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Exercising to lose weight is not for every ‘body’
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.
Breakthrough infections twice as likely to be asymptomatic
Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.
“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”
For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.
They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.
Likelihood of severe symptoms dropped after one dose
After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.
Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.
When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.
The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.
Findings may have implications for health policies
“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”
The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.
The authors of the paper and Dr. Hijano disclosed no conflicts.
Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.
“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”
For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.
They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.
Likelihood of severe symptoms dropped after one dose
After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.
Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.
When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.
The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.
Findings may have implications for health policies
“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”
The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.
The authors of the paper and Dr. Hijano disclosed no conflicts.
Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.
“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”
For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.
They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.
Likelihood of severe symptoms dropped after one dose
After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.
Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.
When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.
The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.
Findings may have implications for health policies
“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”
The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.
The authors of the paper and Dr. Hijano disclosed no conflicts.
FROM THE LANCET INFECTIOUS DISEASES
2021 AGA Rapid Review and Guideline Update: Pre-endoscopy SARS-CoV-2 testing post vaccination
The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.
Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.
These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.
“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”
The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”
Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.
“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.
The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.
“Across 13 studies, asymptomatic prevalence ranged from 0% to 1.5%, but most studies reported a range from 0% to 0.5%,” the panelists wrote, “regardless of local surges of COVID-19 cases.”
Although Dr. Sultan and colleagues acknowledged that pretesting may be reassuring, they noted that, based on available evidence, “there were few to no cases of infections reported among HCWs (performing endoscopy) and patients. Among the few reported cases, the authors could not clearly distinguish between community-acquired infections or health care–acquired infections.”
They went on to quantify the relationship between delays in care and cancer burden, reviewing data from 14 studies that demonstrated an overall reduction in endoscopic-detected colorectal cancers by 31%-71%, esophageal cancers by 27%-37%, and gastric cancer by 27%-52% since the start of the pandemic. A recent study by Ahmad Khan, MD, and colleagues, which focused on the United States from July to November 2020, demonstrated an 11.74% decrease in diagnoses of malignant colorectal cancer, and a 19.78% decline in diagnoses of esophageal and gastric cancer.
The second recommendation – calling for standard nucleic acid testing among centers electing to maintain a pretesting strategy – was also presented with a summary of supporting evidence, largely pertaining to test accuracy.
“Rapid RT-PCR tests that can be easily performed on the day of endoscopy (results within 1 hour) are preferable as they pose less burden to patients,” the panelists wrote. “In the preprocedure setting, the utility of rapid isothermal tests or antigen tests is limited due to concerns of assay sensitivity. There is no role of antibody tests for preprocedure testing.”
For both new recommendations, it is assumed that “all centers have access to PPE, including face shield, eye protection, and surgical mask or N95 (or N99, powered air-purifying respirators)” and that “all centers have implemented universal screening of patients for COVID-19 symptoms, using a screening checklist, and have implemented universal precautions, including physical distancing, masks, and hand hygiene in the endoscopy unit.”
As COVID-19 cases rise in the United States because of the Delta variant, there is renewed concern about infection and transmission of SARS-CoV2 during endoscopy. Stay tuned for updates and visit https://gastro.org/practice-guidance/practice-updates/covid-19/.
Guideline development was funded by the AGA. No panel members received any payments.
The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.
Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.
These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.
“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”
The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”
Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.
“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.
The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.
“Across 13 studies, asymptomatic prevalence ranged from 0% to 1.5%, but most studies reported a range from 0% to 0.5%,” the panelists wrote, “regardless of local surges of COVID-19 cases.”
Although Dr. Sultan and colleagues acknowledged that pretesting may be reassuring, they noted that, based on available evidence, “there were few to no cases of infections reported among HCWs (performing endoscopy) and patients. Among the few reported cases, the authors could not clearly distinguish between community-acquired infections or health care–acquired infections.”
They went on to quantify the relationship between delays in care and cancer burden, reviewing data from 14 studies that demonstrated an overall reduction in endoscopic-detected colorectal cancers by 31%-71%, esophageal cancers by 27%-37%, and gastric cancer by 27%-52% since the start of the pandemic. A recent study by Ahmad Khan, MD, and colleagues, which focused on the United States from July to November 2020, demonstrated an 11.74% decrease in diagnoses of malignant colorectal cancer, and a 19.78% decline in diagnoses of esophageal and gastric cancer.
The second recommendation – calling for standard nucleic acid testing among centers electing to maintain a pretesting strategy – was also presented with a summary of supporting evidence, largely pertaining to test accuracy.
“Rapid RT-PCR tests that can be easily performed on the day of endoscopy (results within 1 hour) are preferable as they pose less burden to patients,” the panelists wrote. “In the preprocedure setting, the utility of rapid isothermal tests or antigen tests is limited due to concerns of assay sensitivity. There is no role of antibody tests for preprocedure testing.”
For both new recommendations, it is assumed that “all centers have access to PPE, including face shield, eye protection, and surgical mask or N95 (or N99, powered air-purifying respirators)” and that “all centers have implemented universal screening of patients for COVID-19 symptoms, using a screening checklist, and have implemented universal precautions, including physical distancing, masks, and hand hygiene in the endoscopy unit.”
As COVID-19 cases rise in the United States because of the Delta variant, there is renewed concern about infection and transmission of SARS-CoV2 during endoscopy. Stay tuned for updates and visit https://gastro.org/practice-guidance/practice-updates/covid-19/.
Guideline development was funded by the AGA. No panel members received any payments.
The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.
Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.
These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.
“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”
The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”
Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.
“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.
The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.
“Across 13 studies, asymptomatic prevalence ranged from 0% to 1.5%, but most studies reported a range from 0% to 0.5%,” the panelists wrote, “regardless of local surges of COVID-19 cases.”
Although Dr. Sultan and colleagues acknowledged that pretesting may be reassuring, they noted that, based on available evidence, “there were few to no cases of infections reported among HCWs (performing endoscopy) and patients. Among the few reported cases, the authors could not clearly distinguish between community-acquired infections or health care–acquired infections.”
They went on to quantify the relationship between delays in care and cancer burden, reviewing data from 14 studies that demonstrated an overall reduction in endoscopic-detected colorectal cancers by 31%-71%, esophageal cancers by 27%-37%, and gastric cancer by 27%-52% since the start of the pandemic. A recent study by Ahmad Khan, MD, and colleagues, which focused on the United States from July to November 2020, demonstrated an 11.74% decrease in diagnoses of malignant colorectal cancer, and a 19.78% decline in diagnoses of esophageal and gastric cancer.
The second recommendation – calling for standard nucleic acid testing among centers electing to maintain a pretesting strategy – was also presented with a summary of supporting evidence, largely pertaining to test accuracy.
“Rapid RT-PCR tests that can be easily performed on the day of endoscopy (results within 1 hour) are preferable as they pose less burden to patients,” the panelists wrote. “In the preprocedure setting, the utility of rapid isothermal tests or antigen tests is limited due to concerns of assay sensitivity. There is no role of antibody tests for preprocedure testing.”
For both new recommendations, it is assumed that “all centers have access to PPE, including face shield, eye protection, and surgical mask or N95 (or N99, powered air-purifying respirators)” and that “all centers have implemented universal screening of patients for COVID-19 symptoms, using a screening checklist, and have implemented universal precautions, including physical distancing, masks, and hand hygiene in the endoscopy unit.”
As COVID-19 cases rise in the United States because of the Delta variant, there is renewed concern about infection and transmission of SARS-CoV2 during endoscopy. Stay tuned for updates and visit https://gastro.org/practice-guidance/practice-updates/covid-19/.
Guideline development was funded by the AGA. No panel members received any payments.
FROM GASTROENTEROLOGY
MS plus depression can increase risk of death, vascular disease
, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.
The study was published in Neurology.
To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.
People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.
As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
Does treating depression decrease the likelihood of vascular disease?
“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?
“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?
“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
Evaluating the biological interaction between MS and depression
Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.
“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.
“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.
Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.
In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”
Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.
, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.
The study was published in Neurology.
To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.
People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.
As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
Does treating depression decrease the likelihood of vascular disease?
“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?
“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?
“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
Evaluating the biological interaction between MS and depression
Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.
“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.
“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.
Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.
In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”
Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.
, a new study has found. “The effects of depression and MS on all-cause mortality are synergistic,” wrote lead author Raffaele Palladino, MD, PhD, research associate, faculty of medicine, Imperial College London.
The study was published in Neurology.
To assess the association between depression, vascular disease, and death in patients with MS, the researchers launched a population-based retrospective cohort study that reviewed English medical records from January 1987 to December 2018 and matched people with and without MS. Ultimately, 12,251 people with MS were matched with 72,572 controls. At baseline, 21% of the MS group (n = 2,535) and 9% of the controls (n = 6,278) had depression. Women were the majority in both cohorts and were more likely than men to be depressed.
People with both MS and depression had an all-cause mortality rate of 10.3 cases per 100,000 person-years (95% confidence interval, 9.17-11.57), compared with 10.6 for people with MS without depression (95% CI, 9.99-11.21), 3.6 for people with depression but not MS (95% CI, 3.18-4.05), and 2.5 for people with neither condition (95% CI, 2.42-2.64). Compared with controls without depression, the 10-year hazard of all-cause mortality was increasingly greater in controls with depression (hazard ratio, 1.75; 95% CI, 1.59-1.91), people with MS but not depression (HR, 3.88; 95% CI, 3.66-4.10), and people with MS and depression (HR, 5.43; 95% CI, 4.88-5.96). Overall, 14% of the observed effect on mortality was attributable to the interaction between MS status and depression.
As for vascular diseases, people with MS had an increased risk regardless of their depression status. That said, people with MS and depression (HR, 3.30; 95% CI, 2.37-4.23) had a notably higher risk than people with MS and no depression (HR, 1.48; 95% CI, 1.23-1.74). Women with MS and depression also had a greater risk of vascular disease than women with MS and no depression, while men with MS did not have significantly different risks of acute coronary syndrome or composite macrovascular disease than those in the control group who did not suffer from depression.
Does treating depression decrease the likelihood of vascular disease?
“The take-home message for me is the importance of treating depression in this population, in which we see it with great regularity,” Joseph Berger, MD, professor of neurology and associate chief of the multiple sclerosis division at the University of Pennsylvania, Philadelphia, said in an interview. “The question that I have is: If you treat depression in an individual with MS or an individual who is simply depressed and thus at risk for the subsequent development of vascular disease, does it decrease the likelihood of their subsequent development of vascular disease in comparison to had you not?
“I presume it does,” he added, noting that “the theories underlying why depression would increase one’s risk of subsequent vascular disease are enumerated by the authors, including such things as increased inflammation. Now, the inflammation may be contributing to the depression, or the depression may be contributing to the inflammation; it may be one of those chicken-and-egg scenarios. But if you decrease the depression, do you thereby decrease the inflammation, which has a pernicious effect on endothelial cells and increases one’s vascular risk?
“Alternatively, lifestyle in depressed patients is also altered,” he said. “They’re far less likely to engage in exercise, healthy habits, and healthy diets, and more likely perhaps to smoke. These all need to be addressed, but this study certainly gives you a greater impetus as a MS neurologist to address the issue of depression, realizing that there is also this comorbidity of vascular disease.”
Evaluating the biological interaction between MS and depression
Based on this and other studies, the joint effect of MS and depression on all-cause mortality may qualify as a biological interaction, Amber Salter, PhD, of the University of Texas Southwestern Medical Center, Dallas, wrote in an accompanying editorial.
“Biological interactions consider whether the joint effect of two factors follow an additive pattern, or the joint effect of two factors is greater than the sum of the individual effects for each factor alone,” she wrote. And though the interaction was not found to be present for vascular disease and cardiovascular mortality, it was for all-cause mortality.
“When warranted, the evaluation of biological interactions in future studies should be considered to provide insight on target subpopulations for interventions or test for potential mechanistic forms of interaction,” she added.
Dr. Salter highlighted the study’s strengths, including a large sample size and six controls matched to each MS patient. She also stated that the researchers’ inability to control for risk factors like body mass index and physical activity means the 14% increase in mortality “may not be a large absolute increase in mortality when other covariates cannot be considered.” In addition, their lack of data on suicide – and its association with depression – offers up the possibility that increases in mortality could be tied to a “potentially modifiable risk” as opposed to a biologically increased one.
In acknowledging their study’s limitations, the authors stated that body mass index, though an important vascular risk factor, has a “modest” association with mortality, and that the average annual suicide rate in the MS population – though higher than in the non-MS population – is still “relatively low.”
Two of the authors disclosed receiving support, including grants and research funding, from various institutions and organizations in the United Kingdom, the United States, and Canada, as well as several pharmaceutical companies. Dr. Salter reported no relevant disclosures.
FROM NEUROLOGY
Even highly allergic adults unlikely to react to COVID-19 vaccine
published Aug. 31, 2021, in JAMA Network Open. Symptoms resolved in a few hours with medication, and no patients required hospitalization.
Risk for allergic reaction has been one of several obstacles in global vaccination efforts, the authors, led by Nancy Agmon-Levin, MD, of the Sheba Medical Center, Ramat Gan, Israel, wrote. Clinical trials for the Moderna and Pfizer-BioNTech COVID-19 vaccines excluded individuals with allergies to any component of the vaccine or with previous allergies to other vaccines. Early reports of anaphylaxis in reaction to the vaccines caused concern among patients and practitioners. Soon after, the Centers for Disease Control and Prevention and other authorities released guidance on preparing for allergic reactions. “Despite these recommendations, uncertainty remains, particularly among patients with a history of anaphylaxis and/or multiple allergies,” the authors added.
In response to early concerns, the Sheba Medical Center opened a COVID-19 referral center to address safety questions and to conduct assessments of allergy risk for the Pfizer-BioNTech vaccine, the first COVID-19 vaccine approved in Israel. From Dec. 27, 2020, to Feb. 22, 2021, the referral center assessed 8,102 patients with allergies. Those who were not clearly at low risk filled out a questionnaire about prior allergic or anaphylactic reactions to drugs or vaccines, other allergies, and other relevant medical history. Patients were considered to be at high risk for allergic reactions if they met at least one of the following criteria: previous anaphylactic reaction to any drug or vaccine, multiple drug allergies, multiple other allergies, and mast cell disorders. Individuals were also classified as high risk if their health care practitioner deferred vaccination because of allergy concerns.
Nearly 95% of the cohort (7,668 individuals) were classified as low risk and received both Pfizer vaccine doses at standard immunization sites and underwent 30 minutes of observation after immunization. Although the study did not follow these lower-risk patients, “no serious allergic reactions were reported back to our referral center by patients or their general practitioner after immunization in the regular settings,” the authors wrote.
Five patients were considered ineligible for immunization because of known sensitivity to polyethylene glycol or multiple anaphylactic reactions to different injectable drugs, following recommendations from the Ministry of Health of Israel at the time. The remaining 429 individuals were deemed high risk and underwent observation for 2 hours from a dedicated allergy team after immunization. For these high-risk patients, both vaccine doses were administered in the same setting. Patients also reported any adverse reactions in the 21 days between the first and second dose.
Women made up most of the high-risk cohort (70.9%). The average age of participants was 52 years. Of the high-risk individuals, 63.2% reported prior anaphylaxis, 32.9% had multiple drug allergies, and 30.3% had multiple other allergies.
During the first 2 hours following immunization, nine individuals (2.1%), all women, experienced allergic reactions. Six individuals (1.4%) experienced minor reactions, including skin flushing, tongue or uvula swelling, or a cough that resolved with antihistamine treatment during the observation period. Three patients (0.7%) had anaphylactic reactions that occurred 10 to 20 minutes after injection. All three patients experienced significant bronchospasm, skin eruption, itching, and shortness of breath. Two patients experienced angioedema, and one patient had gastrointestinal symptoms. They were treated with adrenaline, antihistamines, and an inhaled bronchodilator. All symptoms resolved within 2-6 hours, and no patient required hospitalization.
In the days following vaccination, patients commonly reported pain at the injection site, fatigue, muscle pain, and headache; 14.7% of patients reported skin eruption, itching, or urticaria.
As of Feb. 22, 2021, 218 patients from this highly allergic cohort received their second dose of the vaccine. Four patients (1.8%) had mild allergic reactions. All four developed flushing, and one patient also developed a cough that resolved with antihistamine treatment. Three of these patients had experienced mild allergic reactions to the first dose and were premedicated for the second dose. One patient only reacted to the second dose.
The findings should be “very reassuring” to individuals hesitant to receive the vaccine, Elizabeth Phillips, MD, the director of the Center for Drug Safety and Immunology at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. She was not involved with the research and wrote an invited commentary on the study. “The rates of anaphylaxis and allergic reactions are truly quite low,” she said. Although about 2% of the high-risk group developed allergic reactions to immunization, the overall percentage for the entire cohort would be much lower.
The study did not investigate specific risk factors for and mechanisms of allergic reactions to COVID-19 vaccines, Dr. Phillips said, which is a study limitation that the authors also acknowledge. The National Institute for Allergy and Infectious Diseases is currently trying to answer some of these questions with a multisite, randomized, double-blinded study. The study is intended to help understand why people have these allergic reactions, Dr. Phillips added. Vanderbilt is one of the sites for the study.
While researchers continue to hunt for answers, the algorithm developed by the authors provides “a great strategy to get people that are at higher risk vaccinated in a monitored setting,” she said. The results show that “people should not be avoiding vaccination because of a history of anaphylaxis.”
Dr. Phillips has received institutional grants from the National Institutes of Health and the National Health and Medical Research Council; royalties from UpToDate and Lexicomp; and consulting fees from Janssen, Vertex, Biocryst, and Regeneron.
A version of this article first appeared on Medscape.com.
published Aug. 31, 2021, in JAMA Network Open. Symptoms resolved in a few hours with medication, and no patients required hospitalization.
Risk for allergic reaction has been one of several obstacles in global vaccination efforts, the authors, led by Nancy Agmon-Levin, MD, of the Sheba Medical Center, Ramat Gan, Israel, wrote. Clinical trials for the Moderna and Pfizer-BioNTech COVID-19 vaccines excluded individuals with allergies to any component of the vaccine or with previous allergies to other vaccines. Early reports of anaphylaxis in reaction to the vaccines caused concern among patients and practitioners. Soon after, the Centers for Disease Control and Prevention and other authorities released guidance on preparing for allergic reactions. “Despite these recommendations, uncertainty remains, particularly among patients with a history of anaphylaxis and/or multiple allergies,” the authors added.
In response to early concerns, the Sheba Medical Center opened a COVID-19 referral center to address safety questions and to conduct assessments of allergy risk for the Pfizer-BioNTech vaccine, the first COVID-19 vaccine approved in Israel. From Dec. 27, 2020, to Feb. 22, 2021, the referral center assessed 8,102 patients with allergies. Those who were not clearly at low risk filled out a questionnaire about prior allergic or anaphylactic reactions to drugs or vaccines, other allergies, and other relevant medical history. Patients were considered to be at high risk for allergic reactions if they met at least one of the following criteria: previous anaphylactic reaction to any drug or vaccine, multiple drug allergies, multiple other allergies, and mast cell disorders. Individuals were also classified as high risk if their health care practitioner deferred vaccination because of allergy concerns.
Nearly 95% of the cohort (7,668 individuals) were classified as low risk and received both Pfizer vaccine doses at standard immunization sites and underwent 30 minutes of observation after immunization. Although the study did not follow these lower-risk patients, “no serious allergic reactions were reported back to our referral center by patients or their general practitioner after immunization in the regular settings,” the authors wrote.
Five patients were considered ineligible for immunization because of known sensitivity to polyethylene glycol or multiple anaphylactic reactions to different injectable drugs, following recommendations from the Ministry of Health of Israel at the time. The remaining 429 individuals were deemed high risk and underwent observation for 2 hours from a dedicated allergy team after immunization. For these high-risk patients, both vaccine doses were administered in the same setting. Patients also reported any adverse reactions in the 21 days between the first and second dose.
Women made up most of the high-risk cohort (70.9%). The average age of participants was 52 years. Of the high-risk individuals, 63.2% reported prior anaphylaxis, 32.9% had multiple drug allergies, and 30.3% had multiple other allergies.
During the first 2 hours following immunization, nine individuals (2.1%), all women, experienced allergic reactions. Six individuals (1.4%) experienced minor reactions, including skin flushing, tongue or uvula swelling, or a cough that resolved with antihistamine treatment during the observation period. Three patients (0.7%) had anaphylactic reactions that occurred 10 to 20 minutes after injection. All three patients experienced significant bronchospasm, skin eruption, itching, and shortness of breath. Two patients experienced angioedema, and one patient had gastrointestinal symptoms. They were treated with adrenaline, antihistamines, and an inhaled bronchodilator. All symptoms resolved within 2-6 hours, and no patient required hospitalization.
In the days following vaccination, patients commonly reported pain at the injection site, fatigue, muscle pain, and headache; 14.7% of patients reported skin eruption, itching, or urticaria.
As of Feb. 22, 2021, 218 patients from this highly allergic cohort received their second dose of the vaccine. Four patients (1.8%) had mild allergic reactions. All four developed flushing, and one patient also developed a cough that resolved with antihistamine treatment. Three of these patients had experienced mild allergic reactions to the first dose and were premedicated for the second dose. One patient only reacted to the second dose.
The findings should be “very reassuring” to individuals hesitant to receive the vaccine, Elizabeth Phillips, MD, the director of the Center for Drug Safety and Immunology at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. She was not involved with the research and wrote an invited commentary on the study. “The rates of anaphylaxis and allergic reactions are truly quite low,” she said. Although about 2% of the high-risk group developed allergic reactions to immunization, the overall percentage for the entire cohort would be much lower.
The study did not investigate specific risk factors for and mechanisms of allergic reactions to COVID-19 vaccines, Dr. Phillips said, which is a study limitation that the authors also acknowledge. The National Institute for Allergy and Infectious Diseases is currently trying to answer some of these questions with a multisite, randomized, double-blinded study. The study is intended to help understand why people have these allergic reactions, Dr. Phillips added. Vanderbilt is one of the sites for the study.
While researchers continue to hunt for answers, the algorithm developed by the authors provides “a great strategy to get people that are at higher risk vaccinated in a monitored setting,” she said. The results show that “people should not be avoiding vaccination because of a history of anaphylaxis.”
Dr. Phillips has received institutional grants from the National Institutes of Health and the National Health and Medical Research Council; royalties from UpToDate and Lexicomp; and consulting fees from Janssen, Vertex, Biocryst, and Regeneron.
A version of this article first appeared on Medscape.com.
published Aug. 31, 2021, in JAMA Network Open. Symptoms resolved in a few hours with medication, and no patients required hospitalization.
Risk for allergic reaction has been one of several obstacles in global vaccination efforts, the authors, led by Nancy Agmon-Levin, MD, of the Sheba Medical Center, Ramat Gan, Israel, wrote. Clinical trials for the Moderna and Pfizer-BioNTech COVID-19 vaccines excluded individuals with allergies to any component of the vaccine or with previous allergies to other vaccines. Early reports of anaphylaxis in reaction to the vaccines caused concern among patients and practitioners. Soon after, the Centers for Disease Control and Prevention and other authorities released guidance on preparing for allergic reactions. “Despite these recommendations, uncertainty remains, particularly among patients with a history of anaphylaxis and/or multiple allergies,” the authors added.
In response to early concerns, the Sheba Medical Center opened a COVID-19 referral center to address safety questions and to conduct assessments of allergy risk for the Pfizer-BioNTech vaccine, the first COVID-19 vaccine approved in Israel. From Dec. 27, 2020, to Feb. 22, 2021, the referral center assessed 8,102 patients with allergies. Those who were not clearly at low risk filled out a questionnaire about prior allergic or anaphylactic reactions to drugs or vaccines, other allergies, and other relevant medical history. Patients were considered to be at high risk for allergic reactions if they met at least one of the following criteria: previous anaphylactic reaction to any drug or vaccine, multiple drug allergies, multiple other allergies, and mast cell disorders. Individuals were also classified as high risk if their health care practitioner deferred vaccination because of allergy concerns.
Nearly 95% of the cohort (7,668 individuals) were classified as low risk and received both Pfizer vaccine doses at standard immunization sites and underwent 30 minutes of observation after immunization. Although the study did not follow these lower-risk patients, “no serious allergic reactions were reported back to our referral center by patients or their general practitioner after immunization in the regular settings,” the authors wrote.
Five patients were considered ineligible for immunization because of known sensitivity to polyethylene glycol or multiple anaphylactic reactions to different injectable drugs, following recommendations from the Ministry of Health of Israel at the time. The remaining 429 individuals were deemed high risk and underwent observation for 2 hours from a dedicated allergy team after immunization. For these high-risk patients, both vaccine doses were administered in the same setting. Patients also reported any adverse reactions in the 21 days between the first and second dose.
Women made up most of the high-risk cohort (70.9%). The average age of participants was 52 years. Of the high-risk individuals, 63.2% reported prior anaphylaxis, 32.9% had multiple drug allergies, and 30.3% had multiple other allergies.
During the first 2 hours following immunization, nine individuals (2.1%), all women, experienced allergic reactions. Six individuals (1.4%) experienced minor reactions, including skin flushing, tongue or uvula swelling, or a cough that resolved with antihistamine treatment during the observation period. Three patients (0.7%) had anaphylactic reactions that occurred 10 to 20 minutes after injection. All three patients experienced significant bronchospasm, skin eruption, itching, and shortness of breath. Two patients experienced angioedema, and one patient had gastrointestinal symptoms. They were treated with adrenaline, antihistamines, and an inhaled bronchodilator. All symptoms resolved within 2-6 hours, and no patient required hospitalization.
In the days following vaccination, patients commonly reported pain at the injection site, fatigue, muscle pain, and headache; 14.7% of patients reported skin eruption, itching, or urticaria.
As of Feb. 22, 2021, 218 patients from this highly allergic cohort received their second dose of the vaccine. Four patients (1.8%) had mild allergic reactions. All four developed flushing, and one patient also developed a cough that resolved with antihistamine treatment. Three of these patients had experienced mild allergic reactions to the first dose and were premedicated for the second dose. One patient only reacted to the second dose.
The findings should be “very reassuring” to individuals hesitant to receive the vaccine, Elizabeth Phillips, MD, the director of the Center for Drug Safety and Immunology at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. She was not involved with the research and wrote an invited commentary on the study. “The rates of anaphylaxis and allergic reactions are truly quite low,” she said. Although about 2% of the high-risk group developed allergic reactions to immunization, the overall percentage for the entire cohort would be much lower.
The study did not investigate specific risk factors for and mechanisms of allergic reactions to COVID-19 vaccines, Dr. Phillips said, which is a study limitation that the authors also acknowledge. The National Institute for Allergy and Infectious Diseases is currently trying to answer some of these questions with a multisite, randomized, double-blinded study. The study is intended to help understand why people have these allergic reactions, Dr. Phillips added. Vanderbilt is one of the sites for the study.
While researchers continue to hunt for answers, the algorithm developed by the authors provides “a great strategy to get people that are at higher risk vaccinated in a monitored setting,” she said. The results show that “people should not be avoiding vaccination because of a history of anaphylaxis.”
Dr. Phillips has received institutional grants from the National Institutes of Health and the National Health and Medical Research Council; royalties from UpToDate and Lexicomp; and consulting fees from Janssen, Vertex, Biocryst, and Regeneron.
A version of this article first appeared on Medscape.com.
Bystander rescue breathing CPR in kids tied to better survival
Children who receive CPR with both rescue breathing and compressions from a bystander have greater odds of survival without serious brain damage than if they receive CPR with compressions only, according to a study published online in the Journal of the American College of Cardiology.
Specifically, a child has a 61% better chance of surviving with good neurologic outcomes if they receive compression-only CPR versus no bystander resuscitation, but that child is more than twice as likely to survive if he or she receives rescue breathing as well.
The study’s clinical implications are most important for bystander CPR training, lead author Maryam Y. Naim, MD, MSCE, of the Children’s Hospital of Philadelphia and the University of Pennsylvania, also in Philadelphia, told this news organization.
“Many programs teach compression-only CPR to lay rescuers, and there should be a renewed emphasis on rescue breathing for the possibility a lay rescuer has to perform CPR on a child,” Dr. Naim said.
That said, if a bystander is unfamiliar with how to properly administer rescue breathing or has concerns about hygiene or infection on someone they don’t know, Dr. Naim advises doing compression-only CPR, especially if the child is older than age 1 year. “If a child is younger than a year of age please consider giving rescue breaths with chest compressions,” she added.
Dr. Naim and colleagues analyzed 13,060 pediatric out-of-hospital cardiac arrests from the Cardiac Arrest Registry to Enhance Survival database, which includes data from 911 call centers, emergency medical services (EMS) providers, and receiving hospitals across 28 states. The data sample included all cases age 18 years or younger who experienced nontraumatic out-of-hospital cardiac arrest between January 2013 and December 2019, excluding those with obvious signs of death or a “do not resuscitate” order.
“Because the etiology of cardiac arrest in children is difficult to determine, especially in cases that result in death, all nontraumatic cases were included regardless of presumed etiology, including respiratory, cardiac, drowning, electrocution, or other,” the authors wrote. The researchers defined neurologically favorable survival, the primary endpoint, as “a cerebral performance category score of 1 (no neurologic disability) or 2 (moderate disability)” at discharge. Neurologically unfavorable survival included a score of 3 (severe disability), 4 (coma or vegetative state), or death.
Among the 10,429 cases ultimately analyzed after exclusions and missing data, 46.5% received bystander CPR. Slightly more than half of these (55.6%) received compression-only CPR while the other 45.3% received rescue-breathing CPR.
Dr. Naim was surprised that compression-only CPR was the most common form of CPR given to children with cardiac arrest because the current American Heart Association/International Liaison Committee on Resuscitation recommendations note rescue breathing as the preferred form in children.
That preference exists because respiratory failure occurs more often in children than in adults as a cause of cardiac arrest, explained Sandra Weiss, MD, an interventional cardiologist and the medical director of the cardiac intensive care unit at ChristianaCare’s Christiana Hospital in Newark, Del.
Because of that, “it’s not surprising that if you give respiratory resuscitation to a child who’s arresting from a respiratory cause that they’re going to do better than if you just do chest compressions,” said Dr. Weiss, who was not involved in the study.
The study found the most common presumed cause of arrest to be cardiac, occurring in 44.4% of cases, but it was closely followed by respiratory in nearly one-third of cases (32.8%).
Infants younger than age 1 year were the most common age group to have a cardiac arrest, making up more than all other ages combined. Most out-of-hospital cardiac arrests occurred in a home and were observed by someone when they happened. While rates of bystander CPR did not change during the study’s 6-year period, the incidence of compression-only CPR increased. Lay people without medical training provided the CPR in 93.6% of cases.
Only 8.6% of cardiac arrest cases resulted in neurologically favorable survival, a rate which remained steady throughout the study period. The rate increased with increasing age, at 4.6% of infants, 10.6% of children, and 16.5% of adolescents.
Those who received CPR with rescue breathing had more than double the odds of neurologically favorable survival than if they hadn’t received CPR at all (adjusted odds ratio, 2.16). Survival with a positive neurologic outcome was 1.6 times more likely with compression-only CPR than no CPR (aOR, 1.61). When researchers compared the two forms of CPR, inclusion of rescue breathing increased the child’s likelihood of survival without neurologic sequelae by 36% (aOR, 1.36).
Despite these findings, however, Dr. Weiss agrees with Dr. Naim that offering compression-only CPR is preferable to offering no CPR at all.
“All resuscitation is better than no resuscitation, regardless of whether it’s compression only or respiratory breathing,” Dr. Weiss said in an interview. “The average lay person is probably going to do the easiest thing, and survivability is going to be increased by doing anything rather than nothing.”
Dr. Weiss also noted that it’s easier to instruct people how to do chest compressions, especially, for example, during an emergency phone call with a dispatcher while waiting for EMS to arrive.
“It’s absolutely imperative for people to get the basics, and the basics are compressions,” she said. “That’s really what is the most vital component of all resuscitative efforts, regardless of whether it’s adult or pediatrics.”
Dr. Weiss also acknowledges that laypeople may feel particularly less comfortable administering rescue breaths to a child they don’t know in the midst of the COVID-19 pandemic. Even if the odds are low that the specific child experiencing a cardiac arrest is necessarily infectious, the AHA guidelines include the caveat that, “if there’s a concern for infection transmissibility, that compression only is acceptable,” Dr. Weiss said. “It’s a reality for our current state.”
The superiority of rescue-breathing CPR to compression-only CPR was true across all age groups, but compression-only CPR still resulted in better survival odds than no CPR at all for all age groups except infants, in whom only rescue breathing was associated with a statistically significant increased likelihood of neurologically favorable survival.
Protective factors for positive outcomes included being younger than age 1 year, the arrest being witnessed, and a having shockable rhythm. Risk factors reducing survival included being Black, being in a home, and cardiac arrests linked with automated external defibrillator use before EMS arrived.
The CARES program was previously funded by the Centers for Disease Control and Prevention and is now funded by the American Red Cross, the AHA, Stryker, and Emory University. Dr. Naim was further supported by Children’s Hospital of Philadelphia and the American Red Cross. The authors and Dr. Weiss disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Children who receive CPR with both rescue breathing and compressions from a bystander have greater odds of survival without serious brain damage than if they receive CPR with compressions only, according to a study published online in the Journal of the American College of Cardiology.
Specifically, a child has a 61% better chance of surviving with good neurologic outcomes if they receive compression-only CPR versus no bystander resuscitation, but that child is more than twice as likely to survive if he or she receives rescue breathing as well.
The study’s clinical implications are most important for bystander CPR training, lead author Maryam Y. Naim, MD, MSCE, of the Children’s Hospital of Philadelphia and the University of Pennsylvania, also in Philadelphia, told this news organization.
“Many programs teach compression-only CPR to lay rescuers, and there should be a renewed emphasis on rescue breathing for the possibility a lay rescuer has to perform CPR on a child,” Dr. Naim said.
That said, if a bystander is unfamiliar with how to properly administer rescue breathing or has concerns about hygiene or infection on someone they don’t know, Dr. Naim advises doing compression-only CPR, especially if the child is older than age 1 year. “If a child is younger than a year of age please consider giving rescue breaths with chest compressions,” she added.
Dr. Naim and colleagues analyzed 13,060 pediatric out-of-hospital cardiac arrests from the Cardiac Arrest Registry to Enhance Survival database, which includes data from 911 call centers, emergency medical services (EMS) providers, and receiving hospitals across 28 states. The data sample included all cases age 18 years or younger who experienced nontraumatic out-of-hospital cardiac arrest between January 2013 and December 2019, excluding those with obvious signs of death or a “do not resuscitate” order.
“Because the etiology of cardiac arrest in children is difficult to determine, especially in cases that result in death, all nontraumatic cases were included regardless of presumed etiology, including respiratory, cardiac, drowning, electrocution, or other,” the authors wrote. The researchers defined neurologically favorable survival, the primary endpoint, as “a cerebral performance category score of 1 (no neurologic disability) or 2 (moderate disability)” at discharge. Neurologically unfavorable survival included a score of 3 (severe disability), 4 (coma or vegetative state), or death.
Among the 10,429 cases ultimately analyzed after exclusions and missing data, 46.5% received bystander CPR. Slightly more than half of these (55.6%) received compression-only CPR while the other 45.3% received rescue-breathing CPR.
Dr. Naim was surprised that compression-only CPR was the most common form of CPR given to children with cardiac arrest because the current American Heart Association/International Liaison Committee on Resuscitation recommendations note rescue breathing as the preferred form in children.
That preference exists because respiratory failure occurs more often in children than in adults as a cause of cardiac arrest, explained Sandra Weiss, MD, an interventional cardiologist and the medical director of the cardiac intensive care unit at ChristianaCare’s Christiana Hospital in Newark, Del.
Because of that, “it’s not surprising that if you give respiratory resuscitation to a child who’s arresting from a respiratory cause that they’re going to do better than if you just do chest compressions,” said Dr. Weiss, who was not involved in the study.
The study found the most common presumed cause of arrest to be cardiac, occurring in 44.4% of cases, but it was closely followed by respiratory in nearly one-third of cases (32.8%).
Infants younger than age 1 year were the most common age group to have a cardiac arrest, making up more than all other ages combined. Most out-of-hospital cardiac arrests occurred in a home and were observed by someone when they happened. While rates of bystander CPR did not change during the study’s 6-year period, the incidence of compression-only CPR increased. Lay people without medical training provided the CPR in 93.6% of cases.
Only 8.6% of cardiac arrest cases resulted in neurologically favorable survival, a rate which remained steady throughout the study period. The rate increased with increasing age, at 4.6% of infants, 10.6% of children, and 16.5% of adolescents.
Those who received CPR with rescue breathing had more than double the odds of neurologically favorable survival than if they hadn’t received CPR at all (adjusted odds ratio, 2.16). Survival with a positive neurologic outcome was 1.6 times more likely with compression-only CPR than no CPR (aOR, 1.61). When researchers compared the two forms of CPR, inclusion of rescue breathing increased the child’s likelihood of survival without neurologic sequelae by 36% (aOR, 1.36).
Despite these findings, however, Dr. Weiss agrees with Dr. Naim that offering compression-only CPR is preferable to offering no CPR at all.
“All resuscitation is better than no resuscitation, regardless of whether it’s compression only or respiratory breathing,” Dr. Weiss said in an interview. “The average lay person is probably going to do the easiest thing, and survivability is going to be increased by doing anything rather than nothing.”
Dr. Weiss also noted that it’s easier to instruct people how to do chest compressions, especially, for example, during an emergency phone call with a dispatcher while waiting for EMS to arrive.
“It’s absolutely imperative for people to get the basics, and the basics are compressions,” she said. “That’s really what is the most vital component of all resuscitative efforts, regardless of whether it’s adult or pediatrics.”
Dr. Weiss also acknowledges that laypeople may feel particularly less comfortable administering rescue breaths to a child they don’t know in the midst of the COVID-19 pandemic. Even if the odds are low that the specific child experiencing a cardiac arrest is necessarily infectious, the AHA guidelines include the caveat that, “if there’s a concern for infection transmissibility, that compression only is acceptable,” Dr. Weiss said. “It’s a reality for our current state.”
The superiority of rescue-breathing CPR to compression-only CPR was true across all age groups, but compression-only CPR still resulted in better survival odds than no CPR at all for all age groups except infants, in whom only rescue breathing was associated with a statistically significant increased likelihood of neurologically favorable survival.
Protective factors for positive outcomes included being younger than age 1 year, the arrest being witnessed, and a having shockable rhythm. Risk factors reducing survival included being Black, being in a home, and cardiac arrests linked with automated external defibrillator use before EMS arrived.
The CARES program was previously funded by the Centers for Disease Control and Prevention and is now funded by the American Red Cross, the AHA, Stryker, and Emory University. Dr. Naim was further supported by Children’s Hospital of Philadelphia and the American Red Cross. The authors and Dr. Weiss disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Children who receive CPR with both rescue breathing and compressions from a bystander have greater odds of survival without serious brain damage than if they receive CPR with compressions only, according to a study published online in the Journal of the American College of Cardiology.
Specifically, a child has a 61% better chance of surviving with good neurologic outcomes if they receive compression-only CPR versus no bystander resuscitation, but that child is more than twice as likely to survive if he or she receives rescue breathing as well.
The study’s clinical implications are most important for bystander CPR training, lead author Maryam Y. Naim, MD, MSCE, of the Children’s Hospital of Philadelphia and the University of Pennsylvania, also in Philadelphia, told this news organization.
“Many programs teach compression-only CPR to lay rescuers, and there should be a renewed emphasis on rescue breathing for the possibility a lay rescuer has to perform CPR on a child,” Dr. Naim said.
That said, if a bystander is unfamiliar with how to properly administer rescue breathing or has concerns about hygiene or infection on someone they don’t know, Dr. Naim advises doing compression-only CPR, especially if the child is older than age 1 year. “If a child is younger than a year of age please consider giving rescue breaths with chest compressions,” she added.
Dr. Naim and colleagues analyzed 13,060 pediatric out-of-hospital cardiac arrests from the Cardiac Arrest Registry to Enhance Survival database, which includes data from 911 call centers, emergency medical services (EMS) providers, and receiving hospitals across 28 states. The data sample included all cases age 18 years or younger who experienced nontraumatic out-of-hospital cardiac arrest between January 2013 and December 2019, excluding those with obvious signs of death or a “do not resuscitate” order.
“Because the etiology of cardiac arrest in children is difficult to determine, especially in cases that result in death, all nontraumatic cases were included regardless of presumed etiology, including respiratory, cardiac, drowning, electrocution, or other,” the authors wrote. The researchers defined neurologically favorable survival, the primary endpoint, as “a cerebral performance category score of 1 (no neurologic disability) or 2 (moderate disability)” at discharge. Neurologically unfavorable survival included a score of 3 (severe disability), 4 (coma or vegetative state), or death.
Among the 10,429 cases ultimately analyzed after exclusions and missing data, 46.5% received bystander CPR. Slightly more than half of these (55.6%) received compression-only CPR while the other 45.3% received rescue-breathing CPR.
Dr. Naim was surprised that compression-only CPR was the most common form of CPR given to children with cardiac arrest because the current American Heart Association/International Liaison Committee on Resuscitation recommendations note rescue breathing as the preferred form in children.
That preference exists because respiratory failure occurs more often in children than in adults as a cause of cardiac arrest, explained Sandra Weiss, MD, an interventional cardiologist and the medical director of the cardiac intensive care unit at ChristianaCare’s Christiana Hospital in Newark, Del.
Because of that, “it’s not surprising that if you give respiratory resuscitation to a child who’s arresting from a respiratory cause that they’re going to do better than if you just do chest compressions,” said Dr. Weiss, who was not involved in the study.
The study found the most common presumed cause of arrest to be cardiac, occurring in 44.4% of cases, but it was closely followed by respiratory in nearly one-third of cases (32.8%).
Infants younger than age 1 year were the most common age group to have a cardiac arrest, making up more than all other ages combined. Most out-of-hospital cardiac arrests occurred in a home and were observed by someone when they happened. While rates of bystander CPR did not change during the study’s 6-year period, the incidence of compression-only CPR increased. Lay people without medical training provided the CPR in 93.6% of cases.
Only 8.6% of cardiac arrest cases resulted in neurologically favorable survival, a rate which remained steady throughout the study period. The rate increased with increasing age, at 4.6% of infants, 10.6% of children, and 16.5% of adolescents.
Those who received CPR with rescue breathing had more than double the odds of neurologically favorable survival than if they hadn’t received CPR at all (adjusted odds ratio, 2.16). Survival with a positive neurologic outcome was 1.6 times more likely with compression-only CPR than no CPR (aOR, 1.61). When researchers compared the two forms of CPR, inclusion of rescue breathing increased the child’s likelihood of survival without neurologic sequelae by 36% (aOR, 1.36).
Despite these findings, however, Dr. Weiss agrees with Dr. Naim that offering compression-only CPR is preferable to offering no CPR at all.
“All resuscitation is better than no resuscitation, regardless of whether it’s compression only or respiratory breathing,” Dr. Weiss said in an interview. “The average lay person is probably going to do the easiest thing, and survivability is going to be increased by doing anything rather than nothing.”
Dr. Weiss also noted that it’s easier to instruct people how to do chest compressions, especially, for example, during an emergency phone call with a dispatcher while waiting for EMS to arrive.
“It’s absolutely imperative for people to get the basics, and the basics are compressions,” she said. “That’s really what is the most vital component of all resuscitative efforts, regardless of whether it’s adult or pediatrics.”
Dr. Weiss also acknowledges that laypeople may feel particularly less comfortable administering rescue breaths to a child they don’t know in the midst of the COVID-19 pandemic. Even if the odds are low that the specific child experiencing a cardiac arrest is necessarily infectious, the AHA guidelines include the caveat that, “if there’s a concern for infection transmissibility, that compression only is acceptable,” Dr. Weiss said. “It’s a reality for our current state.”
The superiority of rescue-breathing CPR to compression-only CPR was true across all age groups, but compression-only CPR still resulted in better survival odds than no CPR at all for all age groups except infants, in whom only rescue breathing was associated with a statistically significant increased likelihood of neurologically favorable survival.
Protective factors for positive outcomes included being younger than age 1 year, the arrest being witnessed, and a having shockable rhythm. Risk factors reducing survival included being Black, being in a home, and cardiac arrests linked with automated external defibrillator use before EMS arrived.
The CARES program was previously funded by the Centers for Disease Control and Prevention and is now funded by the American Red Cross, the AHA, Stryker, and Emory University. Dr. Naim was further supported by Children’s Hospital of Philadelphia and the American Red Cross. The authors and Dr. Weiss disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Malaria study shows remarkable 70% reduction in severe disease and death
A new study from Africa shows a remarkable 70% reduction in malaria if two treatments — a vaccine and an antimalarial medication — are combined instead of giving them individually.
Malaria is endemic in the tropics. The World Health Organization (WHO) reports that in 2019, there were 229 million cases and 409,000 deaths from this parasitic infection. Most of the burden (94%) occurs in Africa, and children younger than age 5 account for 67% of the deaths.
In the Sahel region of Africa, a broad, sub-Saharan band that stretches across the continent, high malaria transmission is seasonal. Children in some countries there are treated with monthly courses of sulfadoxine-pyrimethamine and amodiaquine chemoprophylaxis during the four higher-risk months. Such seasonal malaria chemoprophylaxis (SMC) has been shown to reduce infections by up to 88% and costs an average of $3.43 per child per year.
This double-blind, randomized controlled trial enrolled young children (5-17 months old) in Burkina Faso and Mali, where SMC is the current treatment regimen. Nearly 6,000 children received either chemoprophylaxis, the RTS,S/AS01E malaria vaccine (RTS,S), or both treatments. The study, led by investigators at the London School of Hygiene and Tropical Medicine (LSHTM), was reported in the New England Journal of Medicine.
Co-lead investigator Daniel Chandramohan, MBBS, PhD, MSc, professor of public health at LSHTM, said in an interview that SMC administration is quite labor-intensive and that “we thought we can replace these four cycles of seasonal cure prevention with one seasonal vaccination like the flu vaccine ... and that there might be some additive benefit.”
Instead, the study found the combination reduces the incidence of malaria by 62% against clinical malaria infection, 70% against severe malaria, and 73% against death from malaria compared with SMC alone. “Not in our wildest dreams would I have hypothesized that this is a possibility,” Dr. Chandramohan said. He continued that this was unlikely a “freak result” because the findings are “consistent between both countries. Two, it is consistent across the years. Three, all the malaria outcomes ... are consistently showing the protective effect at the same level.”
To maintain the blinded study design, children received injections of rabies vaccine and hepatitis A vaccine instead of a placebo for RTS,S. Both were chosen to provide additional benefits by protecting children against those infections.
With so many children followed over years, accuracy in providing the correct treatment for each study arm can be difficult. Each child was given a QR code and picture identification to facilitate drug distribution each year in this study.
Miriam K. Laufer, MD, professor and associate director for malaria research at the University of Maryland, Baltimore, who was not involved in the study, said in an interview, “This is a spectacular result, you know, decreasing disease by 60%-70% using interventions that we already have.”
RTS,S is not a new vaccine; it was developed in 2001 by GlaxoSmithKline with Path’s Malaria Vaccine Initiative, then manufactured by GSK. The Gates Foundation has supported production. Dr. Chandramohan said GSK has transferred the technology to Bharat, in India, and that it will take 2-3 years to ramp up production. Until then, enough vaccine is available to supply Kenya, Malawi, and Ghana, where the pilot studies are being done.
Dr. Laufer stressed that the “group that got RTS,S did as well as the group that received SMC.” She noted that the use of SMC is limited to specific areas of the Sahel sub-region of Africa, with a brief transmission period. In other areas of Africa where malaria has a longer transmission period, SMC isn’t as effective. “RTS,S vaccine could really have an impact” there, she added.
Asked if RTS,S might be substituted for SMC to reduce the likelihood of resistance emerging, Dr. Laufer said, “Giving RTS,S vaccine is as good as using repeated treatment of malaria drugs during the malaria season. And that’s important for two reasons. One is that the advantage of a vaccine is that you’re not producing pressure of drugs that would enable drug resistance to emerge and spread. So maybe your vaccine efficacy could last longer than drug efficacy. We don’t know the answer to that.”
Hypothesizing about the unexpectedly good trial results, Dr. Laufer explained, “We know that RTS,S decreases the number of parasites that make it into the blood when a child is bitten by an infected mosquito. When drugs like sulfadoxine-pyrimethamine and amodiaquine that have moderate efficacy only have to kill off a small number of parasites, they can work better. Maybe that explains why the combination of RTS,S and SMC created such a positive outcome.”
Dr. Laufer echoed Chandramohan, saying, “Results were much more dramatic than anybody – certainly than I anticipated.” Both physicians anticipate that WHO will give full approval for this combination this fall.
Dr. Chandramohan and Dr. Laufer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study from Africa shows a remarkable 70% reduction in malaria if two treatments — a vaccine and an antimalarial medication — are combined instead of giving them individually.
Malaria is endemic in the tropics. The World Health Organization (WHO) reports that in 2019, there were 229 million cases and 409,000 deaths from this parasitic infection. Most of the burden (94%) occurs in Africa, and children younger than age 5 account for 67% of the deaths.
In the Sahel region of Africa, a broad, sub-Saharan band that stretches across the continent, high malaria transmission is seasonal. Children in some countries there are treated with monthly courses of sulfadoxine-pyrimethamine and amodiaquine chemoprophylaxis during the four higher-risk months. Such seasonal malaria chemoprophylaxis (SMC) has been shown to reduce infections by up to 88% and costs an average of $3.43 per child per year.
This double-blind, randomized controlled trial enrolled young children (5-17 months old) in Burkina Faso and Mali, where SMC is the current treatment regimen. Nearly 6,000 children received either chemoprophylaxis, the RTS,S/AS01E malaria vaccine (RTS,S), or both treatments. The study, led by investigators at the London School of Hygiene and Tropical Medicine (LSHTM), was reported in the New England Journal of Medicine.
Co-lead investigator Daniel Chandramohan, MBBS, PhD, MSc, professor of public health at LSHTM, said in an interview that SMC administration is quite labor-intensive and that “we thought we can replace these four cycles of seasonal cure prevention with one seasonal vaccination like the flu vaccine ... and that there might be some additive benefit.”
Instead, the study found the combination reduces the incidence of malaria by 62% against clinical malaria infection, 70% against severe malaria, and 73% against death from malaria compared with SMC alone. “Not in our wildest dreams would I have hypothesized that this is a possibility,” Dr. Chandramohan said. He continued that this was unlikely a “freak result” because the findings are “consistent between both countries. Two, it is consistent across the years. Three, all the malaria outcomes ... are consistently showing the protective effect at the same level.”
To maintain the blinded study design, children received injections of rabies vaccine and hepatitis A vaccine instead of a placebo for RTS,S. Both were chosen to provide additional benefits by protecting children against those infections.
With so many children followed over years, accuracy in providing the correct treatment for each study arm can be difficult. Each child was given a QR code and picture identification to facilitate drug distribution each year in this study.
Miriam K. Laufer, MD, professor and associate director for malaria research at the University of Maryland, Baltimore, who was not involved in the study, said in an interview, “This is a spectacular result, you know, decreasing disease by 60%-70% using interventions that we already have.”
RTS,S is not a new vaccine; it was developed in 2001 by GlaxoSmithKline with Path’s Malaria Vaccine Initiative, then manufactured by GSK. The Gates Foundation has supported production. Dr. Chandramohan said GSK has transferred the technology to Bharat, in India, and that it will take 2-3 years to ramp up production. Until then, enough vaccine is available to supply Kenya, Malawi, and Ghana, where the pilot studies are being done.
Dr. Laufer stressed that the “group that got RTS,S did as well as the group that received SMC.” She noted that the use of SMC is limited to specific areas of the Sahel sub-region of Africa, with a brief transmission period. In other areas of Africa where malaria has a longer transmission period, SMC isn’t as effective. “RTS,S vaccine could really have an impact” there, she added.
Asked if RTS,S might be substituted for SMC to reduce the likelihood of resistance emerging, Dr. Laufer said, “Giving RTS,S vaccine is as good as using repeated treatment of malaria drugs during the malaria season. And that’s important for two reasons. One is that the advantage of a vaccine is that you’re not producing pressure of drugs that would enable drug resistance to emerge and spread. So maybe your vaccine efficacy could last longer than drug efficacy. We don’t know the answer to that.”
Hypothesizing about the unexpectedly good trial results, Dr. Laufer explained, “We know that RTS,S decreases the number of parasites that make it into the blood when a child is bitten by an infected mosquito. When drugs like sulfadoxine-pyrimethamine and amodiaquine that have moderate efficacy only have to kill off a small number of parasites, they can work better. Maybe that explains why the combination of RTS,S and SMC created such a positive outcome.”
Dr. Laufer echoed Chandramohan, saying, “Results were much more dramatic than anybody – certainly than I anticipated.” Both physicians anticipate that WHO will give full approval for this combination this fall.
Dr. Chandramohan and Dr. Laufer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study from Africa shows a remarkable 70% reduction in malaria if two treatments — a vaccine and an antimalarial medication — are combined instead of giving them individually.
Malaria is endemic in the tropics. The World Health Organization (WHO) reports that in 2019, there were 229 million cases and 409,000 deaths from this parasitic infection. Most of the burden (94%) occurs in Africa, and children younger than age 5 account for 67% of the deaths.
In the Sahel region of Africa, a broad, sub-Saharan band that stretches across the continent, high malaria transmission is seasonal. Children in some countries there are treated with monthly courses of sulfadoxine-pyrimethamine and amodiaquine chemoprophylaxis during the four higher-risk months. Such seasonal malaria chemoprophylaxis (SMC) has been shown to reduce infections by up to 88% and costs an average of $3.43 per child per year.
This double-blind, randomized controlled trial enrolled young children (5-17 months old) in Burkina Faso and Mali, where SMC is the current treatment regimen. Nearly 6,000 children received either chemoprophylaxis, the RTS,S/AS01E malaria vaccine (RTS,S), or both treatments. The study, led by investigators at the London School of Hygiene and Tropical Medicine (LSHTM), was reported in the New England Journal of Medicine.
Co-lead investigator Daniel Chandramohan, MBBS, PhD, MSc, professor of public health at LSHTM, said in an interview that SMC administration is quite labor-intensive and that “we thought we can replace these four cycles of seasonal cure prevention with one seasonal vaccination like the flu vaccine ... and that there might be some additive benefit.”
Instead, the study found the combination reduces the incidence of malaria by 62% against clinical malaria infection, 70% against severe malaria, and 73% against death from malaria compared with SMC alone. “Not in our wildest dreams would I have hypothesized that this is a possibility,” Dr. Chandramohan said. He continued that this was unlikely a “freak result” because the findings are “consistent between both countries. Two, it is consistent across the years. Three, all the malaria outcomes ... are consistently showing the protective effect at the same level.”
To maintain the blinded study design, children received injections of rabies vaccine and hepatitis A vaccine instead of a placebo for RTS,S. Both were chosen to provide additional benefits by protecting children against those infections.
With so many children followed over years, accuracy in providing the correct treatment for each study arm can be difficult. Each child was given a QR code and picture identification to facilitate drug distribution each year in this study.
Miriam K. Laufer, MD, professor and associate director for malaria research at the University of Maryland, Baltimore, who was not involved in the study, said in an interview, “This is a spectacular result, you know, decreasing disease by 60%-70% using interventions that we already have.”
RTS,S is not a new vaccine; it was developed in 2001 by GlaxoSmithKline with Path’s Malaria Vaccine Initiative, then manufactured by GSK. The Gates Foundation has supported production. Dr. Chandramohan said GSK has transferred the technology to Bharat, in India, and that it will take 2-3 years to ramp up production. Until then, enough vaccine is available to supply Kenya, Malawi, and Ghana, where the pilot studies are being done.
Dr. Laufer stressed that the “group that got RTS,S did as well as the group that received SMC.” She noted that the use of SMC is limited to specific areas of the Sahel sub-region of Africa, with a brief transmission period. In other areas of Africa where malaria has a longer transmission period, SMC isn’t as effective. “RTS,S vaccine could really have an impact” there, she added.
Asked if RTS,S might be substituted for SMC to reduce the likelihood of resistance emerging, Dr. Laufer said, “Giving RTS,S vaccine is as good as using repeated treatment of malaria drugs during the malaria season. And that’s important for two reasons. One is that the advantage of a vaccine is that you’re not producing pressure of drugs that would enable drug resistance to emerge and spread. So maybe your vaccine efficacy could last longer than drug efficacy. We don’t know the answer to that.”
Hypothesizing about the unexpectedly good trial results, Dr. Laufer explained, “We know that RTS,S decreases the number of parasites that make it into the blood when a child is bitten by an infected mosquito. When drugs like sulfadoxine-pyrimethamine and amodiaquine that have moderate efficacy only have to kill off a small number of parasites, they can work better. Maybe that explains why the combination of RTS,S and SMC created such a positive outcome.”
Dr. Laufer echoed Chandramohan, saying, “Results were much more dramatic than anybody – certainly than I anticipated.” Both physicians anticipate that WHO will give full approval for this combination this fall.
Dr. Chandramohan and Dr. Laufer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA approves first twice-yearly antipsychotic for schizophrenia
The U.S. Food and Drug Administration has approved a 6-month injection form of the long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera, Janssen Pharmaceuticals) for the treatment of schizophrenia in adults, the company has announced.
This marks the “first-and-only twice-yearly injectable” approved for treating schizophrenia, the company added in a press release.
Before transitioning to the 6-month form, patients must be adequately treated for a minimum of 4 months with the company’s 1-month formulation of paliperidone (Invega Sustenna), or with the 3-month version (Invega Trinza) for at least one 3-month injection cycle.
The FDA approved the twice-yearly formulation on the basis of results from a 12-month, randomized, double-blind, phase 3 study that enrolled 702 adults with schizophrenia from 20 countries.
“The phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence,” Gustavo Alva, MD, medical director at ATP Clinical Research, Costa Mesa, Calif., and 6-month paliperidone palmitate clinical trial investigator, said in the release.
Noninferiority results
In the phase 3 trial, the twice-yearly version of the drug proved noninferior to the 3-month version on the primary endpoint of time to first relapse at the end of 12 months, with 92.5% and 95% of patients, respectively, relapse-free at 12 months.
Relapse was defined as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale (PANSS) total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal/homicidal ideation.
The safety profile observed in the trial was in line with prior studies of the 1-month and 3-month versions, with no new safety signals, the researchers note.
The most common adverse reactions affecting at least 5% of participants in the clinical trial receiving twice-year paliperidone were upper respiratory tract infection (12%), injection site reaction (11%), weight gain (9%), headache (7%), and parkinsonism (5%).
Relapse is common in adults with schizophrenia, often because of missed doses of medication, the company said in the news release.
, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” Dr. Alva said.
Recently updated evidence-based guidelines from the American Psychiatric Association recommend consideration of long-acting injectables for appropriate adults living with schizophrenia.
“Long-acting injectable treatments offer a number of advantages, compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods,” Bill Martin, PhD, with Janssen Research & Development, said in the release.
“Today’s approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication,” Dr. Martin added.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a 6-month injection form of the long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera, Janssen Pharmaceuticals) for the treatment of schizophrenia in adults, the company has announced.
This marks the “first-and-only twice-yearly injectable” approved for treating schizophrenia, the company added in a press release.
Before transitioning to the 6-month form, patients must be adequately treated for a minimum of 4 months with the company’s 1-month formulation of paliperidone (Invega Sustenna), or with the 3-month version (Invega Trinza) for at least one 3-month injection cycle.
The FDA approved the twice-yearly formulation on the basis of results from a 12-month, randomized, double-blind, phase 3 study that enrolled 702 adults with schizophrenia from 20 countries.
“The phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence,” Gustavo Alva, MD, medical director at ATP Clinical Research, Costa Mesa, Calif., and 6-month paliperidone palmitate clinical trial investigator, said in the release.
Noninferiority results
In the phase 3 trial, the twice-yearly version of the drug proved noninferior to the 3-month version on the primary endpoint of time to first relapse at the end of 12 months, with 92.5% and 95% of patients, respectively, relapse-free at 12 months.
Relapse was defined as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale (PANSS) total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal/homicidal ideation.
The safety profile observed in the trial was in line with prior studies of the 1-month and 3-month versions, with no new safety signals, the researchers note.
The most common adverse reactions affecting at least 5% of participants in the clinical trial receiving twice-year paliperidone were upper respiratory tract infection (12%), injection site reaction (11%), weight gain (9%), headache (7%), and parkinsonism (5%).
Relapse is common in adults with schizophrenia, often because of missed doses of medication, the company said in the news release.
, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” Dr. Alva said.
Recently updated evidence-based guidelines from the American Psychiatric Association recommend consideration of long-acting injectables for appropriate adults living with schizophrenia.
“Long-acting injectable treatments offer a number of advantages, compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods,” Bill Martin, PhD, with Janssen Research & Development, said in the release.
“Today’s approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication,” Dr. Martin added.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a 6-month injection form of the long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera, Janssen Pharmaceuticals) for the treatment of schizophrenia in adults, the company has announced.
This marks the “first-and-only twice-yearly injectable” approved for treating schizophrenia, the company added in a press release.
Before transitioning to the 6-month form, patients must be adequately treated for a minimum of 4 months with the company’s 1-month formulation of paliperidone (Invega Sustenna), or with the 3-month version (Invega Trinza) for at least one 3-month injection cycle.
The FDA approved the twice-yearly formulation on the basis of results from a 12-month, randomized, double-blind, phase 3 study that enrolled 702 adults with schizophrenia from 20 countries.
“The phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence,” Gustavo Alva, MD, medical director at ATP Clinical Research, Costa Mesa, Calif., and 6-month paliperidone palmitate clinical trial investigator, said in the release.
Noninferiority results
In the phase 3 trial, the twice-yearly version of the drug proved noninferior to the 3-month version on the primary endpoint of time to first relapse at the end of 12 months, with 92.5% and 95% of patients, respectively, relapse-free at 12 months.
Relapse was defined as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale (PANSS) total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal/homicidal ideation.
The safety profile observed in the trial was in line with prior studies of the 1-month and 3-month versions, with no new safety signals, the researchers note.
The most common adverse reactions affecting at least 5% of participants in the clinical trial receiving twice-year paliperidone were upper respiratory tract infection (12%), injection site reaction (11%), weight gain (9%), headache (7%), and parkinsonism (5%).
Relapse is common in adults with schizophrenia, often because of missed doses of medication, the company said in the news release.
, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” Dr. Alva said.
Recently updated evidence-based guidelines from the American Psychiatric Association recommend consideration of long-acting injectables for appropriate adults living with schizophrenia.
“Long-acting injectable treatments offer a number of advantages, compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods,” Bill Martin, PhD, with Janssen Research & Development, said in the release.
“Today’s approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication,” Dr. Martin added.
A version of this article first appeared on Medscape.com.
Office-based pediatricians unprepared for emergencies
Emergency preparedness in U.S. pediatric offices is variable and less than ideal, especially in smaller independent practices, a 15-month multicenter study has found.
Researchers led by Kamal Abulebda, MD, associate professor of clinical pediatrics in the division of pediatric critical care medicine at Indiana University and Riley Hospital for Children in Indianapolis, report that adherence to the 2007 policy statement of the American Academy of Pediatrics on emergency preparedness in pediatric primary care offices was suboptimal across 42 offices in 9 states. They suggest that academic and community partnerships use in-situ simulation exercises to address preparedness gaps and implement standard procedures for contacting emergency medical services.
The group’s findings were published online in Pediatrics. “These data can be used to guide the development of interventions to improve emergency preparedness and care delivery in pediatric offices, Dr. Abulebda and coauthors wrote, noting that theirs is the first multicenter study to directly measure preparedness and quality of care in pediatric offices.
According to the authors, the incidence of a child’s requiring emergent stabilization in an individual office ranges from weekly to monthly, with seizures and respiratory distress being the most common events.
The study was conducted from 2018 to 2020 by 48 national teams participating in in-situ simulated sessions in the ambulatory setting. Office teams, recruited from practices by members of regional academic medical centers, included two patients – a child with respiratory distress and a child with a seizure. Almost 40% were from Indiana.
The scenarios and checklists for the mock exercises were created by content experts in pediatric emergency medicine and critical care using evidence-based guidelines and best practices.
Previous research has relied on self-reported surveys rather than direct measurement to assess adherence to the AAP guidelines, the authors say. In-person surveys assessed adherence to AAP recommendations for emergency preparedness. In-person surveys were, however, used to gauge adherence to AAP recommendations for emergency preparedness.
Findings
The overall mean emergency preparedness score was 74.7% (standard deviation [SD] 12.9), with an unweighted percentage of adherence to checklists calculated for each case. By emergency type, the median asthma case performance score was 63.6% (interquartile range [IQR] 43.2-81.2), and the median seizure case score was 69.2% (IQR 46.2-80.8).
On the measure of essential equipment and supplies, the mean subscore (relating to availability of such items as oxygen sources, suction devices, and epinephrine, for example) was 82.2% (SD 15.1).
As for recommended policies and protocols (e.g., regular assessment of the office, maintenance of emergency equipment and medications) the mean subscore fell to 57.1% (SD 25.6).
In multivariable analyses, offices with a standardized procedure for contacting EMS had a higher rate of activating that service during the simulations.
Independent practices and smaller total staff size were associated with lower preparedness compared with larger groups: beta = –11.89, 95% confidence interval [CI], 19.33-4.45).
Higher annual patient volume and larger total staff size were slightly associated with higher scores (beta = .001, 95% CI, .00-001, P = .017; and beta = .51, 95% CI, .19-.83, P = .002, respectively).
Affiliation with an academic medical center and the presence of learners were not associated with higher scores. And in multivariable regression, a higher annual patient volume lost its significant association with greater preparedness.
So why the lag in preparedness despite the long-standing AAP recommendations? “It’s most likely due to the rare occurrence of these emergencies in the office setting, in addition to most offices’ dependence on EMS when they encounter pediatric emergencies in their setting,” Dr. Abulebda said in an interview. “A 2018 study published by Yuknis and associates demonstrated that the average time from EMS notification to arrival on scene was just 6 minutes.”
In other study findings, 82% of offices did not have an infant bag valve mask and would therefore need to wait for EMS to administer lifesaving ventilation. “This highlights the need to have this equipment available and maintain the skills necessary to care for patients in respiratory distress, the most common emergency encountered in the office setting,” Dr. Abulebda and associates wrote.
A cardiac arrest board is another example of a potentially lifesaving piece of equipment that was not available in the majority of offices, likely because of the rarity of this event in the office setting, but lack of this item may result in poor cardiopulmonary resuscitation quality before the arrival of EMS.
In an accompanying editorial, Jesse Hackell, MD, a pediatrician at Boston Children’s Health Physicians and New York Medical College in Pomona, N.Y., noted that data from 2 decades ago suggested that many pediatric offices saw multiple children requiring emergency intervention each week. More recent figures, however, indicate the situation has evolved, with fewer than 1% of current pediatric EMS transports originating from the office setting.
Dr. Hackell agrees that implementation of AAP recommendations has been far from universal and cites the cost of equipment and supplies as well as a lack of access to training and evaluation as significant barriers to implementation. “In addition, the infrequent occurrence of these emergencies makes maintenance of resuscitation skills even more difficult without frequent practice,” he wrote.
Further complicating the issue, preparedness needs vary with practice location, the response time of local EMS, and proximity to an emergency department. “Pediatric offices in more rural areas, which are farther from these services, will require more equipment and more skills to provide optimal emergency care to children living in these underresourced areas,” he wrote.
He called for equitable distribution of preparedness training, equipment, and staffing, with guidance designed to meet patient needs and ensure optimal outcomes. “In discussion of recommendations, one should consider the likely conditions requiring this response, availability of resources beyond the pediatric office, and ongoing training and support needed to maintain provider skills at the level needed for a successful response to any pediatric emergency,” Dr. Hackell wrote.
This study was supported by grants from Indiana University Health Values and the RBaby Foundation. One study coauthor is a board observer of a medical device company. No other authors disclosed financial relationships relevant to this work. Dr. Hackell has disclosed having no competing interests.
Emergency preparedness in U.S. pediatric offices is variable and less than ideal, especially in smaller independent practices, a 15-month multicenter study has found.
Researchers led by Kamal Abulebda, MD, associate professor of clinical pediatrics in the division of pediatric critical care medicine at Indiana University and Riley Hospital for Children in Indianapolis, report that adherence to the 2007 policy statement of the American Academy of Pediatrics on emergency preparedness in pediatric primary care offices was suboptimal across 42 offices in 9 states. They suggest that academic and community partnerships use in-situ simulation exercises to address preparedness gaps and implement standard procedures for contacting emergency medical services.
The group’s findings were published online in Pediatrics. “These data can be used to guide the development of interventions to improve emergency preparedness and care delivery in pediatric offices, Dr. Abulebda and coauthors wrote, noting that theirs is the first multicenter study to directly measure preparedness and quality of care in pediatric offices.
According to the authors, the incidence of a child’s requiring emergent stabilization in an individual office ranges from weekly to monthly, with seizures and respiratory distress being the most common events.
The study was conducted from 2018 to 2020 by 48 national teams participating in in-situ simulated sessions in the ambulatory setting. Office teams, recruited from practices by members of regional academic medical centers, included two patients – a child with respiratory distress and a child with a seizure. Almost 40% were from Indiana.
The scenarios and checklists for the mock exercises were created by content experts in pediatric emergency medicine and critical care using evidence-based guidelines and best practices.
Previous research has relied on self-reported surveys rather than direct measurement to assess adherence to the AAP guidelines, the authors say. In-person surveys assessed adherence to AAP recommendations for emergency preparedness. In-person surveys were, however, used to gauge adherence to AAP recommendations for emergency preparedness.
Findings
The overall mean emergency preparedness score was 74.7% (standard deviation [SD] 12.9), with an unweighted percentage of adherence to checklists calculated for each case. By emergency type, the median asthma case performance score was 63.6% (interquartile range [IQR] 43.2-81.2), and the median seizure case score was 69.2% (IQR 46.2-80.8).
On the measure of essential equipment and supplies, the mean subscore (relating to availability of such items as oxygen sources, suction devices, and epinephrine, for example) was 82.2% (SD 15.1).
As for recommended policies and protocols (e.g., regular assessment of the office, maintenance of emergency equipment and medications) the mean subscore fell to 57.1% (SD 25.6).
In multivariable analyses, offices with a standardized procedure for contacting EMS had a higher rate of activating that service during the simulations.
Independent practices and smaller total staff size were associated with lower preparedness compared with larger groups: beta = –11.89, 95% confidence interval [CI], 19.33-4.45).
Higher annual patient volume and larger total staff size were slightly associated with higher scores (beta = .001, 95% CI, .00-001, P = .017; and beta = .51, 95% CI, .19-.83, P = .002, respectively).
Affiliation with an academic medical center and the presence of learners were not associated with higher scores. And in multivariable regression, a higher annual patient volume lost its significant association with greater preparedness.
So why the lag in preparedness despite the long-standing AAP recommendations? “It’s most likely due to the rare occurrence of these emergencies in the office setting, in addition to most offices’ dependence on EMS when they encounter pediatric emergencies in their setting,” Dr. Abulebda said in an interview. “A 2018 study published by Yuknis and associates demonstrated that the average time from EMS notification to arrival on scene was just 6 minutes.”
In other study findings, 82% of offices did not have an infant bag valve mask and would therefore need to wait for EMS to administer lifesaving ventilation. “This highlights the need to have this equipment available and maintain the skills necessary to care for patients in respiratory distress, the most common emergency encountered in the office setting,” Dr. Abulebda and associates wrote.
A cardiac arrest board is another example of a potentially lifesaving piece of equipment that was not available in the majority of offices, likely because of the rarity of this event in the office setting, but lack of this item may result in poor cardiopulmonary resuscitation quality before the arrival of EMS.
In an accompanying editorial, Jesse Hackell, MD, a pediatrician at Boston Children’s Health Physicians and New York Medical College in Pomona, N.Y., noted that data from 2 decades ago suggested that many pediatric offices saw multiple children requiring emergency intervention each week. More recent figures, however, indicate the situation has evolved, with fewer than 1% of current pediatric EMS transports originating from the office setting.
Dr. Hackell agrees that implementation of AAP recommendations has been far from universal and cites the cost of equipment and supplies as well as a lack of access to training and evaluation as significant barriers to implementation. “In addition, the infrequent occurrence of these emergencies makes maintenance of resuscitation skills even more difficult without frequent practice,” he wrote.
Further complicating the issue, preparedness needs vary with practice location, the response time of local EMS, and proximity to an emergency department. “Pediatric offices in more rural areas, which are farther from these services, will require more equipment and more skills to provide optimal emergency care to children living in these underresourced areas,” he wrote.
He called for equitable distribution of preparedness training, equipment, and staffing, with guidance designed to meet patient needs and ensure optimal outcomes. “In discussion of recommendations, one should consider the likely conditions requiring this response, availability of resources beyond the pediatric office, and ongoing training and support needed to maintain provider skills at the level needed for a successful response to any pediatric emergency,” Dr. Hackell wrote.
This study was supported by grants from Indiana University Health Values and the RBaby Foundation. One study coauthor is a board observer of a medical device company. No other authors disclosed financial relationships relevant to this work. Dr. Hackell has disclosed having no competing interests.
Emergency preparedness in U.S. pediatric offices is variable and less than ideal, especially in smaller independent practices, a 15-month multicenter study has found.
Researchers led by Kamal Abulebda, MD, associate professor of clinical pediatrics in the division of pediatric critical care medicine at Indiana University and Riley Hospital for Children in Indianapolis, report that adherence to the 2007 policy statement of the American Academy of Pediatrics on emergency preparedness in pediatric primary care offices was suboptimal across 42 offices in 9 states. They suggest that academic and community partnerships use in-situ simulation exercises to address preparedness gaps and implement standard procedures for contacting emergency medical services.
The group’s findings were published online in Pediatrics. “These data can be used to guide the development of interventions to improve emergency preparedness and care delivery in pediatric offices, Dr. Abulebda and coauthors wrote, noting that theirs is the first multicenter study to directly measure preparedness and quality of care in pediatric offices.
According to the authors, the incidence of a child’s requiring emergent stabilization in an individual office ranges from weekly to monthly, with seizures and respiratory distress being the most common events.
The study was conducted from 2018 to 2020 by 48 national teams participating in in-situ simulated sessions in the ambulatory setting. Office teams, recruited from practices by members of regional academic medical centers, included two patients – a child with respiratory distress and a child with a seizure. Almost 40% were from Indiana.
The scenarios and checklists for the mock exercises were created by content experts in pediatric emergency medicine and critical care using evidence-based guidelines and best practices.
Previous research has relied on self-reported surveys rather than direct measurement to assess adherence to the AAP guidelines, the authors say. In-person surveys assessed adherence to AAP recommendations for emergency preparedness. In-person surveys were, however, used to gauge adherence to AAP recommendations for emergency preparedness.
Findings
The overall mean emergency preparedness score was 74.7% (standard deviation [SD] 12.9), with an unweighted percentage of adherence to checklists calculated for each case. By emergency type, the median asthma case performance score was 63.6% (interquartile range [IQR] 43.2-81.2), and the median seizure case score was 69.2% (IQR 46.2-80.8).
On the measure of essential equipment and supplies, the mean subscore (relating to availability of such items as oxygen sources, suction devices, and epinephrine, for example) was 82.2% (SD 15.1).
As for recommended policies and protocols (e.g., regular assessment of the office, maintenance of emergency equipment and medications) the mean subscore fell to 57.1% (SD 25.6).
In multivariable analyses, offices with a standardized procedure for contacting EMS had a higher rate of activating that service during the simulations.
Independent practices and smaller total staff size were associated with lower preparedness compared with larger groups: beta = –11.89, 95% confidence interval [CI], 19.33-4.45).
Higher annual patient volume and larger total staff size were slightly associated with higher scores (beta = .001, 95% CI, .00-001, P = .017; and beta = .51, 95% CI, .19-.83, P = .002, respectively).
Affiliation with an academic medical center and the presence of learners were not associated with higher scores. And in multivariable regression, a higher annual patient volume lost its significant association with greater preparedness.
So why the lag in preparedness despite the long-standing AAP recommendations? “It’s most likely due to the rare occurrence of these emergencies in the office setting, in addition to most offices’ dependence on EMS when they encounter pediatric emergencies in their setting,” Dr. Abulebda said in an interview. “A 2018 study published by Yuknis and associates demonstrated that the average time from EMS notification to arrival on scene was just 6 minutes.”
In other study findings, 82% of offices did not have an infant bag valve mask and would therefore need to wait for EMS to administer lifesaving ventilation. “This highlights the need to have this equipment available and maintain the skills necessary to care for patients in respiratory distress, the most common emergency encountered in the office setting,” Dr. Abulebda and associates wrote.
A cardiac arrest board is another example of a potentially lifesaving piece of equipment that was not available in the majority of offices, likely because of the rarity of this event in the office setting, but lack of this item may result in poor cardiopulmonary resuscitation quality before the arrival of EMS.
In an accompanying editorial, Jesse Hackell, MD, a pediatrician at Boston Children’s Health Physicians and New York Medical College in Pomona, N.Y., noted that data from 2 decades ago suggested that many pediatric offices saw multiple children requiring emergency intervention each week. More recent figures, however, indicate the situation has evolved, with fewer than 1% of current pediatric EMS transports originating from the office setting.
Dr. Hackell agrees that implementation of AAP recommendations has been far from universal and cites the cost of equipment and supplies as well as a lack of access to training and evaluation as significant barriers to implementation. “In addition, the infrequent occurrence of these emergencies makes maintenance of resuscitation skills even more difficult without frequent practice,” he wrote.
Further complicating the issue, preparedness needs vary with practice location, the response time of local EMS, and proximity to an emergency department. “Pediatric offices in more rural areas, which are farther from these services, will require more equipment and more skills to provide optimal emergency care to children living in these underresourced areas,” he wrote.
He called for equitable distribution of preparedness training, equipment, and staffing, with guidance designed to meet patient needs and ensure optimal outcomes. “In discussion of recommendations, one should consider the likely conditions requiring this response, availability of resources beyond the pediatric office, and ongoing training and support needed to maintain provider skills at the level needed for a successful response to any pediatric emergency,” Dr. Hackell wrote.
This study was supported by grants from Indiana University Health Values and the RBaby Foundation. One study coauthor is a board observer of a medical device company. No other authors disclosed financial relationships relevant to this work. Dr. Hackell has disclosed having no competing interests.
FROM PEDIATRICS
Another COVID-19 patient to get ivermectin after court order
Another case, another state, another judge ordering a hospital to give a patient a controversial horse deworming drug to treat a severe case of COVID-19.
, according to the Ohio Capital Journal. Judge Gregory Howard’s ruling comes after Mr. Smith’s wife sued to force the hospital to provide the controversial drug to her husband, who has been hospitalized since July 15.
Julie Smith has gotten Fred Wagshul, MD, to agree to administer ivermectin to her husband. Dr. Wagshul is known as a member of a group of doctors who say the Centers for Disease Control and Prevention and the Food and Drug Administration are lying about ivermectin’s usefulness in fighting COVID-19. Both agencies have warned against using the drug to treat COVID-19, saying there is no evidence it works and that it can be dangerous in large amounts.
According to the Ohio Capital Journal, Dr. Wagshul accused the CDC and FDA of engaging in a “conspiracy” to prevent ivermectin’s use.
But Arthur L. Caplan, MD, professor of bioethics at New York University’s Langone Medical Center, said, “it is absurd that this order was issued,” according to an interview in Ars Technica. “If I were these doctors, I simply wouldn’t do it.”
It is not the first time a judge has ordered ivermectin’s use against a hospital’s wishes.
A 68-year-old woman with COVID-19 in an Illinois hospital started receiving the controversial drug in May after her family sued the hospital to have someone administer it.
Nurije Fype’s daughter, Desareta, filed suit against Elmhurst Hospital, part of Edward-Elmhurst Health, asking that her mother receive the treatment, which is approved as an antiparasitic drug but not approved for the treatment of COVID-19. Desareta Fype was granted temporary guardianship of her mother.
The FDA has published guidance titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” on its website. The National Institutes of Health said there is not enough data to recommend either for or against its use in treating COVID-19.
But DuPage County Judge James Orel ruled Ms. Fype should be allowed to get the treatment.
Three days later, according to the Daily Herald, the lawyer for the hospital, Joseph Monahan, argued the hospital could not find a hospital-affiliated doctor to administer the ivermectin.
The Herald reported the judge told the hospital to “get out of the way” and allow any board-certified doctor to administer the drug.
When Ms. Fype’s doctor was unable to administer it, the legal team found another doctor, Alan Bain, DO, to do it. Mr. Monahan said Dr. Bain was granted credentials to work at the hospital so he could administer it.
Judge Orel denied a request from Desareta Fype’s lawyer to order the hospital’s nurses to administer further doses. The judge also denied a request to hold the hospital in contempt of court.
A version of this article first appeared on WebMD.com.
Another case, another state, another judge ordering a hospital to give a patient a controversial horse deworming drug to treat a severe case of COVID-19.
, according to the Ohio Capital Journal. Judge Gregory Howard’s ruling comes after Mr. Smith’s wife sued to force the hospital to provide the controversial drug to her husband, who has been hospitalized since July 15.
Julie Smith has gotten Fred Wagshul, MD, to agree to administer ivermectin to her husband. Dr. Wagshul is known as a member of a group of doctors who say the Centers for Disease Control and Prevention and the Food and Drug Administration are lying about ivermectin’s usefulness in fighting COVID-19. Both agencies have warned against using the drug to treat COVID-19, saying there is no evidence it works and that it can be dangerous in large amounts.
According to the Ohio Capital Journal, Dr. Wagshul accused the CDC and FDA of engaging in a “conspiracy” to prevent ivermectin’s use.
But Arthur L. Caplan, MD, professor of bioethics at New York University’s Langone Medical Center, said, “it is absurd that this order was issued,” according to an interview in Ars Technica. “If I were these doctors, I simply wouldn’t do it.”
It is not the first time a judge has ordered ivermectin’s use against a hospital’s wishes.
A 68-year-old woman with COVID-19 in an Illinois hospital started receiving the controversial drug in May after her family sued the hospital to have someone administer it.
Nurije Fype’s daughter, Desareta, filed suit against Elmhurst Hospital, part of Edward-Elmhurst Health, asking that her mother receive the treatment, which is approved as an antiparasitic drug but not approved for the treatment of COVID-19. Desareta Fype was granted temporary guardianship of her mother.
The FDA has published guidance titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” on its website. The National Institutes of Health said there is not enough data to recommend either for or against its use in treating COVID-19.
But DuPage County Judge James Orel ruled Ms. Fype should be allowed to get the treatment.
Three days later, according to the Daily Herald, the lawyer for the hospital, Joseph Monahan, argued the hospital could not find a hospital-affiliated doctor to administer the ivermectin.
The Herald reported the judge told the hospital to “get out of the way” and allow any board-certified doctor to administer the drug.
When Ms. Fype’s doctor was unable to administer it, the legal team found another doctor, Alan Bain, DO, to do it. Mr. Monahan said Dr. Bain was granted credentials to work at the hospital so he could administer it.
Judge Orel denied a request from Desareta Fype’s lawyer to order the hospital’s nurses to administer further doses. The judge also denied a request to hold the hospital in contempt of court.
A version of this article first appeared on WebMD.com.
Another case, another state, another judge ordering a hospital to give a patient a controversial horse deworming drug to treat a severe case of COVID-19.
, according to the Ohio Capital Journal. Judge Gregory Howard’s ruling comes after Mr. Smith’s wife sued to force the hospital to provide the controversial drug to her husband, who has been hospitalized since July 15.
Julie Smith has gotten Fred Wagshul, MD, to agree to administer ivermectin to her husband. Dr. Wagshul is known as a member of a group of doctors who say the Centers for Disease Control and Prevention and the Food and Drug Administration are lying about ivermectin’s usefulness in fighting COVID-19. Both agencies have warned against using the drug to treat COVID-19, saying there is no evidence it works and that it can be dangerous in large amounts.
According to the Ohio Capital Journal, Dr. Wagshul accused the CDC and FDA of engaging in a “conspiracy” to prevent ivermectin’s use.
But Arthur L. Caplan, MD, professor of bioethics at New York University’s Langone Medical Center, said, “it is absurd that this order was issued,” according to an interview in Ars Technica. “If I were these doctors, I simply wouldn’t do it.”
It is not the first time a judge has ordered ivermectin’s use against a hospital’s wishes.
A 68-year-old woman with COVID-19 in an Illinois hospital started receiving the controversial drug in May after her family sued the hospital to have someone administer it.
Nurije Fype’s daughter, Desareta, filed suit against Elmhurst Hospital, part of Edward-Elmhurst Health, asking that her mother receive the treatment, which is approved as an antiparasitic drug but not approved for the treatment of COVID-19. Desareta Fype was granted temporary guardianship of her mother.
The FDA has published guidance titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” on its website. The National Institutes of Health said there is not enough data to recommend either for or against its use in treating COVID-19.
But DuPage County Judge James Orel ruled Ms. Fype should be allowed to get the treatment.
Three days later, according to the Daily Herald, the lawyer for the hospital, Joseph Monahan, argued the hospital could not find a hospital-affiliated doctor to administer the ivermectin.
The Herald reported the judge told the hospital to “get out of the way” and allow any board-certified doctor to administer the drug.
When Ms. Fype’s doctor was unable to administer it, the legal team found another doctor, Alan Bain, DO, to do it. Mr. Monahan said Dr. Bain was granted credentials to work at the hospital so he could administer it.
Judge Orel denied a request from Desareta Fype’s lawyer to order the hospital’s nurses to administer further doses. The judge also denied a request to hold the hospital in contempt of court.
A version of this article first appeared on WebMD.com.