The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

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

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

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

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

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

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

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

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

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

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

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

For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”

At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.

The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. Dr. Gupta advised obtaining phone numbers for crisis services relevant to the location of the patient, and this requires confirming that the patient is where he or she was expected to be.

In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.

The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.

One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.

Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.

Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.

Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.

During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.

“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.

Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.

Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.

“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
 

Uncertainty about future use

Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.

“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.

It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.

“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.

Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.

“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.

For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”

At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.

The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. Dr. Gupta advised obtaining phone numbers for crisis services relevant to the location of the patient, and this requires confirming that the patient is where he or she was expected to be.

In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.

The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.

One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.

Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.

Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.

Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.

During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.

“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.

Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.

Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.

“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
 

Uncertainty about future use

Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.

“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.

It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.

“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.

Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.

“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.

For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”

At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.

The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. Dr. Gupta advised obtaining phone numbers for crisis services relevant to the location of the patient, and this requires confirming that the patient is where he or she was expected to be.

In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.

The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.

One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.

Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.

Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.

Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.

During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.

“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.

Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.

Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.

“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
 

Uncertainty about future use

Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.

“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.

It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.

“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.

Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.

“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.

As millions of children between ages 5-11 became eligible to receive a COVID-19 vaccine recently, several cities and states are including them in vaccine incentive programs that offer cash and giveaways.
 

In New York City, for instance, children can claim $100 if they receive their first dose of the Pfizer vaccine at a city-operated vaccine site. As an alternate choice, they can receive tickets to city attractions such as the Statue of Liberty or the Brooklyn Cyclones baseball team.

“We really want kids to take advantage, families take advantage of that,” Mayor Bill de Blasio said Nov. 4.

“Everyone could use a little more money around the holidays,” he said. “But, most importantly, we want our kids and our families to be safe.”

In Chicago, health officials are offering $100 gift cards to children who get vaccinated at public health events or clinics. The Chicago school district is also closing on Nov. 12 for Vaccination Awareness Day so students can get shots.

“It is rare that we make a late change to the school calendar, but we see this as an important investment in the future of this school year and the health and well-being of our students, staff, and families,” Pedro Martinez, the CEO for Chicago Public Schools, said in a message to parents.

The Centers for Disease Control and Prevention cleared the COVID-19 shot for children as young as age 5 on Nov. 2, making most Americans eligible for the vaccine. Ages 5-11 receive one-third of the dose given to adults and teens.

Other states and cities are offering incentives as well:

• San Antonio: Parents and guardians who take their children to get vaccinated at a Metro Health clinic can receive a $100 gift card for H-E-B grocery stores.
• Louisiana: As part of the “Shot for $100” program, anyone who receives their first shot is eligible for $100. Children between ages 5-11 can receive the cash incentive but require parental consent to get the vaccine.
• Minnesota: As part of the “Kids Deserve a Shot!” program, ages 12-17 can receive a $200 gift card and the opportunity to enter a raffle for a $100,000 college scholarship.

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

As millions of children between ages 5-11 became eligible to receive a COVID-19 vaccine recently, several cities and states are including them in vaccine incentive programs that offer cash and giveaways.
 

In New York City, for instance, children can claim $100 if they receive their first dose of the Pfizer vaccine at a city-operated vaccine site. As an alternate choice, they can receive tickets to city attractions such as the Statue of Liberty or the Brooklyn Cyclones baseball team.

“We really want kids to take advantage, families take advantage of that,” Mayor Bill de Blasio said Nov. 4.

“Everyone could use a little more money around the holidays,” he said. “But, most importantly, we want our kids and our families to be safe.”

In Chicago, health officials are offering $100 gift cards to children who get vaccinated at public health events or clinics. The Chicago school district is also closing on Nov. 12 for Vaccination Awareness Day so students can get shots.

“It is rare that we make a late change to the school calendar, but we see this as an important investment in the future of this school year and the health and well-being of our students, staff, and families,” Pedro Martinez, the CEO for Chicago Public Schools, said in a message to parents.

The Centers for Disease Control and Prevention cleared the COVID-19 shot for children as young as age 5 on Nov. 2, making most Americans eligible for the vaccine. Ages 5-11 receive one-third of the dose given to adults and teens.

Other states and cities are offering incentives as well:

• San Antonio: Parents and guardians who take their children to get vaccinated at a Metro Health clinic can receive a $100 gift card for H-E-B grocery stores.
• Louisiana: As part of the “Shot for $100” program, anyone who receives their first shot is eligible for $100. Children between ages 5-11 can receive the cash incentive but require parental consent to get the vaccine.
• Minnesota: As part of the “Kids Deserve a Shot!” program, ages 12-17 can receive a $200 gift card and the opportunity to enter a raffle for a $100,000 college scholarship.

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

As millions of children between ages 5-11 became eligible to receive a COVID-19 vaccine recently, several cities and states are including them in vaccine incentive programs that offer cash and giveaways.
 

In New York City, for instance, children can claim $100 if they receive their first dose of the Pfizer vaccine at a city-operated vaccine site. As an alternate choice, they can receive tickets to city attractions such as the Statue of Liberty or the Brooklyn Cyclones baseball team.

“We really want kids to take advantage, families take advantage of that,” Mayor Bill de Blasio said Nov. 4.

“Everyone could use a little more money around the holidays,” he said. “But, most importantly, we want our kids and our families to be safe.”

In Chicago, health officials are offering $100 gift cards to children who get vaccinated at public health events or clinics. The Chicago school district is also closing on Nov. 12 for Vaccination Awareness Day so students can get shots.

“It is rare that we make a late change to the school calendar, but we see this as an important investment in the future of this school year and the health and well-being of our students, staff, and families,” Pedro Martinez, the CEO for Chicago Public Schools, said in a message to parents.

The Centers for Disease Control and Prevention cleared the COVID-19 shot for children as young as age 5 on Nov. 2, making most Americans eligible for the vaccine. Ages 5-11 receive one-third of the dose given to adults and teens.

Other states and cities are offering incentives as well:

• San Antonio: Parents and guardians who take their children to get vaccinated at a Metro Health clinic can receive a $100 gift card for H-E-B grocery stores.
• Louisiana: As part of the “Shot for $100” program, anyone who receives their first shot is eligible for $100. Children between ages 5-11 can receive the cash incentive but require parental consent to get the vaccine.
• Minnesota: As part of the “Kids Deserve a Shot!” program, ages 12-17 can receive a $200 gift card and the opportunity to enter a raffle for a $100,000 college scholarship.

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

In September, when Texas’ near-total abortion ban took effect, Planned Parenthood clinics in the Lone Star State started offering every patient who walked in information on Senate Bill 8, as well as emergency contraception, condoms, and two pregnancy tests. The plan is to distribute 22,000 “empowerment kits” this year.

“We felt it was very important for patients to have as many tools on hand to help them meet this really onerous law,” said Elizabeth Cardwell, lead clinician at Planned Parenthood of Greater Texas, which has 24 clinics across the northern and central regions of the state and provides care to tens of thousands of people annually.

Most of their patients – who tend to be uninsured and have annual household incomes of less than $25,000 – had not known about SB 8 the first several weeks after implementation, said Dr. Cardwell. But once they learned about it, patients seemed to rush to get on birth control, she said.

SB 8 allows private citizens, in Texas or elsewhere, to sue anyone who performs an abortion in the state or who “aided or abetted” someone getting an abortion once fetal cardiac activity is detected. This is generally around six weeks, before most people know they’re pregnant. It’s had a chilling effect in Texas, where access to abortion was already limited.

Medical staffs are doubling down on educating patients about birth control. They recognize the strategy isn’t foolproof but are desperate to prevent unintended pregnancies, nearly half of which nationwide end in abortion.

“It’s more important now than it ever has been,” said Dr. Cardwell. “I’ve been in abortion care 30-plus years, and my go-to line was ‘You’ve got plenty of time. You don’t have to feel rushed. Talk with your partner. Talk with your family,’” she said. “Now we don’t have that luxury.”

Patients, too, seem to feel a sense of urgency. During September, according to data from Planned Parenthood of Greater Texas, medical staff provided patients with some form of birth control — for example, pill packs, Depo-Provera shots or IUD implant insertions – in more than 3,750 visits, 5% more than in Sept. 2020.

Dr. Jennifer Liedtke, a family physician in West Texas, said she and her nurse practitioners explain SB 8 to every patient who comes to their private practice and saw a 20% increase in requests for long-acting reversible contraceptive methods, known as LARCs, in September.

LARCs, a category that includes intrauterine devices and hormonal implants, have become increasingly appealing because they are 99% effective at preventing pregnancy and last several years. They are also simpler than the pill, which needs to be taken daily, or the vaginal ring, which needs to be changed monthly.

Still, LARCs are not everyone’s preferred method. For example, inserting an IUD can be painful.

A doctor’s office is one of the few opportunities for reliable birth control education. Texas law doesn’t require schools to teach sex education, and if they do, educators must stress abstinence as the preferred birth control method. Some doctors opt to explain abortion access in the state when naming birth control options.

Dr. Liedtke is used to having to explain new laws passed by the Texas legislature. “It happens all the time,” she said. But the controversy surrounding SB 8 confuses patients all the more as the law works its way through the court system with differing rulings, one of which briefly blocked the measure. The U.S. Supreme Court heard related arguments Nov. 1.

“People just don’t understand,” said Dr. Liedtke. “It was tied up for 48 hours, so they are like, ‘It’s not a law anymore?’ Well, no, technically it is.”

Not all providers are able to talk freely about abortion access. In 2019, the Trump administration barred providers that participate in the federally funded family planning program, Title X, from mentioning abortion care to patients, even if patients themselves raise questions. In early October, the Biden administration reversed that rule. The change will kick in this month. Planned Parenthood can discuss SB 8 in Texas because Texas affiliates do not receive Title X dollars.

Dr. Lindsey Vasquez of Legacy Community Health, the largest federally qualified health center in Texas and a recipient of Title X dollars, said she and other staff members have not discussed abortion or SB 8 because they also must juggle a variety of other priorities. Legacy’s patients are underserved, she said. A majority live at or below the federal poverty level.

Nearly two years into the Covid-19 pandemic, “we’re literally maximizing those visits,” Dr. Vasquez said. Their jobs go beyond offering reproductive care. “We’re making sure they have food resources, that they have their housing stable,” she said. “We really are trying to make sure that all of their needs are met because we know for these types of populations – patients that we serve – this may be our only moment that we get to meet them.”

Specialized family planning clinics that receive Title X dollars do have proactive conversations about contraceptive methods, according to Every Body Texas, the Title X grantee for the state.

Discussions of long-acting reversible contraception must be handled with sensitivity because these forms of birth control have a questionable history among certain populations, primarily lower-income patients. In the 1990s, lawmakers in several states, including Texas, introduced bills to offer cash assistance recipients financial incentives to get an implant or mandate insertion for people on government benefits, a move seen as reproductive coercion.

“It’s important for a client to get on the contraceptive method of their choice,” said Mimi Garcia, communications director for Every Body Texas. “Some people will just say, ‘Let’s get everyone on IUDs’ or ‘Let’s get everybody on hormonal implants’ because those are the most effective methods. ... That’s not something that’s going to work for [every] individual. ... Either they don’t agree with it philosophically, or they don’t like how it makes their body feel.”

It’s a nuanced subject for providers to broach, so some suggest starting the conversation by asking the patient about their future.

“The best question to ask is ‘When do you want to have another baby?’” said Dr. Liedtke. And then if they say, ‘Oh, gosh, I’m not even sure I want to have more kids’ or ‘Five or six years from now,’ then we start talking LARCs. ... But if it’s like, ‘Man, I really want to start trying in a year,’ then I don’t talk to them about putting one of those in.”

The Biden administration expected more demand for birth control in Texas, so Health & Human Services Secretary Xavier Becerra announced in mid-September that Every Body Texas would receive additional Title X funding, as would local providers experiencing an influx of clients as a result of SB 8.

But providers said improved access to contraception will not blunt the law’s effects. It will not protect patients who want to get pregnant but ultimately decide on abortion because they receive a diagnosis of a serious complication, their relationship status changes, or they lose financial or social support, said Dr. Elissa Serapio, an OB-GYN in the Rio Grande Valley and a fellow with Physicians for Reproductive Health.

“It’s the very best that we can do,” said Dr. Cardwell, of Planned Parenthood of Greater Texas. “There’s no 100% effective method of birth control.”

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.

In September, when Texas’ near-total abortion ban took effect, Planned Parenthood clinics in the Lone Star State started offering every patient who walked in information on Senate Bill 8, as well as emergency contraception, condoms, and two pregnancy tests. The plan is to distribute 22,000 “empowerment kits” this year.

“We felt it was very important for patients to have as many tools on hand to help them meet this really onerous law,” said Elizabeth Cardwell, lead clinician at Planned Parenthood of Greater Texas, which has 24 clinics across the northern and central regions of the state and provides care to tens of thousands of people annually.

Most of their patients – who tend to be uninsured and have annual household incomes of less than $25,000 – had not known about SB 8 the first several weeks after implementation, said Dr. Cardwell. But once they learned about it, patients seemed to rush to get on birth control, she said.

SB 8 allows private citizens, in Texas or elsewhere, to sue anyone who performs an abortion in the state or who “aided or abetted” someone getting an abortion once fetal cardiac activity is detected. This is generally around six weeks, before most people know they’re pregnant. It’s had a chilling effect in Texas, where access to abortion was already limited.

Medical staffs are doubling down on educating patients about birth control. They recognize the strategy isn’t foolproof but are desperate to prevent unintended pregnancies, nearly half of which nationwide end in abortion.

“It’s more important now than it ever has been,” said Dr. Cardwell. “I’ve been in abortion care 30-plus years, and my go-to line was ‘You’ve got plenty of time. You don’t have to feel rushed. Talk with your partner. Talk with your family,’” she said. “Now we don’t have that luxury.”

Patients, too, seem to feel a sense of urgency. During September, according to data from Planned Parenthood of Greater Texas, medical staff provided patients with some form of birth control — for example, pill packs, Depo-Provera shots or IUD implant insertions – in more than 3,750 visits, 5% more than in Sept. 2020.

Dr. Jennifer Liedtke, a family physician in West Texas, said she and her nurse practitioners explain SB 8 to every patient who comes to their private practice and saw a 20% increase in requests for long-acting reversible contraceptive methods, known as LARCs, in September.

LARCs, a category that includes intrauterine devices and hormonal implants, have become increasingly appealing because they are 99% effective at preventing pregnancy and last several years. They are also simpler than the pill, which needs to be taken daily, or the vaginal ring, which needs to be changed monthly.

Still, LARCs are not everyone’s preferred method. For example, inserting an IUD can be painful.

A doctor’s office is one of the few opportunities for reliable birth control education. Texas law doesn’t require schools to teach sex education, and if they do, educators must stress abstinence as the preferred birth control method. Some doctors opt to explain abortion access in the state when naming birth control options.

Dr. Liedtke is used to having to explain new laws passed by the Texas legislature. “It happens all the time,” she said. But the controversy surrounding SB 8 confuses patients all the more as the law works its way through the court system with differing rulings, one of which briefly blocked the measure. The U.S. Supreme Court heard related arguments Nov. 1.

“People just don’t understand,” said Dr. Liedtke. “It was tied up for 48 hours, so they are like, ‘It’s not a law anymore?’ Well, no, technically it is.”

Not all providers are able to talk freely about abortion access. In 2019, the Trump administration barred providers that participate in the federally funded family planning program, Title X, from mentioning abortion care to patients, even if patients themselves raise questions. In early October, the Biden administration reversed that rule. The change will kick in this month. Planned Parenthood can discuss SB 8 in Texas because Texas affiliates do not receive Title X dollars.

Dr. Lindsey Vasquez of Legacy Community Health, the largest federally qualified health center in Texas and a recipient of Title X dollars, said she and other staff members have not discussed abortion or SB 8 because they also must juggle a variety of other priorities. Legacy’s patients are underserved, she said. A majority live at or below the federal poverty level.

Nearly two years into the Covid-19 pandemic, “we’re literally maximizing those visits,” Dr. Vasquez said. Their jobs go beyond offering reproductive care. “We’re making sure they have food resources, that they have their housing stable,” she said. “We really are trying to make sure that all of their needs are met because we know for these types of populations – patients that we serve – this may be our only moment that we get to meet them.”

Specialized family planning clinics that receive Title X dollars do have proactive conversations about contraceptive methods, according to Every Body Texas, the Title X grantee for the state.

Discussions of long-acting reversible contraception must be handled with sensitivity because these forms of birth control have a questionable history among certain populations, primarily lower-income patients. In the 1990s, lawmakers in several states, including Texas, introduced bills to offer cash assistance recipients financial incentives to get an implant or mandate insertion for people on government benefits, a move seen as reproductive coercion.

“It’s important for a client to get on the contraceptive method of their choice,” said Mimi Garcia, communications director for Every Body Texas. “Some people will just say, ‘Let’s get everyone on IUDs’ or ‘Let’s get everybody on hormonal implants’ because those are the most effective methods. ... That’s not something that’s going to work for [every] individual. ... Either they don’t agree with it philosophically, or they don’t like how it makes their body feel.”

It’s a nuanced subject for providers to broach, so some suggest starting the conversation by asking the patient about their future.

“The best question to ask is ‘When do you want to have another baby?’” said Dr. Liedtke. And then if they say, ‘Oh, gosh, I’m not even sure I want to have more kids’ or ‘Five or six years from now,’ then we start talking LARCs. ... But if it’s like, ‘Man, I really want to start trying in a year,’ then I don’t talk to them about putting one of those in.”

The Biden administration expected more demand for birth control in Texas, so Health & Human Services Secretary Xavier Becerra announced in mid-September that Every Body Texas would receive additional Title X funding, as would local providers experiencing an influx of clients as a result of SB 8.

But providers said improved access to contraception will not blunt the law’s effects. It will not protect patients who want to get pregnant but ultimately decide on abortion because they receive a diagnosis of a serious complication, their relationship status changes, or they lose financial or social support, said Dr. Elissa Serapio, an OB-GYN in the Rio Grande Valley and a fellow with Physicians for Reproductive Health.

“It’s the very best that we can do,” said Dr. Cardwell, of Planned Parenthood of Greater Texas. “There’s no 100% effective method of birth control.”

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.

In September, when Texas’ near-total abortion ban took effect, Planned Parenthood clinics in the Lone Star State started offering every patient who walked in information on Senate Bill 8, as well as emergency contraception, condoms, and two pregnancy tests. The plan is to distribute 22,000 “empowerment kits” this year.

“We felt it was very important for patients to have as many tools on hand to help them meet this really onerous law,” said Elizabeth Cardwell, lead clinician at Planned Parenthood of Greater Texas, which has 24 clinics across the northern and central regions of the state and provides care to tens of thousands of people annually.

Most of their patients – who tend to be uninsured and have annual household incomes of less than $25,000 – had not known about SB 8 the first several weeks after implementation, said Dr. Cardwell. But once they learned about it, patients seemed to rush to get on birth control, she said.

SB 8 allows private citizens, in Texas or elsewhere, to sue anyone who performs an abortion in the state or who “aided or abetted” someone getting an abortion once fetal cardiac activity is detected. This is generally around six weeks, before most people know they’re pregnant. It’s had a chilling effect in Texas, where access to abortion was already limited.

Medical staffs are doubling down on educating patients about birth control. They recognize the strategy isn’t foolproof but are desperate to prevent unintended pregnancies, nearly half of which nationwide end in abortion.

“It’s more important now than it ever has been,” said Dr. Cardwell. “I’ve been in abortion care 30-plus years, and my go-to line was ‘You’ve got plenty of time. You don’t have to feel rushed. Talk with your partner. Talk with your family,’” she said. “Now we don’t have that luxury.”

Patients, too, seem to feel a sense of urgency. During September, according to data from Planned Parenthood of Greater Texas, medical staff provided patients with some form of birth control — for example, pill packs, Depo-Provera shots or IUD implant insertions – in more than 3,750 visits, 5% more than in Sept. 2020.

Dr. Jennifer Liedtke, a family physician in West Texas, said she and her nurse practitioners explain SB 8 to every patient who comes to their private practice and saw a 20% increase in requests for long-acting reversible contraceptive methods, known as LARCs, in September.

LARCs, a category that includes intrauterine devices and hormonal implants, have become increasingly appealing because they are 99% effective at preventing pregnancy and last several years. They are also simpler than the pill, which needs to be taken daily, or the vaginal ring, which needs to be changed monthly.

Still, LARCs are not everyone’s preferred method. For example, inserting an IUD can be painful.

A doctor’s office is one of the few opportunities for reliable birth control education. Texas law doesn’t require schools to teach sex education, and if they do, educators must stress abstinence as the preferred birth control method. Some doctors opt to explain abortion access in the state when naming birth control options.

Dr. Liedtke is used to having to explain new laws passed by the Texas legislature. “It happens all the time,” she said. But the controversy surrounding SB 8 confuses patients all the more as the law works its way through the court system with differing rulings, one of which briefly blocked the measure. The U.S. Supreme Court heard related arguments Nov. 1.

“People just don’t understand,” said Dr. Liedtke. “It was tied up for 48 hours, so they are like, ‘It’s not a law anymore?’ Well, no, technically it is.”

Not all providers are able to talk freely about abortion access. In 2019, the Trump administration barred providers that participate in the federally funded family planning program, Title X, from mentioning abortion care to patients, even if patients themselves raise questions. In early October, the Biden administration reversed that rule. The change will kick in this month. Planned Parenthood can discuss SB 8 in Texas because Texas affiliates do not receive Title X dollars.

Dr. Lindsey Vasquez of Legacy Community Health, the largest federally qualified health center in Texas and a recipient of Title X dollars, said she and other staff members have not discussed abortion or SB 8 because they also must juggle a variety of other priorities. Legacy’s patients are underserved, she said. A majority live at or below the federal poverty level.

Nearly two years into the Covid-19 pandemic, “we’re literally maximizing those visits,” Dr. Vasquez said. Their jobs go beyond offering reproductive care. “We’re making sure they have food resources, that they have their housing stable,” she said. “We really are trying to make sure that all of their needs are met because we know for these types of populations – patients that we serve – this may be our only moment that we get to meet them.”

Specialized family planning clinics that receive Title X dollars do have proactive conversations about contraceptive methods, according to Every Body Texas, the Title X grantee for the state.

Discussions of long-acting reversible contraception must be handled with sensitivity because these forms of birth control have a questionable history among certain populations, primarily lower-income patients. In the 1990s, lawmakers in several states, including Texas, introduced bills to offer cash assistance recipients financial incentives to get an implant or mandate insertion for people on government benefits, a move seen as reproductive coercion.

“It’s important for a client to get on the contraceptive method of their choice,” said Mimi Garcia, communications director for Every Body Texas. “Some people will just say, ‘Let’s get everyone on IUDs’ or ‘Let’s get everybody on hormonal implants’ because those are the most effective methods. ... That’s not something that’s going to work for [every] individual. ... Either they don’t agree with it philosophically, or they don’t like how it makes their body feel.”

It’s a nuanced subject for providers to broach, so some suggest starting the conversation by asking the patient about their future.

“The best question to ask is ‘When do you want to have another baby?’” said Dr. Liedtke. And then if they say, ‘Oh, gosh, I’m not even sure I want to have more kids’ or ‘Five or six years from now,’ then we start talking LARCs. ... But if it’s like, ‘Man, I really want to start trying in a year,’ then I don’t talk to them about putting one of those in.”

The Biden administration expected more demand for birth control in Texas, so Health & Human Services Secretary Xavier Becerra announced in mid-September that Every Body Texas would receive additional Title X funding, as would local providers experiencing an influx of clients as a result of SB 8.

But providers said improved access to contraception will not blunt the law’s effects. It will not protect patients who want to get pregnant but ultimately decide on abortion because they receive a diagnosis of a serious complication, their relationship status changes, or they lose financial or social support, said Dr. Elissa Serapio, an OB-GYN in the Rio Grande Valley and a fellow with Physicians for Reproductive Health.

“It’s the very best that we can do,” said Dr. Cardwell, of Planned Parenthood of Greater Texas. “There’s no 100% effective method of birth control.”

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.

The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.

“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.

“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”

Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.

Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.

“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
 

Study details

The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.

In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.

Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.

Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.

But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”

Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.

The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.

“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.

“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”

Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.

Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.

“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
 

Study details

The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.

In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.

Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.

Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.

But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”

Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.

The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.

“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.

“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”

Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.

Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.

“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
 

Study details

The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.

In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.

Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.

Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.

But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”

Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.

As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Reported cases of COVID-19 in children totaled over 107,000 for the week of Oct. 29 to Nov. 4 after coming in at just under 101,000 the previous week. Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.

The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.

As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).

Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.

[email protected]

As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Reported cases of COVID-19 in children totaled over 107,000 for the week of Oct. 29 to Nov. 4 after coming in at just under 101,000 the previous week. Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.

The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.

As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).

Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.

[email protected]

As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Reported cases of COVID-19 in children totaled over 107,000 for the week of Oct. 29 to Nov. 4 after coming in at just under 101,000 the previous week. Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.

The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.

As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).

Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.

[email protected]

Just months after the MASTER DAPT trial showed that abbreviated dual-antiplatelet therapy (DAPT) lowers the risk of bleeding after stent placement in patients at high bleeding risk, a new analysis showed the favorable benefit-to-risk ratio was about the same in the subgroup who also had an acute or recent myocardial infarction.

In the new prespecified MASTER DAPT analysis, the data show that the subgroup with both an increased bleeding risk and an increased risk of ischemic events benefited much like the entire study population from a shorter DAPT duration, reported Pieter C. Smits, MD, PhD, at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

“There was no signal towards increased ischemic risk in the abbreviated DAPT population presenting with recent acute MI,” said Dr. Smits, emphasizing the consistency of results in this “bi-risk” subgroup with objective criteria for increased risks of bleeding and ischemic events.

MASTER DAPT main results published

The main results of the MASTER DAPT trial were presented at the 2021 annual meeting of the European Society of Cardiology and published recently in the New England Journal of Medicine. The trial randomized 4,434 patients who met one or more criteria for high bleeding risk. These included age of at least 75 years, documented anemia, a clinical indication for oral anticoagulants, and previous bleeding episodes requiring hospitalization.

In the trial, all patients were maintained on DAPT for 1 month after implantation of a biodegradable-polymer, sirolimus-eluting coronary stent (Ultimaster, Terumo). At the end of the month, those randomized to abbreviated DAPT started immediately on single-agent antiplatelet therapy, while those in the standard DAPT group remained on DAPT for at least 2 additional months.

Over 1 year of follow-up, the bleeding event rate was lower in the abbreviated DAPT group (6.5% vs. 9.4%; P < .0001 for superiority). The slight increase in major ischemic events among those in the abbreviated DAPT group (6.1% vs. 5.9%) was not significantly different (P = .001 for noninferiority).

When compared on the basis of net adverse clinical events (NACE), which comprised all-case death, MI, stroke, or Bleeding Academic Research Consortium (BARC) level 3 or 5 bleeding, there was a slight advantage for abbreviated DAPT (7.5% vs. 7.7%). This did not reach significance, but it was similar (P < .001 for noninferiority), favoring the abbreviated course of DAPT because of the bleeding advantage.

Recent MI vs. no MI

In the new analysis, patients in both the abbreviated and standard DAPT group were stratified into those with no major cardiovascular event within the past 12 months and those with an acute MI or acute coronary syndrome within this time. There were somewhat more patients without a history of MI within the previous 12 months in both the abbreviated DAPT (1,381 vs. 914 patients) and standard DAPT (1,418 vs. 866) groups.

In those without a recent MI, NACE rates were nearly identical over 1-year follow-up for those who received abbreviated versus standard DAPT. In both, slightly more than 6% had a NACE event, producing a hazard ratio of 1.03 for abbreviated versus standard DAPT (P = 0.85).

For those with a recent MI, event rates began to separate within 30 days. By 1 year, NACE rates exceeded 10% in those on standard DAPT, but remained below 9% for those on abbreviated DAPT. The lower hazard ratio in the abbreviated DAPT group (HR, 0.83; P = .22) did not reach statistical significance, but it did echo the larger MASTER DAPT conclusion.

“An abbreviated DAPT strategy significantly reduced clinically relevant bleeding risk in these bi-risk patients without increasing risk of ischemic events,” reported Dr. Smits, director of interventional cardiology at Maasstad Hospital, Rotterdam, the Netherlands.
 

No difference in NACE components

In fact, when the components of NACE were evaluated individually in the subgroup of patients with prior MI, both stroke (HR, 0.47; P = .16) and all-cause death (HR, 0.78; P = .28), although not significant, numerically favored abbreviated DAPT.

There was no difference between abbreviated and standard DAPT for risk of MI at 1 year (HR, 1.03; P = .92).

As in the overall MASTER DAPT results, bleeding risk (BARC 2, 3, or 5 bleeding) was significantly reduced in the substudy among those with a recent prior MI (P = .013) or those with no MI in the prior 12 months (P = .01).

In MASTER DAPT, which was an open-label study that randomized participants in 30 countries, all patients received one type of drug-eluting stent. While Dr. Smits conceded that it is not clear whether the conclusions about abbreviated DAPT can be extrapolated to other stents, he noted that recent long-term outcomes for modern drug-eluting coronary stents have been similar, suggesting these results might be more broadly applicable.

According to Dr. Smit, the consistency of this subgroup analysis with the previously published MASTER DAPT study is mutually reinforcing for a role of abbreviated DAPT in patients at high bleeding risk. Other experts agreed.

“One of the concerns that people have had is exactly what has been addressed here in this subgroup analysis. These are the patients that are not only bleeding-risk high but ischemic-risk high. The question was whether the benefit of reducing bleeding risk is offset by increasing stent thrombosis or other ischemic event outcomes, and the answer from the analysis is really clearly no,” said Philippe Gabriel Steg, MD, chief, department of cardiology, Hôpital Bichat, Paris, at the meeting, sponsored by the Cardiovascular Research Foundation.

Dr. Smits reports financial relationships with Abiomed, Abbott Vascular, Daiichi-Sankyo, Microport, Opsense, and Terumo Medical. Dr. Steg reports financial relationships with Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Idorsia, Merck, Novartis, Regeneron, and Sanofi-Aventis.

Just months after the MASTER DAPT trial showed that abbreviated dual-antiplatelet therapy (DAPT) lowers the risk of bleeding after stent placement in patients at high bleeding risk, a new analysis showed the favorable benefit-to-risk ratio was about the same in the subgroup who also had an acute or recent myocardial infarction.

In the new prespecified MASTER DAPT analysis, the data show that the subgroup with both an increased bleeding risk and an increased risk of ischemic events benefited much like the entire study population from a shorter DAPT duration, reported Pieter C. Smits, MD, PhD, at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

“There was no signal towards increased ischemic risk in the abbreviated DAPT population presenting with recent acute MI,” said Dr. Smits, emphasizing the consistency of results in this “bi-risk” subgroup with objective criteria for increased risks of bleeding and ischemic events.

MASTER DAPT main results published

The main results of the MASTER DAPT trial were presented at the 2021 annual meeting of the European Society of Cardiology and published recently in the New England Journal of Medicine. The trial randomized 4,434 patients who met one or more criteria for high bleeding risk. These included age of at least 75 years, documented anemia, a clinical indication for oral anticoagulants, and previous bleeding episodes requiring hospitalization.

In the trial, all patients were maintained on DAPT for 1 month after implantation of a biodegradable-polymer, sirolimus-eluting coronary stent (Ultimaster, Terumo). At the end of the month, those randomized to abbreviated DAPT started immediately on single-agent antiplatelet therapy, while those in the standard DAPT group remained on DAPT for at least 2 additional months.

Over 1 year of follow-up, the bleeding event rate was lower in the abbreviated DAPT group (6.5% vs. 9.4%; P < .0001 for superiority). The slight increase in major ischemic events among those in the abbreviated DAPT group (6.1% vs. 5.9%) was not significantly different (P = .001 for noninferiority).

When compared on the basis of net adverse clinical events (NACE), which comprised all-case death, MI, stroke, or Bleeding Academic Research Consortium (BARC) level 3 or 5 bleeding, there was a slight advantage for abbreviated DAPT (7.5% vs. 7.7%). This did not reach significance, but it was similar (P < .001 for noninferiority), favoring the abbreviated course of DAPT because of the bleeding advantage.

Recent MI vs. no MI

In the new analysis, patients in both the abbreviated and standard DAPT group were stratified into those with no major cardiovascular event within the past 12 months and those with an acute MI or acute coronary syndrome within this time. There were somewhat more patients without a history of MI within the previous 12 months in both the abbreviated DAPT (1,381 vs. 914 patients) and standard DAPT (1,418 vs. 866) groups.

In those without a recent MI, NACE rates were nearly identical over 1-year follow-up for those who received abbreviated versus standard DAPT. In both, slightly more than 6% had a NACE event, producing a hazard ratio of 1.03 for abbreviated versus standard DAPT (P = 0.85).

For those with a recent MI, event rates began to separate within 30 days. By 1 year, NACE rates exceeded 10% in those on standard DAPT, but remained below 9% for those on abbreviated DAPT. The lower hazard ratio in the abbreviated DAPT group (HR, 0.83; P = .22) did not reach statistical significance, but it did echo the larger MASTER DAPT conclusion.

“An abbreviated DAPT strategy significantly reduced clinically relevant bleeding risk in these bi-risk patients without increasing risk of ischemic events,” reported Dr. Smits, director of interventional cardiology at Maasstad Hospital, Rotterdam, the Netherlands.
 

No difference in NACE components

In fact, when the components of NACE were evaluated individually in the subgroup of patients with prior MI, both stroke (HR, 0.47; P = .16) and all-cause death (HR, 0.78; P = .28), although not significant, numerically favored abbreviated DAPT.

There was no difference between abbreviated and standard DAPT for risk of MI at 1 year (HR, 1.03; P = .92).

As in the overall MASTER DAPT results, bleeding risk (BARC 2, 3, or 5 bleeding) was significantly reduced in the substudy among those with a recent prior MI (P = .013) or those with no MI in the prior 12 months (P = .01).

In MASTER DAPT, which was an open-label study that randomized participants in 30 countries, all patients received one type of drug-eluting stent. While Dr. Smits conceded that it is not clear whether the conclusions about abbreviated DAPT can be extrapolated to other stents, he noted that recent long-term outcomes for modern drug-eluting coronary stents have been similar, suggesting these results might be more broadly applicable.

According to Dr. Smit, the consistency of this subgroup analysis with the previously published MASTER DAPT study is mutually reinforcing for a role of abbreviated DAPT in patients at high bleeding risk. Other experts agreed.

“One of the concerns that people have had is exactly what has been addressed here in this subgroup analysis. These are the patients that are not only bleeding-risk high but ischemic-risk high. The question was whether the benefit of reducing bleeding risk is offset by increasing stent thrombosis or other ischemic event outcomes, and the answer from the analysis is really clearly no,” said Philippe Gabriel Steg, MD, chief, department of cardiology, Hôpital Bichat, Paris, at the meeting, sponsored by the Cardiovascular Research Foundation.

Dr. Smits reports financial relationships with Abiomed, Abbott Vascular, Daiichi-Sankyo, Microport, Opsense, and Terumo Medical. Dr. Steg reports financial relationships with Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Idorsia, Merck, Novartis, Regeneron, and Sanofi-Aventis.

Just months after the MASTER DAPT trial showed that abbreviated dual-antiplatelet therapy (DAPT) lowers the risk of bleeding after stent placement in patients at high bleeding risk, a new analysis showed the favorable benefit-to-risk ratio was about the same in the subgroup who also had an acute or recent myocardial infarction.

In the new prespecified MASTER DAPT analysis, the data show that the subgroup with both an increased bleeding risk and an increased risk of ischemic events benefited much like the entire study population from a shorter DAPT duration, reported Pieter C. Smits, MD, PhD, at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

“There was no signal towards increased ischemic risk in the abbreviated DAPT population presenting with recent acute MI,” said Dr. Smits, emphasizing the consistency of results in this “bi-risk” subgroup with objective criteria for increased risks of bleeding and ischemic events.

MASTER DAPT main results published

The main results of the MASTER DAPT trial were presented at the 2021 annual meeting of the European Society of Cardiology and published recently in the New England Journal of Medicine. The trial randomized 4,434 patients who met one or more criteria for high bleeding risk. These included age of at least 75 years, documented anemia, a clinical indication for oral anticoagulants, and previous bleeding episodes requiring hospitalization.

In the trial, all patients were maintained on DAPT for 1 month after implantation of a biodegradable-polymer, sirolimus-eluting coronary stent (Ultimaster, Terumo). At the end of the month, those randomized to abbreviated DAPT started immediately on single-agent antiplatelet therapy, while those in the standard DAPT group remained on DAPT for at least 2 additional months.

Over 1 year of follow-up, the bleeding event rate was lower in the abbreviated DAPT group (6.5% vs. 9.4%; P < .0001 for superiority). The slight increase in major ischemic events among those in the abbreviated DAPT group (6.1% vs. 5.9%) was not significantly different (P = .001 for noninferiority).

When compared on the basis of net adverse clinical events (NACE), which comprised all-case death, MI, stroke, or Bleeding Academic Research Consortium (BARC) level 3 or 5 bleeding, there was a slight advantage for abbreviated DAPT (7.5% vs. 7.7%). This did not reach significance, but it was similar (P < .001 for noninferiority), favoring the abbreviated course of DAPT because of the bleeding advantage.

Recent MI vs. no MI

In the new analysis, patients in both the abbreviated and standard DAPT group were stratified into those with no major cardiovascular event within the past 12 months and those with an acute MI or acute coronary syndrome within this time. There were somewhat more patients without a history of MI within the previous 12 months in both the abbreviated DAPT (1,381 vs. 914 patients) and standard DAPT (1,418 vs. 866) groups.

In those without a recent MI, NACE rates were nearly identical over 1-year follow-up for those who received abbreviated versus standard DAPT. In both, slightly more than 6% had a NACE event, producing a hazard ratio of 1.03 for abbreviated versus standard DAPT (P = 0.85).

For those with a recent MI, event rates began to separate within 30 days. By 1 year, NACE rates exceeded 10% in those on standard DAPT, but remained below 9% for those on abbreviated DAPT. The lower hazard ratio in the abbreviated DAPT group (HR, 0.83; P = .22) did not reach statistical significance, but it did echo the larger MASTER DAPT conclusion.

“An abbreviated DAPT strategy significantly reduced clinically relevant bleeding risk in these bi-risk patients without increasing risk of ischemic events,” reported Dr. Smits, director of interventional cardiology at Maasstad Hospital, Rotterdam, the Netherlands.
 

No difference in NACE components

In fact, when the components of NACE were evaluated individually in the subgroup of patients with prior MI, both stroke (HR, 0.47; P = .16) and all-cause death (HR, 0.78; P = .28), although not significant, numerically favored abbreviated DAPT.

There was no difference between abbreviated and standard DAPT for risk of MI at 1 year (HR, 1.03; P = .92).

As in the overall MASTER DAPT results, bleeding risk (BARC 2, 3, or 5 bleeding) was significantly reduced in the substudy among those with a recent prior MI (P = .013) or those with no MI in the prior 12 months (P = .01).

In MASTER DAPT, which was an open-label study that randomized participants in 30 countries, all patients received one type of drug-eluting stent. While Dr. Smits conceded that it is not clear whether the conclusions about abbreviated DAPT can be extrapolated to other stents, he noted that recent long-term outcomes for modern drug-eluting coronary stents have been similar, suggesting these results might be more broadly applicable.

According to Dr. Smit, the consistency of this subgroup analysis with the previously published MASTER DAPT study is mutually reinforcing for a role of abbreviated DAPT in patients at high bleeding risk. Other experts agreed.

“One of the concerns that people have had is exactly what has been addressed here in this subgroup analysis. These are the patients that are not only bleeding-risk high but ischemic-risk high. The question was whether the benefit of reducing bleeding risk is offset by increasing stent thrombosis or other ischemic event outcomes, and the answer from the analysis is really clearly no,” said Philippe Gabriel Steg, MD, chief, department of cardiology, Hôpital Bichat, Paris, at the meeting, sponsored by the Cardiovascular Research Foundation.

Dr. Smits reports financial relationships with Abiomed, Abbott Vascular, Daiichi-Sankyo, Microport, Opsense, and Terumo Medical. Dr. Steg reports financial relationships with Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Idorsia, Merck, Novartis, Regeneron, and Sanofi-Aventis.

An electronic nose (eNose) that measures volatile organic compounds (VOCs) emitted from the lungs successfully distinguished sarcoidosis from interstitial lung disease (ILD) and healthy controls, according to a report in the journal CHEST.

The approach has the potential to generate clinical data that can’t be achieved through other noninvasive means, such as the serum biomarker soluble interleukin-2 receptor (sIL-2R). sIL-2R is often used to track disease activity, but it isn’t specific for diagnosing sarcoidosis, and it isn’t available worldwide.

Sarcoidosis is a granulomatous inflammatory disease with no known cause and can affect most organs, but an estimated 89%-99% of cases affect the lungs. There is no simple noninvasive diagnostic test, leaving physicians to rely on clinical features, biopsies to obtain tissue pathology, and the ruling out of other granulomatous diagnoses.

The challenge is more difficult because sarcoidosis is a heterogeneous disease, with great variation in the number of organs affected, severity, rate of progression, and response to therapy.

Previous researchers have used VOCs in an attempt to diagnose diseases, since the compounds reflect pathophysiological processes. Gas chromatography/mass spectrometry (GCMS) is one method to identify the individual VOCs, but the process is time consuming and complex. Some nevertheless showed potential in sarcoidosis, but failed to reproduce their performance in validation cohorts.

In the new study, a cross-sectional analysis showed that exhaled breath analysis using an eNose had excellent sensitivity and specificity for distinguishing sarcoidosis from ILD and healthy controls, and identified sarcoidosis regardless of pulmonary involvement, pulmonary fibrosis, multiple organ involvement, immunosuppressive treatment, or whether or not pathology supported the diagnosis.

The eNose technology produces a “breath-print” after combining information from a broad range of VOCs. The information originates from an array of metal-oxide semiconductor sensors with partial specificity that artificial intelligence processes to discern patterns. Overall, the system functions similarly to the mammalian olfactory system. The artificial intelligence instead views it as a “breath-print” that it can compare against previously learned patterns.

“It is a quite easy, simple, and quick procedure, which is noninvasive. We can collect a lot of data from the VOCs in the exhaled breath because there are several sensors that cross-react. We can create breath profiles and group patients to see if profiles differ. Ultimately, we can use the profiles to diagnose or detect disease in the earlier stage and more accurately,” said Iris van der Sar, MD. Dr. van der Sar is the lead author on the study and a PhD candidate at Erasmus Medical Center in Rotterdam.

The study requires further prospective validation, but the technology could have important clinical benefits, said senior author and principal investigator Marlies Wijsenbeek, MD, PhD, pulmonologist and head of the Interstitial Lung Disease Center at Erasmus Medical Center. “If we in future can avoid a biopsy, that would be most attractive,” said Dr. Wijsenbeek.

“We hope to come to a point-of-care device that can be used to facilitate early diagnosis at low burden for the patient and health care system,” said Karen Moor, MD, PhD, and post-doc on this project. The researchers also hope to determine if the eNose can help evaluate a patient’s response to therapy.

Studies of eNose technology in other chronic diseases have shown promising results, but not all results have been validated yet in independent or external cohorts.

The current study included 569 outpatients, 252 with sarcoidosis and 317 with ILD, along with 48 healthy controls. The researchers constructed a training set using 168 patients with sarcoidosis and 32 healthy controls, and a validation set using 84 patients with sarcoidosis and 16 healthy controls. The eNose differentiated between patients and controls in both groups, with an area under the curve of 1.00 for each regardless of pulmonary involvement or treatment.

It also distinguished those with sarcoidosis and pulmonary involvement from those with ILD, with an AUC of 0.90 (95% confidence interval, 0.87-0.94) in the training set, and an AUC of 0.87 (95% CI, 0.82-0.93) in the validation set.

It differentiated between pulmonary sarcoidosis and hypersensitivity pneumonitis in the training set (AUC 0.95; 95% CI, 0.90-0.99) and the validation set (AUC, 0.88; 95% CI, 0.75-1.00).

The study received no funding. Dr. Wijsenbeek, Dr. van der Sar, and Dr. Moor have no relevant financial disclosures.

An electronic nose (eNose) that measures volatile organic compounds (VOCs) emitted from the lungs successfully distinguished sarcoidosis from interstitial lung disease (ILD) and healthy controls, according to a report in the journal CHEST.

The approach has the potential to generate clinical data that can’t be achieved through other noninvasive means, such as the serum biomarker soluble interleukin-2 receptor (sIL-2R). sIL-2R is often used to track disease activity, but it isn’t specific for diagnosing sarcoidosis, and it isn’t available worldwide.

Sarcoidosis is a granulomatous inflammatory disease with no known cause and can affect most organs, but an estimated 89%-99% of cases affect the lungs. There is no simple noninvasive diagnostic test, leaving physicians to rely on clinical features, biopsies to obtain tissue pathology, and the ruling out of other granulomatous diagnoses.

The challenge is more difficult because sarcoidosis is a heterogeneous disease, with great variation in the number of organs affected, severity, rate of progression, and response to therapy.

Previous researchers have used VOCs in an attempt to diagnose diseases, since the compounds reflect pathophysiological processes. Gas chromatography/mass spectrometry (GCMS) is one method to identify the individual VOCs, but the process is time consuming and complex. Some nevertheless showed potential in sarcoidosis, but failed to reproduce their performance in validation cohorts.

In the new study, a cross-sectional analysis showed that exhaled breath analysis using an eNose had excellent sensitivity and specificity for distinguishing sarcoidosis from ILD and healthy controls, and identified sarcoidosis regardless of pulmonary involvement, pulmonary fibrosis, multiple organ involvement, immunosuppressive treatment, or whether or not pathology supported the diagnosis.

The eNose technology produces a “breath-print” after combining information from a broad range of VOCs. The information originates from an array of metal-oxide semiconductor sensors with partial specificity that artificial intelligence processes to discern patterns. Overall, the system functions similarly to the mammalian olfactory system. The artificial intelligence instead views it as a “breath-print” that it can compare against previously learned patterns.

“It is a quite easy, simple, and quick procedure, which is noninvasive. We can collect a lot of data from the VOCs in the exhaled breath because there are several sensors that cross-react. We can create breath profiles and group patients to see if profiles differ. Ultimately, we can use the profiles to diagnose or detect disease in the earlier stage and more accurately,” said Iris van der Sar, MD. Dr. van der Sar is the lead author on the study and a PhD candidate at Erasmus Medical Center in Rotterdam.

The study requires further prospective validation, but the technology could have important clinical benefits, said senior author and principal investigator Marlies Wijsenbeek, MD, PhD, pulmonologist and head of the Interstitial Lung Disease Center at Erasmus Medical Center. “If we in future can avoid a biopsy, that would be most attractive,” said Dr. Wijsenbeek.

“We hope to come to a point-of-care device that can be used to facilitate early diagnosis at low burden for the patient and health care system,” said Karen Moor, MD, PhD, and post-doc on this project. The researchers also hope to determine if the eNose can help evaluate a patient’s response to therapy.

Studies of eNose technology in other chronic diseases have shown promising results, but not all results have been validated yet in independent or external cohorts.

The current study included 569 outpatients, 252 with sarcoidosis and 317 with ILD, along with 48 healthy controls. The researchers constructed a training set using 168 patients with sarcoidosis and 32 healthy controls, and a validation set using 84 patients with sarcoidosis and 16 healthy controls. The eNose differentiated between patients and controls in both groups, with an area under the curve of 1.00 for each regardless of pulmonary involvement or treatment.

It also distinguished those with sarcoidosis and pulmonary involvement from those with ILD, with an AUC of 0.90 (95% confidence interval, 0.87-0.94) in the training set, and an AUC of 0.87 (95% CI, 0.82-0.93) in the validation set.

It differentiated between pulmonary sarcoidosis and hypersensitivity pneumonitis in the training set (AUC 0.95; 95% CI, 0.90-0.99) and the validation set (AUC, 0.88; 95% CI, 0.75-1.00).

The study received no funding. Dr. Wijsenbeek, Dr. van der Sar, and Dr. Moor have no relevant financial disclosures.

An electronic nose (eNose) that measures volatile organic compounds (VOCs) emitted from the lungs successfully distinguished sarcoidosis from interstitial lung disease (ILD) and healthy controls, according to a report in the journal CHEST.

The approach has the potential to generate clinical data that can’t be achieved through other noninvasive means, such as the serum biomarker soluble interleukin-2 receptor (sIL-2R). sIL-2R is often used to track disease activity, but it isn’t specific for diagnosing sarcoidosis, and it isn’t available worldwide.

Sarcoidosis is a granulomatous inflammatory disease with no known cause and can affect most organs, but an estimated 89%-99% of cases affect the lungs. There is no simple noninvasive diagnostic test, leaving physicians to rely on clinical features, biopsies to obtain tissue pathology, and the ruling out of other granulomatous diagnoses.

The challenge is more difficult because sarcoidosis is a heterogeneous disease, with great variation in the number of organs affected, severity, rate of progression, and response to therapy.

Previous researchers have used VOCs in an attempt to diagnose diseases, since the compounds reflect pathophysiological processes. Gas chromatography/mass spectrometry (GCMS) is one method to identify the individual VOCs, but the process is time consuming and complex. Some nevertheless showed potential in sarcoidosis, but failed to reproduce their performance in validation cohorts.

In the new study, a cross-sectional analysis showed that exhaled breath analysis using an eNose had excellent sensitivity and specificity for distinguishing sarcoidosis from ILD and healthy controls, and identified sarcoidosis regardless of pulmonary involvement, pulmonary fibrosis, multiple organ involvement, immunosuppressive treatment, or whether or not pathology supported the diagnosis.

The eNose technology produces a “breath-print” after combining information from a broad range of VOCs. The information originates from an array of metal-oxide semiconductor sensors with partial specificity that artificial intelligence processes to discern patterns. Overall, the system functions similarly to the mammalian olfactory system. The artificial intelligence instead views it as a “breath-print” that it can compare against previously learned patterns.

“It is a quite easy, simple, and quick procedure, which is noninvasive. We can collect a lot of data from the VOCs in the exhaled breath because there are several sensors that cross-react. We can create breath profiles and group patients to see if profiles differ. Ultimately, we can use the profiles to diagnose or detect disease in the earlier stage and more accurately,” said Iris van der Sar, MD. Dr. van der Sar is the lead author on the study and a PhD candidate at Erasmus Medical Center in Rotterdam.

The study requires further prospective validation, but the technology could have important clinical benefits, said senior author and principal investigator Marlies Wijsenbeek, MD, PhD, pulmonologist and head of the Interstitial Lung Disease Center at Erasmus Medical Center. “If we in future can avoid a biopsy, that would be most attractive,” said Dr. Wijsenbeek.

“We hope to come to a point-of-care device that can be used to facilitate early diagnosis at low burden for the patient and health care system,” said Karen Moor, MD, PhD, and post-doc on this project. The researchers also hope to determine if the eNose can help evaluate a patient’s response to therapy.

Studies of eNose technology in other chronic diseases have shown promising results, but not all results have been validated yet in independent or external cohorts.

The current study included 569 outpatients, 252 with sarcoidosis and 317 with ILD, along with 48 healthy controls. The researchers constructed a training set using 168 patients with sarcoidosis and 32 healthy controls, and a validation set using 84 patients with sarcoidosis and 16 healthy controls. The eNose differentiated between patients and controls in both groups, with an area under the curve of 1.00 for each regardless of pulmonary involvement or treatment.

It also distinguished those with sarcoidosis and pulmonary involvement from those with ILD, with an AUC of 0.90 (95% confidence interval, 0.87-0.94) in the training set, and an AUC of 0.87 (95% CI, 0.82-0.93) in the validation set.

It differentiated between pulmonary sarcoidosis and hypersensitivity pneumonitis in the training set (AUC 0.95; 95% CI, 0.90-0.99) and the validation set (AUC, 0.88; 95% CI, 0.75-1.00).

The study received no funding. Dr. Wijsenbeek, Dr. van der Sar, and Dr. Moor have no relevant financial disclosures.

Early trials are under way to test medicinal mushrooms and Chinese herbs to treat COVID-19 patients with mild to moderate symptoms.

The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.

The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.

The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA  described the trials.

The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.

“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.

For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.

D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.

“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”

Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.

“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.

Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.

“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”

“Not a crazy concept”

Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.

“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”

Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.

“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.

Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.

“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.

As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.

Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.

He gave the example of St. John’s Wort, which has been problematic in HIV treatment.

“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.

Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”

He, too, pointed out that many traditional medicines were discovered from plants.

“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.

He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»

A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.

Early trials are under way to test medicinal mushrooms and Chinese herbs to treat COVID-19 patients with mild to moderate symptoms.

The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.

The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.

The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA  described the trials.

The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.

“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.

For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.

D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.

“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”

Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.

“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.

Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.

“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”

“Not a crazy concept”

Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.

“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”

Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.

“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.

Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.

“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.

As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.

Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.

He gave the example of St. John’s Wort, which has been problematic in HIV treatment.

“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.

Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”

He, too, pointed out that many traditional medicines were discovered from plants.

“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.

He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»

A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.

Early trials are under way to test medicinal mushrooms and Chinese herbs to treat COVID-19 patients with mild to moderate symptoms.

The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.

The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.

The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA  described the trials.

The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.

“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.

For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.

D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.

“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”

Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.

“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.

Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.

“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”

“Not a crazy concept”

Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.

“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”

Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.

“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.

Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.

“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.

As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.

Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.

He gave the example of St. John’s Wort, which has been problematic in HIV treatment.

“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.

Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”

He, too, pointed out that many traditional medicines were discovered from plants.

“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.

He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»

A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.