 92 patients.

The Guardant360 CDx assay has been granted a breakthrough device designation, whereby the FDA provides intensive interaction and guidance on efficient device development to the company.
 

This article first appeared on Medscape.com.

A new test, the first to combine liquid biopsy and next-generation sequencing (NGS), has been approved by the US Food and Drug Administration (FDA) for use in patients with metastatic non–small cell lung cancer (NSCLC) to identify tumors with specific mutation types of the epidermal growth factor receptor (EGFR) gene.

The Guardant360 CDx assay (Guardant Health) is the first to combine the two technologies into a diagnostic test to guide treatment decisions.

Liquid biopsy offers the advantage of obtaining genetic information on a tumor from a simple blood draw instead of a tissue biopsy, which requires fine-needle aspiration of the lung. “ It is less invasive and more easily repeatable in comparison to standard tissue biopsies ... and can be used in cases in which standard tissue biopsies are not feasible, for instance, due to the location of the tumor,” the FDA commented.

NGS offers the advantage of simultaneously detecting mutations in 55 tumor genes, as opposed to conducting a separate test for each gene.

However, although the assay can provide information on multiple solid tumor biomarkers, the approval is specific only to identifying EGFR mutations in patients who will benefit from treatment with osimertinib (Tagrisso, AstraZeneca).

The approval does not validate the test for use in detecting other biomarkers, the FDA noted.

As previously reported, the assay has a comprehensive NGS panel that identifies seven guideline-recommended predictive biomarkers (EGFR, ALK, ROS1, BRAF, RET, MET, ERBB2) — known as the G7 biomarkers — and one prognostic marker (KRAS).

But the FDA noted that “genomic findings for other biomarkers evaluated are not validated for choosing a particular corresponding treatment with this approval.

“If the specific NSCLC mutations associated with today’s approval are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present,” the agency emphasized.

Nevertheless, the FDA announcement highlights the potential of the test to identify these other biomarkers.

“Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, commented in a statement. 

“In addition to benefiting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms,” he noted.

The manufacturer also highlighted this potential. “We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx,” Helmy Eltoukhy, PhD, CEO of Guardant Health, said in a statement.

NILE Study

The FDA did not cite any specific trial of the assay in its announcement of the approval, but Medscape Medical News has previously reported results from the NILE study presented at the 2019 Annual Meeting of the American Association for Cancer Research (AACR).

The NILE trial was conducted in 282 patients with untreated nonsquamous NSCLC who underwent standard-of-care tissue genotyping and had a pretreatment blood sample for cell-free DNA (cfDNA) analysis.

Results showed that a G7 biomarker was identified in a significantly higher proportion of liquid biopsies compared with tissue genotyping (27.3% vs 21.3%; P < .0001).

The lower frequency of G7 biomarkers in tissue genotyping was due to insufficient tissue for sequential sequencing, the authors reported at that time.

Liquid biopsy improved G7 detection frequency by 48%, from 60 to 89 patients, which included samples that were negative by tissue testing (7), not tested (16), or lacked sufficient sample for a tissue-based test (6).

Of 193 patients without a G7 biomarker by tissue or cfDNA, 24 patients (12.4%) had an activating KRAS mutation identified in the tissue alone, and with cfDNA, KRAS-positivity increased from 24 to 92 patients.

The Guardant360 CDx assay has been granted a breakthrough device designation, whereby the FDA provides intensive interaction and guidance on efficient device development to the company.
 

This article first appeared on Medscape.com.

A new test, the first to combine liquid biopsy and next-generation sequencing (NGS), has been approved by the US Food and Drug Administration (FDA) for use in patients with metastatic non–small cell lung cancer (NSCLC) to identify tumors with specific mutation types of the epidermal growth factor receptor (EGFR) gene.

The Guardant360 CDx assay (Guardant Health) is the first to combine the two technologies into a diagnostic test to guide treatment decisions.

Liquid biopsy offers the advantage of obtaining genetic information on a tumor from a simple blood draw instead of a tissue biopsy, which requires fine-needle aspiration of the lung. “ It is less invasive and more easily repeatable in comparison to standard tissue biopsies ... and can be used in cases in which standard tissue biopsies are not feasible, for instance, due to the location of the tumor,” the FDA commented.

NGS offers the advantage of simultaneously detecting mutations in 55 tumor genes, as opposed to conducting a separate test for each gene.

However, although the assay can provide information on multiple solid tumor biomarkers, the approval is specific only to identifying EGFR mutations in patients who will benefit from treatment with osimertinib (Tagrisso, AstraZeneca).

The approval does not validate the test for use in detecting other biomarkers, the FDA noted.

As previously reported, the assay has a comprehensive NGS panel that identifies seven guideline-recommended predictive biomarkers (EGFR, ALK, ROS1, BRAF, RET, MET, ERBB2) — known as the G7 biomarkers — and one prognostic marker (KRAS).

But the FDA noted that “genomic findings for other biomarkers evaluated are not validated for choosing a particular corresponding treatment with this approval.

“If the specific NSCLC mutations associated with today’s approval are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present,” the agency emphasized.

Nevertheless, the FDA announcement highlights the potential of the test to identify these other biomarkers.

“Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, commented in a statement. 

“In addition to benefiting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms,” he noted.

The manufacturer also highlighted this potential. “We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx,” Helmy Eltoukhy, PhD, CEO of Guardant Health, said in a statement.

NILE Study

The FDA did not cite any specific trial of the assay in its announcement of the approval, but Medscape Medical News has previously reported results from the NILE study presented at the 2019 Annual Meeting of the American Association for Cancer Research (AACR).

The NILE trial was conducted in 282 patients with untreated nonsquamous NSCLC who underwent standard-of-care tissue genotyping and had a pretreatment blood sample for cell-free DNA (cfDNA) analysis.

Results showed that a G7 biomarker was identified in a significantly higher proportion of liquid biopsies compared with tissue genotyping (27.3% vs 21.3%; P < .0001).

The lower frequency of G7 biomarkers in tissue genotyping was due to insufficient tissue for sequential sequencing, the authors reported at that time.

Liquid biopsy improved G7 detection frequency by 48%, from 60 to 89 patients, which included samples that were negative by tissue testing (7), not tested (16), or lacked sufficient sample for a tissue-based test (6).

Of 193 patients without a G7 biomarker by tissue or cfDNA, 24 patients (12.4%) had an activating KRAS mutation identified in the tissue alone, and with cfDNA, KRAS-positivity increased from 24 to 92 patients.

The Guardant360 CDx assay has been granted a breakthrough device designation, whereby the FDA provides intensive interaction and guidance on efficient device development to the company.
 

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.

By now it is well known that the COVID-19 pandemic has significantly disrupted primary care. Office visits and revenues have precipitously dropped as physicians and patients alike fear in-person visits may increase their risks of contracting the virus. However, telemedicine has emerged as a lifeline of sorts for many practices, enabling them to conduct visits and maintain contact with patients.

Telemedicine is likely to continue to serve as a tool for primary care providers to improve access to convenient, cost-effective, high-quality care after the pandemic. Another benefit of telemedicine is it can help maintain a portion of a practice’s revenue stream for physicians during uncertain times.

Indeed, the nation has seen recent progress toward telemedicine parity, which refers to the concept of reimbursing providers’ telehealth visits at the same rates as similar in-person visits.

A challenge to adopting telemedicine is that it calls for adjusting established workflows for in-person encounters. A practice cannot simply replicate in-person processes to work for telehealth. While both in-person and virtual visits require adherence to HIPAA, for example, how you actually protect patient privacy will call for different measures. Harking back to the early days of EMR implementation, one does not need to like the telemedicine platform or process, but come to terms with the fact that it is a tool that is here to stay to deliver patient care.

Following are a few tips for primary care practices to help mitigate disruption while embracing telemedicine.

Treat your practice like a laboratory

Adoption may vary between practices depending on many factors, including clinicians’ comfort with technology, clinical tolerance and triage rules for nontouch encounters, state regulations, and more. Every provider group should begin experimenting with telemedicine in specific ways that make sense for them.

One physician may practice telemedicine full-time while the rest abstain, or perhaps the practice prefers to offer telemedicine services during specific hours on specific days. Don’t be afraid to start slowly when you’re trying something new – but do get started with telehealth. It will increasingly be a mainstream medium and more patients will come to expect it.

Train the entire team

Many primary care practices do not enjoy the resources of an information technology team, so all team members essentially need to learn the new skill of telemedicine usage, in addition to assisting patients. That can’t happen without staff buy-in, so it is essential that everyone from the office manager to medical assistants have the training they need to make the technology work. Juggling schedules for telehealth and in-office, activating an account through email, starting and joining a telehealth meeting, and preparing a patient for a visit are just a handful of basic tasks your staff should be trained to do to contribute to the successful integration of telehealth.

Educate and encourage patients to use telehealth

While unfamiliarity with technology may represent a roadblock for some patients, others resist telemedicine simply because no one has explained to them why it’s so important and the benefits it can hold for them. Education and communication are critical, including the sometimes painstaking work of slowly walking patients through the process of performing important functions on the telemedicine app. By providing them with some friendly coaching, patients won’t feel lost or abandoned during what for some may be an unfamiliar and frustrating process.

Manage more behavioral health

Different states and health plans incentivize primary practices for integrating behavioral health into their offerings. Rather than dismiss this addition to your own practice as too cumbersome to take on, I would recommend using telehealth to expand behavioral health care services.

If your practice is working toward a team-based, interdisciplinary approach to care delivery, behavioral health is a critical component. While other elements of this “whole person” health care may be better suited for an office visit, the vast majority of behavioral health services can be delivered virtually.

To decide if your patient may benefit from behavioral health care, the primary care provider (PCP) can conduct a screening via telehealth. Once the screening is complete, the PCP can discuss results and refer the patient to a mental health professional – all via telehealth. While patients may be reluctant to receive behavioral health treatment, perhaps because of stigma or inexperience, they may appreciate the telemedicine option as they can remain in the comfort and familiarity of their homes.

Collaborative Care is both an in-person and virtual model that allows PCP practices to offer behavioral health services in a cost effective way by utilizing a psychiatrist as a “consultant” to the practice as opposed to hiring a full-time psychiatrist. All services within the Collaborative Care Model can be offered via telehealth, and all major insurance providers reimburse primary care providers for delivering Collaborative Care.

When PCPs provide behavioral health treatment as an “extension” of the primary care service offerings, the stigma is reduced and more patients are willing to accept the care they need.

Many areas of the country suffer from a lack of access to behavioral health specialists. In rural counties, for example, the nearest therapist may be located over an hour away. By integrating behavioral telehealth services into your practice’s offerings, you can remove geographic and transportation obstacles to care for your patient population.

Doing this can lead to providing more culturally competent care. It’s important that you’re able to offer mental health services to your patients from a professional with a similar ethnic or racial background. Language barriers and cultural differences may limit a provider’s ability to treat a patient, particularly if the patient faces health disparities related to race or ethnicity. If your practice needs to look outside of your community to tap into a more diverse pool of providers to better meet your patients’ needs, telehealth makes it easier to do that.

Adopting telemedicine for consultative patient visits offers primary care a path toward restoring patient volume and hope for a postpandemic future.
 

Mark Stephan, MD, is chief medical officer at Equality Health, a whole-health delivery system. He practiced family medicine for 19 years, including hospital medicine and obstetrics in rural and urban settings. Dr. Stephan has no conflicts related to the content of this piece.

By now it is well known that the COVID-19 pandemic has significantly disrupted primary care. Office visits and revenues have precipitously dropped as physicians and patients alike fear in-person visits may increase their risks of contracting the virus. However, telemedicine has emerged as a lifeline of sorts for many practices, enabling them to conduct visits and maintain contact with patients.

Telemedicine is likely to continue to serve as a tool for primary care providers to improve access to convenient, cost-effective, high-quality care after the pandemic. Another benefit of telemedicine is it can help maintain a portion of a practice’s revenue stream for physicians during uncertain times.

Indeed, the nation has seen recent progress toward telemedicine parity, which refers to the concept of reimbursing providers’ telehealth visits at the same rates as similar in-person visits.

A challenge to adopting telemedicine is that it calls for adjusting established workflows for in-person encounters. A practice cannot simply replicate in-person processes to work for telehealth. While both in-person and virtual visits require adherence to HIPAA, for example, how you actually protect patient privacy will call for different measures. Harking back to the early days of EMR implementation, one does not need to like the telemedicine platform or process, but come to terms with the fact that it is a tool that is here to stay to deliver patient care.

Following are a few tips for primary care practices to help mitigate disruption while embracing telemedicine.

Treat your practice like a laboratory

Adoption may vary between practices depending on many factors, including clinicians’ comfort with technology, clinical tolerance and triage rules for nontouch encounters, state regulations, and more. Every provider group should begin experimenting with telemedicine in specific ways that make sense for them.

One physician may practice telemedicine full-time while the rest abstain, or perhaps the practice prefers to offer telemedicine services during specific hours on specific days. Don’t be afraid to start slowly when you’re trying something new – but do get started with telehealth. It will increasingly be a mainstream medium and more patients will come to expect it.

Train the entire team

Many primary care practices do not enjoy the resources of an information technology team, so all team members essentially need to learn the new skill of telemedicine usage, in addition to assisting patients. That can’t happen without staff buy-in, so it is essential that everyone from the office manager to medical assistants have the training they need to make the technology work. Juggling schedules for telehealth and in-office, activating an account through email, starting and joining a telehealth meeting, and preparing a patient for a visit are just a handful of basic tasks your staff should be trained to do to contribute to the successful integration of telehealth.

Educate and encourage patients to use telehealth

While unfamiliarity with technology may represent a roadblock for some patients, others resist telemedicine simply because no one has explained to them why it’s so important and the benefits it can hold for them. Education and communication are critical, including the sometimes painstaking work of slowly walking patients through the process of performing important functions on the telemedicine app. By providing them with some friendly coaching, patients won’t feel lost or abandoned during what for some may be an unfamiliar and frustrating process.

Manage more behavioral health

Different states and health plans incentivize primary practices for integrating behavioral health into their offerings. Rather than dismiss this addition to your own practice as too cumbersome to take on, I would recommend using telehealth to expand behavioral health care services.

If your practice is working toward a team-based, interdisciplinary approach to care delivery, behavioral health is a critical component. While other elements of this “whole person” health care may be better suited for an office visit, the vast majority of behavioral health services can be delivered virtually.

To decide if your patient may benefit from behavioral health care, the primary care provider (PCP) can conduct a screening via telehealth. Once the screening is complete, the PCP can discuss results and refer the patient to a mental health professional – all via telehealth. While patients may be reluctant to receive behavioral health treatment, perhaps because of stigma or inexperience, they may appreciate the telemedicine option as they can remain in the comfort and familiarity of their homes.

Collaborative Care is both an in-person and virtual model that allows PCP practices to offer behavioral health services in a cost effective way by utilizing a psychiatrist as a “consultant” to the practice as opposed to hiring a full-time psychiatrist. All services within the Collaborative Care Model can be offered via telehealth, and all major insurance providers reimburse primary care providers for delivering Collaborative Care.

When PCPs provide behavioral health treatment as an “extension” of the primary care service offerings, the stigma is reduced and more patients are willing to accept the care they need.

Many areas of the country suffer from a lack of access to behavioral health specialists. In rural counties, for example, the nearest therapist may be located over an hour away. By integrating behavioral telehealth services into your practice’s offerings, you can remove geographic and transportation obstacles to care for your patient population.

Doing this can lead to providing more culturally competent care. It’s important that you’re able to offer mental health services to your patients from a professional with a similar ethnic or racial background. Language barriers and cultural differences may limit a provider’s ability to treat a patient, particularly if the patient faces health disparities related to race or ethnicity. If your practice needs to look outside of your community to tap into a more diverse pool of providers to better meet your patients’ needs, telehealth makes it easier to do that.

Adopting telemedicine for consultative patient visits offers primary care a path toward restoring patient volume and hope for a postpandemic future.
 

Mark Stephan, MD, is chief medical officer at Equality Health, a whole-health delivery system. He practiced family medicine for 19 years, including hospital medicine and obstetrics in rural and urban settings. Dr. Stephan has no conflicts related to the content of this piece.

By now it is well known that the COVID-19 pandemic has significantly disrupted primary care. Office visits and revenues have precipitously dropped as physicians and patients alike fear in-person visits may increase their risks of contracting the virus. However, telemedicine has emerged as a lifeline of sorts for many practices, enabling them to conduct visits and maintain contact with patients.

Telemedicine is likely to continue to serve as a tool for primary care providers to improve access to convenient, cost-effective, high-quality care after the pandemic. Another benefit of telemedicine is it can help maintain a portion of a practice’s revenue stream for physicians during uncertain times.

Indeed, the nation has seen recent progress toward telemedicine parity, which refers to the concept of reimbursing providers’ telehealth visits at the same rates as similar in-person visits.

A challenge to adopting telemedicine is that it calls for adjusting established workflows for in-person encounters. A practice cannot simply replicate in-person processes to work for telehealth. While both in-person and virtual visits require adherence to HIPAA, for example, how you actually protect patient privacy will call for different measures. Harking back to the early days of EMR implementation, one does not need to like the telemedicine platform or process, but come to terms with the fact that it is a tool that is here to stay to deliver patient care.

Following are a few tips for primary care practices to help mitigate disruption while embracing telemedicine.

Treat your practice like a laboratory

Adoption may vary between practices depending on many factors, including clinicians’ comfort with technology, clinical tolerance and triage rules for nontouch encounters, state regulations, and more. Every provider group should begin experimenting with telemedicine in specific ways that make sense for them.

One physician may practice telemedicine full-time while the rest abstain, or perhaps the practice prefers to offer telemedicine services during specific hours on specific days. Don’t be afraid to start slowly when you’re trying something new – but do get started with telehealth. It will increasingly be a mainstream medium and more patients will come to expect it.

Train the entire team

Many primary care practices do not enjoy the resources of an information technology team, so all team members essentially need to learn the new skill of telemedicine usage, in addition to assisting patients. That can’t happen without staff buy-in, so it is essential that everyone from the office manager to medical assistants have the training they need to make the technology work. Juggling schedules for telehealth and in-office, activating an account through email, starting and joining a telehealth meeting, and preparing a patient for a visit are just a handful of basic tasks your staff should be trained to do to contribute to the successful integration of telehealth.

Educate and encourage patients to use telehealth

While unfamiliarity with technology may represent a roadblock for some patients, others resist telemedicine simply because no one has explained to them why it’s so important and the benefits it can hold for them. Education and communication are critical, including the sometimes painstaking work of slowly walking patients through the process of performing important functions on the telemedicine app. By providing them with some friendly coaching, patients won’t feel lost or abandoned during what for some may be an unfamiliar and frustrating process.

Manage more behavioral health

Different states and health plans incentivize primary practices for integrating behavioral health into their offerings. Rather than dismiss this addition to your own practice as too cumbersome to take on, I would recommend using telehealth to expand behavioral health care services.

If your practice is working toward a team-based, interdisciplinary approach to care delivery, behavioral health is a critical component. While other elements of this “whole person” health care may be better suited for an office visit, the vast majority of behavioral health services can be delivered virtually.

To decide if your patient may benefit from behavioral health care, the primary care provider (PCP) can conduct a screening via telehealth. Once the screening is complete, the PCP can discuss results and refer the patient to a mental health professional – all via telehealth. While patients may be reluctant to receive behavioral health treatment, perhaps because of stigma or inexperience, they may appreciate the telemedicine option as they can remain in the comfort and familiarity of their homes.

Collaborative Care is both an in-person and virtual model that allows PCP practices to offer behavioral health services in a cost effective way by utilizing a psychiatrist as a “consultant” to the practice as opposed to hiring a full-time psychiatrist. All services within the Collaborative Care Model can be offered via telehealth, and all major insurance providers reimburse primary care providers for delivering Collaborative Care.

When PCPs provide behavioral health treatment as an “extension” of the primary care service offerings, the stigma is reduced and more patients are willing to accept the care they need.

Many areas of the country suffer from a lack of access to behavioral health specialists. In rural counties, for example, the nearest therapist may be located over an hour away. By integrating behavioral telehealth services into your practice’s offerings, you can remove geographic and transportation obstacles to care for your patient population.

Doing this can lead to providing more culturally competent care. It’s important that you’re able to offer mental health services to your patients from a professional with a similar ethnic or racial background. Language barriers and cultural differences may limit a provider’s ability to treat a patient, particularly if the patient faces health disparities related to race or ethnicity. If your practice needs to look outside of your community to tap into a more diverse pool of providers to better meet your patients’ needs, telehealth makes it easier to do that.

Adopting telemedicine for consultative patient visits offers primary care a path toward restoring patient volume and hope for a postpandemic future.
 

Mark Stephan, MD, is chief medical officer at Equality Health, a whole-health delivery system. He practiced family medicine for 19 years, including hospital medicine and obstetrics in rural and urban settings. Dr. Stephan has no conflicts related to the content of this piece.

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.

A clinician education program significantly reduced overall antibiotic prescribing during pediatric visits for acute respiratory tract infections, according to data from 57 clinicians who participated in an intervention.

sturti/Getty Images

In a study published in Pediatrics, Matthew P. Kronman, MD, of the University of Washington, Seattle, and associates randomized 57 clinicians at 19 pediatric practices to a stepped-wedge clinical trial. The study included visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infections (defined as ARTI visits) for children aged 6 months to less than 11 years, for a total of 72,723 ARTI visits by 29,762 patients. The primary outcome was overall antibiotic prescribing for ARTI visits.

For the intervention, known as the Dialogue Around Respiratory Illness Treatment (DART) quality improvement (QI) program, clinicians received three program modules containing online tutorials and webinars. These professionally-produced modules included a combination of evidence-based communication strategies and antibiotic prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months.

Overall, the probability of antibiotic prescribing for ARTI visits decreased by 7% (adjusted relative risk 0.93) from baseline to a 2- to 8-month postintervention in an adjusted intent-to-treat analysis.

Analysis of secondary outcomes revealed that prescribing any antibiotics for viral ARTI decreased by 40% during the postintervention period compared to baseline (aRR 0.60).

In addition, second-line antibiotic prescribing decreased from baseline by 34% for streptococcal pharyngitis (aRR 0.66), and by 41% for sinusitis (aRR 0.59); however there was no significant change in prescribing for acute otitis media, the researchers said.

The study findings were limited by several factors including the potential for biased results because of the randomization of clinicians from multiple practices and the potential for clinicians to change their prescribing habits after the start of the study, Dr. Kronman and colleagues noted.

In addition, the study did not include complete data on rapid streptococcal antigen testing, which might eliminate some children from the study population, and the relatively short postintervention period “may not represent the true long-term intervention durability may not represent the true long-term intervention durability,” they said.

However, the results support the potential of the DART program. “The 7% reduction in antibiotic prescribing for all ARTIs, if extrapolated to all ambulatory ARTI visits to pediatricians nationally, would represent 1.5 million fewer antibiotic prescriptions for children with ARTI annually,” they wrote.

“Providing online communication training and evidence-based antibiotic prescribing education in combination with individualized antibiotic prescribing feedback reports may help achieve national goals of reducing unnecessary outpatient antibiotic prescribing for children,” Dr. Kronman and associates concluded.

Combining interventions are key to reducing unnecessary antibiotics use in pediatric ambulatory care, Rana F. Hamdy, MD, MPH, of Children’s National Hospital, Washington, , and Sophie E. Katz, MD, of Vanderbilt University, Nashville, Tenn., wrote in an accompanying editorial (Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-012922).

The researchers in the current study “seem to recognize that clinicians are adult learners, and they combine interventions to implement these adult learning theory tenets to improve appropriate antibiotic prescribing,” they wrote. The DART intervention combined best practices training, communications training, and individualized antibiotic prescribing feedback reports to improve communication between providers and families “especially when faced with a situation in which a parent or guardian might expect an antibiotic prescription but the provider does not think one is necessary,” Dr. Hamdy and Dr. Katz said.

Overall, the findings suggest that the interventions work best in combination vs. being used alone, although the study did not evaluate the separate contributions of each intervention, the editorialists wrote.

“In the current study, nonengaged physicians had an increase in second-line antibiotic prescribing, whereas the engaged physicians had a decrease in second-line antibiotic prescribing,” they noted. “This suggests that the addition of communications training could mitigate the undesirable effects that may result from solely using feedback reports.”

“Each year, U.S. children are prescribed as many as 10 million unnecessary antibiotic courses for acute respiratory tract infections,” Kristina A. Bryant, MD, of the University of Louisville, Ky., said in an interview. “Some of these prescriptions result in side effects or allergic reactions, and they contribute to growing antibiotic resistance. We need effective interventions to reduce antibiotic prescribing.”

Although the DART modules are free and available online, busy clinicians might struggle to find time to view them consistently, said Dr. Bryant.

“One advantage of the study design was that information was pushed to clinicians along with communication booster videos,” she said. “We know that education and reinforcement over time works better than a one and done approach.

“Study participants also received feedback over time about their prescribing habits, which can be a powerful motivator for change, although not all clinicians may have easy access to these reports,” she noted.

To overcome some of the barriers to using the modules, clinicians who are “interested in improving their prescribing could work with their office managers to develop antibiotic prescribing reports and schedule reminders to review them,” said Dr. Bryant.

“An individual could commit to education and review of his or her own prescribing patterns, but support from one’s partners and shared accountability is likely to be even more effective,” she said. “Sharing data within a practice and exploring differences in prescribing patterns can drive improvement.

“Spaced education and regular feedback about prescribing patterns can improve antibiotic prescribing for pharyngitis and sinusitis, and reduce antibiotic prescriptions for ARTIs,” Dr. Bryant said. The take-home from the study is that it should prompt anyone who prescribes antibiotics for children to ask themselves how they can improve their own prescribing habits.

“In this study, prescribing for viral ARTIs was reduced but not eliminated. We need additional studies to further reduce unnecessary antibiotic use,” Dr. Bryant said.

In addition, areas for future research could include longer-term follow-up. “Study participants were followed for 2 to 8 months after the intervention ended in June 2018. It would be interesting to know about their prescribing practices now, and if the changes observed in the study were durable,” she concluded.

The study was supported by the National Institutes of Health, along with additional infrastructure funding from the American Academy of Pediatrics and the Health Resources and Services Administration of the Department of Health and Human Services. The researchers had no financial conflicts to disclose.

Dr. Hamdy and Dr. Katz had no financial conflicts to disclose, but Dr. Katz disclosed grant support through the Centers for Disease Control and Prevention as a recipient of the Leadership in Epidemiology, Antimicrobial Stewardship, and Public Health fellowship, sponsored by the Society for Healthcare Epidemiology of America, Infectious Diseases Society of America, and Pediatric Infectious Diseases Society.

Dr. Bryant disclosed serving as an investigator on multicenter clinical vaccine trials funded by Pfizer (but not in the last year). She also serves as the current president of the Pediatric Infectious Diseases Society, but the opinions expressed here are her own and do not necessarily reflect the views of PIDS.

SOURCE: Kronman MP et al. Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-0038.

A clinician education program significantly reduced overall antibiotic prescribing during pediatric visits for acute respiratory tract infections, according to data from 57 clinicians who participated in an intervention.

sturti/Getty Images

In a study published in Pediatrics, Matthew P. Kronman, MD, of the University of Washington, Seattle, and associates randomized 57 clinicians at 19 pediatric practices to a stepped-wedge clinical trial. The study included visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infections (defined as ARTI visits) for children aged 6 months to less than 11 years, for a total of 72,723 ARTI visits by 29,762 patients. The primary outcome was overall antibiotic prescribing for ARTI visits.

For the intervention, known as the Dialogue Around Respiratory Illness Treatment (DART) quality improvement (QI) program, clinicians received three program modules containing online tutorials and webinars. These professionally-produced modules included a combination of evidence-based communication strategies and antibiotic prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months.

Overall, the probability of antibiotic prescribing for ARTI visits decreased by 7% (adjusted relative risk 0.93) from baseline to a 2- to 8-month postintervention in an adjusted intent-to-treat analysis.

Analysis of secondary outcomes revealed that prescribing any antibiotics for viral ARTI decreased by 40% during the postintervention period compared to baseline (aRR 0.60).

In addition, second-line antibiotic prescribing decreased from baseline by 34% for streptococcal pharyngitis (aRR 0.66), and by 41% for sinusitis (aRR 0.59); however there was no significant change in prescribing for acute otitis media, the researchers said.

The study findings were limited by several factors including the potential for biased results because of the randomization of clinicians from multiple practices and the potential for clinicians to change their prescribing habits after the start of the study, Dr. Kronman and colleagues noted.

In addition, the study did not include complete data on rapid streptococcal antigen testing, which might eliminate some children from the study population, and the relatively short postintervention period “may not represent the true long-term intervention durability may not represent the true long-term intervention durability,” they said.

However, the results support the potential of the DART program. “The 7% reduction in antibiotic prescribing for all ARTIs, if extrapolated to all ambulatory ARTI visits to pediatricians nationally, would represent 1.5 million fewer antibiotic prescriptions for children with ARTI annually,” they wrote.

“Providing online communication training and evidence-based antibiotic prescribing education in combination with individualized antibiotic prescribing feedback reports may help achieve national goals of reducing unnecessary outpatient antibiotic prescribing for children,” Dr. Kronman and associates concluded.

Combining interventions are key to reducing unnecessary antibiotics use in pediatric ambulatory care, Rana F. Hamdy, MD, MPH, of Children’s National Hospital, Washington, , and Sophie E. Katz, MD, of Vanderbilt University, Nashville, Tenn., wrote in an accompanying editorial (Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-012922).

The researchers in the current study “seem to recognize that clinicians are adult learners, and they combine interventions to implement these adult learning theory tenets to improve appropriate antibiotic prescribing,” they wrote. The DART intervention combined best practices training, communications training, and individualized antibiotic prescribing feedback reports to improve communication between providers and families “especially when faced with a situation in which a parent or guardian might expect an antibiotic prescription but the provider does not think one is necessary,” Dr. Hamdy and Dr. Katz said.

Overall, the findings suggest that the interventions work best in combination vs. being used alone, although the study did not evaluate the separate contributions of each intervention, the editorialists wrote.

“In the current study, nonengaged physicians had an increase in second-line antibiotic prescribing, whereas the engaged physicians had a decrease in second-line antibiotic prescribing,” they noted. “This suggests that the addition of communications training could mitigate the undesirable effects that may result from solely using feedback reports.”

“Each year, U.S. children are prescribed as many as 10 million unnecessary antibiotic courses for acute respiratory tract infections,” Kristina A. Bryant, MD, of the University of Louisville, Ky., said in an interview. “Some of these prescriptions result in side effects or allergic reactions, and they contribute to growing antibiotic resistance. We need effective interventions to reduce antibiotic prescribing.”

Although the DART modules are free and available online, busy clinicians might struggle to find time to view them consistently, said Dr. Bryant.

“One advantage of the study design was that information was pushed to clinicians along with communication booster videos,” she said. “We know that education and reinforcement over time works better than a one and done approach.

“Study participants also received feedback over time about their prescribing habits, which can be a powerful motivator for change, although not all clinicians may have easy access to these reports,” she noted.

To overcome some of the barriers to using the modules, clinicians who are “interested in improving their prescribing could work with their office managers to develop antibiotic prescribing reports and schedule reminders to review them,” said Dr. Bryant.

“An individual could commit to education and review of his or her own prescribing patterns, but support from one’s partners and shared accountability is likely to be even more effective,” she said. “Sharing data within a practice and exploring differences in prescribing patterns can drive improvement.

“Spaced education and regular feedback about prescribing patterns can improve antibiotic prescribing for pharyngitis and sinusitis, and reduce antibiotic prescriptions for ARTIs,” Dr. Bryant said. The take-home from the study is that it should prompt anyone who prescribes antibiotics for children to ask themselves how they can improve their own prescribing habits.

“In this study, prescribing for viral ARTIs was reduced but not eliminated. We need additional studies to further reduce unnecessary antibiotic use,” Dr. Bryant said.

In addition, areas for future research could include longer-term follow-up. “Study participants were followed for 2 to 8 months after the intervention ended in June 2018. It would be interesting to know about their prescribing practices now, and if the changes observed in the study were durable,” she concluded.

The study was supported by the National Institutes of Health, along with additional infrastructure funding from the American Academy of Pediatrics and the Health Resources and Services Administration of the Department of Health and Human Services. The researchers had no financial conflicts to disclose.

Dr. Hamdy and Dr. Katz had no financial conflicts to disclose, but Dr. Katz disclosed grant support through the Centers for Disease Control and Prevention as a recipient of the Leadership in Epidemiology, Antimicrobial Stewardship, and Public Health fellowship, sponsored by the Society for Healthcare Epidemiology of America, Infectious Diseases Society of America, and Pediatric Infectious Diseases Society.

Dr. Bryant disclosed serving as an investigator on multicenter clinical vaccine trials funded by Pfizer (but not in the last year). She also serves as the current president of the Pediatric Infectious Diseases Society, but the opinions expressed here are her own and do not necessarily reflect the views of PIDS.

SOURCE: Kronman MP et al. Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-0038.

A clinician education program significantly reduced overall antibiotic prescribing during pediatric visits for acute respiratory tract infections, according to data from 57 clinicians who participated in an intervention.

sturti/Getty Images

In a study published in Pediatrics, Matthew P. Kronman, MD, of the University of Washington, Seattle, and associates randomized 57 clinicians at 19 pediatric practices to a stepped-wedge clinical trial. The study included visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infections (defined as ARTI visits) for children aged 6 months to less than 11 years, for a total of 72,723 ARTI visits by 29,762 patients. The primary outcome was overall antibiotic prescribing for ARTI visits.

For the intervention, known as the Dialogue Around Respiratory Illness Treatment (DART) quality improvement (QI) program, clinicians received three program modules containing online tutorials and webinars. These professionally-produced modules included a combination of evidence-based communication strategies and antibiotic prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months.

Overall, the probability of antibiotic prescribing for ARTI visits decreased by 7% (adjusted relative risk 0.93) from baseline to a 2- to 8-month postintervention in an adjusted intent-to-treat analysis.

Analysis of secondary outcomes revealed that prescribing any antibiotics for viral ARTI decreased by 40% during the postintervention period compared to baseline (aRR 0.60).

In addition, second-line antibiotic prescribing decreased from baseline by 34% for streptococcal pharyngitis (aRR 0.66), and by 41% for sinusitis (aRR 0.59); however there was no significant change in prescribing for acute otitis media, the researchers said.

The study findings were limited by several factors including the potential for biased results because of the randomization of clinicians from multiple practices and the potential for clinicians to change their prescribing habits after the start of the study, Dr. Kronman and colleagues noted.

In addition, the study did not include complete data on rapid streptococcal antigen testing, which might eliminate some children from the study population, and the relatively short postintervention period “may not represent the true long-term intervention durability may not represent the true long-term intervention durability,” they said.

However, the results support the potential of the DART program. “The 7% reduction in antibiotic prescribing for all ARTIs, if extrapolated to all ambulatory ARTI visits to pediatricians nationally, would represent 1.5 million fewer antibiotic prescriptions for children with ARTI annually,” they wrote.

“Providing online communication training and evidence-based antibiotic prescribing education in combination with individualized antibiotic prescribing feedback reports may help achieve national goals of reducing unnecessary outpatient antibiotic prescribing for children,” Dr. Kronman and associates concluded.

Combining interventions are key to reducing unnecessary antibiotics use in pediatric ambulatory care, Rana F. Hamdy, MD, MPH, of Children’s National Hospital, Washington, , and Sophie E. Katz, MD, of Vanderbilt University, Nashville, Tenn., wrote in an accompanying editorial (Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-012922).

The researchers in the current study “seem to recognize that clinicians are adult learners, and they combine interventions to implement these adult learning theory tenets to improve appropriate antibiotic prescribing,” they wrote. The DART intervention combined best practices training, communications training, and individualized antibiotic prescribing feedback reports to improve communication between providers and families “especially when faced with a situation in which a parent or guardian might expect an antibiotic prescription but the provider does not think one is necessary,” Dr. Hamdy and Dr. Katz said.

Overall, the findings suggest that the interventions work best in combination vs. being used alone, although the study did not evaluate the separate contributions of each intervention, the editorialists wrote.

“In the current study, nonengaged physicians had an increase in second-line antibiotic prescribing, whereas the engaged physicians had a decrease in second-line antibiotic prescribing,” they noted. “This suggests that the addition of communications training could mitigate the undesirable effects that may result from solely using feedback reports.”

“Each year, U.S. children are prescribed as many as 10 million unnecessary antibiotic courses for acute respiratory tract infections,” Kristina A. Bryant, MD, of the University of Louisville, Ky., said in an interview. “Some of these prescriptions result in side effects or allergic reactions, and they contribute to growing antibiotic resistance. We need effective interventions to reduce antibiotic prescribing.”

Although the DART modules are free and available online, busy clinicians might struggle to find time to view them consistently, said Dr. Bryant.

“One advantage of the study design was that information was pushed to clinicians along with communication booster videos,” she said. “We know that education and reinforcement over time works better than a one and done approach.

“Study participants also received feedback over time about their prescribing habits, which can be a powerful motivator for change, although not all clinicians may have easy access to these reports,” she noted.

To overcome some of the barriers to using the modules, clinicians who are “interested in improving their prescribing could work with their office managers to develop antibiotic prescribing reports and schedule reminders to review them,” said Dr. Bryant.

“An individual could commit to education and review of his or her own prescribing patterns, but support from one’s partners and shared accountability is likely to be even more effective,” she said. “Sharing data within a practice and exploring differences in prescribing patterns can drive improvement.

“Spaced education and regular feedback about prescribing patterns can improve antibiotic prescribing for pharyngitis and sinusitis, and reduce antibiotic prescriptions for ARTIs,” Dr. Bryant said. The take-home from the study is that it should prompt anyone who prescribes antibiotics for children to ask themselves how they can improve their own prescribing habits.

“In this study, prescribing for viral ARTIs was reduced but not eliminated. We need additional studies to further reduce unnecessary antibiotic use,” Dr. Bryant said.

In addition, areas for future research could include longer-term follow-up. “Study participants were followed for 2 to 8 months after the intervention ended in June 2018. It would be interesting to know about their prescribing practices now, and if the changes observed in the study were durable,” she concluded.

The study was supported by the National Institutes of Health, along with additional infrastructure funding from the American Academy of Pediatrics and the Health Resources and Services Administration of the Department of Health and Human Services. The researchers had no financial conflicts to disclose.

Dr. Hamdy and Dr. Katz had no financial conflicts to disclose, but Dr. Katz disclosed grant support through the Centers for Disease Control and Prevention as a recipient of the Leadership in Epidemiology, Antimicrobial Stewardship, and Public Health fellowship, sponsored by the Society for Healthcare Epidemiology of America, Infectious Diseases Society of America, and Pediatric Infectious Diseases Society.

Dr. Bryant disclosed serving as an investigator on multicenter clinical vaccine trials funded by Pfizer (but not in the last year). She also serves as the current president of the Pediatric Infectious Diseases Society, but the opinions expressed here are her own and do not necessarily reflect the views of PIDS.

SOURCE: Kronman MP et al. Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-0038.

A study of patients with pulmonary hypertension suggests a reconsideration of the accepted benchmark for pulmonary vascular hypertension as a predictor of heart failure may be warranted.

An elevated pulmonary vascular resistance of 3.0 Wood units or greater has been used as a prognostic marker for death and heart failure in pulmonary hypertension subgroups. But a large, multiyear study of a veterans population suggests that shifting that threshold to 2.2 Wood units in patients with right-heart catheterization may be justified.

Bradley A. Maron, MD, of the Veterans Affairs Boston Healthcare System and Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues evaluated 40,082 veterans in the VA Clinical Assessment, Reporting and Tracking (CART) program who had right-heart catheterization (RHC) in the VA system from Oct. 1, 2007, to Sept. 30, 2016.

“To our knowledge, these data provide the first evidence-based information on the continuum of clinical risk related to PVR in patients with elevated pulmonary artery pressure,” the researchers wrote. Their report was published online in Lancet Respiratory Medicine (2020 Jul 27. doi: 10.1016/S2213-2600(20)30317-9).

The retrospective cohort study found that all-cause mortality hazard ratio (HR), when adjusted for clinical variables, and mean pulmonary artery pressure (mPAP) increased progressively beginning at around 2.0 Wood units (WU). Clinically significant mortality HR emerged at 2.2 WU, with an adjusted risk 9% greater than a PVR of 2.1 Wood units (P < .0034), which the study considered the upper limit of normal PVR in health adults of a similar age range (61.5 to 73.5 years) as the study cohort. The researchers noted that a PVR of 3.0 WU has been the standard for forecasting outcomes in pulmonary hypertension (PH) (Eur Heart J. 2010;31:2915-57).

“Overall, these results suggest that reconsidering the hemodynamic parameters that define pulmonary hypertension in patients with cardiopulmonary disease is warranted, and they identify a need for early detection strategies to capture this large and vulnerable population,” the researchers wrote.

A subsequent analysis focused on patients with an mPAP of >19 mm HG (n = 32,725) and found that all-cause death when adjusted over a wide range of clinical variables that included PVR of 2.2 WU increased to a 25% HR. “However,” the researchers added, “a median cardiac output of < 4.0 L/min, which has been shown to be independently associated with adverse outcome, was present only when PVR was more than 4.0 Wood units.”

For a PVR of 2.2-3.0 WU, the median cardiac output was 4.87 L/min; for > 3.0 WU, it was 4.13 L/min. Among the patients with PVR > 2.2 WU (n = 15,780), 13.6% (n = 2,147) had an mPAP of 19-24 mm Hg.

In all patients with mPAP > 19 mm HG, pulmonary artery wedge pressure (PAWP) became a determining risk factor, with 15 mm HG the demarcation between low and high PAWP. At PVR of 2.2 WU, low-PAWP patients had a 52% greater adjusted risk of death and high-PAWP a 23% greater risk. At 4.0 WU, those adjusted risks rose dramatically – to 272% and 58%, for the low- and high-PAWP subgroups, respectively (P < .0001).

“Stratification of patients by PAWP had a major effect on outcome estimates in our study, illustrating the limitations of using the same PVR level to define clinical risk between precapillary and postcapillary pulmonary hypertension,” the researchers wrote.

They called for further study into how these findings impact people with PH but lower levels of cardiopulmonary disease than the cohort. “Overall, these findings support reconsidering the combination of hemodynamic variables used to identify patients with pulmonary hypertension,” the researchers stated.

The analyses of the VA CART database makes this “an interesting study,” said G. Hossein Almassi, MD, FCCP, of the Medical College of Wisconsin and Zablocki VA Medical Center in Milwaukee. “Within its limitation as a retrospective cohort study, the findings of a lower PVR and a lower mean PAP of > 19 mm being associated with increased risk of all-cause mortality and HF hospitalization are significant.”

He added: “Time will tell whether this will be an impetus for the clinicians to consider earlier therapeutic interventions in addition to lifestyle modification such as smoking cessation in this group of patients.”

Dr. Maron disclosed a financial relationship with Actelion.

SOURCE: Maron BA et al. Lancet Respir Med. 2020 Jul 27. doi: 10.1016/S2213-2600(20)30317-9.

A study of patients with pulmonary hypertension suggests a reconsideration of the accepted benchmark for pulmonary vascular hypertension as a predictor of heart failure may be warranted.

An elevated pulmonary vascular resistance of 3.0 Wood units or greater has been used as a prognostic marker for death and heart failure in pulmonary hypertension subgroups. But a large, multiyear study of a veterans population suggests that shifting that threshold to 2.2 Wood units in patients with right-heart catheterization may be justified.

Bradley A. Maron, MD, of the Veterans Affairs Boston Healthcare System and Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues evaluated 40,082 veterans in the VA Clinical Assessment, Reporting and Tracking (CART) program who had right-heart catheterization (RHC) in the VA system from Oct. 1, 2007, to Sept. 30, 2016.

“To our knowledge, these data provide the first evidence-based information on the continuum of clinical risk related to PVR in patients with elevated pulmonary artery pressure,” the researchers wrote. Their report was published online in Lancet Respiratory Medicine (2020 Jul 27. doi: 10.1016/S2213-2600(20)30317-9).

The retrospective cohort study found that all-cause mortality hazard ratio (HR), when adjusted for clinical variables, and mean pulmonary artery pressure (mPAP) increased progressively beginning at around 2.0 Wood units (WU). Clinically significant mortality HR emerged at 2.2 WU, with an adjusted risk 9% greater than a PVR of 2.1 Wood units (P < .0034), which the study considered the upper limit of normal PVR in health adults of a similar age range (61.5 to 73.5 years) as the study cohort. The researchers noted that a PVR of 3.0 WU has been the standard for forecasting outcomes in pulmonary hypertension (PH) (Eur Heart J. 2010;31:2915-57).

“Overall, these results suggest that reconsidering the hemodynamic parameters that define pulmonary hypertension in patients with cardiopulmonary disease is warranted, and they identify a need for early detection strategies to capture this large and vulnerable population,” the researchers wrote.

A subsequent analysis focused on patients with an mPAP of >19 mm HG (n = 32,725) and found that all-cause death when adjusted over a wide range of clinical variables that included PVR of 2.2 WU increased to a 25% HR. “However,” the researchers added, “a median cardiac output of < 4.0 L/min, which has been shown to be independently associated with adverse outcome, was present only when PVR was more than 4.0 Wood units.”

For a PVR of 2.2-3.0 WU, the median cardiac output was 4.87 L/min; for > 3.0 WU, it was 4.13 L/min. Among the patients with PVR > 2.2 WU (n = 15,780), 13.6% (n = 2,147) had an mPAP of 19-24 mm Hg.

In all patients with mPAP > 19 mm HG, pulmonary artery wedge pressure (PAWP) became a determining risk factor, with 15 mm HG the demarcation between low and high PAWP. At PVR of 2.2 WU, low-PAWP patients had a 52% greater adjusted risk of death and high-PAWP a 23% greater risk. At 4.0 WU, those adjusted risks rose dramatically – to 272% and 58%, for the low- and high-PAWP subgroups, respectively (P < .0001).

“Stratification of patients by PAWP had a major effect on outcome estimates in our study, illustrating the limitations of using the same PVR level to define clinical risk between precapillary and postcapillary pulmonary hypertension,” the researchers wrote.

They called for further study into how these findings impact people with PH but lower levels of cardiopulmonary disease than the cohort. “Overall, these findings support reconsidering the combination of hemodynamic variables used to identify patients with pulmonary hypertension,” the researchers stated.

The analyses of the VA CART database makes this “an interesting study,” said G. Hossein Almassi, MD, FCCP, of the Medical College of Wisconsin and Zablocki VA Medical Center in Milwaukee. “Within its limitation as a retrospective cohort study, the findings of a lower PVR and a lower mean PAP of > 19 mm being associated with increased risk of all-cause mortality and HF hospitalization are significant.”

He added: “Time will tell whether this will be an impetus for the clinicians to consider earlier therapeutic interventions in addition to lifestyle modification such as smoking cessation in this group of patients.”

Dr. Maron disclosed a financial relationship with Actelion.

SOURCE: Maron BA et al. Lancet Respir Med. 2020 Jul 27. doi: 10.1016/S2213-2600(20)30317-9.

A study of patients with pulmonary hypertension suggests a reconsideration of the accepted benchmark for pulmonary vascular hypertension as a predictor of heart failure may be warranted.

An elevated pulmonary vascular resistance of 3.0 Wood units or greater has been used as a prognostic marker for death and heart failure in pulmonary hypertension subgroups. But a large, multiyear study of a veterans population suggests that shifting that threshold to 2.2 Wood units in patients with right-heart catheterization may be justified.

Bradley A. Maron, MD, of the Veterans Affairs Boston Healthcare System and Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues evaluated 40,082 veterans in the VA Clinical Assessment, Reporting and Tracking (CART) program who had right-heart catheterization (RHC) in the VA system from Oct. 1, 2007, to Sept. 30, 2016.

“To our knowledge, these data provide the first evidence-based information on the continuum of clinical risk related to PVR in patients with elevated pulmonary artery pressure,” the researchers wrote. Their report was published online in Lancet Respiratory Medicine (2020 Jul 27. doi: 10.1016/S2213-2600(20)30317-9).

The retrospective cohort study found that all-cause mortality hazard ratio (HR), when adjusted for clinical variables, and mean pulmonary artery pressure (mPAP) increased progressively beginning at around 2.0 Wood units (WU). Clinically significant mortality HR emerged at 2.2 WU, with an adjusted risk 9% greater than a PVR of 2.1 Wood units (P < .0034), which the study considered the upper limit of normal PVR in health adults of a similar age range (61.5 to 73.5 years) as the study cohort. The researchers noted that a PVR of 3.0 WU has been the standard for forecasting outcomes in pulmonary hypertension (PH) (Eur Heart J. 2010;31:2915-57).

“Overall, these results suggest that reconsidering the hemodynamic parameters that define pulmonary hypertension in patients with cardiopulmonary disease is warranted, and they identify a need for early detection strategies to capture this large and vulnerable population,” the researchers wrote.

A subsequent analysis focused on patients with an mPAP of >19 mm HG (n = 32,725) and found that all-cause death when adjusted over a wide range of clinical variables that included PVR of 2.2 WU increased to a 25% HR. “However,” the researchers added, “a median cardiac output of < 4.0 L/min, which has been shown to be independently associated with adverse outcome, was present only when PVR was more than 4.0 Wood units.”

For a PVR of 2.2-3.0 WU, the median cardiac output was 4.87 L/min; for > 3.0 WU, it was 4.13 L/min. Among the patients with PVR > 2.2 WU (n = 15,780), 13.6% (n = 2,147) had an mPAP of 19-24 mm Hg.

In all patients with mPAP > 19 mm HG, pulmonary artery wedge pressure (PAWP) became a determining risk factor, with 15 mm HG the demarcation between low and high PAWP. At PVR of 2.2 WU, low-PAWP patients had a 52% greater adjusted risk of death and high-PAWP a 23% greater risk. At 4.0 WU, those adjusted risks rose dramatically – to 272% and 58%, for the low- and high-PAWP subgroups, respectively (P < .0001).

“Stratification of patients by PAWP had a major effect on outcome estimates in our study, illustrating the limitations of using the same PVR level to define clinical risk between precapillary and postcapillary pulmonary hypertension,” the researchers wrote.

They called for further study into how these findings impact people with PH but lower levels of cardiopulmonary disease than the cohort. “Overall, these findings support reconsidering the combination of hemodynamic variables used to identify patients with pulmonary hypertension,” the researchers stated.

The analyses of the VA CART database makes this “an interesting study,” said G. Hossein Almassi, MD, FCCP, of the Medical College of Wisconsin and Zablocki VA Medical Center in Milwaukee. “Within its limitation as a retrospective cohort study, the findings of a lower PVR and a lower mean PAP of > 19 mm being associated with increased risk of all-cause mortality and HF hospitalization are significant.”

He added: “Time will tell whether this will be an impetus for the clinicians to consider earlier therapeutic interventions in addition to lifestyle modification such as smoking cessation in this group of patients.”

Dr. Maron disclosed a financial relationship with Actelion.

SOURCE: Maron BA et al. Lancet Respir Med. 2020 Jul 27. doi: 10.1016/S2213-2600(20)30317-9.

Most children who tested positive for SARS-CoV-2 had no respiratory illness, according to data from a retrospective study of 22 patients at a single center.

Fuse/thinkstockphotos.com

To date, children account for less than 5% of COVID-19 cases in the United States, but details of the clinical presentations in children are limited, wrote Rabia Agha, MD, and colleagues of Maimonides Children’s Hospital, Brooklyn, N.Y.

In a study published in Hospital Pediatrics, the researchers reviewed data from 22 children aged 0-18 years who tested positive for SARS-CoV-2 by polymerase chain reaction (PCR) and were admitted to a single hospital over a 4-week period from March 18, 2020, to April 15, 2020.

Overall, 9 patients (41%) presented with a respiratory illness, and 7 (32%) required respiratory support. Of four patients requiring mechanical ventilation, two had underlying pulmonary disease. The other two patients who required intubation were one with cerebral palsy and status epilepticus and one who presented in a state of cardiac arrest.

The study population ranged from 11 days to 18 years of age, but 45% were infants younger than 1 year. None of the children had a travel history that might increase their risk for SARS-CoV-2 infection; 27% had confirmed exposure to the virus.

Most of the children (82%) were hospitalized within 3 days of the onset of symptoms, and no deaths occurred during the study period. The most common symptom was fever without a source in five (23%) otherwise healthy infants aged 11-35 days. All five of these children underwent a sepsis evaluation, received empiric antibiotics, and were discharged home with negative bacterial cultures within 48-72 hours. Another 10 children had fever in combination with other symptoms.

Other presenting symptoms were respiratory (9), fatigue (6), seizures (2), and headache (1).

Most children with respiratory illness were treated with supportive therapy and antibiotics, but three of those on mechanical ventilation also were treated with remdesivir; all three were ultimately extubated.

Neurological abnormalities occurred in two patients: an 11-year-old otherwise healthy boy who presented with fever, headache, confusion, and seizure but ultimately improved without short-term sequelae; and a 12-year-old girl with cerebral palsy who developed new onset seizures and required mechanical ventilation, but ultimately improved to baseline.

Positive PCR results were identified in seven patients (32%) during the second half of the study period who were initially hospitalized for non-COVID related symptoms; four with bacterial infections, two with illnesses of unknown etiology, and one with cardiac arrest. Another two children were completely asymptomatic at the time of admission but then tested positive by PCR; one child had been admitted for routine chemotherapy and the other for social reasons, Dr. Agha and associates said.

The study findings contrast with early data from China in which respiratory illness of varying severity was the major presentation in children with COVID-19, but support a more recent meta-analysis of 551 cases, the researchers noted. The findings also highlight the value of universal testing for children.

“Our initial testing strategy was according to the federal and local guidelines that recommended PCR testing for the symptoms of fever, cough and shortness of breath, or travel to certain countries or close contact with a confirmed case,” Dr. Agha and colleagues said.

“With the implementation of our universal screening strategy of all admitted pediatric patients, we identified 9 (41%) patients with COVID-19 that would have been missed, as they did not meet the then-recommended criteria for testing,” they wrote.

The results suggest the need for broader guidelines to test pediatric patients because children presenting with other illnesses may be positive for SARS-CoV-2 as well, the researchers said.

“Testing of all hospitalized patients will not only identify cases early in the course of their admission process, but will also help prevent inadvertent exposure of other patients and health care workers, assist in cohorting infected patients, and aid in conservation of personal protective equipment,” Dr. Agha and associates concluded.

The current study is important as clinicians continue to learn about how infection with SARS-CoV-2 presents in different populations, Diana Lee, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Understanding how it can present in the pediatric population is important in identifying children who may have the infection and developing strategies for testing,” she said.

“I was not surprised by the finding that most children did not present with the classic symptoms of COVID-19 in adults based on other published studies and my personal clinical experience taking care of hospitalized children in New York City,” said Dr. Lee. “Studies from the U.S. and other countries have reported that fewer children experience fever, cough, and shortness of breath [compared with] adults, and that most children have a milder clinical course, though there is a small percentage of children who can have severe or critical illness,” she said.

“A multisystem inflammatory syndrome in children associated with COVID-19 has also emerged and appears to be a postinfectious process with a presentation that often differs from classic COVID-19 infection in adults,” she added.

The take-home message for clinicians is the reminder that SARS-CoV-2 infection often presents differently in children than in adults, said Dr. Lee.

“Children who present to the hospital with non-classic COVID-19 symptoms or with other diagnoses may be positive for SARS-CoV-2 on testing. Broadly testing hospitalized children for SARS-CoV-2 and instituting appropriate isolation precautions may help to protect other individuals from being exposed to the virus,” she said.  

“Further research is needed to understand which individuals are contagious and how to accurately distinguish those who are infectious versus those who are not,” said Dr. Lee. “There have been individuals who persistently test positive for SARS-CoV-2 RNA (the genetic material of the virus), but were not found to have virus in their bodies that can replicate and thereby infect others,” she emphasized. “Further study is needed regarding the likelihood of household exposures in children with SARS-CoV-2 infection given that this study was done early in the epidemic in New York City when testing and contact tracing was less established,” she said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Lee had no financial conflicts to disclose.

SOURCE: Agha R et al. Hosp Pediatr. 2020 July. doi: 10.1542/hpeds.2020-000257.

Most children who tested positive for SARS-CoV-2 had no respiratory illness, according to data from a retrospective study of 22 patients at a single center.

Fuse/thinkstockphotos.com

To date, children account for less than 5% of COVID-19 cases in the United States, but details of the clinical presentations in children are limited, wrote Rabia Agha, MD, and colleagues of Maimonides Children’s Hospital, Brooklyn, N.Y.

In a study published in Hospital Pediatrics, the researchers reviewed data from 22 children aged 0-18 years who tested positive for SARS-CoV-2 by polymerase chain reaction (PCR) and were admitted to a single hospital over a 4-week period from March 18, 2020, to April 15, 2020.

Overall, 9 patients (41%) presented with a respiratory illness, and 7 (32%) required respiratory support. Of four patients requiring mechanical ventilation, two had underlying pulmonary disease. The other two patients who required intubation were one with cerebral palsy and status epilepticus and one who presented in a state of cardiac arrest.

The study population ranged from 11 days to 18 years of age, but 45% were infants younger than 1 year. None of the children had a travel history that might increase their risk for SARS-CoV-2 infection; 27% had confirmed exposure to the virus.

Most of the children (82%) were hospitalized within 3 days of the onset of symptoms, and no deaths occurred during the study period. The most common symptom was fever without a source in five (23%) otherwise healthy infants aged 11-35 days. All five of these children underwent a sepsis evaluation, received empiric antibiotics, and were discharged home with negative bacterial cultures within 48-72 hours. Another 10 children had fever in combination with other symptoms.

Other presenting symptoms were respiratory (9), fatigue (6), seizures (2), and headache (1).

Most children with respiratory illness were treated with supportive therapy and antibiotics, but three of those on mechanical ventilation also were treated with remdesivir; all three were ultimately extubated.

Neurological abnormalities occurred in two patients: an 11-year-old otherwise healthy boy who presented with fever, headache, confusion, and seizure but ultimately improved without short-term sequelae; and a 12-year-old girl with cerebral palsy who developed new onset seizures and required mechanical ventilation, but ultimately improved to baseline.

Positive PCR results were identified in seven patients (32%) during the second half of the study period who were initially hospitalized for non-COVID related symptoms; four with bacterial infections, two with illnesses of unknown etiology, and one with cardiac arrest. Another two children were completely asymptomatic at the time of admission but then tested positive by PCR; one child had been admitted for routine chemotherapy and the other for social reasons, Dr. Agha and associates said.

The study findings contrast with early data from China in which respiratory illness of varying severity was the major presentation in children with COVID-19, but support a more recent meta-analysis of 551 cases, the researchers noted. The findings also highlight the value of universal testing for children.

“Our initial testing strategy was according to the federal and local guidelines that recommended PCR testing for the symptoms of fever, cough and shortness of breath, or travel to certain countries or close contact with a confirmed case,” Dr. Agha and colleagues said.

“With the implementation of our universal screening strategy of all admitted pediatric patients, we identified 9 (41%) patients with COVID-19 that would have been missed, as they did not meet the then-recommended criteria for testing,” they wrote.

The results suggest the need for broader guidelines to test pediatric patients because children presenting with other illnesses may be positive for SARS-CoV-2 as well, the researchers said.

“Testing of all hospitalized patients will not only identify cases early in the course of their admission process, but will also help prevent inadvertent exposure of other patients and health care workers, assist in cohorting infected patients, and aid in conservation of personal protective equipment,” Dr. Agha and associates concluded.

The current study is important as clinicians continue to learn about how infection with SARS-CoV-2 presents in different populations, Diana Lee, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Understanding how it can present in the pediatric population is important in identifying children who may have the infection and developing strategies for testing,” she said.

“I was not surprised by the finding that most children did not present with the classic symptoms of COVID-19 in adults based on other published studies and my personal clinical experience taking care of hospitalized children in New York City,” said Dr. Lee. “Studies from the U.S. and other countries have reported that fewer children experience fever, cough, and shortness of breath [compared with] adults, and that most children have a milder clinical course, though there is a small percentage of children who can have severe or critical illness,” she said.

“A multisystem inflammatory syndrome in children associated with COVID-19 has also emerged and appears to be a postinfectious process with a presentation that often differs from classic COVID-19 infection in adults,” she added.

The take-home message for clinicians is the reminder that SARS-CoV-2 infection often presents differently in children than in adults, said Dr. Lee.

“Children who present to the hospital with non-classic COVID-19 symptoms or with other diagnoses may be positive for SARS-CoV-2 on testing. Broadly testing hospitalized children for SARS-CoV-2 and instituting appropriate isolation precautions may help to protect other individuals from being exposed to the virus,” she said.  

“Further research is needed to understand which individuals are contagious and how to accurately distinguish those who are infectious versus those who are not,” said Dr. Lee. “There have been individuals who persistently test positive for SARS-CoV-2 RNA (the genetic material of the virus), but were not found to have virus in their bodies that can replicate and thereby infect others,” she emphasized. “Further study is needed regarding the likelihood of household exposures in children with SARS-CoV-2 infection given that this study was done early in the epidemic in New York City when testing and contact tracing was less established,” she said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Lee had no financial conflicts to disclose.

SOURCE: Agha R et al. Hosp Pediatr. 2020 July. doi: 10.1542/hpeds.2020-000257.

Most children who tested positive for SARS-CoV-2 had no respiratory illness, according to data from a retrospective study of 22 patients at a single center.

Fuse/thinkstockphotos.com

To date, children account for less than 5% of COVID-19 cases in the United States, but details of the clinical presentations in children are limited, wrote Rabia Agha, MD, and colleagues of Maimonides Children’s Hospital, Brooklyn, N.Y.

In a study published in Hospital Pediatrics, the researchers reviewed data from 22 children aged 0-18 years who tested positive for SARS-CoV-2 by polymerase chain reaction (PCR) and were admitted to a single hospital over a 4-week period from March 18, 2020, to April 15, 2020.

Overall, 9 patients (41%) presented with a respiratory illness, and 7 (32%) required respiratory support. Of four patients requiring mechanical ventilation, two had underlying pulmonary disease. The other two patients who required intubation were one with cerebral palsy and status epilepticus and one who presented in a state of cardiac arrest.

The study population ranged from 11 days to 18 years of age, but 45% were infants younger than 1 year. None of the children had a travel history that might increase their risk for SARS-CoV-2 infection; 27% had confirmed exposure to the virus.

Most of the children (82%) were hospitalized within 3 days of the onset of symptoms, and no deaths occurred during the study period. The most common symptom was fever without a source in five (23%) otherwise healthy infants aged 11-35 days. All five of these children underwent a sepsis evaluation, received empiric antibiotics, and were discharged home with negative bacterial cultures within 48-72 hours. Another 10 children had fever in combination with other symptoms.

Other presenting symptoms were respiratory (9), fatigue (6), seizures (2), and headache (1).

Most children with respiratory illness were treated with supportive therapy and antibiotics, but three of those on mechanical ventilation also were treated with remdesivir; all three were ultimately extubated.

Neurological abnormalities occurred in two patients: an 11-year-old otherwise healthy boy who presented with fever, headache, confusion, and seizure but ultimately improved without short-term sequelae; and a 12-year-old girl with cerebral palsy who developed new onset seizures and required mechanical ventilation, but ultimately improved to baseline.

Positive PCR results were identified in seven patients (32%) during the second half of the study period who were initially hospitalized for non-COVID related symptoms; four with bacterial infections, two with illnesses of unknown etiology, and one with cardiac arrest. Another two children were completely asymptomatic at the time of admission but then tested positive by PCR; one child had been admitted for routine chemotherapy and the other for social reasons, Dr. Agha and associates said.

The study findings contrast with early data from China in which respiratory illness of varying severity was the major presentation in children with COVID-19, but support a more recent meta-analysis of 551 cases, the researchers noted. The findings also highlight the value of universal testing for children.

“Our initial testing strategy was according to the federal and local guidelines that recommended PCR testing for the symptoms of fever, cough and shortness of breath, or travel to certain countries or close contact with a confirmed case,” Dr. Agha and colleagues said.

“With the implementation of our universal screening strategy of all admitted pediatric patients, we identified 9 (41%) patients with COVID-19 that would have been missed, as they did not meet the then-recommended criteria for testing,” they wrote.

The results suggest the need for broader guidelines to test pediatric patients because children presenting with other illnesses may be positive for SARS-CoV-2 as well, the researchers said.

“Testing of all hospitalized patients will not only identify cases early in the course of their admission process, but will also help prevent inadvertent exposure of other patients and health care workers, assist in cohorting infected patients, and aid in conservation of personal protective equipment,” Dr. Agha and associates concluded.

The current study is important as clinicians continue to learn about how infection with SARS-CoV-2 presents in different populations, Diana Lee, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Understanding how it can present in the pediatric population is important in identifying children who may have the infection and developing strategies for testing,” she said.

“I was not surprised by the finding that most children did not present with the classic symptoms of COVID-19 in adults based on other published studies and my personal clinical experience taking care of hospitalized children in New York City,” said Dr. Lee. “Studies from the U.S. and other countries have reported that fewer children experience fever, cough, and shortness of breath [compared with] adults, and that most children have a milder clinical course, though there is a small percentage of children who can have severe or critical illness,” she said.

“A multisystem inflammatory syndrome in children associated with COVID-19 has also emerged and appears to be a postinfectious process with a presentation that often differs from classic COVID-19 infection in adults,” she added.

The take-home message for clinicians is the reminder that SARS-CoV-2 infection often presents differently in children than in adults, said Dr. Lee.

“Children who present to the hospital with non-classic COVID-19 symptoms or with other diagnoses may be positive for SARS-CoV-2 on testing. Broadly testing hospitalized children for SARS-CoV-2 and instituting appropriate isolation precautions may help to protect other individuals from being exposed to the virus,” she said.  

“Further research is needed to understand which individuals are contagious and how to accurately distinguish those who are infectious versus those who are not,” said Dr. Lee. “There have been individuals who persistently test positive for SARS-CoV-2 RNA (the genetic material of the virus), but were not found to have virus in their bodies that can replicate and thereby infect others,” she emphasized. “Further study is needed regarding the likelihood of household exposures in children with SARS-CoV-2 infection given that this study was done early in the epidemic in New York City when testing and contact tracing was less established,” she said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Lee had no financial conflicts to disclose.

SOURCE: Agha R et al. Hosp Pediatr. 2020 July. doi: 10.1542/hpeds.2020-000257.

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.

Immune checkpoint inhibition was not associated with an increased mortality risk from COVID-19 in patients with cancer in an international observational study.

The study included 113 cancer patients who had laboratory-confirmed COVID-19 within 12 months of receiving immune checkpoint inhibitor therapy. The patients did not receive chemotherapy within 3 months of testing positive for COVID-19.

In all, 33 patients were admitted to the hospital, including 6 who were admitted to the ICU, and 9 patients died.

“Nine out of 113 patients is a mortality rate of 8%, which is in the middle of the earlier reported rates for cancer patients in general [7.6%-12%],” said Aljosja Rogiers, MD, PhD, of the Melanoma Institute Australia in Sydney.

COVID-19 was the primary cause of death in seven of the patients, including three of those who were admitted to the ICU, Dr. Rogiers noted.

He reported these results during the AACR virtual meeting: COVID-19 and Cancer.
 

Study details

Patients in this study were treated at 19 hospitals in North America, Europe, and Australia, and the data cutoff was May 15, 2020. Most patients (64%) were treated in Europe, which was the epicenter for the COVID-19 pandemic at the time of data collection, Dr. Rogiers noted. A third of patients were in North America, and 3% were in Australia.

The patients’ median age was 63 years (range, 27-86 years). Most patients were men (65%), and most had Eastern Cooperative Oncology Group performance scores of 0-1 (90%).

The most common malignancies were melanoma (57%), non–small cell lung cancer (17%), and renal cell carcinoma (9%). Treatment was for early cancer in 26% of patients and for advanced cancer in 74%. Comorbidities included cardiovascular disease in 27% of patients, diabetes in 15%, pulmonary disease in 12%, and renal disease in 5%.

Immunosuppressive therapy equivalent to a prednisone dose of 10 mg or greater daily was given in 13% of patients, and other immunosuppressive therapies, such as infliximab, were given in 3%.

Among the 60% of patients with COVID-19 symptoms, 68% had fever, 59% had cough, 34% had dyspnea, and 15% had myalgia. Most of the 40% of asymptomatic patients were tested because they had COVID-19–positive contact, Dr. Rogiers noted.

Immune checkpoint inhibitor treatment included monotherapy with a programmed death–1/PD–ligand 1 inhibitor in 82% of patients, combination anti-PD-1 and anti-CTLA4 therapy in 13%, and other therapy – usually a checkpoint inhibitor combined with a different type of targeted agent – in 5%.

At the time of COVID-19 diagnosis, 30% of patients had achieved a partial response, complete response, or had no evidence of disease, 18% had stable disease, and 15% had progression. Response data were not available in 37% of cases, usually because treatment was only recently started prior to COVID-19 diagnosis, Dr. Rogiers said.

Treatments administered for COVID-19 included antibiotic therapy in 25% of patients, oxygen therapy in 20%, glucocorticoids in 10%, antiviral drugs in 6%, and intravenous immunoglobulin or anti–interleukin-6 in 2% each.

Among patients admitted to the ICU, 3% required mechanical ventilation, 2% had vasopressin, and 1% received renal replacement therapy.

At the data cutoff, 20 of 33 hospitalized patients (61%) had been discharged, and 4 (12%) were still in the hospital.
 

Mortality results

Nine patients died. The rate of death was 8% overall and 27% among hospitalized patients.

“The mortality rate of COVID-19 in the general population without comorbidities is about 1.4%,” Dr. Rogiers said. “For cancer patients, this is reported to be in the range of 7.6%-12%. To what extent patients on immune checkpoint inhibition are at a higher risk of mortality is currently unknown.”

Theoretically, immune checkpoint inhibition could either mitigate or exacerbate COVID-19 infection. It has been hypothesized that immune checkpoint inhibitors could increase the risk of severe acute lung injury or other complications of COVID-19, Dr. Rogiers said, explaining the rationale for the study.

The study shows that the patients who died had a median age of 72 years (range, 49-81 years), which is slightly higher than the median overall age of 63 years. Six patients were from North America, and three were from Italy.

“Two melanoma patients and two non–small cell lung cancer patients died,” Dr. Rogiers said. He noted that two other deaths were in patients with renal cell carcinoma, and three deaths were in other cancer types. All patients had advanced or metastatic disease.

Given that 57% of patients in the study had melanoma and 17% had NSCLC, this finding may indicate that COVID-19 has a slightly higher mortality rate in NSCLC patients than in melanoma patients, but the numbers are small, Dr. Rogiers said.

Notably, six of the patients who died were not admitted to the ICU. In four cases, this was because of underlying malignancy; in the other two cases, it was because of a constrained health care system, Dr. Rogiers said.

Overall, the findings show that the mortality rate of patients with COVID-19 and cancer treated with immune checkpoint inhibitors is similar to the mortality rate reported in the general cancer population, Dr. Rogiers said.

“Treatment with immune checkpoint inhibition does not seem to pose an additional mortality risk for cancer patients with COVID-19,” he concluded.

Dr. Rogiers reported having no conflicts of interest. There was no funding disclosed for the study.

[email protected]

SOURCE: Rogiers A et al. AACR: COVID-19 and Cancer, Abstract S02-01.

Immune checkpoint inhibition was not associated with an increased mortality risk from COVID-19 in patients with cancer in an international observational study.

The study included 113 cancer patients who had laboratory-confirmed COVID-19 within 12 months of receiving immune checkpoint inhibitor therapy. The patients did not receive chemotherapy within 3 months of testing positive for COVID-19.

In all, 33 patients were admitted to the hospital, including 6 who were admitted to the ICU, and 9 patients died.

“Nine out of 113 patients is a mortality rate of 8%, which is in the middle of the earlier reported rates for cancer patients in general [7.6%-12%],” said Aljosja Rogiers, MD, PhD, of the Melanoma Institute Australia in Sydney.

COVID-19 was the primary cause of death in seven of the patients, including three of those who were admitted to the ICU, Dr. Rogiers noted.

He reported these results during the AACR virtual meeting: COVID-19 and Cancer.
 

Study details

Patients in this study were treated at 19 hospitals in North America, Europe, and Australia, and the data cutoff was May 15, 2020. Most patients (64%) were treated in Europe, which was the epicenter for the COVID-19 pandemic at the time of data collection, Dr. Rogiers noted. A third of patients were in North America, and 3% were in Australia.

The patients’ median age was 63 years (range, 27-86 years). Most patients were men (65%), and most had Eastern Cooperative Oncology Group performance scores of 0-1 (90%).

The most common malignancies were melanoma (57%), non–small cell lung cancer (17%), and renal cell carcinoma (9%). Treatment was for early cancer in 26% of patients and for advanced cancer in 74%. Comorbidities included cardiovascular disease in 27% of patients, diabetes in 15%, pulmonary disease in 12%, and renal disease in 5%.

Immunosuppressive therapy equivalent to a prednisone dose of 10 mg or greater daily was given in 13% of patients, and other immunosuppressive therapies, such as infliximab, were given in 3%.

Among the 60% of patients with COVID-19 symptoms, 68% had fever, 59% had cough, 34% had dyspnea, and 15% had myalgia. Most of the 40% of asymptomatic patients were tested because they had COVID-19–positive contact, Dr. Rogiers noted.

Immune checkpoint inhibitor treatment included monotherapy with a programmed death–1/PD–ligand 1 inhibitor in 82% of patients, combination anti-PD-1 and anti-CTLA4 therapy in 13%, and other therapy – usually a checkpoint inhibitor combined with a different type of targeted agent – in 5%.

At the time of COVID-19 diagnosis, 30% of patients had achieved a partial response, complete response, or had no evidence of disease, 18% had stable disease, and 15% had progression. Response data were not available in 37% of cases, usually because treatment was only recently started prior to COVID-19 diagnosis, Dr. Rogiers said.

Treatments administered for COVID-19 included antibiotic therapy in 25% of patients, oxygen therapy in 20%, glucocorticoids in 10%, antiviral drugs in 6%, and intravenous immunoglobulin or anti–interleukin-6 in 2% each.

Among patients admitted to the ICU, 3% required mechanical ventilation, 2% had vasopressin, and 1% received renal replacement therapy.

At the data cutoff, 20 of 33 hospitalized patients (61%) had been discharged, and 4 (12%) were still in the hospital.
 

Mortality results

Nine patients died. The rate of death was 8% overall and 27% among hospitalized patients.

“The mortality rate of COVID-19 in the general population without comorbidities is about 1.4%,” Dr. Rogiers said. “For cancer patients, this is reported to be in the range of 7.6%-12%. To what extent patients on immune checkpoint inhibition are at a higher risk of mortality is currently unknown.”

Theoretically, immune checkpoint inhibition could either mitigate or exacerbate COVID-19 infection. It has been hypothesized that immune checkpoint inhibitors could increase the risk of severe acute lung injury or other complications of COVID-19, Dr. Rogiers said, explaining the rationale for the study.

The study shows that the patients who died had a median age of 72 years (range, 49-81 years), which is slightly higher than the median overall age of 63 years. Six patients were from North America, and three were from Italy.

“Two melanoma patients and two non–small cell lung cancer patients died,” Dr. Rogiers said. He noted that two other deaths were in patients with renal cell carcinoma, and three deaths were in other cancer types. All patients had advanced or metastatic disease.

Given that 57% of patients in the study had melanoma and 17% had NSCLC, this finding may indicate that COVID-19 has a slightly higher mortality rate in NSCLC patients than in melanoma patients, but the numbers are small, Dr. Rogiers said.

Notably, six of the patients who died were not admitted to the ICU. In four cases, this was because of underlying malignancy; in the other two cases, it was because of a constrained health care system, Dr. Rogiers said.

Overall, the findings show that the mortality rate of patients with COVID-19 and cancer treated with immune checkpoint inhibitors is similar to the mortality rate reported in the general cancer population, Dr. Rogiers said.

“Treatment with immune checkpoint inhibition does not seem to pose an additional mortality risk for cancer patients with COVID-19,” he concluded.

Dr. Rogiers reported having no conflicts of interest. There was no funding disclosed for the study.

[email protected]

SOURCE: Rogiers A et al. AACR: COVID-19 and Cancer, Abstract S02-01.

Immune checkpoint inhibition was not associated with an increased mortality risk from COVID-19 in patients with cancer in an international observational study.

The study included 113 cancer patients who had laboratory-confirmed COVID-19 within 12 months of receiving immune checkpoint inhibitor therapy. The patients did not receive chemotherapy within 3 months of testing positive for COVID-19.

In all, 33 patients were admitted to the hospital, including 6 who were admitted to the ICU, and 9 patients died.

“Nine out of 113 patients is a mortality rate of 8%, which is in the middle of the earlier reported rates for cancer patients in general [7.6%-12%],” said Aljosja Rogiers, MD, PhD, of the Melanoma Institute Australia in Sydney.

COVID-19 was the primary cause of death in seven of the patients, including three of those who were admitted to the ICU, Dr. Rogiers noted.

He reported these results during the AACR virtual meeting: COVID-19 and Cancer.
 

Study details

Patients in this study were treated at 19 hospitals in North America, Europe, and Australia, and the data cutoff was May 15, 2020. Most patients (64%) were treated in Europe, which was the epicenter for the COVID-19 pandemic at the time of data collection, Dr. Rogiers noted. A third of patients were in North America, and 3% were in Australia.

The patients’ median age was 63 years (range, 27-86 years). Most patients were men (65%), and most had Eastern Cooperative Oncology Group performance scores of 0-1 (90%).

The most common malignancies were melanoma (57%), non–small cell lung cancer (17%), and renal cell carcinoma (9%). Treatment was for early cancer in 26% of patients and for advanced cancer in 74%. Comorbidities included cardiovascular disease in 27% of patients, diabetes in 15%, pulmonary disease in 12%, and renal disease in 5%.

Immunosuppressive therapy equivalent to a prednisone dose of 10 mg or greater daily was given in 13% of patients, and other immunosuppressive therapies, such as infliximab, were given in 3%.

Among the 60% of patients with COVID-19 symptoms, 68% had fever, 59% had cough, 34% had dyspnea, and 15% had myalgia. Most of the 40% of asymptomatic patients were tested because they had COVID-19–positive contact, Dr. Rogiers noted.

Immune checkpoint inhibitor treatment included monotherapy with a programmed death–1/PD–ligand 1 inhibitor in 82% of patients, combination anti-PD-1 and anti-CTLA4 therapy in 13%, and other therapy – usually a checkpoint inhibitor combined with a different type of targeted agent – in 5%.

At the time of COVID-19 diagnosis, 30% of patients had achieved a partial response, complete response, or had no evidence of disease, 18% had stable disease, and 15% had progression. Response data were not available in 37% of cases, usually because treatment was only recently started prior to COVID-19 diagnosis, Dr. Rogiers said.

Treatments administered for COVID-19 included antibiotic therapy in 25% of patients, oxygen therapy in 20%, glucocorticoids in 10%, antiviral drugs in 6%, and intravenous immunoglobulin or anti–interleukin-6 in 2% each.

Among patients admitted to the ICU, 3% required mechanical ventilation, 2% had vasopressin, and 1% received renal replacement therapy.

At the data cutoff, 20 of 33 hospitalized patients (61%) had been discharged, and 4 (12%) were still in the hospital.
 

Mortality results

Nine patients died. The rate of death was 8% overall and 27% among hospitalized patients.

“The mortality rate of COVID-19 in the general population without comorbidities is about 1.4%,” Dr. Rogiers said. “For cancer patients, this is reported to be in the range of 7.6%-12%. To what extent patients on immune checkpoint inhibition are at a higher risk of mortality is currently unknown.”

Theoretically, immune checkpoint inhibition could either mitigate or exacerbate COVID-19 infection. It has been hypothesized that immune checkpoint inhibitors could increase the risk of severe acute lung injury or other complications of COVID-19, Dr. Rogiers said, explaining the rationale for the study.

The study shows that the patients who died had a median age of 72 years (range, 49-81 years), which is slightly higher than the median overall age of 63 years. Six patients were from North America, and three were from Italy.

“Two melanoma patients and two non–small cell lung cancer patients died,” Dr. Rogiers said. He noted that two other deaths were in patients with renal cell carcinoma, and three deaths were in other cancer types. All patients had advanced or metastatic disease.

Given that 57% of patients in the study had melanoma and 17% had NSCLC, this finding may indicate that COVID-19 has a slightly higher mortality rate in NSCLC patients than in melanoma patients, but the numbers are small, Dr. Rogiers said.

Notably, six of the patients who died were not admitted to the ICU. In four cases, this was because of underlying malignancy; in the other two cases, it was because of a constrained health care system, Dr. Rogiers said.

Overall, the findings show that the mortality rate of patients with COVID-19 and cancer treated with immune checkpoint inhibitors is similar to the mortality rate reported in the general cancer population, Dr. Rogiers said.

“Treatment with immune checkpoint inhibition does not seem to pose an additional mortality risk for cancer patients with COVID-19,” he concluded.

Dr. Rogiers reported having no conflicts of interest. There was no funding disclosed for the study.

[email protected]

SOURCE: Rogiers A et al. AACR: COVID-19 and Cancer, Abstract S02-01.