Business of Medicine

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

Headlines from earlier in the fall were grim: Thanks to the COVID-19 pandemic, life expectancy in the United States has fallen for 2 years running. Last year, according to health officials, the average American newborn could hope to reach 76.1 years, down from 79 years in 2019.

So far, so bad. But the headlines don’t tell the full story, which is much less dire. In fact, 2022 is the best year in human history for a child to arrive on Earth.

For a child born this year, in a developed country, into a family with access to good health care, the odds of living into the 22nd century are almost 50%. One in three will live to be 100. Those estimates reflect only incremental progress in medicine and public health, with COVID-19 baked in. They don’t account for biotechnologies beckoning to take control of the cell cycle and aging itself – which could make the outlook much brighter.

For some perspective, consider that a century ago, life expectancy for an American neonate was about 60 years. That 1922 figure was itself nothing short of miraculous, representing a 25% jump since 1901 – a leap that far outstrips the first 2 decades of the current century, during which life expectancy rose by just 2.5 years.

A gain of 2.5 years over 2 decades might not sound impressive, even without COVID-19 causing life expectancy in this country and abroad to sag. But during the pandemic, exciting new technologies that could drive gains in lifespan and healthspan, even bigger than those seen in the early 20th century, have moved closer to clinical reality. Think Star Trek-ish technologies like human hibernation, universal blood, mRNA therapy able to reprogram immune cells to hunt malignancies and fibrotic tissue, even head transplantation.

How long that last one will take to reach a clinic near you is hard to predict, but advances in the needed technology to anastomose cephalic and somatic portions of the spinal cord are mind-boggling. All this means that, from a medical standpoint, the future for babies born in the early 2020s looks dazzlingly bright.

Those sunny rays of optimism likely have failed to pierce the gloom of public discourse. Between “breakthrough infections,” “long COVID,” “Paxlovid rebound,” vaccine-induced myopericarditis, the current respiratory syncytial virus (RSV) outbreak, school shootings, climate change, and the youth mental health crisis, news headlines are undoubtedly frightful.
 

RSV: What’s old is new again

For the youngest children, the RSV outbreak is currently the scariest story. With social interactions returning toward a pre-COVID state, RSV has rebounded with a vengeance. In many places, pediatric wards are close to, at, or even beyond capacity. With no antiviral treatment for RSV, no licensed vaccine quite yet, and passive immunization (intravenous palivizumab) reserved for children at greatest risk (those under age 6 months and born preterm 35 weeks or earlier), the situation does have the feel of the first year of COVID-19, when treatments were similarly limited.

But let’s keep some perspective. RSV has always been a devastating infection. Prior to COVID-19, in the United States alone RSV killed 100-300 children below age 5 and 6,000-10,000 adults above age 65. The toll has always been worse on the international level. In 2019, 3.6 million people around the world were hospitalized for RSV infections, mostly the very old and the very young. Among causes of death below the age of 5, RSV ranks second only to malaria.

Postvaccine myopericarditis, a favorite concern of the vaccine hesitant, is a real phenomenon in young males. But generally, the condition has a subclinical to mild manifestation and fully resolves within 2 weeks.
 

Vaccines on the horizon

Monkeypox also was putting a damper on health news in recent months. Yet outreach efforts and selective vaccination and other precautions based on risk stratification appear to have calmed the outbreak. That’s good news, as is the fact that the struggle against malaria may be about to change. After decades of trying, we now have a malaria vaccine with what appears to be 80% efficacy against the infection. The same goes for RSV; finally, not one but two RSV vaccines are showing promise in late-stage clinical trials.

To be sure, for many young people, the times don’t seem so wonderful. The rate of teen suicide is alarming – yet it remains well below that seen in the 1990s. Are social media to blame, or is it something more complex?

If COVID-19 has taught us anything, it’s that development of vaccines and treatments need not take a decade or more. Operation Warp Speed may have seemed like a marketing gimmick and political grandstanding, but you can’t argue with the results.

Keep that perspective in mind to appreciate the moment – which I believe is coming soon – when the same type of intramuscular injection that we now use to trigger immunity against SARS-CoV-2 hits clinics, only this time as a way to cure cancer. Or when you read the stories of young victims of firearm violence who would have died but are rapidly cooled and kept hibernating for hours, so that their wounds can be repaired. And although you may not see that head transplant, one of these new babies might see it, or even might perform the procedure.
 

Dr. Warmflash is a freelance health and science writer living in Portland, Ore. His recent book, Moon: An Illustrated History: From Ancient Myths to the Colonies of Tomorrow, tells the story of the moon’s role in a plethora of historical events, from the origin of life to early calendar systems, the emergence of science and technology, and the dawn of the Space Age. He reported having no relevant financial disclosures. A version of this article first appeared on Medscape.com.

Headlines from earlier in the fall were grim: Thanks to the COVID-19 pandemic, life expectancy in the United States has fallen for 2 years running. Last year, according to health officials, the average American newborn could hope to reach 76.1 years, down from 79 years in 2019.

So far, so bad. But the headlines don’t tell the full story, which is much less dire. In fact, 2022 is the best year in human history for a child to arrive on Earth.

For a child born this year, in a developed country, into a family with access to good health care, the odds of living into the 22nd century are almost 50%. One in three will live to be 100. Those estimates reflect only incremental progress in medicine and public health, with COVID-19 baked in. They don’t account for biotechnologies beckoning to take control of the cell cycle and aging itself – which could make the outlook much brighter.

For some perspective, consider that a century ago, life expectancy for an American neonate was about 60 years. That 1922 figure was itself nothing short of miraculous, representing a 25% jump since 1901 – a leap that far outstrips the first 2 decades of the current century, during which life expectancy rose by just 2.5 years.

A gain of 2.5 years over 2 decades might not sound impressive, even without COVID-19 causing life expectancy in this country and abroad to sag. But during the pandemic, exciting new technologies that could drive gains in lifespan and healthspan, even bigger than those seen in the early 20th century, have moved closer to clinical reality. Think Star Trek-ish technologies like human hibernation, universal blood, mRNA therapy able to reprogram immune cells to hunt malignancies and fibrotic tissue, even head transplantation.

How long that last one will take to reach a clinic near you is hard to predict, but advances in the needed technology to anastomose cephalic and somatic portions of the spinal cord are mind-boggling. All this means that, from a medical standpoint, the future for babies born in the early 2020s looks dazzlingly bright.

Those sunny rays of optimism likely have failed to pierce the gloom of public discourse. Between “breakthrough infections,” “long COVID,” “Paxlovid rebound,” vaccine-induced myopericarditis, the current respiratory syncytial virus (RSV) outbreak, school shootings, climate change, and the youth mental health crisis, news headlines are undoubtedly frightful.
 

RSV: What’s old is new again

For the youngest children, the RSV outbreak is currently the scariest story. With social interactions returning toward a pre-COVID state, RSV has rebounded with a vengeance. In many places, pediatric wards are close to, at, or even beyond capacity. With no antiviral treatment for RSV, no licensed vaccine quite yet, and passive immunization (intravenous palivizumab) reserved for children at greatest risk (those under age 6 months and born preterm 35 weeks or earlier), the situation does have the feel of the first year of COVID-19, when treatments were similarly limited.

But let’s keep some perspective. RSV has always been a devastating infection. Prior to COVID-19, in the United States alone RSV killed 100-300 children below age 5 and 6,000-10,000 adults above age 65. The toll has always been worse on the international level. In 2019, 3.6 million people around the world were hospitalized for RSV infections, mostly the very old and the very young. Among causes of death below the age of 5, RSV ranks second only to malaria.

Postvaccine myopericarditis, a favorite concern of the vaccine hesitant, is a real phenomenon in young males. But generally, the condition has a subclinical to mild manifestation and fully resolves within 2 weeks.
 

Vaccines on the horizon

Monkeypox also was putting a damper on health news in recent months. Yet outreach efforts and selective vaccination and other precautions based on risk stratification appear to have calmed the outbreak. That’s good news, as is the fact that the struggle against malaria may be about to change. After decades of trying, we now have a malaria vaccine with what appears to be 80% efficacy against the infection. The same goes for RSV; finally, not one but two RSV vaccines are showing promise in late-stage clinical trials.

To be sure, for many young people, the times don’t seem so wonderful. The rate of teen suicide is alarming – yet it remains well below that seen in the 1990s. Are social media to blame, or is it something more complex?

If COVID-19 has taught us anything, it’s that development of vaccines and treatments need not take a decade or more. Operation Warp Speed may have seemed like a marketing gimmick and political grandstanding, but you can’t argue with the results.

Keep that perspective in mind to appreciate the moment – which I believe is coming soon – when the same type of intramuscular injection that we now use to trigger immunity against SARS-CoV-2 hits clinics, only this time as a way to cure cancer. Or when you read the stories of young victims of firearm violence who would have died but are rapidly cooled and kept hibernating for hours, so that their wounds can be repaired. And although you may not see that head transplant, one of these new babies might see it, or even might perform the procedure.
 

Dr. Warmflash is a freelance health and science writer living in Portland, Ore. His recent book, Moon: An Illustrated History: From Ancient Myths to the Colonies of Tomorrow, tells the story of the moon’s role in a plethora of historical events, from the origin of life to early calendar systems, the emergence of science and technology, and the dawn of the Space Age. He reported having no relevant financial disclosures. A version of this article first appeared on Medscape.com.

Headlines from earlier in the fall were grim: Thanks to the COVID-19 pandemic, life expectancy in the United States has fallen for 2 years running. Last year, according to health officials, the average American newborn could hope to reach 76.1 years, down from 79 years in 2019.

So far, so bad. But the headlines don’t tell the full story, which is much less dire. In fact, 2022 is the best year in human history for a child to arrive on Earth.

For a child born this year, in a developed country, into a family with access to good health care, the odds of living into the 22nd century are almost 50%. One in three will live to be 100. Those estimates reflect only incremental progress in medicine and public health, with COVID-19 baked in. They don’t account for biotechnologies beckoning to take control of the cell cycle and aging itself – which could make the outlook much brighter.

For some perspective, consider that a century ago, life expectancy for an American neonate was about 60 years. That 1922 figure was itself nothing short of miraculous, representing a 25% jump since 1901 – a leap that far outstrips the first 2 decades of the current century, during which life expectancy rose by just 2.5 years.

A gain of 2.5 years over 2 decades might not sound impressive, even without COVID-19 causing life expectancy in this country and abroad to sag. But during the pandemic, exciting new technologies that could drive gains in lifespan and healthspan, even bigger than those seen in the early 20th century, have moved closer to clinical reality. Think Star Trek-ish technologies like human hibernation, universal blood, mRNA therapy able to reprogram immune cells to hunt malignancies and fibrotic tissue, even head transplantation.

How long that last one will take to reach a clinic near you is hard to predict, but advances in the needed technology to anastomose cephalic and somatic portions of the spinal cord are mind-boggling. All this means that, from a medical standpoint, the future for babies born in the early 2020s looks dazzlingly bright.

Those sunny rays of optimism likely have failed to pierce the gloom of public discourse. Between “breakthrough infections,” “long COVID,” “Paxlovid rebound,” vaccine-induced myopericarditis, the current respiratory syncytial virus (RSV) outbreak, school shootings, climate change, and the youth mental health crisis, news headlines are undoubtedly frightful.
 

RSV: What’s old is new again

For the youngest children, the RSV outbreak is currently the scariest story. With social interactions returning toward a pre-COVID state, RSV has rebounded with a vengeance. In many places, pediatric wards are close to, at, or even beyond capacity. With no antiviral treatment for RSV, no licensed vaccine quite yet, and passive immunization (intravenous palivizumab) reserved for children at greatest risk (those under age 6 months and born preterm 35 weeks or earlier), the situation does have the feel of the first year of COVID-19, when treatments were similarly limited.

But let’s keep some perspective. RSV has always been a devastating infection. Prior to COVID-19, in the United States alone RSV killed 100-300 children below age 5 and 6,000-10,000 adults above age 65. The toll has always been worse on the international level. In 2019, 3.6 million people around the world were hospitalized for RSV infections, mostly the very old and the very young. Among causes of death below the age of 5, RSV ranks second only to malaria.

Postvaccine myopericarditis, a favorite concern of the vaccine hesitant, is a real phenomenon in young males. But generally, the condition has a subclinical to mild manifestation and fully resolves within 2 weeks.
 

Vaccines on the horizon

Monkeypox also was putting a damper on health news in recent months. Yet outreach efforts and selective vaccination and other precautions based on risk stratification appear to have calmed the outbreak. That’s good news, as is the fact that the struggle against malaria may be about to change. After decades of trying, we now have a malaria vaccine with what appears to be 80% efficacy against the infection. The same goes for RSV; finally, not one but two RSV vaccines are showing promise in late-stage clinical trials.

To be sure, for many young people, the times don’t seem so wonderful. The rate of teen suicide is alarming – yet it remains well below that seen in the 1990s. Are social media to blame, or is it something more complex?

If COVID-19 has taught us anything, it’s that development of vaccines and treatments need not take a decade or more. Operation Warp Speed may have seemed like a marketing gimmick and political grandstanding, but you can’t argue with the results.

Keep that perspective in mind to appreciate the moment – which I believe is coming soon – when the same type of intramuscular injection that we now use to trigger immunity against SARS-CoV-2 hits clinics, only this time as a way to cure cancer. Or when you read the stories of young victims of firearm violence who would have died but are rapidly cooled and kept hibernating for hours, so that their wounds can be repaired. And although you may not see that head transplant, one of these new babies might see it, or even might perform the procedure.
 

Dr. Warmflash is a freelance health and science writer living in Portland, Ore. His recent book, Moon: An Illustrated History: From Ancient Myths to the Colonies of Tomorrow, tells the story of the moon’s role in a plethora of historical events, from the origin of life to early calendar systems, the emergence of science and technology, and the dawn of the Space Age. He reported having no relevant financial disclosures. A version of this article first appeared on Medscape.com.

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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

Because of the high out-of-pocket costs of new-to-market neurologic drugs that are of similar benefit as older agents, only a small percentage of patients with neurologic disorders have access to these cutting-edge medications, new research shows.

“Our study of people with neurologic conditions found that fewer than 20% were being treated with new medications,” study author Brian C. Callaghan, MD, with University of Michigan Health in Ann Arbor, said in a statement.

“For new, high-cost medications that have similar effectiveness to older drugs, limited use is likely appropriate. However, future studies are needed to look into whether the high costs are barriers to those new medications that can really make a difference for people living with neurologic disease,” Dr. Callaghan said.

The study was published online in Neurology.
 

Most expensive drugs

Using insurance claims data, the investigators compared the utilization and costs of new-to-market drugs from 2014 to 2018 with those for existing guideline-supported medications for treating 11 neurologic conditions.

The new drugs included:

• erenumab, fremanezumab, and galcanezumab for migraine.
• ocrelizumab and peginterferon beta-1a for multiple sclerosis (MS).
• pimavanserin and safinamide for Parkinson’s disease.
• droxidopa for orthostatic hypertension.
• eculizumab for myasthenia gravis (MG).
• edaravone for amyotrophic lateral sclerosis (ALS).
• deutetrabenazine and valbenazine for Huntington’s disease and tardive dyskinesia.
• patisiran and inotersen for transthyretin amyloidosis (ATTR).
• eteplirsen and deflazacort for Duchenne disease.
• nusinersen for spinal muscular atrophy (SMA).

Utilization of new drugs was modest – they accounted for one in five prescriptions for every condition except tardive dyskinesia (32% for valbenazine), the researchers noted.

Mean out-of-pocket costs were significantly higher for the new medications, although there was large variability among individual drugs.

The two most expensive drugs were edaravone, for ALS, with a mean out-of-pocket cost of $713 for a 30-day supply, and eculizumab, for MG, which costs $91 per month.

“For new-to-market medications, the distribution of out-of-pocket costs were highly variable and the trends over time were unpredictable compared with existing guideline-supported medications,” the authors reported.

They noted that potential reasons for low utilization of newer agents include delay in provider uptake and prescriber and/or patient avoidance because of high cost.

Given that most of the new neurologic agents offer little advantage compared with existing treatments – exceptions being new drugs for SMA and ATTR – drug costs should be a key consideration in prescribing decisions, Dr. Callaghan and colleagues concluded.

One limitation of the study is that follow-up time was short for some of the recently approved medications. Another limitation is that the number of people in the study who had rare diseases was small.
 

Revolution in neurotherapeutics

“We are living in a time when new treatments bring hope to people with neurologic diseases and disorders,” Orly Avitzur, MD, president of the American Academy of Neurology, said in a statement.

“However, even existing prescription medication can be expensive and drug prices continue to rise. In order for neurologists to provide people with the highest quality care, it is imperative that new drugs are accessible and affordable to the people who need them,” Dr. Avitzur added.

Writing in a linked editorial, A. Gordon Smith, MD, professor and chair, department of neurology, Virginia Commonwealth University, Richmond, said there is a revolution in neurotherapeutics, with particularly robust growth in new drug approvals for orphan diseases (those affecting < 200,000 Americans).

“This study adds to a growing literature indicating rising drug prices are a threat to the health care system. No matter how effective a disease-modifying therapy may be, if a patient cannot afford the cost, it doesn’t work,” Dr. Smith wrote.

He added that neurologists must be “diligent in assessing for financial toxicity and appropriately tailor individual treatment recommendations. We must insist on development of point-of-care tools to accurately estimate each patient’s potential financial toxicity including RTBT [real-time benefit tools].

“Neurologists’ primary obligation is to the individual patient, but we are also compelled to support access to high-quality care for all people, which requires advocacy for appropriate policy reforms to ensure value based and fair drug pricing and treatment success,” Dr. Smith added.

The study was funded by the American Academy of Neurology Health Services Research Subcommittee. Dr. Callaghan consults for a PCORI grant, DynaMed, receives research support from the American Academy of Neurology, and performs medical/legal consultations, including consultations for the Vaccine Injury Compensation Program. Dr. Smith has disclosed no relevant financial relationships.

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

Because of the high out-of-pocket costs of new-to-market neurologic drugs that are of similar benefit as older agents, only a small percentage of patients with neurologic disorders have access to these cutting-edge medications, new research shows.

“Our study of people with neurologic conditions found that fewer than 20% were being treated with new medications,” study author Brian C. Callaghan, MD, with University of Michigan Health in Ann Arbor, said in a statement.

“For new, high-cost medications that have similar effectiveness to older drugs, limited use is likely appropriate. However, future studies are needed to look into whether the high costs are barriers to those new medications that can really make a difference for people living with neurologic disease,” Dr. Callaghan said.

The study was published online in Neurology.
 

Most expensive drugs

Using insurance claims data, the investigators compared the utilization and costs of new-to-market drugs from 2014 to 2018 with those for existing guideline-supported medications for treating 11 neurologic conditions.

The new drugs included:

• erenumab, fremanezumab, and galcanezumab for migraine.
• ocrelizumab and peginterferon beta-1a for multiple sclerosis (MS).
• pimavanserin and safinamide for Parkinson’s disease.
• droxidopa for orthostatic hypertension.
• eculizumab for myasthenia gravis (MG).
• edaravone for amyotrophic lateral sclerosis (ALS).
• deutetrabenazine and valbenazine for Huntington’s disease and tardive dyskinesia.
• patisiran and inotersen for transthyretin amyloidosis (ATTR).
• eteplirsen and deflazacort for Duchenne disease.
• nusinersen for spinal muscular atrophy (SMA).

Utilization of new drugs was modest – they accounted for one in five prescriptions for every condition except tardive dyskinesia (32% for valbenazine), the researchers noted.

Mean out-of-pocket costs were significantly higher for the new medications, although there was large variability among individual drugs.

The two most expensive drugs were edaravone, for ALS, with a mean out-of-pocket cost of $713 for a 30-day supply, and eculizumab, for MG, which costs $91 per month.

“For new-to-market medications, the distribution of out-of-pocket costs were highly variable and the trends over time were unpredictable compared with existing guideline-supported medications,” the authors reported.

They noted that potential reasons for low utilization of newer agents include delay in provider uptake and prescriber and/or patient avoidance because of high cost.

Given that most of the new neurologic agents offer little advantage compared with existing treatments – exceptions being new drugs for SMA and ATTR – drug costs should be a key consideration in prescribing decisions, Dr. Callaghan and colleagues concluded.

One limitation of the study is that follow-up time was short for some of the recently approved medications. Another limitation is that the number of people in the study who had rare diseases was small.
 

Revolution in neurotherapeutics

“We are living in a time when new treatments bring hope to people with neurologic diseases and disorders,” Orly Avitzur, MD, president of the American Academy of Neurology, said in a statement.

“However, even existing prescription medication can be expensive and drug prices continue to rise. In order for neurologists to provide people with the highest quality care, it is imperative that new drugs are accessible and affordable to the people who need them,” Dr. Avitzur added.

Writing in a linked editorial, A. Gordon Smith, MD, professor and chair, department of neurology, Virginia Commonwealth University, Richmond, said there is a revolution in neurotherapeutics, with particularly robust growth in new drug approvals for orphan diseases (those affecting < 200,000 Americans).

“This study adds to a growing literature indicating rising drug prices are a threat to the health care system. No matter how effective a disease-modifying therapy may be, if a patient cannot afford the cost, it doesn’t work,” Dr. Smith wrote.

He added that neurologists must be “diligent in assessing for financial toxicity and appropriately tailor individual treatment recommendations. We must insist on development of point-of-care tools to accurately estimate each patient’s potential financial toxicity including RTBT [real-time benefit tools].

“Neurologists’ primary obligation is to the individual patient, but we are also compelled to support access to high-quality care for all people, which requires advocacy for appropriate policy reforms to ensure value based and fair drug pricing and treatment success,” Dr. Smith added.

The study was funded by the American Academy of Neurology Health Services Research Subcommittee. Dr. Callaghan consults for a PCORI grant, DynaMed, receives research support from the American Academy of Neurology, and performs medical/legal consultations, including consultations for the Vaccine Injury Compensation Program. Dr. Smith has disclosed no relevant financial relationships.

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

Because of the high out-of-pocket costs of new-to-market neurologic drugs that are of similar benefit as older agents, only a small percentage of patients with neurologic disorders have access to these cutting-edge medications, new research shows.

“Our study of people with neurologic conditions found that fewer than 20% were being treated with new medications,” study author Brian C. Callaghan, MD, with University of Michigan Health in Ann Arbor, said in a statement.

“For new, high-cost medications that have similar effectiveness to older drugs, limited use is likely appropriate. However, future studies are needed to look into whether the high costs are barriers to those new medications that can really make a difference for people living with neurologic disease,” Dr. Callaghan said.

The study was published online in Neurology.
 

Most expensive drugs

Using insurance claims data, the investigators compared the utilization and costs of new-to-market drugs from 2014 to 2018 with those for existing guideline-supported medications for treating 11 neurologic conditions.

The new drugs included:

• erenumab, fremanezumab, and galcanezumab for migraine.
• ocrelizumab and peginterferon beta-1a for multiple sclerosis (MS).
• pimavanserin and safinamide for Parkinson’s disease.
• droxidopa for orthostatic hypertension.
• eculizumab for myasthenia gravis (MG).
• edaravone for amyotrophic lateral sclerosis (ALS).
• deutetrabenazine and valbenazine for Huntington’s disease and tardive dyskinesia.
• patisiran and inotersen for transthyretin amyloidosis (ATTR).
• eteplirsen and deflazacort for Duchenne disease.
• nusinersen for spinal muscular atrophy (SMA).

Utilization of new drugs was modest – they accounted for one in five prescriptions for every condition except tardive dyskinesia (32% for valbenazine), the researchers noted.

Mean out-of-pocket costs were significantly higher for the new medications, although there was large variability among individual drugs.

The two most expensive drugs were edaravone, for ALS, with a mean out-of-pocket cost of $713 for a 30-day supply, and eculizumab, for MG, which costs $91 per month.

“For new-to-market medications, the distribution of out-of-pocket costs were highly variable and the trends over time were unpredictable compared with existing guideline-supported medications,” the authors reported.

They noted that potential reasons for low utilization of newer agents include delay in provider uptake and prescriber and/or patient avoidance because of high cost.

Given that most of the new neurologic agents offer little advantage compared with existing treatments – exceptions being new drugs for SMA and ATTR – drug costs should be a key consideration in prescribing decisions, Dr. Callaghan and colleagues concluded.

One limitation of the study is that follow-up time was short for some of the recently approved medications. Another limitation is that the number of people in the study who had rare diseases was small.
 

Revolution in neurotherapeutics

“We are living in a time when new treatments bring hope to people with neurologic diseases and disorders,” Orly Avitzur, MD, president of the American Academy of Neurology, said in a statement.

“However, even existing prescription medication can be expensive and drug prices continue to rise. In order for neurologists to provide people with the highest quality care, it is imperative that new drugs are accessible and affordable to the people who need them,” Dr. Avitzur added.

Writing in a linked editorial, A. Gordon Smith, MD, professor and chair, department of neurology, Virginia Commonwealth University, Richmond, said there is a revolution in neurotherapeutics, with particularly robust growth in new drug approvals for orphan diseases (those affecting < 200,000 Americans).

“This study adds to a growing literature indicating rising drug prices are a threat to the health care system. No matter how effective a disease-modifying therapy may be, if a patient cannot afford the cost, it doesn’t work,” Dr. Smith wrote.

He added that neurologists must be “diligent in assessing for financial toxicity and appropriately tailor individual treatment recommendations. We must insist on development of point-of-care tools to accurately estimate each patient’s potential financial toxicity including RTBT [real-time benefit tools].

“Neurologists’ primary obligation is to the individual patient, but we are also compelled to support access to high-quality care for all people, which requires advocacy for appropriate policy reforms to ensure value based and fair drug pricing and treatment success,” Dr. Smith added.

The study was funded by the American Academy of Neurology Health Services Research Subcommittee. Dr. Callaghan consults for a PCORI grant, DynaMed, receives research support from the American Academy of Neurology, and performs medical/legal consultations, including consultations for the Vaccine Injury Compensation Program. Dr. Smith has disclosed no relevant financial relationships.

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

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

I don’t do email. Or texting. You want to talk to me and my staff? Pick up a phone.

Some people say I’m old fashioned, or not patient-friendly, or whatever.

I don’t care.

To me there are too many issues with things that can get missed in emails, too many security concerns, too many ways to alter them so it looks like something different was said.

Now, a recent study of an EHR system found that 3% of emails from patients had negative, if not downright nasty, sentiments expressed to their physicians.

Here’s some examples:

“I hope and expect that you will spend eternity in hell. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

The study also noted that the most common expletive used by patients is the F-bomb, and that words with violent connotations, such as “shoot,” “fight,” and “kill” were often used in such emails. The last are definitely concerning in an era of increased violence directed at doctors and other health care workers who are just trying to do their jobs.

Now, I know doctors are a microcosm of society. Like patients, most are decent people trying their best, but a few are ... not particularly nice.

But still, I don’t think we, or anyone for that matter, need to be getting emails of this nature. It certainly doesn’t put anyone in a good position, or allow for objective, unbiased, care. Even if they’re only 3% of emails, that can still be quite a few.

Who needs that?

One of the issues with email is that it’s easy to type something nasty and hit “send,” then later have it occur to you that maybe you should have calmed down first. Granted, that sort of thing can (and does) happen when talking to another person (by phone or in person), but it’s harder.

Direct personal contact, especially face-to-face, appears to lessen impulsive reactions for most. The other person isn’t an invisible email address, they’re someone you’re talking to. You can read tone-of-voice and facial expressions. Again, I’m aware people still can lose their cool in person, but it’s harder.

In-person communication, or on the phone, adds a greater chance to reason through things, explain misunderstandings, and clarify statements rather than just hitting send and running into the next exam room. Plus, it ensures that all noncritical patient interactions occur during business hours, when we’re in doctor mode, rather than at 2:45 a.m. when we look at the iPhone while waiting for the dog to come back in. That’s a terrible time to receive and send medical (or any) emails for both doctor and patient.

A lot rides on every one of my patient interactions, and that’s why I still want them done directly. If that makes me old-fashioned, so be it.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I don’t do email. Or texting. You want to talk to me and my staff? Pick up a phone.

Some people say I’m old fashioned, or not patient-friendly, or whatever.

I don’t care.

To me there are too many issues with things that can get missed in emails, too many security concerns, too many ways to alter them so it looks like something different was said.

Now, a recent study of an EHR system found that 3% of emails from patients had negative, if not downright nasty, sentiments expressed to their physicians.

Here’s some examples:

“I hope and expect that you will spend eternity in hell. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

The study also noted that the most common expletive used by patients is the F-bomb, and that words with violent connotations, such as “shoot,” “fight,” and “kill” were often used in such emails. The last are definitely concerning in an era of increased violence directed at doctors and other health care workers who are just trying to do their jobs.

Now, I know doctors are a microcosm of society. Like patients, most are decent people trying their best, but a few are ... not particularly nice.

But still, I don’t think we, or anyone for that matter, need to be getting emails of this nature. It certainly doesn’t put anyone in a good position, or allow for objective, unbiased, care. Even if they’re only 3% of emails, that can still be quite a few.

Who needs that?

One of the issues with email is that it’s easy to type something nasty and hit “send,” then later have it occur to you that maybe you should have calmed down first. Granted, that sort of thing can (and does) happen when talking to another person (by phone or in person), but it’s harder.

Direct personal contact, especially face-to-face, appears to lessen impulsive reactions for most. The other person isn’t an invisible email address, they’re someone you’re talking to. You can read tone-of-voice and facial expressions. Again, I’m aware people still can lose their cool in person, but it’s harder.

In-person communication, or on the phone, adds a greater chance to reason through things, explain misunderstandings, and clarify statements rather than just hitting send and running into the next exam room. Plus, it ensures that all noncritical patient interactions occur during business hours, when we’re in doctor mode, rather than at 2:45 a.m. when we look at the iPhone while waiting for the dog to come back in. That’s a terrible time to receive and send medical (or any) emails for both doctor and patient.

A lot rides on every one of my patient interactions, and that’s why I still want them done directly. If that makes me old-fashioned, so be it.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I don’t do email. Or texting. You want to talk to me and my staff? Pick up a phone.

Some people say I’m old fashioned, or not patient-friendly, or whatever.

I don’t care.

To me there are too many issues with things that can get missed in emails, too many security concerns, too many ways to alter them so it looks like something different was said.

Now, a recent study of an EHR system found that 3% of emails from patients had negative, if not downright nasty, sentiments expressed to their physicians.

Here’s some examples:

“I hope and expect that you will spend eternity in hell. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

The study also noted that the most common expletive used by patients is the F-bomb, and that words with violent connotations, such as “shoot,” “fight,” and “kill” were often used in such emails. The last are definitely concerning in an era of increased violence directed at doctors and other health care workers who are just trying to do their jobs.

Now, I know doctors are a microcosm of society. Like patients, most are decent people trying their best, but a few are ... not particularly nice.

But still, I don’t think we, or anyone for that matter, need to be getting emails of this nature. It certainly doesn’t put anyone in a good position, or allow for objective, unbiased, care. Even if they’re only 3% of emails, that can still be quite a few.

Who needs that?

One of the issues with email is that it’s easy to type something nasty and hit “send,” then later have it occur to you that maybe you should have calmed down first. Granted, that sort of thing can (and does) happen when talking to another person (by phone or in person), but it’s harder.

Direct personal contact, especially face-to-face, appears to lessen impulsive reactions for most. The other person isn’t an invisible email address, they’re someone you’re talking to. You can read tone-of-voice and facial expressions. Again, I’m aware people still can lose their cool in person, but it’s harder.

In-person communication, or on the phone, adds a greater chance to reason through things, explain misunderstandings, and clarify statements rather than just hitting send and running into the next exam room. Plus, it ensures that all noncritical patient interactions occur during business hours, when we’re in doctor mode, rather than at 2:45 a.m. when we look at the iPhone while waiting for the dog to come back in. That’s a terrible time to receive and send medical (or any) emails for both doctor and patient.

A lot rides on every one of my patient interactions, and that’s why I still want them done directly. If that makes me old-fashioned, so be it.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.

“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.

However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.

Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.

Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
 

Groups most likely to forgo further tests

The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).

Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.

“It caught a lot of women by surprise,” she told this news organization.

The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.

However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
 

Reducing false-positive recalls

The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”

Physicians who order additional tests must also consider the financial burden for patients, she said.

Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.

Further compounding the problem is that not every insurer is subject to state law, she said.

Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.

“It would be great to have a federal law that is inclusive,” she said.
 

Education efforts may help

Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”

He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”

Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.

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

CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.

“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.

However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.

Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.

Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
 

Groups most likely to forgo further tests

The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).

Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.

“It caught a lot of women by surprise,” she told this news organization.

The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.

However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
 

Reducing false-positive recalls

The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”

Physicians who order additional tests must also consider the financial burden for patients, she said.

Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.

Further compounding the problem is that not every insurer is subject to state law, she said.

Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.

“It would be great to have a federal law that is inclusive,” she said.
 

Education efforts may help

Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”

He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”

Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.

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

CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.

“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.

However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.

Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.

Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
 

Groups most likely to forgo further tests

The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).

Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.

“It caught a lot of women by surprise,” she told this news organization.

The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.

However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
 

Reducing false-positive recalls

The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”

Physicians who order additional tests must also consider the financial burden for patients, she said.

Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.

Further compounding the problem is that not every insurer is subject to state law, she said.

Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.

“It would be great to have a federal law that is inclusive,” she said.
 

Education efforts may help

Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”

He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”

Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.

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