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Booster shot back-and-forth creates uncertainty, confusion
Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.
, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.
The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.
“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.
This kind of mixed messaging is generating more questions than answers.
“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.
When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”
“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association.
Boosting misinformation?
“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.
Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”
These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.
“That’s unfortunate because it’s a complete fallacy.”
Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”
“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.
More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
‘Gaming the system’
Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.
“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.
To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.
“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”
“Some people are gaming the system to get their booster or second shot of J&J,” he said.
For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”
“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”
Dr. Edje is likewise seeing interest from some ineligible patients, she said.
Crossing a liability line?
Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.
“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”
Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.
But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.
The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.
“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.
“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
Despite confusion, demand is up
Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.
“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”
“There is quite a bit of excitement out there,” he said.
Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”
Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
‘Walk, don’t run’
To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.
“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.
CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.
“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.
“We will come and look at the data for Moderna and J&J in very short order.”
Dr. Edje and Mr. Caswell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.
, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.
The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.
“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.
This kind of mixed messaging is generating more questions than answers.
“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.
When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”
“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association.
Boosting misinformation?
“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.
Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”
These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.
“That’s unfortunate because it’s a complete fallacy.”
Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”
“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.
More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
‘Gaming the system’
Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.
“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.
To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.
“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”
“Some people are gaming the system to get their booster or second shot of J&J,” he said.
For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”
“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”
Dr. Edje is likewise seeing interest from some ineligible patients, she said.
Crossing a liability line?
Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.
“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”
Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.
But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.
The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.
“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.
“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
Despite confusion, demand is up
Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.
“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”
“There is quite a bit of excitement out there,” he said.
Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”
Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
‘Walk, don’t run’
To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.
“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.
CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.
“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.
“We will come and look at the data for Moderna and J&J in very short order.”
Dr. Edje and Mr. Caswell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many people are confused — patients and healthcare providers alike — in the wake of the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcements about who is authorized to get a third or ‘booster’ shot of the Pfizer/BioNTech COVID-19 vaccine.
, healthcare providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.
The confusion started, in part, with the August 13 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 — an announcement later rolled back — followed by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) limiting boosters to select groups last week.
“It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it’s back to a select crew,” Louito Edje, MD, a family physician in private practice in Cincinnati, said in an interview with this news organization.
This kind of mixed messaging is generating more questions than answers.
“Even though that is following the science, translating the science into policy, it’s really fraught with confusion for patients, especially,” added Dr. Edje, professor educator in the departments of medical education and family and community medicine at UC Health and a fellow of the American Academy of Family Physicians.
When asked if he’s seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said: “I’m going to have to say yes because I’ve been confused myself at times.”
“Yes, there is a lot of confusion,” added Mr. Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association.
Boosting misinformation?
“Unfortunately, confusion leads to an acceleration of misinformation,” Mr. Caswell said.
Dr. Edje shared an example. “The folks who have been hesitant to even get the first vaccine appear now a little less likely to want to go ahead and get vaccinated.”
These patients point to breakthrough COVID-19 cases of the Delta variant, which “reinforces that they don’t need to get vaccinated in the first place,” Dr. Edje said.
“That’s unfortunate because it’s a complete fallacy.”
Clearer communication from the federal government could help alleviate confusion, Mr. Caswell said. “I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us.”
“For myself, I’ve got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing,” he said.
More clarity is needed for individuals seeking boosters as well. “It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm,” Mr. Caswell said.
‘Gaming the system’
Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.
“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.
To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.
“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”
“Some people are gaming the system to get their booster or second shot of J&J,” he said.
For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”
“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”
Dr. Edje is likewise seeing interest from some ineligible patients, she said.
Crossing a liability line?
Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.
“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”
Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.
But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.
The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.
“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.
“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
Despite confusion, demand is up
Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.
“The requests have gone up quite a bit. We’ve seen a number of requests from people in person and over the phone looking to get a booster,” Mr. Caswell said. “Since the discussion at the federal level...there has been a lot of interest in the third shot booster, itself, as well as about a booster for J&J.”
“There is quite a bit of excitement out there,” he said.
Dr. Edje agreed: “I take care of a fair number of folks...including the elderly and healthcare professionals. They are already asking for the booster.”
Interestingly, Dr. Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
‘Walk, don’t run’
To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still have some protection against COVID-19.
“If you’re a person who ultimately might get a booster that will make you optimally protected, you don’t necessarily need to get it tomorrow,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases told CNN.
CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who received a Moderna or Johnson & Johnson vaccine will be addressed with urgency.
“I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don’t run to your booster appointment,” she said.
“We will come and look at the data for Moderna and J&J in very short order.”
Dr. Edje and Mr. Caswell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cook your amphibians before you eat them
Novel food for thought
When you were growing up, your parents probably told you to brush your teeth before you went to bed, warned you not to run with the scissors or play with matches, and punished you whenever you used the neighbor children to play Schrödinger’s cat.
They did those things for your own good, of course, and now the nation’s mother – the Centers for Disease Control and Prevention – is doing the same by warning us about novel outbreak–associated foods. As in, “Put down that novel outbreak–associated food! You don’t know where it’s been!”
Seriously, you don’t know where it’s been. CDC investigators identified 28 novel foods that were linked to 36 foodborne-disease outbreaks that occurred during 2007-2016, including moringa leaf (herb/spice), tempeh (grain), frog, sprouted nut butter, and skate.
The novel foods implicated in these outbreaks were more likely to be imported, compared with 14,216 outbreaks that occurred from 1973 to 2016, and about half didn’t require refrigeration. Two-thirds did not need to be cooked after purchase. Another thing your parents wouldn’t like: Some can’t be washed, like sheep milk, sugar cane, or the aforementioned nut butter.
We wanted to get a food expert to comment on these novel foods, but our editor said that the assistant manager of our local Burger King wasn’t expert enough, so we’ve commandeered someone else’s expert. Cynthia Sears, MD, of Johns Hopkins University in Baltimore, told Today.com all about the dangers of frogs: “Essentially all amphibians are contaminated, often with salmonella. Eating any amphibian that is not thoroughly cooked is a risk.”
Be sure to cook your amphibians before you eat them. Advice that your parents would be proud to share.
Dieters should stay away from diet drinks
When a drink is labeled “diet” many assume that the calorie-free beverage is the best choice. However, one of the largest studies to date on artificial sweeteners is out to set the record straight.
Artificial sweeteners, or nonnutritive sweeteners (NNS), are used in most if not all diet products to give the illusion of sweetness without the caloric guilt. Some studies say they help with weight loss for that very reason, but others say they can contribute to weight gain. So which is it?
Researchers at the University of Southern California sought to add some clarity to the research already out there.
They looked at an even-gendered split of 74 participants who drank 300 mL of drinks sweetened with NNS, table sugar, or water. The researchers then used functional MRI to see how parts of the brain responsible for appetite and cravings responded to images of high-calorie foods. They also looked at glucose, insulin, and other metabolic hormone levels, as well as how much food the participants ate at their free buffet. (In the participants’ defense, who can say no to a free buffet?)
The researchers made some interesting observations:
- Women who drank the NNS drink ate more than did the table-sugar group, but all men ate the same.
- Images of those calorie-packed goodies increased cravings and appetite for obese men and women in the NNS group, compared with the table-sugar group.
- For all participants who drank the NNS drink, there was a decrease in the hormone that tells the body it’s full.
“By studying different groups we were able to show that females and people with obesity may be more sensitive to artificial sweeteners. For these groups, drinking artificially sweetened drinks may trick the brain into feeling hungry, which may in turn result in more calories being consumed,” Kathleen Page, MD, the study’s corresponding author, said in a separate statement.
Today’s lesson? Don’t believe every label you read.
Instagram vegetables and the triumph of peer pressure
You and your family are sitting down for dinner. You’ve taken the time to prepare a healthy, nutritious meal. Vegetables, rice, seafood – all the right things. But the children around you refuse to partake. What can you do? Why, show them a highly liked photo of broccoli on Instagram!
In reality, kids will probably never like to eat their vegetables, but according to a study published in Appetite, viewing highly liked images on social media can compel adults to eat theirs.
The investigators recruited a group of 169 adults aged 18-28 (average age, 21) and showed them a series of mock Instagram posts of all sorts of food, everything from Brussels sprouts to chocolate cake, as well as nonfood images to act as a baseline. The images had a varying amount of likes. After viewing the images, study participants were offered a snack buffet consisting of grapes and cookies.
The results were a triumph of peer pressure. Those who viewed highly liked images of nutritious foods ate a significantly larger proportion of grapes, compared with those who saw highly liked images of unhealthy food or nonfood.
The authors cautioned that more research is needed, but they said that they’re onto something in the eternal struggle of getting people to eat better. If Mikey liked it, maybe you should, too. Just as long as you don’t try to encourage the eating of peas. That is a dark road none should take, and no one should ever be subjected to that cursed food.
It’s nice to share … hypertension?
You may have heard that, over time, you begin to resemble your spouse. You may have also heard that, as time goes by, your pet might start to resemble you, but that is a story for another time.
A lot of the time, it’s human nature that people partner with someone who is similar to them in physical and environmental status. If you like to go jogging at 5 a.m., you might want a spouse who does the same. A study done using data from couples in Japan and the Netherlands found that couples who had the same lifestyle had similar levels of blood pressure, cholesterol, and triglycerides. They also had similar illnesses such as hypertension and diabetes.
It’s important to note that many of the couples were not very genetically similar but had similar lifestyles. Encourage your partner to have a healthier lifestyle, so you can live on for many years to come!
Novel food for thought
When you were growing up, your parents probably told you to brush your teeth before you went to bed, warned you not to run with the scissors or play with matches, and punished you whenever you used the neighbor children to play Schrödinger’s cat.
They did those things for your own good, of course, and now the nation’s mother – the Centers for Disease Control and Prevention – is doing the same by warning us about novel outbreak–associated foods. As in, “Put down that novel outbreak–associated food! You don’t know where it’s been!”
Seriously, you don’t know where it’s been. CDC investigators identified 28 novel foods that were linked to 36 foodborne-disease outbreaks that occurred during 2007-2016, including moringa leaf (herb/spice), tempeh (grain), frog, sprouted nut butter, and skate.
The novel foods implicated in these outbreaks were more likely to be imported, compared with 14,216 outbreaks that occurred from 1973 to 2016, and about half didn’t require refrigeration. Two-thirds did not need to be cooked after purchase. Another thing your parents wouldn’t like: Some can’t be washed, like sheep milk, sugar cane, or the aforementioned nut butter.
We wanted to get a food expert to comment on these novel foods, but our editor said that the assistant manager of our local Burger King wasn’t expert enough, so we’ve commandeered someone else’s expert. Cynthia Sears, MD, of Johns Hopkins University in Baltimore, told Today.com all about the dangers of frogs: “Essentially all amphibians are contaminated, often with salmonella. Eating any amphibian that is not thoroughly cooked is a risk.”
Be sure to cook your amphibians before you eat them. Advice that your parents would be proud to share.
Dieters should stay away from diet drinks
When a drink is labeled “diet” many assume that the calorie-free beverage is the best choice. However, one of the largest studies to date on artificial sweeteners is out to set the record straight.
Artificial sweeteners, or nonnutritive sweeteners (NNS), are used in most if not all diet products to give the illusion of sweetness without the caloric guilt. Some studies say they help with weight loss for that very reason, but others say they can contribute to weight gain. So which is it?
Researchers at the University of Southern California sought to add some clarity to the research already out there.
They looked at an even-gendered split of 74 participants who drank 300 mL of drinks sweetened with NNS, table sugar, or water. The researchers then used functional MRI to see how parts of the brain responsible for appetite and cravings responded to images of high-calorie foods. They also looked at glucose, insulin, and other metabolic hormone levels, as well as how much food the participants ate at their free buffet. (In the participants’ defense, who can say no to a free buffet?)
The researchers made some interesting observations:
- Women who drank the NNS drink ate more than did the table-sugar group, but all men ate the same.
- Images of those calorie-packed goodies increased cravings and appetite for obese men and women in the NNS group, compared with the table-sugar group.
- For all participants who drank the NNS drink, there was a decrease in the hormone that tells the body it’s full.
“By studying different groups we were able to show that females and people with obesity may be more sensitive to artificial sweeteners. For these groups, drinking artificially sweetened drinks may trick the brain into feeling hungry, which may in turn result in more calories being consumed,” Kathleen Page, MD, the study’s corresponding author, said in a separate statement.
Today’s lesson? Don’t believe every label you read.
Instagram vegetables and the triumph of peer pressure
You and your family are sitting down for dinner. You’ve taken the time to prepare a healthy, nutritious meal. Vegetables, rice, seafood – all the right things. But the children around you refuse to partake. What can you do? Why, show them a highly liked photo of broccoli on Instagram!
In reality, kids will probably never like to eat their vegetables, but according to a study published in Appetite, viewing highly liked images on social media can compel adults to eat theirs.
The investigators recruited a group of 169 adults aged 18-28 (average age, 21) and showed them a series of mock Instagram posts of all sorts of food, everything from Brussels sprouts to chocolate cake, as well as nonfood images to act as a baseline. The images had a varying amount of likes. After viewing the images, study participants were offered a snack buffet consisting of grapes and cookies.
The results were a triumph of peer pressure. Those who viewed highly liked images of nutritious foods ate a significantly larger proportion of grapes, compared with those who saw highly liked images of unhealthy food or nonfood.
The authors cautioned that more research is needed, but they said that they’re onto something in the eternal struggle of getting people to eat better. If Mikey liked it, maybe you should, too. Just as long as you don’t try to encourage the eating of peas. That is a dark road none should take, and no one should ever be subjected to that cursed food.
It’s nice to share … hypertension?
You may have heard that, over time, you begin to resemble your spouse. You may have also heard that, as time goes by, your pet might start to resemble you, but that is a story for another time.
A lot of the time, it’s human nature that people partner with someone who is similar to them in physical and environmental status. If you like to go jogging at 5 a.m., you might want a spouse who does the same. A study done using data from couples in Japan and the Netherlands found that couples who had the same lifestyle had similar levels of blood pressure, cholesterol, and triglycerides. They also had similar illnesses such as hypertension and diabetes.
It’s important to note that many of the couples were not very genetically similar but had similar lifestyles. Encourage your partner to have a healthier lifestyle, so you can live on for many years to come!
Novel food for thought
When you were growing up, your parents probably told you to brush your teeth before you went to bed, warned you not to run with the scissors or play with matches, and punished you whenever you used the neighbor children to play Schrödinger’s cat.
They did those things for your own good, of course, and now the nation’s mother – the Centers for Disease Control and Prevention – is doing the same by warning us about novel outbreak–associated foods. As in, “Put down that novel outbreak–associated food! You don’t know where it’s been!”
Seriously, you don’t know where it’s been. CDC investigators identified 28 novel foods that were linked to 36 foodborne-disease outbreaks that occurred during 2007-2016, including moringa leaf (herb/spice), tempeh (grain), frog, sprouted nut butter, and skate.
The novel foods implicated in these outbreaks were more likely to be imported, compared with 14,216 outbreaks that occurred from 1973 to 2016, and about half didn’t require refrigeration. Two-thirds did not need to be cooked after purchase. Another thing your parents wouldn’t like: Some can’t be washed, like sheep milk, sugar cane, or the aforementioned nut butter.
We wanted to get a food expert to comment on these novel foods, but our editor said that the assistant manager of our local Burger King wasn’t expert enough, so we’ve commandeered someone else’s expert. Cynthia Sears, MD, of Johns Hopkins University in Baltimore, told Today.com all about the dangers of frogs: “Essentially all amphibians are contaminated, often with salmonella. Eating any amphibian that is not thoroughly cooked is a risk.”
Be sure to cook your amphibians before you eat them. Advice that your parents would be proud to share.
Dieters should stay away from diet drinks
When a drink is labeled “diet” many assume that the calorie-free beverage is the best choice. However, one of the largest studies to date on artificial sweeteners is out to set the record straight.
Artificial sweeteners, or nonnutritive sweeteners (NNS), are used in most if not all diet products to give the illusion of sweetness without the caloric guilt. Some studies say they help with weight loss for that very reason, but others say they can contribute to weight gain. So which is it?
Researchers at the University of Southern California sought to add some clarity to the research already out there.
They looked at an even-gendered split of 74 participants who drank 300 mL of drinks sweetened with NNS, table sugar, or water. The researchers then used functional MRI to see how parts of the brain responsible for appetite and cravings responded to images of high-calorie foods. They also looked at glucose, insulin, and other metabolic hormone levels, as well as how much food the participants ate at their free buffet. (In the participants’ defense, who can say no to a free buffet?)
The researchers made some interesting observations:
- Women who drank the NNS drink ate more than did the table-sugar group, but all men ate the same.
- Images of those calorie-packed goodies increased cravings and appetite for obese men and women in the NNS group, compared with the table-sugar group.
- For all participants who drank the NNS drink, there was a decrease in the hormone that tells the body it’s full.
“By studying different groups we were able to show that females and people with obesity may be more sensitive to artificial sweeteners. For these groups, drinking artificially sweetened drinks may trick the brain into feeling hungry, which may in turn result in more calories being consumed,” Kathleen Page, MD, the study’s corresponding author, said in a separate statement.
Today’s lesson? Don’t believe every label you read.
Instagram vegetables and the triumph of peer pressure
You and your family are sitting down for dinner. You’ve taken the time to prepare a healthy, nutritious meal. Vegetables, rice, seafood – all the right things. But the children around you refuse to partake. What can you do? Why, show them a highly liked photo of broccoli on Instagram!
In reality, kids will probably never like to eat their vegetables, but according to a study published in Appetite, viewing highly liked images on social media can compel adults to eat theirs.
The investigators recruited a group of 169 adults aged 18-28 (average age, 21) and showed them a series of mock Instagram posts of all sorts of food, everything from Brussels sprouts to chocolate cake, as well as nonfood images to act as a baseline. The images had a varying amount of likes. After viewing the images, study participants were offered a snack buffet consisting of grapes and cookies.
The results were a triumph of peer pressure. Those who viewed highly liked images of nutritious foods ate a significantly larger proportion of grapes, compared with those who saw highly liked images of unhealthy food or nonfood.
The authors cautioned that more research is needed, but they said that they’re onto something in the eternal struggle of getting people to eat better. If Mikey liked it, maybe you should, too. Just as long as you don’t try to encourage the eating of peas. That is a dark road none should take, and no one should ever be subjected to that cursed food.
It’s nice to share … hypertension?
You may have heard that, over time, you begin to resemble your spouse. You may have also heard that, as time goes by, your pet might start to resemble you, but that is a story for another time.
A lot of the time, it’s human nature that people partner with someone who is similar to them in physical and environmental status. If you like to go jogging at 5 a.m., you might want a spouse who does the same. A study done using data from couples in Japan and the Netherlands found that couples who had the same lifestyle had similar levels of blood pressure, cholesterol, and triglycerides. They also had similar illnesses such as hypertension and diabetes.
It’s important to note that many of the couples were not very genetically similar but had similar lifestyles. Encourage your partner to have a healthier lifestyle, so you can live on for many years to come!
Greater portal use gives patients access, doctors headaches
The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.
These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”
But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.
According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.
The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.
Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.
Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
The pros and cons of patient portals, greater access
Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.
Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.
Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”
Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”
The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.
Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.
Making patient records portable
Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.
About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.
Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.
Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.
“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”
Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.
Managing data is a challenge
Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.
“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.
Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”
A version of this article first appeared on Medscape.com.
The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.
These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”
But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.
According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.
The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.
Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.
Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
The pros and cons of patient portals, greater access
Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.
Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.
Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”
Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”
The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.
Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.
Making patient records portable
Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.
About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.
Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.
Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.
“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”
Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.
Managing data is a challenge
Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.
“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.
Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”
A version of this article first appeared on Medscape.com.
The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.
These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”
But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.
According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.
The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.
Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.
Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
The pros and cons of patient portals, greater access
Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.
Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.
Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”
Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”
The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.
Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.
Making patient records portable
Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.
About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.
Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.
Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.
“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”
Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.
Managing data is a challenge
Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.
“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.
Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”
A version of this article first appeared on Medscape.com.
Fraudulent misbranding of PPE nets $22 million settlement
Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE
A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.
Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.
According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.
Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.
“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
Company pays $38.75 million to settle allegations of knowingly selling defective devices
Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices.
From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes.
While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.
In 2016, the product was taken off the market at the request of the FDA.
Mass. doctor, wife charged in international money laundering, fraud scheme
Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs.
Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology.
Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
Jury convicts medical equipment company owners of $27 million fraud
A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.
Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions.
Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces.
At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.
At sentencing, the Hagens each face a maximum sentence of 25 years in prison.
A version of this article first appeared on Medscape.com.
Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE
A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.
Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.
According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.
Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.
“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
Company pays $38.75 million to settle allegations of knowingly selling defective devices
Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices.
From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes.
While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.
In 2016, the product was taken off the market at the request of the FDA.
Mass. doctor, wife charged in international money laundering, fraud scheme
Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs.
Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology.
Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
Jury convicts medical equipment company owners of $27 million fraud
A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.
Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions.
Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces.
At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.
At sentencing, the Hagens each face a maximum sentence of 25 years in prison.
A version of this article first appeared on Medscape.com.
Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE
A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.
Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.
According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.
Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.
“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
Company pays $38.75 million to settle allegations of knowingly selling defective devices
Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices.
From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes.
While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.
In 2016, the product was taken off the market at the request of the FDA.
Mass. doctor, wife charged in international money laundering, fraud scheme
Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs.
Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology.
Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
Jury convicts medical equipment company owners of $27 million fraud
A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.
Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions.
Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces.
At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.
At sentencing, the Hagens each face a maximum sentence of 25 years in prison.
A version of this article first appeared on Medscape.com.
Children and COVID: New cases topped 200,000 after 3 weeks of declines
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
based on the data in the AAP/CHA joint weekly report on COVID in children.
In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)
The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.
There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.
The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.
COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.
“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.
Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.
These schools use weekly testing to keep kids in class – and COVID out
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). 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.
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). 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.
On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.
At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.
“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”
The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.
Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.
Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.
These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.
Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.
Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.
“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.
So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.
Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.
“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”
Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.
“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”
Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.
“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.
Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.
Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.
Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.
Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.
A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.
Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.
“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”
Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.
If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.
In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.
Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.
The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.
For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.
This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.
But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.
A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.
“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.
“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”
This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN (Kaiser Health News). 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.
Intracranial hemorrhaging a high risk for patients with hemophilia, especially neonates
The observed rates of intracranial hemorrhaging (ICH) in patients with hemophilia were higher compared to the general populations among all age groups examined, according to a meta-analysis of studies reported online ahead of print in Blood.
As previously reported, the risk seemed higher in the group of infants and toddlers, and neonates with hemophilia showed a 33-fold higher risk of ICH than newborns in the general population, in the current study.
The researchers performed a literature review and assessed 45 studies that represented 54,470 patients, 809,151 person-years and 5,326 live births of patients with hemophilia. Pooled ICH incidence and mortality were calculated for three age groups: persons of all ages with hemophilia; children and young adults below 25 years of age with hemophilia; and neonates with hemophilia.
Overall results
Among the persons of all ages, the pooled ICH incidence and mortality rates were 2.3 (95% confidence interval, 1.2-4.8) and 0.8 (95% CI, 0.5-1.2) per 1,000 person-years, respectively, according to the authors. They found that in children and young adults, the pooled ICH incidence and mortality rates were 7.4 (95% CI, 4.9-11.1) and 0.5 (95% CI, 0.3-0.9) per 1,000 person-years, respectively. In neonates, the pooled cumulative ICH incidence was 2.1% (95% CI, 1.5-2.8) per 100 live births and the pooled ICH cumulative mortality was 0.2% (95% CI, 0.0-1.2) per 100 live births.
Overall, the occurrence of ICH was classified as spontaneous in 35%-58% of cases.
Neonates at risk
The observed ICH rates in hemophilia were higher compared to the general populations among the age groups assessed. Neonates showed the highest risk of ICH, which is confirmed by other studies in severe hemophilia demonstrating that neonates were at 11.2 times higher risk for ICH compared with 1- to 12-month-old children, and is also strongly increased compared to neonates in the general populations, the researchers stated.
A previous large study of term infants reported 361 intracranial bleeding episodes per 583,340 live births (0.062% per 100 live births), and comparing this to the current pooled estimate of 2.1% per 100 live births, neonates with hemophilia showed a 33-fold higher risk of ICH than newborns in the general population, according to the researchers.
Monitoring and follow-up
“Our findings suggest that adequate follow-up and monitoring of patients is warranted among all ages, especially in the presence of risk factors. Prophylaxis seems to halve ICH risk in children and adults with severe hemophilia, which supports existing recommendations encouraging early initiation of prophylactic treatment,” the authors advised.
Accurate capture of the true frequency of ICH is challenged by considerable clinical heterogeneity, limiting the precision and generalizability of the pooled estimates, leading to the likelihood that ICH and mortality were underdiagnosed in this analysis, according to the authors.
“We found high ICH incidence and mortality rates in patients with hemophilia. Our findings suggest that ICH is still an important problem in hemophilia requiring adequate counseling of patients of all ages,” the researchers concluded.
This work was supported by a grant from Sobi. Some of the authors reported research, consulting or lecturing fees from a variety of pharmaceutical companies, including Sobi.
The observed rates of intracranial hemorrhaging (ICH) in patients with hemophilia were higher compared to the general populations among all age groups examined, according to a meta-analysis of studies reported online ahead of print in Blood.
As previously reported, the risk seemed higher in the group of infants and toddlers, and neonates with hemophilia showed a 33-fold higher risk of ICH than newborns in the general population, in the current study.
The researchers performed a literature review and assessed 45 studies that represented 54,470 patients, 809,151 person-years and 5,326 live births of patients with hemophilia. Pooled ICH incidence and mortality were calculated for three age groups: persons of all ages with hemophilia; children and young adults below 25 years of age with hemophilia; and neonates with hemophilia.
Overall results
Among the persons of all ages, the pooled ICH incidence and mortality rates were 2.3 (95% confidence interval, 1.2-4.8) and 0.8 (95% CI, 0.5-1.2) per 1,000 person-years, respectively, according to the authors. They found that in children and young adults, the pooled ICH incidence and mortality rates were 7.4 (95% CI, 4.9-11.1) and 0.5 (95% CI, 0.3-0.9) per 1,000 person-years, respectively. In neonates, the pooled cumulative ICH incidence was 2.1% (95% CI, 1.5-2.8) per 100 live births and the pooled ICH cumulative mortality was 0.2% (95% CI, 0.0-1.2) per 100 live births.
Overall, the occurrence of ICH was classified as spontaneous in 35%-58% of cases.
Neonates at risk
The observed ICH rates in hemophilia were higher compared to the general populations among the age groups assessed. Neonates showed the highest risk of ICH, which is confirmed by other studies in severe hemophilia demonstrating that neonates were at 11.2 times higher risk for ICH compared with 1- to 12-month-old children, and is also strongly increased compared to neonates in the general populations, the researchers stated.
A previous large study of term infants reported 361 intracranial bleeding episodes per 583,340 live births (0.062% per 100 live births), and comparing this to the current pooled estimate of 2.1% per 100 live births, neonates with hemophilia showed a 33-fold higher risk of ICH than newborns in the general population, according to the researchers.
Monitoring and follow-up
“Our findings suggest that adequate follow-up and monitoring of patients is warranted among all ages, especially in the presence of risk factors. Prophylaxis seems to halve ICH risk in children and adults with severe hemophilia, which supports existing recommendations encouraging early initiation of prophylactic treatment,” the authors advised.
Accurate capture of the true frequency of ICH is challenged by considerable clinical heterogeneity, limiting the precision and generalizability of the pooled estimates, leading to the likelihood that ICH and mortality were underdiagnosed in this analysis, according to the authors.
“We found high ICH incidence and mortality rates in patients with hemophilia. Our findings suggest that ICH is still an important problem in hemophilia requiring adequate counseling of patients of all ages,” the researchers concluded.
This work was supported by a grant from Sobi. Some of the authors reported research, consulting or lecturing fees from a variety of pharmaceutical companies, including Sobi.
The observed rates of intracranial hemorrhaging (ICH) in patients with hemophilia were higher compared to the general populations among all age groups examined, according to a meta-analysis of studies reported online ahead of print in Blood.
As previously reported, the risk seemed higher in the group of infants and toddlers, and neonates with hemophilia showed a 33-fold higher risk of ICH than newborns in the general population, in the current study.
The researchers performed a literature review and assessed 45 studies that represented 54,470 patients, 809,151 person-years and 5,326 live births of patients with hemophilia. Pooled ICH incidence and mortality were calculated for three age groups: persons of all ages with hemophilia; children and young adults below 25 years of age with hemophilia; and neonates with hemophilia.
Overall results
Among the persons of all ages, the pooled ICH incidence and mortality rates were 2.3 (95% confidence interval, 1.2-4.8) and 0.8 (95% CI, 0.5-1.2) per 1,000 person-years, respectively, according to the authors. They found that in children and young adults, the pooled ICH incidence and mortality rates were 7.4 (95% CI, 4.9-11.1) and 0.5 (95% CI, 0.3-0.9) per 1,000 person-years, respectively. In neonates, the pooled cumulative ICH incidence was 2.1% (95% CI, 1.5-2.8) per 100 live births and the pooled ICH cumulative mortality was 0.2% (95% CI, 0.0-1.2) per 100 live births.
Overall, the occurrence of ICH was classified as spontaneous in 35%-58% of cases.
Neonates at risk
The observed ICH rates in hemophilia were higher compared to the general populations among the age groups assessed. Neonates showed the highest risk of ICH, which is confirmed by other studies in severe hemophilia demonstrating that neonates were at 11.2 times higher risk for ICH compared with 1- to 12-month-old children, and is also strongly increased compared to neonates in the general populations, the researchers stated.
A previous large study of term infants reported 361 intracranial bleeding episodes per 583,340 live births (0.062% per 100 live births), and comparing this to the current pooled estimate of 2.1% per 100 live births, neonates with hemophilia showed a 33-fold higher risk of ICH than newborns in the general population, according to the researchers.
Monitoring and follow-up
“Our findings suggest that adequate follow-up and monitoring of patients is warranted among all ages, especially in the presence of risk factors. Prophylaxis seems to halve ICH risk in children and adults with severe hemophilia, which supports existing recommendations encouraging early initiation of prophylactic treatment,” the authors advised.
Accurate capture of the true frequency of ICH is challenged by considerable clinical heterogeneity, limiting the precision and generalizability of the pooled estimates, leading to the likelihood that ICH and mortality were underdiagnosed in this analysis, according to the authors.
“We found high ICH incidence and mortality rates in patients with hemophilia. Our findings suggest that ICH is still an important problem in hemophilia requiring adequate counseling of patients of all ages,” the researchers concluded.
This work was supported by a grant from Sobi. Some of the authors reported research, consulting or lecturing fees from a variety of pharmaceutical companies, including Sobi.
FROM BLOOD
Nutritious meals, more fruits and vegetables boost children’s mental and emotional health
Good nutrition has long been linked to better behavior and academic performance in schoolchildren, as longstanding breakfast and lunch programs in U.S. schools attest. Now British researchers report that nutrition, a modifiable risk factor that can adversely impact mental health, should be part of public health strategies to boost children’s psychological wellness.
In a cross-sectional study published online Sept. 27 in BMJ Nutrition, Prevention & Health, a team from the University of East Anglia in Norwich, England, found a nutritious breakfast and lunch were linked to emotional well-being in schoolchildren of both primary and secondary school age. They also found that some school kids ate neither breakfast nor lunch.
In particular, eating more fruits and vegetables was significantly associated with better mental health in secondary schoolchildren, while a nutritious breakfast and lunch were linked to emotional well-being in students across the age spectrum, according to senior lecturer Richard P. Hayhoe, PhD, of East Anglia University and Anglia Ruskin University in Norwich and colleagues.
They found that primary school pupils who ate only a snack for breakfast had mental well-being scores 5.50 units lower than those eating a substantial breakfast, while having no lunch was tied to scores more than 6 units lower.
“The importance of good-quality nutrition for childhood growth and development is well established,” the authors wrote. “As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being.”
Their current analysis examined data on 7,570 secondary and 1,253 primary school children from 50 schools participating in the Norfolk Children and Young People Health and Well-being Survey 2017.
Multivariable linear regression measured the association between nutritional factors and mental well-being assessed by the Warwick-Edinburgh Mental Well-being Scale for secondary school pupils or by the Stirling Children’s Well-being Scale for primary school pupils. All analyses were adjusted for covariates including demographic, health variables, living/home situations, and adverse experiences.
“The 2017 survey provided a means for Norfolk children and young people to share their feelings on topics such as healthy lifestyles and nutrition, relationships, school experiences, bullying, and their mental well-being,” Dr. Hayhoe said in an interview. “Initial analysis of the data suggested an association between nutrition and well-being and so we decided to investigate this further.”
Dr. Hayhoe added that, as in the United States, youngsters in England get a high proportion of their daily calories from ultraprocessed convenience foods of lesser nutritional value.
“But what we didn’t know was whether the dietary habits of children in our survey had any association with their mental well-being,” he said. “Our current findings suggest that increasing fruit and vegetable consumption and ensuring all schoolchildren eat a nutritional breakfast and lunch may be of benefit to their mental well-being.”
His group cautions, however, that this is an observational study that cannot establish direct causation.
“This study provides the first insights into how fruit and vegetable intake affects children’s mental health, and contributes to the emerging evidence around ‘food and mood,’ ” said Sumantra Ray, MD, executive director of the NNEdPro Global Centre for Nutrition and Health in Cambridge, England.
“The findings are timely, not only because of the impact the pandemic has had on mental well-being, food security, and diet quality, especially in school children, but also in light of the recently published National Food Strategy for England, which highlighted gaps in school meal provision,” added Dr. Ray, who was not involved in the study.
Study results
In total, 10,853 schoolchildren completed the survey: 9% of Norfolk primary school children aged 9-11 and 22% of secondary school students, with approximately 6% of these in the 17- and 18-year-old age bracket. Comprehensive dietary questions explored fruit and vegetable intake, as well as type of breakfast and lunch eaten, alcohol intake, eligibility for free school meals, and satisfaction with weight.
The survey also gathered information on parameters ranging from having one’s own bedroom and bed and exposure to violence or discord in the home.
“Some of these were found to be associated with lower mental well-being scores, but we did not specifically investigate the interaction between these factors and the nutritional factors,” Dr. Hayhoe said. However, the difference in mental well-being between children who ate the most fruit and vegetables and those who ate the least was on a similar scale to those reporting daily, or almost daily, arguing or violence at home, he said.
Average mental health was assessed using validated age-appropriate measures. The mean mental health score of participants was 46.6 out of 70 for secondary school students and 46 out of 60 for primary school pupils.
Among the survey findings were:
- Just 25% of secondary school participants and 28.5% of primary school pupils reported eating the recommended five portions of fruits and vegetables a day, with 10% and 9%, respectively, eating none.
- 21% of secondary and 12% of primary school pupils consumed only a non–energy drink or nothing for breakfast, while 11.5% of secondary schoolchildren ate no lunch. In one high school class of 30, for example, four had nothing to eat or drink before starting classes in the morning, and three had nothing to eat or drink before starting classes in the afternoon.
- Higher combined fruit and vegetable intake was significantly associated in dose-related fashion with higher mental health scores: 3.73 (95% confidence interval, 2.94- 4.53) units higher in those consuming five or more fruits and vegetables (P < .001), compared with none.
- Breakfast or lunch type also correlated with significant differences in well-being scores. Compared with children consuming a conventional breakfast (porridge, toast, cereal, yogurt, fruit, or a cooked meal), those eating no breakfast had mean well-being scores that were 2.73 (95% CI, 2.11-3.35) units lower (P < .001). Those consuming only an energy drink scored even worse: 3.14 (95% CI, 1.20- 5.09) units lower (P = .002).
- Skipping lunch resulted in a 2.95-unit drop in well-being score (95% CI, 2.22-3.68, P < .001), compared with consuming a packed lunch.
In terms of the amounts of fruits and vegetables consumed, one or two daily portions were associated with a score 1.42 units higher, while three or four portions correlated with a score 2.34 units higher. Those eating five or more portions scored 3.73 units higher.
- For primary school pupils, eating only a snack for breakfast was associated with a score 5.50 units lower, and consuming only a non–energy drink was tied to a score 2.67 units lower than eating a conventional breakfast. Not eating any breakfast was associated with a score 3.62 units lower.
- Eating school food versus a packed lunch was associated with a score 1.27 units lower, although this wasn’t statistically significant. Having no lunch was associated with a score 6.08 units lower, although only a few children fell into this group.
“As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being,” the authors wrote, calling for further investigation of the association between nutrition and mental well-being.
This study was commissioned by Norfolk County Council Public Health and the Norfolk Safeguarding Children Board. The University of East Anglia and Social Care Partners provided funding to support Dr. Hayhoe’s work on this project.
Some coauthors are employed by the Norfolk County Council that commissioned the survey.
Good nutrition has long been linked to better behavior and academic performance in schoolchildren, as longstanding breakfast and lunch programs in U.S. schools attest. Now British researchers report that nutrition, a modifiable risk factor that can adversely impact mental health, should be part of public health strategies to boost children’s psychological wellness.
In a cross-sectional study published online Sept. 27 in BMJ Nutrition, Prevention & Health, a team from the University of East Anglia in Norwich, England, found a nutritious breakfast and lunch were linked to emotional well-being in schoolchildren of both primary and secondary school age. They also found that some school kids ate neither breakfast nor lunch.
In particular, eating more fruits and vegetables was significantly associated with better mental health in secondary schoolchildren, while a nutritious breakfast and lunch were linked to emotional well-being in students across the age spectrum, according to senior lecturer Richard P. Hayhoe, PhD, of East Anglia University and Anglia Ruskin University in Norwich and colleagues.
They found that primary school pupils who ate only a snack for breakfast had mental well-being scores 5.50 units lower than those eating a substantial breakfast, while having no lunch was tied to scores more than 6 units lower.
“The importance of good-quality nutrition for childhood growth and development is well established,” the authors wrote. “As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being.”
Their current analysis examined data on 7,570 secondary and 1,253 primary school children from 50 schools participating in the Norfolk Children and Young People Health and Well-being Survey 2017.
Multivariable linear regression measured the association between nutritional factors and mental well-being assessed by the Warwick-Edinburgh Mental Well-being Scale for secondary school pupils or by the Stirling Children’s Well-being Scale for primary school pupils. All analyses were adjusted for covariates including demographic, health variables, living/home situations, and adverse experiences.
“The 2017 survey provided a means for Norfolk children and young people to share their feelings on topics such as healthy lifestyles and nutrition, relationships, school experiences, bullying, and their mental well-being,” Dr. Hayhoe said in an interview. “Initial analysis of the data suggested an association between nutrition and well-being and so we decided to investigate this further.”
Dr. Hayhoe added that, as in the United States, youngsters in England get a high proportion of their daily calories from ultraprocessed convenience foods of lesser nutritional value.
“But what we didn’t know was whether the dietary habits of children in our survey had any association with their mental well-being,” he said. “Our current findings suggest that increasing fruit and vegetable consumption and ensuring all schoolchildren eat a nutritional breakfast and lunch may be of benefit to their mental well-being.”
His group cautions, however, that this is an observational study that cannot establish direct causation.
“This study provides the first insights into how fruit and vegetable intake affects children’s mental health, and contributes to the emerging evidence around ‘food and mood,’ ” said Sumantra Ray, MD, executive director of the NNEdPro Global Centre for Nutrition and Health in Cambridge, England.
“The findings are timely, not only because of the impact the pandemic has had on mental well-being, food security, and diet quality, especially in school children, but also in light of the recently published National Food Strategy for England, which highlighted gaps in school meal provision,” added Dr. Ray, who was not involved in the study.
Study results
In total, 10,853 schoolchildren completed the survey: 9% of Norfolk primary school children aged 9-11 and 22% of secondary school students, with approximately 6% of these in the 17- and 18-year-old age bracket. Comprehensive dietary questions explored fruit and vegetable intake, as well as type of breakfast and lunch eaten, alcohol intake, eligibility for free school meals, and satisfaction with weight.
The survey also gathered information on parameters ranging from having one’s own bedroom and bed and exposure to violence or discord in the home.
“Some of these were found to be associated with lower mental well-being scores, but we did not specifically investigate the interaction between these factors and the nutritional factors,” Dr. Hayhoe said. However, the difference in mental well-being between children who ate the most fruit and vegetables and those who ate the least was on a similar scale to those reporting daily, or almost daily, arguing or violence at home, he said.
Average mental health was assessed using validated age-appropriate measures. The mean mental health score of participants was 46.6 out of 70 for secondary school students and 46 out of 60 for primary school pupils.
Among the survey findings were:
- Just 25% of secondary school participants and 28.5% of primary school pupils reported eating the recommended five portions of fruits and vegetables a day, with 10% and 9%, respectively, eating none.
- 21% of secondary and 12% of primary school pupils consumed only a non–energy drink or nothing for breakfast, while 11.5% of secondary schoolchildren ate no lunch. In one high school class of 30, for example, four had nothing to eat or drink before starting classes in the morning, and three had nothing to eat or drink before starting classes in the afternoon.
- Higher combined fruit and vegetable intake was significantly associated in dose-related fashion with higher mental health scores: 3.73 (95% confidence interval, 2.94- 4.53) units higher in those consuming five or more fruits and vegetables (P < .001), compared with none.
- Breakfast or lunch type also correlated with significant differences in well-being scores. Compared with children consuming a conventional breakfast (porridge, toast, cereal, yogurt, fruit, or a cooked meal), those eating no breakfast had mean well-being scores that were 2.73 (95% CI, 2.11-3.35) units lower (P < .001). Those consuming only an energy drink scored even worse: 3.14 (95% CI, 1.20- 5.09) units lower (P = .002).
- Skipping lunch resulted in a 2.95-unit drop in well-being score (95% CI, 2.22-3.68, P < .001), compared with consuming a packed lunch.
In terms of the amounts of fruits and vegetables consumed, one or two daily portions were associated with a score 1.42 units higher, while three or four portions correlated with a score 2.34 units higher. Those eating five or more portions scored 3.73 units higher.
- For primary school pupils, eating only a snack for breakfast was associated with a score 5.50 units lower, and consuming only a non–energy drink was tied to a score 2.67 units lower than eating a conventional breakfast. Not eating any breakfast was associated with a score 3.62 units lower.
- Eating school food versus a packed lunch was associated with a score 1.27 units lower, although this wasn’t statistically significant. Having no lunch was associated with a score 6.08 units lower, although only a few children fell into this group.
“As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being,” the authors wrote, calling for further investigation of the association between nutrition and mental well-being.
This study was commissioned by Norfolk County Council Public Health and the Norfolk Safeguarding Children Board. The University of East Anglia and Social Care Partners provided funding to support Dr. Hayhoe’s work on this project.
Some coauthors are employed by the Norfolk County Council that commissioned the survey.
Good nutrition has long been linked to better behavior and academic performance in schoolchildren, as longstanding breakfast and lunch programs in U.S. schools attest. Now British researchers report that nutrition, a modifiable risk factor that can adversely impact mental health, should be part of public health strategies to boost children’s psychological wellness.
In a cross-sectional study published online Sept. 27 in BMJ Nutrition, Prevention & Health, a team from the University of East Anglia in Norwich, England, found a nutritious breakfast and lunch were linked to emotional well-being in schoolchildren of both primary and secondary school age. They also found that some school kids ate neither breakfast nor lunch.
In particular, eating more fruits and vegetables was significantly associated with better mental health in secondary schoolchildren, while a nutritious breakfast and lunch were linked to emotional well-being in students across the age spectrum, according to senior lecturer Richard P. Hayhoe, PhD, of East Anglia University and Anglia Ruskin University in Norwich and colleagues.
They found that primary school pupils who ate only a snack for breakfast had mental well-being scores 5.50 units lower than those eating a substantial breakfast, while having no lunch was tied to scores more than 6 units lower.
“The importance of good-quality nutrition for childhood growth and development is well established,” the authors wrote. “As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being.”
Their current analysis examined data on 7,570 secondary and 1,253 primary school children from 50 schools participating in the Norfolk Children and Young People Health and Well-being Survey 2017.
Multivariable linear regression measured the association between nutritional factors and mental well-being assessed by the Warwick-Edinburgh Mental Well-being Scale for secondary school pupils or by the Stirling Children’s Well-being Scale for primary school pupils. All analyses were adjusted for covariates including demographic, health variables, living/home situations, and adverse experiences.
“The 2017 survey provided a means for Norfolk children and young people to share their feelings on topics such as healthy lifestyles and nutrition, relationships, school experiences, bullying, and their mental well-being,” Dr. Hayhoe said in an interview. “Initial analysis of the data suggested an association between nutrition and well-being and so we decided to investigate this further.”
Dr. Hayhoe added that, as in the United States, youngsters in England get a high proportion of their daily calories from ultraprocessed convenience foods of lesser nutritional value.
“But what we didn’t know was whether the dietary habits of children in our survey had any association with their mental well-being,” he said. “Our current findings suggest that increasing fruit and vegetable consumption and ensuring all schoolchildren eat a nutritional breakfast and lunch may be of benefit to their mental well-being.”
His group cautions, however, that this is an observational study that cannot establish direct causation.
“This study provides the first insights into how fruit and vegetable intake affects children’s mental health, and contributes to the emerging evidence around ‘food and mood,’ ” said Sumantra Ray, MD, executive director of the NNEdPro Global Centre for Nutrition and Health in Cambridge, England.
“The findings are timely, not only because of the impact the pandemic has had on mental well-being, food security, and diet quality, especially in school children, but also in light of the recently published National Food Strategy for England, which highlighted gaps in school meal provision,” added Dr. Ray, who was not involved in the study.
Study results
In total, 10,853 schoolchildren completed the survey: 9% of Norfolk primary school children aged 9-11 and 22% of secondary school students, with approximately 6% of these in the 17- and 18-year-old age bracket. Comprehensive dietary questions explored fruit and vegetable intake, as well as type of breakfast and lunch eaten, alcohol intake, eligibility for free school meals, and satisfaction with weight.
The survey also gathered information on parameters ranging from having one’s own bedroom and bed and exposure to violence or discord in the home.
“Some of these were found to be associated with lower mental well-being scores, but we did not specifically investigate the interaction between these factors and the nutritional factors,” Dr. Hayhoe said. However, the difference in mental well-being between children who ate the most fruit and vegetables and those who ate the least was on a similar scale to those reporting daily, or almost daily, arguing or violence at home, he said.
Average mental health was assessed using validated age-appropriate measures. The mean mental health score of participants was 46.6 out of 70 for secondary school students and 46 out of 60 for primary school pupils.
Among the survey findings were:
- Just 25% of secondary school participants and 28.5% of primary school pupils reported eating the recommended five portions of fruits and vegetables a day, with 10% and 9%, respectively, eating none.
- 21% of secondary and 12% of primary school pupils consumed only a non–energy drink or nothing for breakfast, while 11.5% of secondary schoolchildren ate no lunch. In one high school class of 30, for example, four had nothing to eat or drink before starting classes in the morning, and three had nothing to eat or drink before starting classes in the afternoon.
- Higher combined fruit and vegetable intake was significantly associated in dose-related fashion with higher mental health scores: 3.73 (95% confidence interval, 2.94- 4.53) units higher in those consuming five or more fruits and vegetables (P < .001), compared with none.
- Breakfast or lunch type also correlated with significant differences in well-being scores. Compared with children consuming a conventional breakfast (porridge, toast, cereal, yogurt, fruit, or a cooked meal), those eating no breakfast had mean well-being scores that were 2.73 (95% CI, 2.11-3.35) units lower (P < .001). Those consuming only an energy drink scored even worse: 3.14 (95% CI, 1.20- 5.09) units lower (P = .002).
- Skipping lunch resulted in a 2.95-unit drop in well-being score (95% CI, 2.22-3.68, P < .001), compared with consuming a packed lunch.
In terms of the amounts of fruits and vegetables consumed, one or two daily portions were associated with a score 1.42 units higher, while three or four portions correlated with a score 2.34 units higher. Those eating five or more portions scored 3.73 units higher.
- For primary school pupils, eating only a snack for breakfast was associated with a score 5.50 units lower, and consuming only a non–energy drink was tied to a score 2.67 units lower than eating a conventional breakfast. Not eating any breakfast was associated with a score 3.62 units lower.
- Eating school food versus a packed lunch was associated with a score 1.27 units lower, although this wasn’t statistically significant. Having no lunch was associated with a score 6.08 units lower, although only a few children fell into this group.
“As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being,” the authors wrote, calling for further investigation of the association between nutrition and mental well-being.
This study was commissioned by Norfolk County Council Public Health and the Norfolk Safeguarding Children Board. The University of East Anglia and Social Care Partners provided funding to support Dr. Hayhoe’s work on this project.
Some coauthors are employed by the Norfolk County Council that commissioned the survey.
BMJ NUTRITION, PREVENTION & HEALTH
Top questions answered about COVID-19 boosters for your patients
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.
Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.
On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.
The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.
As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:
- People aged 65 years and older.
- People aged 18 years and older in long-term care settings.
- People aged 50-64 years with underlying medical conditions.
The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:
- People aged 18-49 years with underlying medical conditions.
- People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
The CDC currently considers the following groups at increased risk for COVID-19:
- First responders (health care workers, firefighters, police, congregate care staff).
- Education staff (teachers, support staff, day care workers).
- Food and agriculture workers.
- Manufacturing workers.
- Corrections workers.
- U.S. Postal Service workers.
- Public transit workers.
- Grocery store workers.
Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.
“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.
“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.
1. What is the biggest concern you are hearing from patients about getting a booster?
“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.
2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?
“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.
Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”
3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer?
The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.
More data will be needed before other vaccine boosters are authorized, she added.
“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.
4. When are the “mix-and-match” vaccine study results expected to come out?
“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.
5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization?
“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.
“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.
”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”
“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”
6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial?
“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”
“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”
It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.
“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”
7. What is the likelihood that one shot will combine COVID and flu protection in the near future?
It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”
Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.
8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant?
“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”
9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?
“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”
“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.
Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.
“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.
10. What does the future hold for booster shots?
“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said.
“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.
One in three children fall short of sleep recommendations
Just over one-third of children in the United States get less sleep than recommended, with higher rates occurring among several racial/ethnic and socioeconomic groups, according to a report from the Centers for Disease Control and Prevention.
, Anne G. Wheaton, PhD, and Angelika H. Claussen, PhD, said in the Morbidity and Mortality Weekly Report.
Unlike previous reports, this analysis showed that adolescents were less likely than infants to have short sleep duration, 31.2% vs. 40.3%. These latest data are based on the 2016-2018 editions of the National Survey of Children’s Health, and the “difference might be explained by NSCH’s reliance on parent report rather than self-report with Youth Risk Behavior Surveys,” they suggested.
Black children had the highest prevalence of any group included in the study, as parents reported that 50.8% of all ages were not getting the recommended amount of sleep, compared with 39.1% among Hispanics, 34.6% for other races, and 28.8% for Whites. The figure for Black infants was 64.2%, almost double the prevalence for White infants (32.9%), said Dr. Wheaton and Dr. Claussen of the CDC.
Short sleep duration also was more common in children from lower-income families and among those with less educated parents. Geography had an effect as well, with prevalence “highest in the Southeast, similar to geographic variation in adequate sleep observed for adults,” they noted.
Previous research has shown that “sleep disparity was associated with various social determinants of health (e.g., poverty, food insecurity, and perceived racism), which can increase chronic and acute stress and result in environmental and psychological factors that negatively affect sleep duration and can compound long-term health risks,” the investigators wrote.
Short sleep duration by age group was defined as less the following amounts: Twelve hours for infants (4-11 months), 11 hours for children aged 1-2 years, 10 hours for children aged 3-5 years, 9 hours for children aged 6-12, and 8 hours for adolescents (13-17 years), they explained. Responses for the survey’s sleep-duration question totaled 99,842 for the 3 years included.
Just over one-third of children in the United States get less sleep than recommended, with higher rates occurring among several racial/ethnic and socioeconomic groups, according to a report from the Centers for Disease Control and Prevention.
, Anne G. Wheaton, PhD, and Angelika H. Claussen, PhD, said in the Morbidity and Mortality Weekly Report.
Unlike previous reports, this analysis showed that adolescents were less likely than infants to have short sleep duration, 31.2% vs. 40.3%. These latest data are based on the 2016-2018 editions of the National Survey of Children’s Health, and the “difference might be explained by NSCH’s reliance on parent report rather than self-report with Youth Risk Behavior Surveys,” they suggested.
Black children had the highest prevalence of any group included in the study, as parents reported that 50.8% of all ages were not getting the recommended amount of sleep, compared with 39.1% among Hispanics, 34.6% for other races, and 28.8% for Whites. The figure for Black infants was 64.2%, almost double the prevalence for White infants (32.9%), said Dr. Wheaton and Dr. Claussen of the CDC.
Short sleep duration also was more common in children from lower-income families and among those with less educated parents. Geography had an effect as well, with prevalence “highest in the Southeast, similar to geographic variation in adequate sleep observed for adults,” they noted.
Previous research has shown that “sleep disparity was associated with various social determinants of health (e.g., poverty, food insecurity, and perceived racism), which can increase chronic and acute stress and result in environmental and psychological factors that negatively affect sleep duration and can compound long-term health risks,” the investigators wrote.
Short sleep duration by age group was defined as less the following amounts: Twelve hours for infants (4-11 months), 11 hours for children aged 1-2 years, 10 hours for children aged 3-5 years, 9 hours for children aged 6-12, and 8 hours for adolescents (13-17 years), they explained. Responses for the survey’s sleep-duration question totaled 99,842 for the 3 years included.
Just over one-third of children in the United States get less sleep than recommended, with higher rates occurring among several racial/ethnic and socioeconomic groups, according to a report from the Centers for Disease Control and Prevention.
, Anne G. Wheaton, PhD, and Angelika H. Claussen, PhD, said in the Morbidity and Mortality Weekly Report.
Unlike previous reports, this analysis showed that adolescents were less likely than infants to have short sleep duration, 31.2% vs. 40.3%. These latest data are based on the 2016-2018 editions of the National Survey of Children’s Health, and the “difference might be explained by NSCH’s reliance on parent report rather than self-report with Youth Risk Behavior Surveys,” they suggested.
Black children had the highest prevalence of any group included in the study, as parents reported that 50.8% of all ages were not getting the recommended amount of sleep, compared with 39.1% among Hispanics, 34.6% for other races, and 28.8% for Whites. The figure for Black infants was 64.2%, almost double the prevalence for White infants (32.9%), said Dr. Wheaton and Dr. Claussen of the CDC.
Short sleep duration also was more common in children from lower-income families and among those with less educated parents. Geography had an effect as well, with prevalence “highest in the Southeast, similar to geographic variation in adequate sleep observed for adults,” they noted.
Previous research has shown that “sleep disparity was associated with various social determinants of health (e.g., poverty, food insecurity, and perceived racism), which can increase chronic and acute stress and result in environmental and psychological factors that negatively affect sleep duration and can compound long-term health risks,” the investigators wrote.
Short sleep duration by age group was defined as less the following amounts: Twelve hours for infants (4-11 months), 11 hours for children aged 1-2 years, 10 hours for children aged 3-5 years, 9 hours for children aged 6-12, and 8 hours for adolescents (13-17 years), they explained. Responses for the survey’s sleep-duration question totaled 99,842 for the 3 years included.
FROM MMWR