Clinical Endocrinology News

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

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

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

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

Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.

But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.

Some good news has made primary care and some other physicians happy.

The government’s proposal includes significant changes to reimbursement for all physicians. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.

According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.

The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.

These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.

If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.

The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.

For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.

Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.

The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.

A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.

The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.

Other key changes include the following:

• The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
• Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
• Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
• A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”

To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.

Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.

The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.

Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.

CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.

MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.

The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.

CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.

The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.

Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.

Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.

The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.

If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).

This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
 

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

“A treat-to-target approach is useful in the management of osteoporosis” was the motion proposed in a debate during the recent virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting, and when the votes came in, Michael McClung, MD, who argued against the motion, carried the day.

Agreement with the motion dropped from 63%-46% after McClung, of the Oregon Osteoporosis Center, Portland, put his views forward in opposition to those of Celia L. Gregson, PhD, University of Bristol (England), who argued for the motion on behalf of the European Calcified Tissue Society (ECTS).

Disagreement with the statement rose from 37% predebate to 54% in the postdebate audience polls.

“The debate is part education and part entertainment,” said Dr. McClung, who represented the ASBMR. “I could just as easily have made a strong argument for the motion,” he emphasized in an interview.

On the other hand, “had I been in the audience, as a member of ASBMR relying on data and evidence to make clinical decisions, I would have voted against the motion. As appealing as the strategy sounds, we don’t yet have the hard evidence to support its use nor is there a consensus about what an appropriate target should be, he noted.

Similarly, the debate comoderator and incoming ASBMR President, Suzanne M. Jan de Beur, MD, from Johns Hopkins University, Baltimore, said that a treat-to-target strategy for osteoporosis is an attractive idea, but there is no consensus on how to apply it nor evidence that it improves clinical outcomes.
 

Treat to target to guide osteoporosis therapy is like going “backwards”

In treat to target, the target – such as bone mineral density (BMD) (the most common one) – is identified before treatment is started, Dr. McClung explained (and as stated in a review article in the New England Journal of Medicine he coauthored on the topic). 

“While treat to target has appealing concepts, using risk factors to guide therapy is almost backwards,” he said. “We can’t change bone density very much.”

Treat to target is “not quite ready for prime time,” he concluded in his rebuttal.

Invited to speculate on which of Dr. McClung’s arguments swayed the audience, Dr. Gregson conceded that with a treat-to-target strategy “there is too much focus on getting one target for the whole global population with osteoporosis.”

“This is an oversimplification of a complex disease, and it misses the main message that the target should be decided with the patient not for the patient, which means one can’t just have one rule for everyone. There has to be scope to have different targets for different people so that we can deliver individualized care.”

Also, she noted, “generally people don’t vote to change familiar systems.”
 

Arguments for treat to target

Dr. Gregson began her argument, however, by stating that treat to target “is now a feasible and useful approach in osteoporosis care.”

The main reasons for adopting this treatment strategy are as follows:

• It provides a proactive approach with a clear goal.
• It includes periodic treatment reassessment, which allows for prompt revisions to treatment.
• It can use targets to guide treatment timing and patient monitoring.
• It includes shared decision-making, the preferred method of patient care.
• It could improve treatment adherence through patient “buy-in” of the target.
• It can use targets to address the risk of rare side effects.
• It allows for sequential treatments, especially for patients at highest risk of fracture.
• It can include more patient-centered outcomes such as reduced , restored range of movement, and ability to live independently.

“Patients are not interested in their T-score. They are interested in pain,” said Dr. Gregson.

“Reduced fracture risk is a very important goal,” she emphasized. Patients “with osteoporosis and a high fracture risk have the most to gain from a treat-to-target approach.”

“Improved access to anabolic osteoporosis treatments mean achieving those goals or targets are now more achievable than ever,” she concluded.

Arguments against treat to target

“Do we truly have an appropriate, meaningful target for osteoporosis?” Dr. McClung began in his counterargument, which cast a seed of doubt in the minds of the audience.

Targets such as no fractures, fracture risk (FRAX score), bone turnover markers, and bone strength have limitations.

Moreover, “do we have treatment strategies to move patients to the chosen target?” he continued. “What is the evidence that a treat-to-target strategy provides better outcomes than our current treatment paradigm?”

After pointing out a lack of evidence that treat to target leads to better outcomes in osteoporosis, he did allow that “recent data about the relationship between treatment-related BMD values and current fracture risk are appreciated and welcomed.”

“However, a treat-to-target strategy will only be successful if the targets are individualized for each patient, those targets are attainable for most patients, and we have evidence that adopting this strategy improves clinical outcomes,” he summarized.

He then quoted his late wife Betsy Love McClung, RN, MN, who had said, “We don’t treat osteoporosis; we treat patients with osteoporosis.”

Dr. McClung wrapped up by stressing: “We should not treat T-scores or any other specific target. We should individualize our therapy based upon the patient’s risk of fracture and other clinical factors.”

As members of the ECTS and ASBMR, and “proud of our reputation of our societies as being scientifically based and driven,” Dr. McClung concluded, “recognizing that a treat-to-target strategy has appeal, we should certainly encourage more research and be attentive to those results.

“But we must hold off on the adoption of the strategy until we have evidence convincing us of its clinical value.”
 

When to use a treat-to-target strategy

However, “there are some specific situations where I use something like a treat-to-target strategy,” Dr. McClung conceded. “That is, I make decisions and recommendations to the patients about one drug rather than another because I want to maximize the improvement in their bone density.”

For example, “We have known for 15 years that denosumab results in greater increases in bone density than do bisphosphonates,” he continued.

“So I have used that information to make treatment decisions long before the term ‘treat to target’ entered the vocabulary of osteoporosis experts. I simply wanted to induce the largest possible gains in bone density – but I didn’t have a ‘target’ in mind.”

But for most patients, treatment decisions are made based on other factors, such as their fracture risk, he added. BMD is an important risk factor for fracture, but not as important as having had a recent fracture or being old and frail.

“Unfortunately, in most of today’s health systems, decisions about treatment are made on the basis of cost,” he continued. “More often than not, the health plan rules rather than optimal medical practice are the main guides to treatment decisions.”   

According to Dr. Gregson, “in some instances, treat to target would be very helpful. I don’t think it will suit everyone, but I think we should have it in our portfolio of management approaches, and we should as an osteoporosis community be trained in its use.”
 

“Attractive idea, but ...”

Invited to weigh in, Dr. Jan de Beur noted that A1c, blood pressure, and LDL cholesterol targets are used to improve clinical outcomes in patients with diabetes, hypertension, and hyperlipidemia, respectively.

However, “treat to target for the treatment of low BMD is controversial because it is an attractive idea but without consensus on what the target should be and without evidence that treat to target improves clinical outcomes,” she reiterated.

“The potential benefits of treat to target are proactive, clear goals to achieve, shared decision-making with the patient, the possibility for improved adherence, justification for sequence treatments, and balancing risk of rare side effects.”

On the other hand, “barriers to operationalizing the treat-to-target concept is that there is lack of consensus on the target to be achieved [as any specific target may minimize other important risk factors],” she noted.

There is also a “lack of evidence that demonstrates improved clinical outcomes over choosing therapy based on fracture risk, and lack of ability to achieve the target with available therapies in those with very-low bone density,” she concluded.

Dr. McClung has reported receiving consulting fees from Amgen and Myovant and speaker honoraria from Amgen. Dr. Gregson and Dr. Jan de Beur have reported no relevant financial relationships.
 

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

“A treat-to-target approach is useful in the management of osteoporosis” was the motion proposed in a debate during the recent virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting, and when the votes came in, Michael McClung, MD, who argued against the motion, carried the day.

Agreement with the motion dropped from 63%-46% after McClung, of the Oregon Osteoporosis Center, Portland, put his views forward in opposition to those of Celia L. Gregson, PhD, University of Bristol (England), who argued for the motion on behalf of the European Calcified Tissue Society (ECTS).

Disagreement with the statement rose from 37% predebate to 54% in the postdebate audience polls.

“The debate is part education and part entertainment,” said Dr. McClung, who represented the ASBMR. “I could just as easily have made a strong argument for the motion,” he emphasized in an interview.

On the other hand, “had I been in the audience, as a member of ASBMR relying on data and evidence to make clinical decisions, I would have voted against the motion. As appealing as the strategy sounds, we don’t yet have the hard evidence to support its use nor is there a consensus about what an appropriate target should be, he noted.

Similarly, the debate comoderator and incoming ASBMR President, Suzanne M. Jan de Beur, MD, from Johns Hopkins University, Baltimore, said that a treat-to-target strategy for osteoporosis is an attractive idea, but there is no consensus on how to apply it nor evidence that it improves clinical outcomes.
 

Treat to target to guide osteoporosis therapy is like going “backwards”

In treat to target, the target – such as bone mineral density (BMD) (the most common one) – is identified before treatment is started, Dr. McClung explained (and as stated in a review article in the New England Journal of Medicine he coauthored on the topic). 

“While treat to target has appealing concepts, using risk factors to guide therapy is almost backwards,” he said. “We can’t change bone density very much.”

Treat to target is “not quite ready for prime time,” he concluded in his rebuttal.

Invited to speculate on which of Dr. McClung’s arguments swayed the audience, Dr. Gregson conceded that with a treat-to-target strategy “there is too much focus on getting one target for the whole global population with osteoporosis.”

“This is an oversimplification of a complex disease, and it misses the main message that the target should be decided with the patient not for the patient, which means one can’t just have one rule for everyone. There has to be scope to have different targets for different people so that we can deliver individualized care.”

Also, she noted, “generally people don’t vote to change familiar systems.”
 

Arguments for treat to target

Dr. Gregson began her argument, however, by stating that treat to target “is now a feasible and useful approach in osteoporosis care.”

The main reasons for adopting this treatment strategy are as follows:

• It provides a proactive approach with a clear goal.
• It includes periodic treatment reassessment, which allows for prompt revisions to treatment.
• It can use targets to guide treatment timing and patient monitoring.
• It includes shared decision-making, the preferred method of patient care.
• It could improve treatment adherence through patient “buy-in” of the target.
• It can use targets to address the risk of rare side effects.
• It allows for sequential treatments, especially for patients at highest risk of fracture.
• It can include more patient-centered outcomes such as reduced , restored range of movement, and ability to live independently.

“Patients are not interested in their T-score. They are interested in pain,” said Dr. Gregson.

“Reduced fracture risk is a very important goal,” she emphasized. Patients “with osteoporosis and a high fracture risk have the most to gain from a treat-to-target approach.”

“Improved access to anabolic osteoporosis treatments mean achieving those goals or targets are now more achievable than ever,” she concluded.

Arguments against treat to target

“Do we truly have an appropriate, meaningful target for osteoporosis?” Dr. McClung began in his counterargument, which cast a seed of doubt in the minds of the audience.

Targets such as no fractures, fracture risk (FRAX score), bone turnover markers, and bone strength have limitations.

Moreover, “do we have treatment strategies to move patients to the chosen target?” he continued. “What is the evidence that a treat-to-target strategy provides better outcomes than our current treatment paradigm?”

After pointing out a lack of evidence that treat to target leads to better outcomes in osteoporosis, he did allow that “recent data about the relationship between treatment-related BMD values and current fracture risk are appreciated and welcomed.”

“However, a treat-to-target strategy will only be successful if the targets are individualized for each patient, those targets are attainable for most patients, and we have evidence that adopting this strategy improves clinical outcomes,” he summarized.

He then quoted his late wife Betsy Love McClung, RN, MN, who had said, “We don’t treat osteoporosis; we treat patients with osteoporosis.”

Dr. McClung wrapped up by stressing: “We should not treat T-scores or any other specific target. We should individualize our therapy based upon the patient’s risk of fracture and other clinical factors.”

As members of the ECTS and ASBMR, and “proud of our reputation of our societies as being scientifically based and driven,” Dr. McClung concluded, “recognizing that a treat-to-target strategy has appeal, we should certainly encourage more research and be attentive to those results.

“But we must hold off on the adoption of the strategy until we have evidence convincing us of its clinical value.”
 

When to use a treat-to-target strategy

However, “there are some specific situations where I use something like a treat-to-target strategy,” Dr. McClung conceded. “That is, I make decisions and recommendations to the patients about one drug rather than another because I want to maximize the improvement in their bone density.”

For example, “We have known for 15 years that denosumab results in greater increases in bone density than do bisphosphonates,” he continued.

“So I have used that information to make treatment decisions long before the term ‘treat to target’ entered the vocabulary of osteoporosis experts. I simply wanted to induce the largest possible gains in bone density – but I didn’t have a ‘target’ in mind.”

But for most patients, treatment decisions are made based on other factors, such as their fracture risk, he added. BMD is an important risk factor for fracture, but not as important as having had a recent fracture or being old and frail.

“Unfortunately, in most of today’s health systems, decisions about treatment are made on the basis of cost,” he continued. “More often than not, the health plan rules rather than optimal medical practice are the main guides to treatment decisions.”   

According to Dr. Gregson, “in some instances, treat to target would be very helpful. I don’t think it will suit everyone, but I think we should have it in our portfolio of management approaches, and we should as an osteoporosis community be trained in its use.”
 

“Attractive idea, but ...”

Invited to weigh in, Dr. Jan de Beur noted that A1c, blood pressure, and LDL cholesterol targets are used to improve clinical outcomes in patients with diabetes, hypertension, and hyperlipidemia, respectively.

However, “treat to target for the treatment of low BMD is controversial because it is an attractive idea but without consensus on what the target should be and without evidence that treat to target improves clinical outcomes,” she reiterated.

“The potential benefits of treat to target are proactive, clear goals to achieve, shared decision-making with the patient, the possibility for improved adherence, justification for sequence treatments, and balancing risk of rare side effects.”

On the other hand, “barriers to operationalizing the treat-to-target concept is that there is lack of consensus on the target to be achieved [as any specific target may minimize other important risk factors],” she noted.

There is also a “lack of evidence that demonstrates improved clinical outcomes over choosing therapy based on fracture risk, and lack of ability to achieve the target with available therapies in those with very-low bone density,” she concluded.

Dr. McClung has reported receiving consulting fees from Amgen and Myovant and speaker honoraria from Amgen. Dr. Gregson and Dr. Jan de Beur have reported no relevant financial relationships.
 

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

“A treat-to-target approach is useful in the management of osteoporosis” was the motion proposed in a debate during the recent virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting, and when the votes came in, Michael McClung, MD, who argued against the motion, carried the day.

Agreement with the motion dropped from 63%-46% after McClung, of the Oregon Osteoporosis Center, Portland, put his views forward in opposition to those of Celia L. Gregson, PhD, University of Bristol (England), who argued for the motion on behalf of the European Calcified Tissue Society (ECTS).

Disagreement with the statement rose from 37% predebate to 54% in the postdebate audience polls.

“The debate is part education and part entertainment,” said Dr. McClung, who represented the ASBMR. “I could just as easily have made a strong argument for the motion,” he emphasized in an interview.

On the other hand, “had I been in the audience, as a member of ASBMR relying on data and evidence to make clinical decisions, I would have voted against the motion. As appealing as the strategy sounds, we don’t yet have the hard evidence to support its use nor is there a consensus about what an appropriate target should be, he noted.

Similarly, the debate comoderator and incoming ASBMR President, Suzanne M. Jan de Beur, MD, from Johns Hopkins University, Baltimore, said that a treat-to-target strategy for osteoporosis is an attractive idea, but there is no consensus on how to apply it nor evidence that it improves clinical outcomes.
 

Treat to target to guide osteoporosis therapy is like going “backwards”

In treat to target, the target – such as bone mineral density (BMD) (the most common one) – is identified before treatment is started, Dr. McClung explained (and as stated in a review article in the New England Journal of Medicine he coauthored on the topic). 

“While treat to target has appealing concepts, using risk factors to guide therapy is almost backwards,” he said. “We can’t change bone density very much.”

Treat to target is “not quite ready for prime time,” he concluded in his rebuttal.

Invited to speculate on which of Dr. McClung’s arguments swayed the audience, Dr. Gregson conceded that with a treat-to-target strategy “there is too much focus on getting one target for the whole global population with osteoporosis.”

“This is an oversimplification of a complex disease, and it misses the main message that the target should be decided with the patient not for the patient, which means one can’t just have one rule for everyone. There has to be scope to have different targets for different people so that we can deliver individualized care.”

Also, she noted, “generally people don’t vote to change familiar systems.”
 

Arguments for treat to target

Dr. Gregson began her argument, however, by stating that treat to target “is now a feasible and useful approach in osteoporosis care.”

The main reasons for adopting this treatment strategy are as follows:

• It provides a proactive approach with a clear goal.
• It includes periodic treatment reassessment, which allows for prompt revisions to treatment.
• It can use targets to guide treatment timing and patient monitoring.
• It includes shared decision-making, the preferred method of patient care.
• It could improve treatment adherence through patient “buy-in” of the target.
• It can use targets to address the risk of rare side effects.
• It allows for sequential treatments, especially for patients at highest risk of fracture.
• It can include more patient-centered outcomes such as reduced , restored range of movement, and ability to live independently.

“Patients are not interested in their T-score. They are interested in pain,” said Dr. Gregson.

“Reduced fracture risk is a very important goal,” she emphasized. Patients “with osteoporosis and a high fracture risk have the most to gain from a treat-to-target approach.”

“Improved access to anabolic osteoporosis treatments mean achieving those goals or targets are now more achievable than ever,” she concluded.

Arguments against treat to target

“Do we truly have an appropriate, meaningful target for osteoporosis?” Dr. McClung began in his counterargument, which cast a seed of doubt in the minds of the audience.

Targets such as no fractures, fracture risk (FRAX score), bone turnover markers, and bone strength have limitations.

Moreover, “do we have treatment strategies to move patients to the chosen target?” he continued. “What is the evidence that a treat-to-target strategy provides better outcomes than our current treatment paradigm?”

After pointing out a lack of evidence that treat to target leads to better outcomes in osteoporosis, he did allow that “recent data about the relationship between treatment-related BMD values and current fracture risk are appreciated and welcomed.”

“However, a treat-to-target strategy will only be successful if the targets are individualized for each patient, those targets are attainable for most patients, and we have evidence that adopting this strategy improves clinical outcomes,” he summarized.

He then quoted his late wife Betsy Love McClung, RN, MN, who had said, “We don’t treat osteoporosis; we treat patients with osteoporosis.”

Dr. McClung wrapped up by stressing: “We should not treat T-scores or any other specific target. We should individualize our therapy based upon the patient’s risk of fracture and other clinical factors.”

As members of the ECTS and ASBMR, and “proud of our reputation of our societies as being scientifically based and driven,” Dr. McClung concluded, “recognizing that a treat-to-target strategy has appeal, we should certainly encourage more research and be attentive to those results.

“But we must hold off on the adoption of the strategy until we have evidence convincing us of its clinical value.”
 

When to use a treat-to-target strategy

However, “there are some specific situations where I use something like a treat-to-target strategy,” Dr. McClung conceded. “That is, I make decisions and recommendations to the patients about one drug rather than another because I want to maximize the improvement in their bone density.”

For example, “We have known for 15 years that denosumab results in greater increases in bone density than do bisphosphonates,” he continued.

“So I have used that information to make treatment decisions long before the term ‘treat to target’ entered the vocabulary of osteoporosis experts. I simply wanted to induce the largest possible gains in bone density – but I didn’t have a ‘target’ in mind.”

But for most patients, treatment decisions are made based on other factors, such as their fracture risk, he added. BMD is an important risk factor for fracture, but not as important as having had a recent fracture or being old and frail.

“Unfortunately, in most of today’s health systems, decisions about treatment are made on the basis of cost,” he continued. “More often than not, the health plan rules rather than optimal medical practice are the main guides to treatment decisions.”   

According to Dr. Gregson, “in some instances, treat to target would be very helpful. I don’t think it will suit everyone, but I think we should have it in our portfolio of management approaches, and we should as an osteoporosis community be trained in its use.”
 

“Attractive idea, but ...”

Invited to weigh in, Dr. Jan de Beur noted that A1c, blood pressure, and LDL cholesterol targets are used to improve clinical outcomes in patients with diabetes, hypertension, and hyperlipidemia, respectively.

However, “treat to target for the treatment of low BMD is controversial because it is an attractive idea but without consensus on what the target should be and without evidence that treat to target improves clinical outcomes,” she reiterated.

“The potential benefits of treat to target are proactive, clear goals to achieve, shared decision-making with the patient, the possibility for improved adherence, justification for sequence treatments, and balancing risk of rare side effects.”

On the other hand, “barriers to operationalizing the treat-to-target concept is that there is lack of consensus on the target to be achieved [as any specific target may minimize other important risk factors],” she noted.

There is also a “lack of evidence that demonstrates improved clinical outcomes over choosing therapy based on fracture risk, and lack of ability to achieve the target with available therapies in those with very-low bone density,” she concluded.

Dr. McClung has reported receiving consulting fees from Amgen and Myovant and speaker honoraria from Amgen. Dr. Gregson and Dr. Jan de Beur have reported no relevant financial relationships.
 

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

Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.

“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.

Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.

However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.

In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.

Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.

“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”

And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”

“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.

103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls

Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.

Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.

There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.

To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:

• 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
• 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
• 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.

Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).

Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).

Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.

About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).

The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.

Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.

Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.

They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).  

Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).

Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.

“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.

He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”

Gennari, Meltzer, and Manson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.

“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.

Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.

However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.

In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.

Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.

“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”

And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”

“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.

103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls

Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.

Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.

There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.

To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:

• 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
• 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
• 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.

Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).

Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).

Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.

About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).

The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.

Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.

Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.

They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).  

Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).

Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.

“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.

He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”

Gennari, Meltzer, and Manson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.

“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.

Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.

However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.

In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.

Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.

“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”

And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”

“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.

103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls

Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.

Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.

There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.

To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:

• 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
• 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
• 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.

Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).

Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).

Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.

About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).

The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.

Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.

Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.

They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).  

Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).

Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.

“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.

He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”

Gennari, Meltzer, and Manson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.

Yuri_Arcurs/DigitalVision/Getty Images

Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.

There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).

The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.

Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.

There are different kinds of busy, and there are strategies to minimize the kind of busy that leads to burnout. Enabling a system that generates an excess of patient messages is looking for trouble.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.

Yuri_Arcurs/DigitalVision/Getty Images

Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.

There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).

The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.

Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.

There are different kinds of busy, and there are strategies to minimize the kind of busy that leads to burnout. Enabling a system that generates an excess of patient messages is looking for trouble.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.

Yuri_Arcurs/DigitalVision/Getty Images

Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.

There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).

The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.

Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.

There are different kinds of busy, and there are strategies to minimize the kind of busy that leads to burnout. Enabling a system that generates an excess of patient messages is looking for trouble.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.

Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.

But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.

The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.

Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.

“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a  health consultant who has worked with Colorado on its importation proposal.

Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.

Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.

The DeSantis administration did not respond to requests for comment.

Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”

The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.

The proposal would regulate how states set up their own programs for importing drugs from Canada.

Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.

The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.

But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.

“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”

Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.

Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.

For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.

About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.

The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.

The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.

The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”

The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.

Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.

The second program would be geared to the broader state population.

In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.

“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.

Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.

Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.

Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.

However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.

Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.

“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.

Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.

Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.

“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald. 

Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.

Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.

But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.

The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.

Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.

“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a  health consultant who has worked with Colorado on its importation proposal.

Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.

Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.

The DeSantis administration did not respond to requests for comment.

Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”

The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.

The proposal would regulate how states set up their own programs for importing drugs from Canada.

Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.

The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.

But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.

“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”

Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.

Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.

For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.

About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.

The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.

The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.

The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”

The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.

Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.

The second program would be geared to the broader state population.

In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.

“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.

Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.

Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.

Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.

However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.

Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.

“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.

Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.

Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.

“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald. 

Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.

Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.

But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.

The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.

Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.

“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a  health consultant who has worked with Colorado on its importation proposal.

Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.

Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.

The DeSantis administration did not respond to requests for comment.

Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”

The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.

The proposal would regulate how states set up their own programs for importing drugs from Canada.

Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.

The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.

But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.

“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”

Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.

Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.

For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.

About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.

The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.

The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.

The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”

The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.

Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.

The second program would be geared to the broader state population.

In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.

“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.

Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.

Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.

Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.

However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.

Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.

“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.

Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.

Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.

“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald. 

Almost a quarter of adults in the United States are very concerned about access to health care during the COVID-19 pandemic, according to the results of a survey conducted Aug. 7-26.

Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.

At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.

When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.

Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:

• Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
• Frequently washing hands: 74.7% very, 1.6% not at all.
• Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
• Wearing a face mask in public: 75.7% very, 3.5% not at all.

The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.

rfranki@mdedge.com

Almost a quarter of adults in the United States are very concerned about access to health care during the COVID-19 pandemic, according to the results of a survey conducted Aug. 7-26.

Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.

At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.

When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.

Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:

• Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
• Frequently washing hands: 74.7% very, 1.6% not at all.
• Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
• Wearing a face mask in public: 75.7% very, 3.5% not at all.

The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.

rfranki@mdedge.com

Almost a quarter of adults in the United States are very concerned about access to health care during the COVID-19 pandemic, according to the results of a survey conducted Aug. 7-26.

Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.

At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.

When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.

Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:

• Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
• Frequently washing hands: 74.7% very, 1.6% not at all.
• Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
• Wearing a face mask in public: 75.7% very, 3.5% not at all.

The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.

rfranki@mdedge.com

This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.

The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.

In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”

Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.

“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.  

EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
 

More cardiovascular and renal outcomes for SGLT2 inhibitors 

The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.

Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).

Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”

A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.

The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”

Del Prato also named that symposium as a meeting highlight.

“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
 

Who’s “right” – diabetologists or cardiologists?

Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.

Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”

Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”

“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
 

Other big trial results: CGM after MI, semaglutide for obesity

Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).

LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.

The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.

Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
 

Personalized medicine, COVID-19, intermittent fasting, and much more

Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.

Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”

This field, he predicted, “will grow enormously in the next 10 years.”

Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”

Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.  

There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”

“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.

Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda. 

This article first appeared on Medscape.com.

This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.

The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.

In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”

Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.

“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.  

EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
 

More cardiovascular and renal outcomes for SGLT2 inhibitors 

The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.

Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).

Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”

A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.

The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”

Del Prato also named that symposium as a meeting highlight.

“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
 

Who’s “right” – diabetologists or cardiologists?

Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.

Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”

Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”

“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
 

Other big trial results: CGM after MI, semaglutide for obesity

Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).

LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.

The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.

Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
 

Personalized medicine, COVID-19, intermittent fasting, and much more

Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.

Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”

This field, he predicted, “will grow enormously in the next 10 years.”

Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”

Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.  

There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”

“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.

Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda. 

This article first appeared on Medscape.com.

This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.

The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.

In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”

Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.

“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.  

EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
 

More cardiovascular and renal outcomes for SGLT2 inhibitors 

The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.

Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).

Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”

A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.

The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”

Del Prato also named that symposium as a meeting highlight.

“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
 

Who’s “right” – diabetologists or cardiologists?

Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.

Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”

Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”

“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
 

Other big trial results: CGM after MI, semaglutide for obesity

Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).

LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.

The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.

Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
 

Personalized medicine, COVID-19, intermittent fasting, and much more

Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.

Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”

This field, he predicted, “will grow enormously in the next 10 years.”

Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”

Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.  

There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”

“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.

Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda. 

This article first appeared on Medscape.com.

Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.

In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.

“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.

“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.

She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
 

A challenging recommendation

The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.

They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).

They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.

Overall, there was no significant difference in the average BP obtained at any of the rest periods.

After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.

When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.

However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
 

More efficient, economic

“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.

“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.

Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”

“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.

“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.

She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.

The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.

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

Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.

In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.

“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.

“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.

She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
 

A challenging recommendation

The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.

They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).

They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.

Overall, there was no significant difference in the average BP obtained at any of the rest periods.

After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.

When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.

However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
 

More efficient, economic

“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.

“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.

Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”

“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.

“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.

She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.

The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.

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

Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.

In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.

“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.

“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.

She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
 

A challenging recommendation

The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.

They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).

They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.

Overall, there was no significant difference in the average BP obtained at any of the rest periods.

After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.

When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.

However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
 

More efficient, economic

“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.

“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.

Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”

“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.

“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.

She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.

The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.

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

Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.

Will 2020-2021 be different?

Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.

The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.

Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
 

SARS-CoV-2’s potential interaction

Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.^1,2

However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not. The worry is that SARS-CoV-2 as a coinfecting agent may not provide an identifiable clinical signal as primary or coinfecting ARI pathogen.
 

Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis

If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.

A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.³ Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.

Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.

These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
 

Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness

In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.⁴

While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.⁵

So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.⁶ That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.

We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.

 

Summary

Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.

But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at pdnews@mdedge.com.

References

1. Pediatrics. 2020;146(1):e20200961.

2. JAMA. 2020 May 26;323(20):2085-6.

3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.

4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.

5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.

6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.

Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.

Will 2020-2021 be different?

Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.

The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.

Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
 

SARS-CoV-2’s potential interaction

Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.^1,2

However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not. The worry is that SARS-CoV-2 as a coinfecting agent may not provide an identifiable clinical signal as primary or coinfecting ARI pathogen.
 

Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis

If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.

A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.³ Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.

Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.

These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
 

Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness

In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.⁴

While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.⁵

So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.⁶ That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.

We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.

 

Summary

Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.

But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at pdnews@mdedge.com.

References

1. Pediatrics. 2020;146(1):e20200961.

2. JAMA. 2020 May 26;323(20):2085-6.

3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.

4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.

5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.

6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.

Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.

Will 2020-2021 be different?

Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.

The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.

Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
 

SARS-CoV-2’s potential interaction

Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.^1,2

However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not. The worry is that SARS-CoV-2 as a coinfecting agent may not provide an identifiable clinical signal as primary or coinfecting ARI pathogen.
 

Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis

If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.

A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.³ Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.

Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.

These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
 

Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness

In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.⁴

While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.⁵

So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.⁶ That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.

We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.

 

Summary

Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.

But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at pdnews@mdedge.com.

References

1. Pediatrics. 2020;146(1):e20200961.

2. JAMA. 2020 May 26;323(20):2085-6.

3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.

4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.

5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.

6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.

SSRIs are associated with a much lower risk of type 2 diabetes (T2D) in children and adolescents than previously reported, new research shows.

Investigators found publicly insured patients treated with SSRIs had a 13% increased risk for T2D, compared with those not treated with these agents. In addition, those taking SSRIs continuously (defined as receiving one or more prescriptions every 3 months) had a 33% increased risk of T2D.

On the other hand, privately insured youth had a much lower increased risk – a finding that may be attributable to a lower prevalence of risk factors for T2D in this group.

“We cannot exclude that children and adolescents treated with SSRIs may be at a small increased risk of developing T2D, particularly publicly insured patients, but the magnitude of association was weaker than previous thought and much smaller than other known risk factors for T2DM, such as obesity, race, and poverty,” lead investigator Jenny Sun, PhD, said in an interview.

“When weighing the known benefits and risks of SSRI treatment in children and adolescents, our findings provide reassurance that the risk of T2DM is not as substantial as initially reported,” said Dr. Sun, a postdoctoral research fellow in the department of population medicine at Harvard Medical School’s Harvard Pilgrim Health Care Institute, Boston.

The study was published online Sept. 2 in JAMA Psychiatry.

Limited evidence

Previous research suggested that SSRIs increase the risk of T2D by up to 90% in children and adolescents.

However, the investigators noted, the study reporting this finding was too small to draw conclusions about the SSRI class as a whole also did not examine specific SSRIs.

In addition, although “several studies have reported that antidepressant use may be a risk factor for T2D in adults, evidence was limited in children and adolescents,” said Dr. Sun.

“Rapid changes in growth during childhood and adolescents can alter drugs’ pharmacokinetics and pharmacodynamics, so high-quality, age-specific data are needed to inform prescribing decisions,” she said.

For the current study, the researchers analyzed claims data on almost 1.6 million patients aged 10-19 years (58.3% female; mean age, 15.1 years) from two large claims databases.

The analysis focused on those with a diagnosis warranting treatment with an SSRI, including depression, generalized or social anxiety disorder, obsessive compulsive disorder, PTSD, panic disorder, or bulimia nervosa.

The Medicaid Analytic Extract database consisted of 316,178 patients insured through Medicaid or the Children’s Health Insurance Program. The IBM MarketScan database consisted of 211,460 privately insured patients. Patients were followed up for a mean of 2.3 and 2.2 years, respectively.

Patients who initiated SSRI treatment were compared with those with a similar indication but who were not taking an SSRI. Secondary analyses compared new SSRI users with patients who recently initiated treatment with bupropion, which has no metabolic side effects, or with patients who recently initiated psychotherapy.

“In observational data, it is difficult to mimic a placebo group, often used in RCTs [randomized, controlled trials], therefore several comparator groups were explored to broaden our understanding,” said Dr. Sun.

In addition, the researchers compared the individual SSRI medications, using fluoxetine as a comparator.

A wide range of more than 100 potential confounders or “proxies of confounders,” were taken into account, including demographic characteristics, psychiatric diagnoses, metabolic conditions, concomitant medications, and use of health care services.

The researchers conducted two analyses. They included an intention-to-treat (ITT) analysis that was restricted to patients with one or more additional SSRI prescriptions during the 6 months following the index exposure assessment period.

Close monitoring required

An as-treated analysis estimated the association of continuous SSRI treatment (vs. untreated, bupropion treatment, and psychotherapy), with adherence assessed at 3-month intervals.

Initiation and continuation of SSRI treatment in publicly insured patients were both associated with a considerably higher risk of T2D, compared with untreated patients, and a steeper risk, compared with their privately insured counterparts.

For newly treated publicly insured patients initiated on SSRI treatment, the ITT adjusted hazard ratio was 1.13 (95% confidence interval, 1.04-1.22).

There was an even stronger association among continuously treated publicly insured patients, with an as-treated aHR of 1.33 (95% CI, 1.21-1.47). The authors noted that this corresponds to 6.6 additional T2D cases per 10,000 patients continuously treated for at least 2 years.

The association was weaker in privately insured patients (ITT aHR, 1.01; 95% CI, 0.84-1.23; as-treated aHR, 1.10; 95% CI, 0.88-1.36).

The secondary analyses yielded similar findings: When SSRI treatment was compared with psychotherapy, the as-treated aHR for publicly insured patients was 1.44 (95% CI, 1.25-1.65), whereas the aHR for privately insured patients was lower at 1.21 (95% CI, 0.93-1.57)

The investigators found no increased risk when SSRIs were compared with bupropion, and the within-class analysis showed that none of the SSRIs carried an increased hazard of T2D, compared with fluoxetine.

“Publicly insured patients are enrolled in Medicaid and the Children’s Health Insurance Program, whereas privately insured patients are generally covered by their parent’s employer-sponsored insurance,” said Dr. Sun.

“Publicly insured patients are of lower socioeconomic status and represent a population with greater overall medical burden, more comorbidities, and a higher prevalence of risk factors for T2D, such as obesity, at the time of treatment initiation,” she said.

She added that high-risk children and youth should be closely monitored and clinicians should also consider recommending dietary modifications and increased exercise to offset T2D risk.

Useful ‘real-world data’

William Cooper, MD, MPH, professor of pediatrics and health policy at Vanderbilt University Medical Center in Nashville, Tenn., said that the study “provides a fascinating look at risks of SSRI medications in children and adolescents.”

Dr. Cooper, who was not involved with the study, said that the authors “draw from real-world data representing two different populations and carefully consider factors which might confound the associations.”

The results, he said, “provide important benefits for patients, families, and clinicians as they weigh the risks and benefits of using SSRIs for children who need treatment for depression and anxiety disorders.

“As a pediatrician, I would find these results useful as I work with my patients, their families, and behavioral health colleagues in making important treatment decisions.”

The study was supported by a training grant from the program in pharmacoepidemiology at the Harvard School of Public Health. Dr. Sun disclosed no relevant financial relationships. Dr. Cooper disclosed no relevant financial relationships.

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

SSRIs are associated with a much lower risk of type 2 diabetes (T2D) in children and adolescents than previously reported, new research shows.

Investigators found publicly insured patients treated with SSRIs had a 13% increased risk for T2D, compared with those not treated with these agents. In addition, those taking SSRIs continuously (defined as receiving one or more prescriptions every 3 months) had a 33% increased risk of T2D.

On the other hand, privately insured youth had a much lower increased risk – a finding that may be attributable to a lower prevalence of risk factors for T2D in this group.

“We cannot exclude that children and adolescents treated with SSRIs may be at a small increased risk of developing T2D, particularly publicly insured patients, but the magnitude of association was weaker than previous thought and much smaller than other known risk factors for T2DM, such as obesity, race, and poverty,” lead investigator Jenny Sun, PhD, said in an interview.

“When weighing the known benefits and risks of SSRI treatment in children and adolescents, our findings provide reassurance that the risk of T2DM is not as substantial as initially reported,” said Dr. Sun, a postdoctoral research fellow in the department of population medicine at Harvard Medical School’s Harvard Pilgrim Health Care Institute, Boston.

The study was published online Sept. 2 in JAMA Psychiatry.

Limited evidence

Previous research suggested that SSRIs increase the risk of T2D by up to 90% in children and adolescents.

However, the investigators noted, the study reporting this finding was too small to draw conclusions about the SSRI class as a whole also did not examine specific SSRIs.

In addition, although “several studies have reported that antidepressant use may be a risk factor for T2D in adults, evidence was limited in children and adolescents,” said Dr. Sun.

“Rapid changes in growth during childhood and adolescents can alter drugs’ pharmacokinetics and pharmacodynamics, so high-quality, age-specific data are needed to inform prescribing decisions,” she said.

For the current study, the researchers analyzed claims data on almost 1.6 million patients aged 10-19 years (58.3% female; mean age, 15.1 years) from two large claims databases.

The analysis focused on those with a diagnosis warranting treatment with an SSRI, including depression, generalized or social anxiety disorder, obsessive compulsive disorder, PTSD, panic disorder, or bulimia nervosa.

The Medicaid Analytic Extract database consisted of 316,178 patients insured through Medicaid or the Children’s Health Insurance Program. The IBM MarketScan database consisted of 211,460 privately insured patients. Patients were followed up for a mean of 2.3 and 2.2 years, respectively.

Patients who initiated SSRI treatment were compared with those with a similar indication but who were not taking an SSRI. Secondary analyses compared new SSRI users with patients who recently initiated treatment with bupropion, which has no metabolic side effects, or with patients who recently initiated psychotherapy.

“In observational data, it is difficult to mimic a placebo group, often used in RCTs [randomized, controlled trials], therefore several comparator groups were explored to broaden our understanding,” said Dr. Sun.

In addition, the researchers compared the individual SSRI medications, using fluoxetine as a comparator.

A wide range of more than 100 potential confounders or “proxies of confounders,” were taken into account, including demographic characteristics, psychiatric diagnoses, metabolic conditions, concomitant medications, and use of health care services.

The researchers conducted two analyses. They included an intention-to-treat (ITT) analysis that was restricted to patients with one or more additional SSRI prescriptions during the 6 months following the index exposure assessment period.

Close monitoring required

An as-treated analysis estimated the association of continuous SSRI treatment (vs. untreated, bupropion treatment, and psychotherapy), with adherence assessed at 3-month intervals.

Initiation and continuation of SSRI treatment in publicly insured patients were both associated with a considerably higher risk of T2D, compared with untreated patients, and a steeper risk, compared with their privately insured counterparts.

For newly treated publicly insured patients initiated on SSRI treatment, the ITT adjusted hazard ratio was 1.13 (95% confidence interval, 1.04-1.22).

There was an even stronger association among continuously treated publicly insured patients, with an as-treated aHR of 1.33 (95% CI, 1.21-1.47). The authors noted that this corresponds to 6.6 additional T2D cases per 10,000 patients continuously treated for at least 2 years.

The association was weaker in privately insured patients (ITT aHR, 1.01; 95% CI, 0.84-1.23; as-treated aHR, 1.10; 95% CI, 0.88-1.36).

The secondary analyses yielded similar findings: When SSRI treatment was compared with psychotherapy, the as-treated aHR for publicly insured patients was 1.44 (95% CI, 1.25-1.65), whereas the aHR for privately insured patients was lower at 1.21 (95% CI, 0.93-1.57)

The investigators found no increased risk when SSRIs were compared with bupropion, and the within-class analysis showed that none of the SSRIs carried an increased hazard of T2D, compared with fluoxetine.

“Publicly insured patients are enrolled in Medicaid and the Children’s Health Insurance Program, whereas privately insured patients are generally covered by their parent’s employer-sponsored insurance,” said Dr. Sun.

“Publicly insured patients are of lower socioeconomic status and represent a population with greater overall medical burden, more comorbidities, and a higher prevalence of risk factors for T2D, such as obesity, at the time of treatment initiation,” she said.

She added that high-risk children and youth should be closely monitored and clinicians should also consider recommending dietary modifications and increased exercise to offset T2D risk.

Useful ‘real-world data’

William Cooper, MD, MPH, professor of pediatrics and health policy at Vanderbilt University Medical Center in Nashville, Tenn., said that the study “provides a fascinating look at risks of SSRI medications in children and adolescents.”

Dr. Cooper, who was not involved with the study, said that the authors “draw from real-world data representing two different populations and carefully consider factors which might confound the associations.”

The results, he said, “provide important benefits for patients, families, and clinicians as they weigh the risks and benefits of using SSRIs for children who need treatment for depression and anxiety disorders.

“As a pediatrician, I would find these results useful as I work with my patients, their families, and behavioral health colleagues in making important treatment decisions.”

The study was supported by a training grant from the program in pharmacoepidemiology at the Harvard School of Public Health. Dr. Sun disclosed no relevant financial relationships. Dr. Cooper disclosed no relevant financial relationships.

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

SSRIs are associated with a much lower risk of type 2 diabetes (T2D) in children and adolescents than previously reported, new research shows.

Investigators found publicly insured patients treated with SSRIs had a 13% increased risk for T2D, compared with those not treated with these agents. In addition, those taking SSRIs continuously (defined as receiving one or more prescriptions every 3 months) had a 33% increased risk of T2D.

On the other hand, privately insured youth had a much lower increased risk – a finding that may be attributable to a lower prevalence of risk factors for T2D in this group.

“We cannot exclude that children and adolescents treated with SSRIs may be at a small increased risk of developing T2D, particularly publicly insured patients, but the magnitude of association was weaker than previous thought and much smaller than other known risk factors for T2DM, such as obesity, race, and poverty,” lead investigator Jenny Sun, PhD, said in an interview.

“When weighing the known benefits and risks of SSRI treatment in children and adolescents, our findings provide reassurance that the risk of T2DM is not as substantial as initially reported,” said Dr. Sun, a postdoctoral research fellow in the department of population medicine at Harvard Medical School’s Harvard Pilgrim Health Care Institute, Boston.

The study was published online Sept. 2 in JAMA Psychiatry.

Limited evidence

Previous research suggested that SSRIs increase the risk of T2D by up to 90% in children and adolescents.

However, the investigators noted, the study reporting this finding was too small to draw conclusions about the SSRI class as a whole also did not examine specific SSRIs.

In addition, although “several studies have reported that antidepressant use may be a risk factor for T2D in adults, evidence was limited in children and adolescents,” said Dr. Sun.

“Rapid changes in growth during childhood and adolescents can alter drugs’ pharmacokinetics and pharmacodynamics, so high-quality, age-specific data are needed to inform prescribing decisions,” she said.

For the current study, the researchers analyzed claims data on almost 1.6 million patients aged 10-19 years (58.3% female; mean age, 15.1 years) from two large claims databases.

The analysis focused on those with a diagnosis warranting treatment with an SSRI, including depression, generalized or social anxiety disorder, obsessive compulsive disorder, PTSD, panic disorder, or bulimia nervosa.

The Medicaid Analytic Extract database consisted of 316,178 patients insured through Medicaid or the Children’s Health Insurance Program. The IBM MarketScan database consisted of 211,460 privately insured patients. Patients were followed up for a mean of 2.3 and 2.2 years, respectively.

Patients who initiated SSRI treatment were compared with those with a similar indication but who were not taking an SSRI. Secondary analyses compared new SSRI users with patients who recently initiated treatment with bupropion, which has no metabolic side effects, or with patients who recently initiated psychotherapy.

“In observational data, it is difficult to mimic a placebo group, often used in RCTs [randomized, controlled trials], therefore several comparator groups were explored to broaden our understanding,” said Dr. Sun.

In addition, the researchers compared the individual SSRI medications, using fluoxetine as a comparator.

A wide range of more than 100 potential confounders or “proxies of confounders,” were taken into account, including demographic characteristics, psychiatric diagnoses, metabolic conditions, concomitant medications, and use of health care services.

The researchers conducted two analyses. They included an intention-to-treat (ITT) analysis that was restricted to patients with one or more additional SSRI prescriptions during the 6 months following the index exposure assessment period.

Close monitoring required

An as-treated analysis estimated the association of continuous SSRI treatment (vs. untreated, bupropion treatment, and psychotherapy), with adherence assessed at 3-month intervals.

Initiation and continuation of SSRI treatment in publicly insured patients were both associated with a considerably higher risk of T2D, compared with untreated patients, and a steeper risk, compared with their privately insured counterparts.

For newly treated publicly insured patients initiated on SSRI treatment, the ITT adjusted hazard ratio was 1.13 (95% confidence interval, 1.04-1.22).

There was an even stronger association among continuously treated publicly insured patients, with an as-treated aHR of 1.33 (95% CI, 1.21-1.47). The authors noted that this corresponds to 6.6 additional T2D cases per 10,000 patients continuously treated for at least 2 years.

The association was weaker in privately insured patients (ITT aHR, 1.01; 95% CI, 0.84-1.23; as-treated aHR, 1.10; 95% CI, 0.88-1.36).

The secondary analyses yielded similar findings: When SSRI treatment was compared with psychotherapy, the as-treated aHR for publicly insured patients was 1.44 (95% CI, 1.25-1.65), whereas the aHR for privately insured patients was lower at 1.21 (95% CI, 0.93-1.57)

The investigators found no increased risk when SSRIs were compared with bupropion, and the within-class analysis showed that none of the SSRIs carried an increased hazard of T2D, compared with fluoxetine.

“Publicly insured patients are enrolled in Medicaid and the Children’s Health Insurance Program, whereas privately insured patients are generally covered by their parent’s employer-sponsored insurance,” said Dr. Sun.

“Publicly insured patients are of lower socioeconomic status and represent a population with greater overall medical burden, more comorbidities, and a higher prevalence of risk factors for T2D, such as obesity, at the time of treatment initiation,” she said.

She added that high-risk children and youth should be closely monitored and clinicians should also consider recommending dietary modifications and increased exercise to offset T2D risk.

Useful ‘real-world data’

William Cooper, MD, MPH, professor of pediatrics and health policy at Vanderbilt University Medical Center in Nashville, Tenn., said that the study “provides a fascinating look at risks of SSRI medications in children and adolescents.”

Dr. Cooper, who was not involved with the study, said that the authors “draw from real-world data representing two different populations and carefully consider factors which might confound the associations.”

The results, he said, “provide important benefits for patients, families, and clinicians as they weigh the risks and benefits of using SSRIs for children who need treatment for depression and anxiety disorders.

“As a pediatrician, I would find these results useful as I work with my patients, their families, and behavioral health colleagues in making important treatment decisions.”

The study was supported by a training grant from the program in pharmacoepidemiology at the Harvard School of Public Health. Dr. Sun disclosed no relevant financial relationships. Dr. Cooper disclosed no relevant financial relationships.

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