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Three wild technologies about to change health care
When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.
A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.
Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.
Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.
Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality.
Human hibernation
Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.
(In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)
Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.
That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.
Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).
But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”
The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.
Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
Artificial womb
Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”
In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.
Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.
The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.
The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.
Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.
No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
Messenger RNA therapeutics
Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.
But vaccines are just the beginning of what this technology can do.
A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.
The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.
Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.
As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.
A version of this article first appeared on WebMD.com.
When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.
A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.
Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.
Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.
Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality.
Human hibernation
Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.
(In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)
Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.
That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.
Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).
But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”
The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.
Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
Artificial womb
Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”
In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.
Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.
The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.
The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.
Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.
No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
Messenger RNA therapeutics
Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.
But vaccines are just the beginning of what this technology can do.
A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.
The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.
Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.
As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.
A version of this article first appeared on WebMD.com.
When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.
A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.
Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.
Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.
Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality.
Human hibernation
Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.
(In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)
Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.
That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.
Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).
But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”
The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.
Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
Artificial womb
Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”
In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.
Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.
The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.
The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.
Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.
No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
Messenger RNA therapeutics
Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.
But vaccines are just the beginning of what this technology can do.
A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.
The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.
Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.
As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.
A version of this article first appeared on WebMD.com.
Can a hormone shot rescue low libido?
according to results from two small randomized controlled trials.
The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.
Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.
One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
Unmet need
HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.
“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.
Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.
In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.
At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.
The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
Similar data in men, women
While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).
In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).
Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.
The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.
“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.
“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.
The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.
A version of this article first appeared on Medscape.com.
according to results from two small randomized controlled trials.
The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.
Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.
One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
Unmet need
HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.
“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.
Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.
In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.
At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.
The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
Similar data in men, women
While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).
In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).
Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.
The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.
“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.
“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.
The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.
A version of this article first appeared on Medscape.com.
according to results from two small randomized controlled trials.
The data suggest that injections of kisspeptin can boost sexual desire in men and women and can increase penile rigidity in men.
Together, these two studies provide proof of concept for the development of kisspeptin-based therapeutics for men and women with distressing hypoactive sexual desire disorder (HSDD), study investigator Alexander Comninos, MD, PhD, Imperial College London, said in a news release.
One study was published online Feb. 3, 2022, in JAMA Network Open. The other was published in October 2022.
Unmet need
HSDD affects up to 10% of women and 8% of men worldwide and leads to psychological and social harm, the news release noted.
“There is a real unmet need to find new, safer, and more effective therapies for this distressing condition for both women and men seeking treatment,” Dr. Comninos said.
Kisspeptin is a naturally occurring reproductive hormone that serves as a crucial activator of the reproductive system. Emerging evidence from animal models shows that kisspeptin signaling has key roles in modulating reproductive behavior, including sexual motivation and erections.
In a double-blind, placebo-controlled, crossover study, the researchers enrolled 32 healthy heterosexual men (mean age, 37.9 years) who had HSDD.
At the first study visit, the men were given an infusion of kisspeptin-54 (1 nmol/kg per hour) or placebo (saline) over 75 minutes. The participants then crossed over to the other treatment at a second study visit at least 7 days later.
The active treatment significantly increased circulating kisspeptin levels. A steady state was reached after 30-75 minutes of infusion, the researchers reported.
Similar data in men, women
While the men viewed sexual videos, kisspeptin significantly modulated brain activity on fMRI in key structures of the sexual-processing network, compared with placebo (P = .003).
In addition, the treatment led to significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; P = .02) and behavioral measures of sexual desire – most notably increased happiness about sex (P = .02).
Given the significant stimulatory effect of kisspeptin administration on penile rigidity, coupled with its demonstrated proerectile effect in rodents, future studies should examine the use of kisspeptin for patients with erectile dysfunction, the researchers wrote.
The second study included 32 women with HSDD and had the same design. Its results also showed that kisspeptin restored sexual and attraction brain processing without adverse effects.
“It is highly encouraging to see the same boosting effect in both women and men, although the precise brain pathways were slightly different, as might be expected,” coinvestigator Waljit Dhillo, PhD, Imperial College London, said in the news release.
“Collectively, the results suggest that kisspeptin may offer a safe and much-needed treatment for HSDD that affects millions of people around the world; and we look forward to taking this forward in future larger studies and in other patient groups,” Dr. Dhillo added.
The study was funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and the Medical Research Council, part of UK Research and Innovation. Dr. Comninos reported no relevant financial relationships. Dr. Dhillo reported receiving consulting fees from Myovant Sciences and KaNDy Therapeutics outside the submitted work.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
IVF-conceived children show strong developmental performance
In vitro fertilization has been around long enough that researchers can now compare developmental and academic achievements between these children and peers at school age.
Amber Kennedy, MBBS, and colleagues did just that. They found little difference in these milestones between a total of 11,059 IVF-conceived children and 401,654 spontaneously conceived children in a new study.
“Parents considering IVF and health care professionals can be reassured that the school age developmental and educational outcomes of IVF-conceived children are equivalent to their peers,” said Dr. Kennedy, lead author and obstetrician and gynecologist at Mercy Hospital for Women at the University of Melbourne.
The findings were published online in PLOS Medicine.
“Overall, we know that children born through IVF are doing fine in terms of health, but also emotionally and cognitively. So I wasn’t surprised. I live in this world,” said Ariadna Cymet Lanski, PsyD, chair of the American Society for Reproductive Medicine Mental Health Professional Group, who was not affiliated with the study.
Some previous researchers linked conception via IVF to an increased risk of congenital abnormalities, autism spectrum disorder, developmental delay, and intellectual disability.
Asked why the current study did not find increased risks, Dr. Kennedy said, “Our population included a relatively recent birth cohort, which may explain some differences from previous studies as IVF practices have evolved over time.”
An estimated 8 million people worldwide have been conceived through IVF since the first birth in 1978, the researchers said. In Australia, this has grown from 2% of births in the year 2000 to now nearly 5% or 1 in 20 live births, Dr. Kennedy noted. “Consequently, it is important to understand the longer-term outcomes for this population of children.”
Along with senior author Anthea Lindquist, MBBS, Dr. Kennedy and colleagues studied 585,659 single births in Victoria, Australia, between 2005 and 2014. They did not include multiple births such as twins or triplets.
The investigators compared 4,697 children conceived via IVF and 168,503 others conceived spontaneously using a standard developmental measure, the Australian Early Developmental Census (AEDC). They also assessed 8,976 children in the IVF group and 333,335 other children on a standard educational measure, the National Assessment Program–Literacy and Numeracy (NAPLAN).
For example, the developmental census measures developmental vulnerability. Dr. Kennedy and colleagues found a 0.3% difference in favor of IVF-conceived children, which statistically was no different than zero.
Similarly, the researchers reported that IVF conception had essentially no effect on overall the literacy score, with an adjusted average difference of 0.03.
Dr. Lanski said the results should be reassuring for people considering IVF. “I can see the value of the study.” The findings “probably brings a lot of comfort ... if you want to build a family, and medically this is what’s recommended.”
Not all IVF techniques are the same, and the researchers want to take a deeper dive to evaluate any distinctions among them. For example, Dr. Kennedy said, “We plan to investigate the same school-aged outcomes after specific IVF-associated techniques.”
A version of this article first appeared on WebMD.com.
In vitro fertilization has been around long enough that researchers can now compare developmental and academic achievements between these children and peers at school age.
Amber Kennedy, MBBS, and colleagues did just that. They found little difference in these milestones between a total of 11,059 IVF-conceived children and 401,654 spontaneously conceived children in a new study.
“Parents considering IVF and health care professionals can be reassured that the school age developmental and educational outcomes of IVF-conceived children are equivalent to their peers,” said Dr. Kennedy, lead author and obstetrician and gynecologist at Mercy Hospital for Women at the University of Melbourne.
The findings were published online in PLOS Medicine.
“Overall, we know that children born through IVF are doing fine in terms of health, but also emotionally and cognitively. So I wasn’t surprised. I live in this world,” said Ariadna Cymet Lanski, PsyD, chair of the American Society for Reproductive Medicine Mental Health Professional Group, who was not affiliated with the study.
Some previous researchers linked conception via IVF to an increased risk of congenital abnormalities, autism spectrum disorder, developmental delay, and intellectual disability.
Asked why the current study did not find increased risks, Dr. Kennedy said, “Our population included a relatively recent birth cohort, which may explain some differences from previous studies as IVF practices have evolved over time.”
An estimated 8 million people worldwide have been conceived through IVF since the first birth in 1978, the researchers said. In Australia, this has grown from 2% of births in the year 2000 to now nearly 5% or 1 in 20 live births, Dr. Kennedy noted. “Consequently, it is important to understand the longer-term outcomes for this population of children.”
Along with senior author Anthea Lindquist, MBBS, Dr. Kennedy and colleagues studied 585,659 single births in Victoria, Australia, between 2005 and 2014. They did not include multiple births such as twins or triplets.
The investigators compared 4,697 children conceived via IVF and 168,503 others conceived spontaneously using a standard developmental measure, the Australian Early Developmental Census (AEDC). They also assessed 8,976 children in the IVF group and 333,335 other children on a standard educational measure, the National Assessment Program–Literacy and Numeracy (NAPLAN).
For example, the developmental census measures developmental vulnerability. Dr. Kennedy and colleagues found a 0.3% difference in favor of IVF-conceived children, which statistically was no different than zero.
Similarly, the researchers reported that IVF conception had essentially no effect on overall the literacy score, with an adjusted average difference of 0.03.
Dr. Lanski said the results should be reassuring for people considering IVF. “I can see the value of the study.” The findings “probably brings a lot of comfort ... if you want to build a family, and medically this is what’s recommended.”
Not all IVF techniques are the same, and the researchers want to take a deeper dive to evaluate any distinctions among them. For example, Dr. Kennedy said, “We plan to investigate the same school-aged outcomes after specific IVF-associated techniques.”
A version of this article first appeared on WebMD.com.
In vitro fertilization has been around long enough that researchers can now compare developmental and academic achievements between these children and peers at school age.
Amber Kennedy, MBBS, and colleagues did just that. They found little difference in these milestones between a total of 11,059 IVF-conceived children and 401,654 spontaneously conceived children in a new study.
“Parents considering IVF and health care professionals can be reassured that the school age developmental and educational outcomes of IVF-conceived children are equivalent to their peers,” said Dr. Kennedy, lead author and obstetrician and gynecologist at Mercy Hospital for Women at the University of Melbourne.
The findings were published online in PLOS Medicine.
“Overall, we know that children born through IVF are doing fine in terms of health, but also emotionally and cognitively. So I wasn’t surprised. I live in this world,” said Ariadna Cymet Lanski, PsyD, chair of the American Society for Reproductive Medicine Mental Health Professional Group, who was not affiliated with the study.
Some previous researchers linked conception via IVF to an increased risk of congenital abnormalities, autism spectrum disorder, developmental delay, and intellectual disability.
Asked why the current study did not find increased risks, Dr. Kennedy said, “Our population included a relatively recent birth cohort, which may explain some differences from previous studies as IVF practices have evolved over time.”
An estimated 8 million people worldwide have been conceived through IVF since the first birth in 1978, the researchers said. In Australia, this has grown from 2% of births in the year 2000 to now nearly 5% or 1 in 20 live births, Dr. Kennedy noted. “Consequently, it is important to understand the longer-term outcomes for this population of children.”
Along with senior author Anthea Lindquist, MBBS, Dr. Kennedy and colleagues studied 585,659 single births in Victoria, Australia, between 2005 and 2014. They did not include multiple births such as twins or triplets.
The investigators compared 4,697 children conceived via IVF and 168,503 others conceived spontaneously using a standard developmental measure, the Australian Early Developmental Census (AEDC). They also assessed 8,976 children in the IVF group and 333,335 other children on a standard educational measure, the National Assessment Program–Literacy and Numeracy (NAPLAN).
For example, the developmental census measures developmental vulnerability. Dr. Kennedy and colleagues found a 0.3% difference in favor of IVF-conceived children, which statistically was no different than zero.
Similarly, the researchers reported that IVF conception had essentially no effect on overall the literacy score, with an adjusted average difference of 0.03.
Dr. Lanski said the results should be reassuring for people considering IVF. “I can see the value of the study.” The findings “probably brings a lot of comfort ... if you want to build a family, and medically this is what’s recommended.”
Not all IVF techniques are the same, and the researchers want to take a deeper dive to evaluate any distinctions among them. For example, Dr. Kennedy said, “We plan to investigate the same school-aged outcomes after specific IVF-associated techniques.”
A version of this article first appeared on WebMD.com.
FROM PLOS MEDICINE
We don’t lose our keys (or other things) as much as we think
Can’t find your keys? Misplaced your glasses? No clue where you parked your car?
We all lose things from time to time. And we’ve all heard the standard-issue advice: Picture when you had the object last. Despite this common experience,
“It is well known that we have massive recognition memory for objects,” says study coauthor Jeremy Wolfe, PhD, a professor of ophthalmology and radiology at Harvard Medical School, Boston. In other words, we’re good at recognizing objects we’ve seen before. “For example, after viewing 100 objects for 2-3 seconds each, observers can discriminate those 100 old images from 100 new ones with well over 80% accuracy.”
But remembering what your keys look like won’t necessarily help you find them. “We often want to know when and where we saw [an object],” Dr. Wolfe says. “So our goal was to measure these spatial and temporal memories.”
In a series of experiments, reported in Current Biology, Wolfe and colleagues asked people in the study to remember objects placed on a grid. They viewed 300 objects (pictures of things like a vase, a wedding dress, camo pants, a wet suit) and were asked to recall each one and where it had been located on the grid.
About a third of the people remembered 100 or more locations, by choosing either the correct square on the grid or one directly next to it. Another third remembered between 50 and 100, and the rest remembered less than 50.
Results would likely be even better in the real world “because no one gives up and decides ‘I can’t remember where anything is. I will just guess in this silly experiment,’ ” Dr. Wolfe says.
Later, they were shown items one at a time and asked to click on a time line to indicate when they had seen them. Between 60% and 80% of the time, they identified when they had seen an object within 10% of the correct time. That’s a lot better than the 40% they would have achieved by guessing.
The findings build on previous research and expand our understanding of memory, Dr. Wolfe says. “We knew that people could remember where some things were located. However, no one had tried to quantify that memory,” he says.
But wait: If we’re so good at remembering the where and when, why do we struggle to locate lost objects so much? Chances are, we don’t. We just feel that way because we tend to focus on the fails and overlook the many wins.
“This [study] is showing us something about how we come to know where hundreds of things are in our world,” Dr. Wolfe says. “We tend to notice when this fails – ‘where are my keys?’ – but on a normal day, you are successfully tapping a massive memory on a regular basis.”
Next, the researchers plan to investigate whether spatial and temporal memories are correlated – if you’re good at one, are you good at the other? So far, “that correlation looks rather weak,” Dr. Wolfe says.
A version of this article first appeared on WebMD.com.
Can’t find your keys? Misplaced your glasses? No clue where you parked your car?
We all lose things from time to time. And we’ve all heard the standard-issue advice: Picture when you had the object last. Despite this common experience,
“It is well known that we have massive recognition memory for objects,” says study coauthor Jeremy Wolfe, PhD, a professor of ophthalmology and radiology at Harvard Medical School, Boston. In other words, we’re good at recognizing objects we’ve seen before. “For example, after viewing 100 objects for 2-3 seconds each, observers can discriminate those 100 old images from 100 new ones with well over 80% accuracy.”
But remembering what your keys look like won’t necessarily help you find them. “We often want to know when and where we saw [an object],” Dr. Wolfe says. “So our goal was to measure these spatial and temporal memories.”
In a series of experiments, reported in Current Biology, Wolfe and colleagues asked people in the study to remember objects placed on a grid. They viewed 300 objects (pictures of things like a vase, a wedding dress, camo pants, a wet suit) and were asked to recall each one and where it had been located on the grid.
About a third of the people remembered 100 or more locations, by choosing either the correct square on the grid or one directly next to it. Another third remembered between 50 and 100, and the rest remembered less than 50.
Results would likely be even better in the real world “because no one gives up and decides ‘I can’t remember where anything is. I will just guess in this silly experiment,’ ” Dr. Wolfe says.
Later, they were shown items one at a time and asked to click on a time line to indicate when they had seen them. Between 60% and 80% of the time, they identified when they had seen an object within 10% of the correct time. That’s a lot better than the 40% they would have achieved by guessing.
The findings build on previous research and expand our understanding of memory, Dr. Wolfe says. “We knew that people could remember where some things were located. However, no one had tried to quantify that memory,” he says.
But wait: If we’re so good at remembering the where and when, why do we struggle to locate lost objects so much? Chances are, we don’t. We just feel that way because we tend to focus on the fails and overlook the many wins.
“This [study] is showing us something about how we come to know where hundreds of things are in our world,” Dr. Wolfe says. “We tend to notice when this fails – ‘where are my keys?’ – but on a normal day, you are successfully tapping a massive memory on a regular basis.”
Next, the researchers plan to investigate whether spatial and temporal memories are correlated – if you’re good at one, are you good at the other? So far, “that correlation looks rather weak,” Dr. Wolfe says.
A version of this article first appeared on WebMD.com.
Can’t find your keys? Misplaced your glasses? No clue where you parked your car?
We all lose things from time to time. And we’ve all heard the standard-issue advice: Picture when you had the object last. Despite this common experience,
“It is well known that we have massive recognition memory for objects,” says study coauthor Jeremy Wolfe, PhD, a professor of ophthalmology and radiology at Harvard Medical School, Boston. In other words, we’re good at recognizing objects we’ve seen before. “For example, after viewing 100 objects for 2-3 seconds each, observers can discriminate those 100 old images from 100 new ones with well over 80% accuracy.”
But remembering what your keys look like won’t necessarily help you find them. “We often want to know when and where we saw [an object],” Dr. Wolfe says. “So our goal was to measure these spatial and temporal memories.”
In a series of experiments, reported in Current Biology, Wolfe and colleagues asked people in the study to remember objects placed on a grid. They viewed 300 objects (pictures of things like a vase, a wedding dress, camo pants, a wet suit) and were asked to recall each one and where it had been located on the grid.
About a third of the people remembered 100 or more locations, by choosing either the correct square on the grid or one directly next to it. Another third remembered between 50 and 100, and the rest remembered less than 50.
Results would likely be even better in the real world “because no one gives up and decides ‘I can’t remember where anything is. I will just guess in this silly experiment,’ ” Dr. Wolfe says.
Later, they were shown items one at a time and asked to click on a time line to indicate when they had seen them. Between 60% and 80% of the time, they identified when they had seen an object within 10% of the correct time. That’s a lot better than the 40% they would have achieved by guessing.
The findings build on previous research and expand our understanding of memory, Dr. Wolfe says. “We knew that people could remember where some things were located. However, no one had tried to quantify that memory,” he says.
But wait: If we’re so good at remembering the where and when, why do we struggle to locate lost objects so much? Chances are, we don’t. We just feel that way because we tend to focus on the fails and overlook the many wins.
“This [study] is showing us something about how we come to know where hundreds of things are in our world,” Dr. Wolfe says. “We tend to notice when this fails – ‘where are my keys?’ – but on a normal day, you are successfully tapping a massive memory on a regular basis.”
Next, the researchers plan to investigate whether spatial and temporal memories are correlated – if you’re good at one, are you good at the other? So far, “that correlation looks rather weak,” Dr. Wolfe says.
A version of this article first appeared on WebMD.com.
FROM CURRENT BIOLOGY
Remote electrical neuromodulation device helps reduce migraine days
, according to recent research published in the journal Headache.
The prospective, randomized, double-blind, placebo-controlled, multicenter trial showed that remote electrical neuromodulation (REN) with Nerivio (Theranica Bio-Electronics Ltd.; Bridgewater, N.J.) found a mean reduction/decrease in the number of migraine days by an average of 4.0 days per month, according to Stewart J. Tepper MD, of the Geisel School of Medicine at Dartmouth in Hanover, N.H., and colleagues.*
“The statistically significant results were maintained in separate subanalyses of the chronic and episodic subsamples, as well as in the separate subanalyses of participants who used and did not use migraine prophylaxis,” Dr. Tepper and colleagues wrote.
A nonpharmacological alternative
Researchers randomized 248 participants into active and placebo groups, with 95 participants in the active group and 84 participants in the placebo group meeting the criteria for a modified intention-to-treat (mITT) analysis. Most of the participants in the ITT dataset were women (85.9%) with an average age of 41.7 years, and a baseline average of 12.2 migraine days and 15.6 headache days. Overall, 52.4% of participants in the ITT dataset had chronic migraine, 25.0% had migraine with aura, and 41.1% were taking preventative medication.
Dr. Tepper and colleagues followed participants for 4 weeks at baseline for observation followed by 8 weeks of participants using the REN device every other day for 45 minutes, or a placebo device that “produces electrical pulses of the same maximum intensity (34 mA) and overall energy, but with different pulse durations and much lower frequencies compared with the active device.” Participants completed a daily diary where they recorded their symptoms.
Researchers assessed the mean change in number of migraine days per month as a primary outcome, and evaluated participants who experienced episodic and chronic migraines separately in subgroup analyses. Secondary outcome measures included mean change in number of moderate or severe headache days, 50% reduction in mean number of headache days compared with baseline, Headache Impact Test short form (HIT-6) and Migraine Specific Quality of Life Questionnaire (MSQ) Role Function Domain total score mean change at 12 weeks compared with week 1, and reduction in mean number of days taking acute headache or migraine medication.
Participants receiving REN treatment had a significant reduction in mean migraine days per month compared with the placebo group (4.0 days vs. 1.3 days; 95% confidence interval, –3.9 days to –1.5 days; P < .001). In subgroup analyses, a significant reduction in migraine days was seen in participants receiving REN treatment with episodic migraine (3.2 days vs. 1.0 days; P = .003) and chronic migraine (4.7 days vs. 1.6 days; P = .001) compared with placebo.
Dr. Tepper and colleagues found a significant reduction in moderate and/or severe headache days among participants receiving REN treatment compared with placebo (3.8 days vs. 2.2 days; P = .005), a significant reduction in headache days overall compared with placebo (4.5 days vs. 1.8 days; P < .001), a significant percentage of patients who experienced 50% reduction in moderate and/or severe headache days compared with placebo (51.6% vs. 35.7%; P = .033), and a significant reduction in acute medication days compared with placebo (3.5 days vs. 1.4 days; P = .001). Dr. Tepper and colleagues found no serious device-related adverse events in either group.
The researchers noted that REN therapy is a “much-needed nonpharmacological alternative” to other preventive and acute treatments for migraine. “Given the previously well-established clinical efficacy and high safety profile in acute treatment of migraine, REN can cover the entire treatment spectrum of migraine, including both acute and preventive treatments,” they said.
‘A good place to start’
Commenting on the study, Alan M. Rapoport, MD, clinical professor of neurology at University of California, Los Angeles; past president of the International Headache Society; and editor-in-chief of Neurology Reviews, said the study was well designed, but acknowledged the 8-week follow-up time for participants as one potential area where he would have wanted to see more data.
As a medical device cleared for use by the Food and Drug Administration for acute treatment of migraine, the REM device also appears to be effective as a migraine preventative based on the results of the study with “virtually no adverse events,” he noted.
“I think this is a great treatment. I think it’s a good place to start,” Dr. Rapoport said. Given the low adverse event rate, he said he would be willing to offer the device to patients as a first option for preventing migraine and either switch to another preventative option or add an additional medication in combination based on how the patient responds. However, at the moment, he noted that this device is not covered by insurance.
Now that a REN device has been shown to work in the acute setting and as a preventative, Dr. Rapoport said he is interested in seeing other devices that have been cleared by the FDA as migraine treatments evaluated in migraine prevention. “I think we need more patients tried on the devices so we get an idea of which ones work acutely, which ones work preventively,” he said.
The authors reported personal and institutional relationships in the form of advisory board positions, consultancies, grants, research principal investigator roles, royalties, speakers bureau positions, and stockholders for a variety of pharmaceutical companies, agencies, and other organizations. Several authors disclosed ties with Theranica, the manufacturer of the REN device used in the study. Dr. Rapoport is editor-in-chief of Neurology Reviews and a consultant for Theranica, but was not involved in studies associated with the REN device.
Correction, 2/10/23: An earlier version of this article misstated the reduction in number of migraine days.
, according to recent research published in the journal Headache.
The prospective, randomized, double-blind, placebo-controlled, multicenter trial showed that remote electrical neuromodulation (REN) with Nerivio (Theranica Bio-Electronics Ltd.; Bridgewater, N.J.) found a mean reduction/decrease in the number of migraine days by an average of 4.0 days per month, according to Stewart J. Tepper MD, of the Geisel School of Medicine at Dartmouth in Hanover, N.H., and colleagues.*
“The statistically significant results were maintained in separate subanalyses of the chronic and episodic subsamples, as well as in the separate subanalyses of participants who used and did not use migraine prophylaxis,” Dr. Tepper and colleagues wrote.
A nonpharmacological alternative
Researchers randomized 248 participants into active and placebo groups, with 95 participants in the active group and 84 participants in the placebo group meeting the criteria for a modified intention-to-treat (mITT) analysis. Most of the participants in the ITT dataset were women (85.9%) with an average age of 41.7 years, and a baseline average of 12.2 migraine days and 15.6 headache days. Overall, 52.4% of participants in the ITT dataset had chronic migraine, 25.0% had migraine with aura, and 41.1% were taking preventative medication.
Dr. Tepper and colleagues followed participants for 4 weeks at baseline for observation followed by 8 weeks of participants using the REN device every other day for 45 minutes, or a placebo device that “produces electrical pulses of the same maximum intensity (34 mA) and overall energy, but with different pulse durations and much lower frequencies compared with the active device.” Participants completed a daily diary where they recorded their symptoms.
Researchers assessed the mean change in number of migraine days per month as a primary outcome, and evaluated participants who experienced episodic and chronic migraines separately in subgroup analyses. Secondary outcome measures included mean change in number of moderate or severe headache days, 50% reduction in mean number of headache days compared with baseline, Headache Impact Test short form (HIT-6) and Migraine Specific Quality of Life Questionnaire (MSQ) Role Function Domain total score mean change at 12 weeks compared with week 1, and reduction in mean number of days taking acute headache or migraine medication.
Participants receiving REN treatment had a significant reduction in mean migraine days per month compared with the placebo group (4.0 days vs. 1.3 days; 95% confidence interval, –3.9 days to –1.5 days; P < .001). In subgroup analyses, a significant reduction in migraine days was seen in participants receiving REN treatment with episodic migraine (3.2 days vs. 1.0 days; P = .003) and chronic migraine (4.7 days vs. 1.6 days; P = .001) compared with placebo.
Dr. Tepper and colleagues found a significant reduction in moderate and/or severe headache days among participants receiving REN treatment compared with placebo (3.8 days vs. 2.2 days; P = .005), a significant reduction in headache days overall compared with placebo (4.5 days vs. 1.8 days; P < .001), a significant percentage of patients who experienced 50% reduction in moderate and/or severe headache days compared with placebo (51.6% vs. 35.7%; P = .033), and a significant reduction in acute medication days compared with placebo (3.5 days vs. 1.4 days; P = .001). Dr. Tepper and colleagues found no serious device-related adverse events in either group.
The researchers noted that REN therapy is a “much-needed nonpharmacological alternative” to other preventive and acute treatments for migraine. “Given the previously well-established clinical efficacy and high safety profile in acute treatment of migraine, REN can cover the entire treatment spectrum of migraine, including both acute and preventive treatments,” they said.
‘A good place to start’
Commenting on the study, Alan M. Rapoport, MD, clinical professor of neurology at University of California, Los Angeles; past president of the International Headache Society; and editor-in-chief of Neurology Reviews, said the study was well designed, but acknowledged the 8-week follow-up time for participants as one potential area where he would have wanted to see more data.
As a medical device cleared for use by the Food and Drug Administration for acute treatment of migraine, the REM device also appears to be effective as a migraine preventative based on the results of the study with “virtually no adverse events,” he noted.
“I think this is a great treatment. I think it’s a good place to start,” Dr. Rapoport said. Given the low adverse event rate, he said he would be willing to offer the device to patients as a first option for preventing migraine and either switch to another preventative option or add an additional medication in combination based on how the patient responds. However, at the moment, he noted that this device is not covered by insurance.
Now that a REN device has been shown to work in the acute setting and as a preventative, Dr. Rapoport said he is interested in seeing other devices that have been cleared by the FDA as migraine treatments evaluated in migraine prevention. “I think we need more patients tried on the devices so we get an idea of which ones work acutely, which ones work preventively,” he said.
The authors reported personal and institutional relationships in the form of advisory board positions, consultancies, grants, research principal investigator roles, royalties, speakers bureau positions, and stockholders for a variety of pharmaceutical companies, agencies, and other organizations. Several authors disclosed ties with Theranica, the manufacturer of the REN device used in the study. Dr. Rapoport is editor-in-chief of Neurology Reviews and a consultant for Theranica, but was not involved in studies associated with the REN device.
Correction, 2/10/23: An earlier version of this article misstated the reduction in number of migraine days.
, according to recent research published in the journal Headache.
The prospective, randomized, double-blind, placebo-controlled, multicenter trial showed that remote electrical neuromodulation (REN) with Nerivio (Theranica Bio-Electronics Ltd.; Bridgewater, N.J.) found a mean reduction/decrease in the number of migraine days by an average of 4.0 days per month, according to Stewart J. Tepper MD, of the Geisel School of Medicine at Dartmouth in Hanover, N.H., and colleagues.*
“The statistically significant results were maintained in separate subanalyses of the chronic and episodic subsamples, as well as in the separate subanalyses of participants who used and did not use migraine prophylaxis,” Dr. Tepper and colleagues wrote.
A nonpharmacological alternative
Researchers randomized 248 participants into active and placebo groups, with 95 participants in the active group and 84 participants in the placebo group meeting the criteria for a modified intention-to-treat (mITT) analysis. Most of the participants in the ITT dataset were women (85.9%) with an average age of 41.7 years, and a baseline average of 12.2 migraine days and 15.6 headache days. Overall, 52.4% of participants in the ITT dataset had chronic migraine, 25.0% had migraine with aura, and 41.1% were taking preventative medication.
Dr. Tepper and colleagues followed participants for 4 weeks at baseline for observation followed by 8 weeks of participants using the REN device every other day for 45 minutes, or a placebo device that “produces electrical pulses of the same maximum intensity (34 mA) and overall energy, but with different pulse durations and much lower frequencies compared with the active device.” Participants completed a daily diary where they recorded their symptoms.
Researchers assessed the mean change in number of migraine days per month as a primary outcome, and evaluated participants who experienced episodic and chronic migraines separately in subgroup analyses. Secondary outcome measures included mean change in number of moderate or severe headache days, 50% reduction in mean number of headache days compared with baseline, Headache Impact Test short form (HIT-6) and Migraine Specific Quality of Life Questionnaire (MSQ) Role Function Domain total score mean change at 12 weeks compared with week 1, and reduction in mean number of days taking acute headache or migraine medication.
Participants receiving REN treatment had a significant reduction in mean migraine days per month compared with the placebo group (4.0 days vs. 1.3 days; 95% confidence interval, –3.9 days to –1.5 days; P < .001). In subgroup analyses, a significant reduction in migraine days was seen in participants receiving REN treatment with episodic migraine (3.2 days vs. 1.0 days; P = .003) and chronic migraine (4.7 days vs. 1.6 days; P = .001) compared with placebo.
Dr. Tepper and colleagues found a significant reduction in moderate and/or severe headache days among participants receiving REN treatment compared with placebo (3.8 days vs. 2.2 days; P = .005), a significant reduction in headache days overall compared with placebo (4.5 days vs. 1.8 days; P < .001), a significant percentage of patients who experienced 50% reduction in moderate and/or severe headache days compared with placebo (51.6% vs. 35.7%; P = .033), and a significant reduction in acute medication days compared with placebo (3.5 days vs. 1.4 days; P = .001). Dr. Tepper and colleagues found no serious device-related adverse events in either group.
The researchers noted that REN therapy is a “much-needed nonpharmacological alternative” to other preventive and acute treatments for migraine. “Given the previously well-established clinical efficacy and high safety profile in acute treatment of migraine, REN can cover the entire treatment spectrum of migraine, including both acute and preventive treatments,” they said.
‘A good place to start’
Commenting on the study, Alan M. Rapoport, MD, clinical professor of neurology at University of California, Los Angeles; past president of the International Headache Society; and editor-in-chief of Neurology Reviews, said the study was well designed, but acknowledged the 8-week follow-up time for participants as one potential area where he would have wanted to see more data.
As a medical device cleared for use by the Food and Drug Administration for acute treatment of migraine, the REM device also appears to be effective as a migraine preventative based on the results of the study with “virtually no adverse events,” he noted.
“I think this is a great treatment. I think it’s a good place to start,” Dr. Rapoport said. Given the low adverse event rate, he said he would be willing to offer the device to patients as a first option for preventing migraine and either switch to another preventative option or add an additional medication in combination based on how the patient responds. However, at the moment, he noted that this device is not covered by insurance.
Now that a REN device has been shown to work in the acute setting and as a preventative, Dr. Rapoport said he is interested in seeing other devices that have been cleared by the FDA as migraine treatments evaluated in migraine prevention. “I think we need more patients tried on the devices so we get an idea of which ones work acutely, which ones work preventively,” he said.
The authors reported personal and institutional relationships in the form of advisory board positions, consultancies, grants, research principal investigator roles, royalties, speakers bureau positions, and stockholders for a variety of pharmaceutical companies, agencies, and other organizations. Several authors disclosed ties with Theranica, the manufacturer of the REN device used in the study. Dr. Rapoport is editor-in-chief of Neurology Reviews and a consultant for Theranica, but was not involved in studies associated with the REN device.
Correction, 2/10/23: An earlier version of this article misstated the reduction in number of migraine days.
FROM HEADACHE
Frequent visits to green spaces linked to lower use of some meds
Frequent visits to green spaces such as parks and community gardens are associated with a reduced use of certain prescription medications among city dwellers, a new analysis suggests.
In a cross-sectional cohort study, frequent green space visits were associated with less frequent use of psychotropic, antihypertensive, and asthma medications in urban environments.
Viewing green or so called “blue” spaces (views of lakes, rivers, or other water views) from the home was not associated with reduced medication use.
The growing scientific evidence supporting the health benefits of nature exposure is likely to increase the availability of high-quality green spaces in urban environments and promote the use of these spaces, lead author Anu W. Turunen, PhD, from the Finnish Institute for Health and Welfare, Kuopio, Finland, told this news organization.
This might be one way to improve health and well-being among city dwellers, Dr. Turunen added.
The findings were published online in Occupational and Environmental Medicine.
Nature exposure a timely topic
Exposure to natural environments is thought to be beneficial for human health, but the evidence is inconsistent, Dr. Turunen said.
“The potential health benefits of nature exposure is a very timely topic in environmental epidemiology. Scientific evidence indicates that residential exposure to greenery and water bodies might be beneficial, especially for mental, cardiovascular, and respiratory health, but the findings are partly inconsistent and thus, more detailed information is needed,” she said.
In the current cross-sectional study, the investigators surveyed 16,000 residents of three urban areas in Finland – Helsinki, Espoo, and Vantaa – over the period of 12 months from 2015 to 2016, about their exposure to green and blue spaces.
Of this number, 43% responded, resulting in 7,321 participants.
In the questionnaire, green areas were defined as forests, parks, fields, meadows, boglands, and rocks, as well as any playgrounds or playing fields within those areas, and blue areas were defined as sea, lakes, and rivers.
Residents were asked about their use of anxiolytics, hypnotics, antidepressants, antihypertensives, and asthma medication within the past 7 to 52 weeks.
They were also asked if they had any green and blue views from any of the windows of their home, and if so, how often did they look out of those windows, selecting “seldom” to “often.”
They were also asked about how much time they spent outdoors in green spaces during the months of May and September. If so, did they spend any of that time exercising? Options ranged from never to five or more times a week.
In addition, amounts of residential green and blue spaces located within a 1 km radius of the respondents’ homes were assessed from land use and land cover data.
Covariates included health behaviors, outdoor air pollution and noise, and socioeconomic status, including household income and educational attainment.
Results showed that the presence of green and blue spaces at home, and the amount of time spent viewing them, had no association with the use of the prescribed medicines.
However, greater frequency of green space visits was associated with lower odds of using the medications surveyed.
For psychotropic medications, the odds ratios were 0.67 (95% confidence interval, 0.55-0.82) for 3-4 times per week and 0.78 (95% CI, 0.63-0.96) for 5 or more times per week.
For antihypertensive meds, the ORs were 0.64 (95% CI, 0.52-0.78) for 3-4 times per week and 0.59 (95% CI, 0.48-0.74) for 5 or more times per week.
For asthma medications, the ORs were 0.74 (95% CI, 0.58-0.94) for 3-4 times per week and 0.76 (95% CI, 0.59-0.99) for 5 or more times per week.
The observed associations were attenuated by body mass index.
“We observed that those who reported visiting green spaces often had a slightly lower BMI than those who visited green spaces less often,” Dr. Turunen said. However, no consistent interactions with socioeconomic status indicators were observed.
“We are hoping to see new results from different countries and different settings,” she noted. “Longitudinal studies, especially, are needed. In epidemiology, a large body of consistent evidence is needed to draw strong conclusions and to make recommendations.”
Evidence mounts on the benefits of nature
There is growing evidence that exposure to nature could benefit human health, especially mental and cardiovascular health, says Jochem Klompmaker, PhD, a postdoctoral researcher in the department of environmental health at the Harvard T.H. Chan School of Public Health, Boston.
Dr. Klompmaker has researched the association between exposure to green spaces and health outcomes related to neurological diseases.
In a study recently published in JAMA Network Open, and reported by this news organization, Dr. Klompmaker and his team found that among a large cohort of about 6.7 million fee-for-service Medicare beneficiaries in the United States aged 65 or older, living in areas rich with greenery, parks, and waterways was associated with fewer hospitalizations for certain neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and related dementias.
Commenting on the current study, Dr. Klompmaker noted its strengths.
“A particular strength of this study is that they used data about the amount of green and blue spaces around the residential addresses of the participants, data about green space visit frequency, and data about green and blue views from home. Most other studies only have data about the amount of green and blue spaces in general,” he said.
“The strong protective associations of frequency of green space visits make sense to me and indicate the importance of one’s actual nature exposure,” he added. “Like the results of our study, these results provide clinicians with more evidence of the importance of being close to nature and of encouraging patients to take more walks. If they live near a park, that could be a good place to be more physically active and reduce stress levels.”
The study was supported by the Academy of Finland and the Ministry of the Environment. Dr. Turunen and Dr. Klompmaker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Frequent visits to green spaces such as parks and community gardens are associated with a reduced use of certain prescription medications among city dwellers, a new analysis suggests.
In a cross-sectional cohort study, frequent green space visits were associated with less frequent use of psychotropic, antihypertensive, and asthma medications in urban environments.
Viewing green or so called “blue” spaces (views of lakes, rivers, or other water views) from the home was not associated with reduced medication use.
The growing scientific evidence supporting the health benefits of nature exposure is likely to increase the availability of high-quality green spaces in urban environments and promote the use of these spaces, lead author Anu W. Turunen, PhD, from the Finnish Institute for Health and Welfare, Kuopio, Finland, told this news organization.
This might be one way to improve health and well-being among city dwellers, Dr. Turunen added.
The findings were published online in Occupational and Environmental Medicine.
Nature exposure a timely topic
Exposure to natural environments is thought to be beneficial for human health, but the evidence is inconsistent, Dr. Turunen said.
“The potential health benefits of nature exposure is a very timely topic in environmental epidemiology. Scientific evidence indicates that residential exposure to greenery and water bodies might be beneficial, especially for mental, cardiovascular, and respiratory health, but the findings are partly inconsistent and thus, more detailed information is needed,” she said.
In the current cross-sectional study, the investigators surveyed 16,000 residents of three urban areas in Finland – Helsinki, Espoo, and Vantaa – over the period of 12 months from 2015 to 2016, about their exposure to green and blue spaces.
Of this number, 43% responded, resulting in 7,321 participants.
In the questionnaire, green areas were defined as forests, parks, fields, meadows, boglands, and rocks, as well as any playgrounds or playing fields within those areas, and blue areas were defined as sea, lakes, and rivers.
Residents were asked about their use of anxiolytics, hypnotics, antidepressants, antihypertensives, and asthma medication within the past 7 to 52 weeks.
They were also asked if they had any green and blue views from any of the windows of their home, and if so, how often did they look out of those windows, selecting “seldom” to “often.”
They were also asked about how much time they spent outdoors in green spaces during the months of May and September. If so, did they spend any of that time exercising? Options ranged from never to five or more times a week.
In addition, amounts of residential green and blue spaces located within a 1 km radius of the respondents’ homes were assessed from land use and land cover data.
Covariates included health behaviors, outdoor air pollution and noise, and socioeconomic status, including household income and educational attainment.
Results showed that the presence of green and blue spaces at home, and the amount of time spent viewing them, had no association with the use of the prescribed medicines.
However, greater frequency of green space visits was associated with lower odds of using the medications surveyed.
For psychotropic medications, the odds ratios were 0.67 (95% confidence interval, 0.55-0.82) for 3-4 times per week and 0.78 (95% CI, 0.63-0.96) for 5 or more times per week.
For antihypertensive meds, the ORs were 0.64 (95% CI, 0.52-0.78) for 3-4 times per week and 0.59 (95% CI, 0.48-0.74) for 5 or more times per week.
For asthma medications, the ORs were 0.74 (95% CI, 0.58-0.94) for 3-4 times per week and 0.76 (95% CI, 0.59-0.99) for 5 or more times per week.
The observed associations were attenuated by body mass index.
“We observed that those who reported visiting green spaces often had a slightly lower BMI than those who visited green spaces less often,” Dr. Turunen said. However, no consistent interactions with socioeconomic status indicators were observed.
“We are hoping to see new results from different countries and different settings,” she noted. “Longitudinal studies, especially, are needed. In epidemiology, a large body of consistent evidence is needed to draw strong conclusions and to make recommendations.”
Evidence mounts on the benefits of nature
There is growing evidence that exposure to nature could benefit human health, especially mental and cardiovascular health, says Jochem Klompmaker, PhD, a postdoctoral researcher in the department of environmental health at the Harvard T.H. Chan School of Public Health, Boston.
Dr. Klompmaker has researched the association between exposure to green spaces and health outcomes related to neurological diseases.
In a study recently published in JAMA Network Open, and reported by this news organization, Dr. Klompmaker and his team found that among a large cohort of about 6.7 million fee-for-service Medicare beneficiaries in the United States aged 65 or older, living in areas rich with greenery, parks, and waterways was associated with fewer hospitalizations for certain neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and related dementias.
Commenting on the current study, Dr. Klompmaker noted its strengths.
“A particular strength of this study is that they used data about the amount of green and blue spaces around the residential addresses of the participants, data about green space visit frequency, and data about green and blue views from home. Most other studies only have data about the amount of green and blue spaces in general,” he said.
“The strong protective associations of frequency of green space visits make sense to me and indicate the importance of one’s actual nature exposure,” he added. “Like the results of our study, these results provide clinicians with more evidence of the importance of being close to nature and of encouraging patients to take more walks. If they live near a park, that could be a good place to be more physically active and reduce stress levels.”
The study was supported by the Academy of Finland and the Ministry of the Environment. Dr. Turunen and Dr. Klompmaker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Frequent visits to green spaces such as parks and community gardens are associated with a reduced use of certain prescription medications among city dwellers, a new analysis suggests.
In a cross-sectional cohort study, frequent green space visits were associated with less frequent use of psychotropic, antihypertensive, and asthma medications in urban environments.
Viewing green or so called “blue” spaces (views of lakes, rivers, or other water views) from the home was not associated with reduced medication use.
The growing scientific evidence supporting the health benefits of nature exposure is likely to increase the availability of high-quality green spaces in urban environments and promote the use of these spaces, lead author Anu W. Turunen, PhD, from the Finnish Institute for Health and Welfare, Kuopio, Finland, told this news organization.
This might be one way to improve health and well-being among city dwellers, Dr. Turunen added.
The findings were published online in Occupational and Environmental Medicine.
Nature exposure a timely topic
Exposure to natural environments is thought to be beneficial for human health, but the evidence is inconsistent, Dr. Turunen said.
“The potential health benefits of nature exposure is a very timely topic in environmental epidemiology. Scientific evidence indicates that residential exposure to greenery and water bodies might be beneficial, especially for mental, cardiovascular, and respiratory health, but the findings are partly inconsistent and thus, more detailed information is needed,” she said.
In the current cross-sectional study, the investigators surveyed 16,000 residents of three urban areas in Finland – Helsinki, Espoo, and Vantaa – over the period of 12 months from 2015 to 2016, about their exposure to green and blue spaces.
Of this number, 43% responded, resulting in 7,321 participants.
In the questionnaire, green areas were defined as forests, parks, fields, meadows, boglands, and rocks, as well as any playgrounds or playing fields within those areas, and blue areas were defined as sea, lakes, and rivers.
Residents were asked about their use of anxiolytics, hypnotics, antidepressants, antihypertensives, and asthma medication within the past 7 to 52 weeks.
They were also asked if they had any green and blue views from any of the windows of their home, and if so, how often did they look out of those windows, selecting “seldom” to “often.”
They were also asked about how much time they spent outdoors in green spaces during the months of May and September. If so, did they spend any of that time exercising? Options ranged from never to five or more times a week.
In addition, amounts of residential green and blue spaces located within a 1 km radius of the respondents’ homes were assessed from land use and land cover data.
Covariates included health behaviors, outdoor air pollution and noise, and socioeconomic status, including household income and educational attainment.
Results showed that the presence of green and blue spaces at home, and the amount of time spent viewing them, had no association with the use of the prescribed medicines.
However, greater frequency of green space visits was associated with lower odds of using the medications surveyed.
For psychotropic medications, the odds ratios were 0.67 (95% confidence interval, 0.55-0.82) for 3-4 times per week and 0.78 (95% CI, 0.63-0.96) for 5 or more times per week.
For antihypertensive meds, the ORs were 0.64 (95% CI, 0.52-0.78) for 3-4 times per week and 0.59 (95% CI, 0.48-0.74) for 5 or more times per week.
For asthma medications, the ORs were 0.74 (95% CI, 0.58-0.94) for 3-4 times per week and 0.76 (95% CI, 0.59-0.99) for 5 or more times per week.
The observed associations were attenuated by body mass index.
“We observed that those who reported visiting green spaces often had a slightly lower BMI than those who visited green spaces less often,” Dr. Turunen said. However, no consistent interactions with socioeconomic status indicators were observed.
“We are hoping to see new results from different countries and different settings,” she noted. “Longitudinal studies, especially, are needed. In epidemiology, a large body of consistent evidence is needed to draw strong conclusions and to make recommendations.”
Evidence mounts on the benefits of nature
There is growing evidence that exposure to nature could benefit human health, especially mental and cardiovascular health, says Jochem Klompmaker, PhD, a postdoctoral researcher in the department of environmental health at the Harvard T.H. Chan School of Public Health, Boston.
Dr. Klompmaker has researched the association between exposure to green spaces and health outcomes related to neurological diseases.
In a study recently published in JAMA Network Open, and reported by this news organization, Dr. Klompmaker and his team found that among a large cohort of about 6.7 million fee-for-service Medicare beneficiaries in the United States aged 65 or older, living in areas rich with greenery, parks, and waterways was associated with fewer hospitalizations for certain neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and related dementias.
Commenting on the current study, Dr. Klompmaker noted its strengths.
“A particular strength of this study is that they used data about the amount of green and blue spaces around the residential addresses of the participants, data about green space visit frequency, and data about green and blue views from home. Most other studies only have data about the amount of green and blue spaces in general,” he said.
“The strong protective associations of frequency of green space visits make sense to me and indicate the importance of one’s actual nature exposure,” he added. “Like the results of our study, these results provide clinicians with more evidence of the importance of being close to nature and of encouraging patients to take more walks. If they live near a park, that could be a good place to be more physically active and reduce stress levels.”
The study was supported by the Academy of Finland and the Ministry of the Environment. Dr. Turunen and Dr. Klompmaker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
More data back Guillain-Barré risk with Janssen COVID shot
Over 14 months, GBS reporting rates within 21 and 42 days of administration of Janssen’s replication-incompetent adenoviral vector vaccine were approximately 9 to 12 times higher than after administration of the Pfizer-BioNTech (BNT162b2) or the Moderna (mRNA-1273) mRNA COVID vaccines.
Additionally, observed GBS cases after the Janssen shot were 2 to 3 times greater than expected, based on background rates within 21 and 42 days of vaccination.
Conversely, and confirming prior data, there was no increased risk for GBS with the Pfizer or Moderna vaccines and no significant difference between observed and expected numbers of GBS cases after either mRNA COVID-19 vaccine.
The findings were published online in JAMA Network Open.
More precise risk estimates
Winston Abara, MD, with the U.S. Centers for Disease Control and Prevention, and colleagues analyzed GBS reports submitted to the VAERS between December 2020 and January 2022.
Among 487.6 million COVID-19 vaccine doses administered, 3.7% were Janssen’s Ad26.COV2.S vaccine, 54.7% were Pfizer’s BNT162b2 vaccine, and 41.6% were Moderna’s mRNA-1273 vaccine.
There were 295 verified reports of GBS identified after COVID-19 vaccination. Of these, 209 occurred within 21 days of vaccination and 253 within 42 days.
Within 21 days of vaccination, GBS reporting rates per 1 million doses were 3.29 for the Janssen vaccine versus 0.29 and 0.35 for the Pfizer and Moderna vaccines, respectively. Within 42 days of vaccination, reporting rates per 1 million doses were 4.07, 0.34, and 0.44, respectively.
Also within 21 days of vaccination, GBS reporting rates were significantly higher with the Janssen vaccine than the Pfizer vaccine (reporting rate ratio, 11.40) and the Moderna vaccine (RRR, 9.26). Similar findings were observed within 42 days after vaccination.
The observed-to-expected ratios were 3.79 for 21-day and 2.34 for 42-day intervals after receipt of the Janssen vaccine, and less than 1 (not significant) after the Pfizer or Moderna vaccine within both post-vaccination periods.
“Unlike prior studies, our analysis included all U.S. reports of verified GBS cases that met the Brighton Collaboration GBS case definition criteria (Brighton Levels 1, 2, and 3) submitted over a 14-month surveillance period to the to the Vaccine Adverse Event Reporting System,” Dr. Abara said in an interview. “Because we used all U.S. reports, the sample of verified GBS cases in this analysis is larger than other studies. Therefore, it may provide a more precise estimate of the GBS risk within 21 and 42 days after mRNA and Ad26.COV2.S vaccination,” he said.
‘Remarkably low’ use
Nicola Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Oakland, Calif., noted that this is a “nice confirmatory analysis that supports and further expands what’s been observed before.”
Last year, as reported by this news organization, Dr. Klein and colleagues reported data from the Vaccine Safety Datalink confirming a small but statistically significant increased risk for GBS in the 3 weeks after receipt of the Janssen COVID-19 vaccine but not the Pfizer or Moderna vaccines.
Unlike VAERS, the Vaccine Safety Datalink is not a reporting system. It’s an active surveillance of medical records in the Kaiser Permanente system. The VAERS is a passive system, so it requires individuals to report GBS cases to the VAERS team, Dr. Klein explained.
So although the two studies are slightly different, overall, the VAERS data is “consistent with what we found,” she said.
Also weighing in, C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and professor of pediatrics at the Vanderbilt University School of Medicine, Nashville, Tenn., said it is “important to realize that GBS had been observed after adenovirus-vectored vaccines earlier in the pandemic, both for the AstraZeneca vaccine and the Janssen vaccine.”
The Advisory Committee on Immunization Practices (ACIP) preferentially recommends that people age 18 years and older receive an mRNA COVID-19 vaccine rather than the Janssen adenoviral vector vaccine when both types of COVID-19 vaccine are available.
“Thus, the use of the Janssen vaccine is remarkably low in the U.S. right now,” Dr. Creech said.
“Nevertheless, we have a firm commitment, both scientifically and ethically, to track potential side effects after vaccination and to make sure that the vaccines in use for COVID, and other important infectious diseases, are safe and effective,” he added.
The study had no commercial funding. Dr. Abara and Dr. Creech have reported no relevant financial relationships. Dr. Klein reported having received grants from Pfizer research support for a COVID vaccine clinical trial, as well as grants from Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur).
A version of this article first appeared on Medscape.com.
Over 14 months, GBS reporting rates within 21 and 42 days of administration of Janssen’s replication-incompetent adenoviral vector vaccine were approximately 9 to 12 times higher than after administration of the Pfizer-BioNTech (BNT162b2) or the Moderna (mRNA-1273) mRNA COVID vaccines.
Additionally, observed GBS cases after the Janssen shot were 2 to 3 times greater than expected, based on background rates within 21 and 42 days of vaccination.
Conversely, and confirming prior data, there was no increased risk for GBS with the Pfizer or Moderna vaccines and no significant difference between observed and expected numbers of GBS cases after either mRNA COVID-19 vaccine.
The findings were published online in JAMA Network Open.
More precise risk estimates
Winston Abara, MD, with the U.S. Centers for Disease Control and Prevention, and colleagues analyzed GBS reports submitted to the VAERS between December 2020 and January 2022.
Among 487.6 million COVID-19 vaccine doses administered, 3.7% were Janssen’s Ad26.COV2.S vaccine, 54.7% were Pfizer’s BNT162b2 vaccine, and 41.6% were Moderna’s mRNA-1273 vaccine.
There were 295 verified reports of GBS identified after COVID-19 vaccination. Of these, 209 occurred within 21 days of vaccination and 253 within 42 days.
Within 21 days of vaccination, GBS reporting rates per 1 million doses were 3.29 for the Janssen vaccine versus 0.29 and 0.35 for the Pfizer and Moderna vaccines, respectively. Within 42 days of vaccination, reporting rates per 1 million doses were 4.07, 0.34, and 0.44, respectively.
Also within 21 days of vaccination, GBS reporting rates were significantly higher with the Janssen vaccine than the Pfizer vaccine (reporting rate ratio, 11.40) and the Moderna vaccine (RRR, 9.26). Similar findings were observed within 42 days after vaccination.
The observed-to-expected ratios were 3.79 for 21-day and 2.34 for 42-day intervals after receipt of the Janssen vaccine, and less than 1 (not significant) after the Pfizer or Moderna vaccine within both post-vaccination periods.
“Unlike prior studies, our analysis included all U.S. reports of verified GBS cases that met the Brighton Collaboration GBS case definition criteria (Brighton Levels 1, 2, and 3) submitted over a 14-month surveillance period to the to the Vaccine Adverse Event Reporting System,” Dr. Abara said in an interview. “Because we used all U.S. reports, the sample of verified GBS cases in this analysis is larger than other studies. Therefore, it may provide a more precise estimate of the GBS risk within 21 and 42 days after mRNA and Ad26.COV2.S vaccination,” he said.
‘Remarkably low’ use
Nicola Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Oakland, Calif., noted that this is a “nice confirmatory analysis that supports and further expands what’s been observed before.”
Last year, as reported by this news organization, Dr. Klein and colleagues reported data from the Vaccine Safety Datalink confirming a small but statistically significant increased risk for GBS in the 3 weeks after receipt of the Janssen COVID-19 vaccine but not the Pfizer or Moderna vaccines.
Unlike VAERS, the Vaccine Safety Datalink is not a reporting system. It’s an active surveillance of medical records in the Kaiser Permanente system. The VAERS is a passive system, so it requires individuals to report GBS cases to the VAERS team, Dr. Klein explained.
So although the two studies are slightly different, overall, the VAERS data is “consistent with what we found,” she said.
Also weighing in, C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and professor of pediatrics at the Vanderbilt University School of Medicine, Nashville, Tenn., said it is “important to realize that GBS had been observed after adenovirus-vectored vaccines earlier in the pandemic, both for the AstraZeneca vaccine and the Janssen vaccine.”
The Advisory Committee on Immunization Practices (ACIP) preferentially recommends that people age 18 years and older receive an mRNA COVID-19 vaccine rather than the Janssen adenoviral vector vaccine when both types of COVID-19 vaccine are available.
“Thus, the use of the Janssen vaccine is remarkably low in the U.S. right now,” Dr. Creech said.
“Nevertheless, we have a firm commitment, both scientifically and ethically, to track potential side effects after vaccination and to make sure that the vaccines in use for COVID, and other important infectious diseases, are safe and effective,” he added.
The study had no commercial funding. Dr. Abara and Dr. Creech have reported no relevant financial relationships. Dr. Klein reported having received grants from Pfizer research support for a COVID vaccine clinical trial, as well as grants from Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur).
A version of this article first appeared on Medscape.com.
Over 14 months, GBS reporting rates within 21 and 42 days of administration of Janssen’s replication-incompetent adenoviral vector vaccine were approximately 9 to 12 times higher than after administration of the Pfizer-BioNTech (BNT162b2) or the Moderna (mRNA-1273) mRNA COVID vaccines.
Additionally, observed GBS cases after the Janssen shot were 2 to 3 times greater than expected, based on background rates within 21 and 42 days of vaccination.
Conversely, and confirming prior data, there was no increased risk for GBS with the Pfizer or Moderna vaccines and no significant difference between observed and expected numbers of GBS cases after either mRNA COVID-19 vaccine.
The findings were published online in JAMA Network Open.
More precise risk estimates
Winston Abara, MD, with the U.S. Centers for Disease Control and Prevention, and colleagues analyzed GBS reports submitted to the VAERS between December 2020 and January 2022.
Among 487.6 million COVID-19 vaccine doses administered, 3.7% were Janssen’s Ad26.COV2.S vaccine, 54.7% were Pfizer’s BNT162b2 vaccine, and 41.6% were Moderna’s mRNA-1273 vaccine.
There were 295 verified reports of GBS identified after COVID-19 vaccination. Of these, 209 occurred within 21 days of vaccination and 253 within 42 days.
Within 21 days of vaccination, GBS reporting rates per 1 million doses were 3.29 for the Janssen vaccine versus 0.29 and 0.35 for the Pfizer and Moderna vaccines, respectively. Within 42 days of vaccination, reporting rates per 1 million doses were 4.07, 0.34, and 0.44, respectively.
Also within 21 days of vaccination, GBS reporting rates were significantly higher with the Janssen vaccine than the Pfizer vaccine (reporting rate ratio, 11.40) and the Moderna vaccine (RRR, 9.26). Similar findings were observed within 42 days after vaccination.
The observed-to-expected ratios were 3.79 for 21-day and 2.34 for 42-day intervals after receipt of the Janssen vaccine, and less than 1 (not significant) after the Pfizer or Moderna vaccine within both post-vaccination periods.
“Unlike prior studies, our analysis included all U.S. reports of verified GBS cases that met the Brighton Collaboration GBS case definition criteria (Brighton Levels 1, 2, and 3) submitted over a 14-month surveillance period to the to the Vaccine Adverse Event Reporting System,” Dr. Abara said in an interview. “Because we used all U.S. reports, the sample of verified GBS cases in this analysis is larger than other studies. Therefore, it may provide a more precise estimate of the GBS risk within 21 and 42 days after mRNA and Ad26.COV2.S vaccination,” he said.
‘Remarkably low’ use
Nicola Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Oakland, Calif., noted that this is a “nice confirmatory analysis that supports and further expands what’s been observed before.”
Last year, as reported by this news organization, Dr. Klein and colleagues reported data from the Vaccine Safety Datalink confirming a small but statistically significant increased risk for GBS in the 3 weeks after receipt of the Janssen COVID-19 vaccine but not the Pfizer or Moderna vaccines.
Unlike VAERS, the Vaccine Safety Datalink is not a reporting system. It’s an active surveillance of medical records in the Kaiser Permanente system. The VAERS is a passive system, so it requires individuals to report GBS cases to the VAERS team, Dr. Klein explained.
So although the two studies are slightly different, overall, the VAERS data is “consistent with what we found,” she said.
Also weighing in, C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and professor of pediatrics at the Vanderbilt University School of Medicine, Nashville, Tenn., said it is “important to realize that GBS had been observed after adenovirus-vectored vaccines earlier in the pandemic, both for the AstraZeneca vaccine and the Janssen vaccine.”
The Advisory Committee on Immunization Practices (ACIP) preferentially recommends that people age 18 years and older receive an mRNA COVID-19 vaccine rather than the Janssen adenoviral vector vaccine when both types of COVID-19 vaccine are available.
“Thus, the use of the Janssen vaccine is remarkably low in the U.S. right now,” Dr. Creech said.
“Nevertheless, we have a firm commitment, both scientifically and ethically, to track potential side effects after vaccination and to make sure that the vaccines in use for COVID, and other important infectious diseases, are safe and effective,” he added.
The study had no commercial funding. Dr. Abara and Dr. Creech have reported no relevant financial relationships. Dr. Klein reported having received grants from Pfizer research support for a COVID vaccine clinical trial, as well as grants from Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur).
A version of this article first appeared on Medscape.com.
Long-term depression may hasten brain aging in midlife
Previous research suggests a possible link between depression and increased risk of dementia in older adults, but the association between depression and brain health in early adulthood and midlife has not been well studied, wrote Christina S. Dintica, PhD, of the University of California, San Francisco, and colleagues.
In a study published in the Journal of Affective Disorders, the researchers identified 649 individuals aged 23-36 at baseline who were part of the Coronary Artery Risk Development in Young Adults (CARDIA) study. All participants underwent brain MRI and cognitive testing. Depressive symptoms were assessed six times over a 25-year period using the Center for Epidemiological Studies Depression scale (CES–D), and the scores were analyzed as time-weighted averages (TWA). Elevated depressive symptoms were defined as CES-D scores of 16 or higher. Brain age was assessed via high-dimensional neuroimaging. Approximately half of the participants were female, and half were Black.
Overall, each 5-point increment in TWA depression symptoms over 25 years was associated with a 1-year increase in brain age, and individuals with elevated TWA depression averaged a 3-year increase in brain age compared with those with lower levels of depression after controlling for factors including chronological age, sex, education, race, MRI scanning site, and intracranial volume, they said. The association was attenuated in a model controlling for antidepressant use, and further attenuated after adjusting for smoking, alcohol consumption, income, body mass index, diabetes, and physical exercise.
The researchers also investigated the impact of the age period of elevated depressive symptoms on brain age. Compared with low depressive symptoms, elevated TWA CES-D at ages 30-39 years, 40-49 years, and 50-59 years was associated with increased brain ages of 2.43, 3.19, and 1.82.
In addition, elevated depressive symptoms were associated with a threefold increase in the odds of poor cognitive function at midlife (odds ratio, 3.30), although these odds were reduced after adjusting for use of antidepressants (OR, 1.47).
The mechanisms of action for the link between depression and accelerated brain aging remains uncertain, the researchers wrote in their discussion. “Studies over the last 20 years have demonstrated that increased inflammation and hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis are two of the most consistent biological findings in major depression, which have been linked to premature aging,” they noted. “Alternative explanations for the link between depression and adverse brain health could be underlying factors that explain both outcomes rather independently, such as low socioeconomic status, childhood maltreatment, or shared genetic effects,” they added.
Adjustment for antidepressant use had little effect overall on the association between depressive symptom severity and brain age, they said.
The current study findings were limited by the single assessment of brain age, which prevented evaluation of the temporality of the association between brain aging and depression, the researchers noted.
However, the results were strengthened by the large and diverse cohort, long-term follow-up, and use of high-dimensional neuroimaging, they said. Longitudinal studies are needed to explore mechanisms of action and the potential benefits of antidepressants, they added.
In the meantime, monitoring and treating depressive symptoms in young adults may help promote brain health in midlife and older age, they concluded.
The CARDIA study was supported by the National Heart, Lung, and Blood Institute, the National Institute on Aging, and the Alzheimer’s Association. The researchers had no financial conflicts to disclose.
Previous research suggests a possible link between depression and increased risk of dementia in older adults, but the association between depression and brain health in early adulthood and midlife has not been well studied, wrote Christina S. Dintica, PhD, of the University of California, San Francisco, and colleagues.
In a study published in the Journal of Affective Disorders, the researchers identified 649 individuals aged 23-36 at baseline who were part of the Coronary Artery Risk Development in Young Adults (CARDIA) study. All participants underwent brain MRI and cognitive testing. Depressive symptoms were assessed six times over a 25-year period using the Center for Epidemiological Studies Depression scale (CES–D), and the scores were analyzed as time-weighted averages (TWA). Elevated depressive symptoms were defined as CES-D scores of 16 or higher. Brain age was assessed via high-dimensional neuroimaging. Approximately half of the participants were female, and half were Black.
Overall, each 5-point increment in TWA depression symptoms over 25 years was associated with a 1-year increase in brain age, and individuals with elevated TWA depression averaged a 3-year increase in brain age compared with those with lower levels of depression after controlling for factors including chronological age, sex, education, race, MRI scanning site, and intracranial volume, they said. The association was attenuated in a model controlling for antidepressant use, and further attenuated after adjusting for smoking, alcohol consumption, income, body mass index, diabetes, and physical exercise.
The researchers also investigated the impact of the age period of elevated depressive symptoms on brain age. Compared with low depressive symptoms, elevated TWA CES-D at ages 30-39 years, 40-49 years, and 50-59 years was associated with increased brain ages of 2.43, 3.19, and 1.82.
In addition, elevated depressive symptoms were associated with a threefold increase in the odds of poor cognitive function at midlife (odds ratio, 3.30), although these odds were reduced after adjusting for use of antidepressants (OR, 1.47).
The mechanisms of action for the link between depression and accelerated brain aging remains uncertain, the researchers wrote in their discussion. “Studies over the last 20 years have demonstrated that increased inflammation and hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis are two of the most consistent biological findings in major depression, which have been linked to premature aging,” they noted. “Alternative explanations for the link between depression and adverse brain health could be underlying factors that explain both outcomes rather independently, such as low socioeconomic status, childhood maltreatment, or shared genetic effects,” they added.
Adjustment for antidepressant use had little effect overall on the association between depressive symptom severity and brain age, they said.
The current study findings were limited by the single assessment of brain age, which prevented evaluation of the temporality of the association between brain aging and depression, the researchers noted.
However, the results were strengthened by the large and diverse cohort, long-term follow-up, and use of high-dimensional neuroimaging, they said. Longitudinal studies are needed to explore mechanisms of action and the potential benefits of antidepressants, they added.
In the meantime, monitoring and treating depressive symptoms in young adults may help promote brain health in midlife and older age, they concluded.
The CARDIA study was supported by the National Heart, Lung, and Blood Institute, the National Institute on Aging, and the Alzheimer’s Association. The researchers had no financial conflicts to disclose.
Previous research suggests a possible link between depression and increased risk of dementia in older adults, but the association between depression and brain health in early adulthood and midlife has not been well studied, wrote Christina S. Dintica, PhD, of the University of California, San Francisco, and colleagues.
In a study published in the Journal of Affective Disorders, the researchers identified 649 individuals aged 23-36 at baseline who were part of the Coronary Artery Risk Development in Young Adults (CARDIA) study. All participants underwent brain MRI and cognitive testing. Depressive symptoms were assessed six times over a 25-year period using the Center for Epidemiological Studies Depression scale (CES–D), and the scores were analyzed as time-weighted averages (TWA). Elevated depressive symptoms were defined as CES-D scores of 16 or higher. Brain age was assessed via high-dimensional neuroimaging. Approximately half of the participants were female, and half were Black.
Overall, each 5-point increment in TWA depression symptoms over 25 years was associated with a 1-year increase in brain age, and individuals with elevated TWA depression averaged a 3-year increase in brain age compared with those with lower levels of depression after controlling for factors including chronological age, sex, education, race, MRI scanning site, and intracranial volume, they said. The association was attenuated in a model controlling for antidepressant use, and further attenuated after adjusting for smoking, alcohol consumption, income, body mass index, diabetes, and physical exercise.
The researchers also investigated the impact of the age period of elevated depressive symptoms on brain age. Compared with low depressive symptoms, elevated TWA CES-D at ages 30-39 years, 40-49 years, and 50-59 years was associated with increased brain ages of 2.43, 3.19, and 1.82.
In addition, elevated depressive symptoms were associated with a threefold increase in the odds of poor cognitive function at midlife (odds ratio, 3.30), although these odds were reduced after adjusting for use of antidepressants (OR, 1.47).
The mechanisms of action for the link between depression and accelerated brain aging remains uncertain, the researchers wrote in their discussion. “Studies over the last 20 years have demonstrated that increased inflammation and hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis are two of the most consistent biological findings in major depression, which have been linked to premature aging,” they noted. “Alternative explanations for the link between depression and adverse brain health could be underlying factors that explain both outcomes rather independently, such as low socioeconomic status, childhood maltreatment, or shared genetic effects,” they added.
Adjustment for antidepressant use had little effect overall on the association between depressive symptom severity and brain age, they said.
The current study findings were limited by the single assessment of brain age, which prevented evaluation of the temporality of the association between brain aging and depression, the researchers noted.
However, the results were strengthened by the large and diverse cohort, long-term follow-up, and use of high-dimensional neuroimaging, they said. Longitudinal studies are needed to explore mechanisms of action and the potential benefits of antidepressants, they added.
In the meantime, monitoring and treating depressive symptoms in young adults may help promote brain health in midlife and older age, they concluded.
The CARDIA study was supported by the National Heart, Lung, and Blood Institute, the National Institute on Aging, and the Alzheimer’s Association. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Brain scans show effect of poverty, stress on Black children
Childhood stress can change the brain negatively, according to a new study that says Black children are affected more because they experience more poverty and adversity.
“The researchers analyzed MRI scans to identify small differences in the volume of certain brain structures, and said these could accumulate as children age and play a role in the later development of mental health problems,” STAT News reported. “The finding, part of an emerging research field looking at how racism and other social factors may affect the physical architecture of the brain, may help explain longstanding racial disparities in the prevalence of psychiatric disorders such as PTSD.”
The study was published in The American Journal of Psychiatry.
Brain development is affected by “disparities faced by certain groups of people,” even among children as young as 9 years old, said Nathaniel Harnett, an assistant professor of psychiatry at Harvard Medical School, Boston, and the study’s senior author. “If we’re going to treat the world as colorblind, we’re not going to create mental health solutions that are effective for all people.”
The study used evidence from the Adolescent Brain Cognitive Development Study, which the National Institutes of Health established in 2015 to study the brains and experiences of thousands of American children through early adulthood.
Brain scans revealed that Black children had less gray matter in 11 of 14 brain areas that were examined. Disparities in 8 of the 14 brain areas were affected by childhood adversity, particularly poverty.
A version of this article first appeared on WebMD.com.
Childhood stress can change the brain negatively, according to a new study that says Black children are affected more because they experience more poverty and adversity.
“The researchers analyzed MRI scans to identify small differences in the volume of certain brain structures, and said these could accumulate as children age and play a role in the later development of mental health problems,” STAT News reported. “The finding, part of an emerging research field looking at how racism and other social factors may affect the physical architecture of the brain, may help explain longstanding racial disparities in the prevalence of psychiatric disorders such as PTSD.”
The study was published in The American Journal of Psychiatry.
Brain development is affected by “disparities faced by certain groups of people,” even among children as young as 9 years old, said Nathaniel Harnett, an assistant professor of psychiatry at Harvard Medical School, Boston, and the study’s senior author. “If we’re going to treat the world as colorblind, we’re not going to create mental health solutions that are effective for all people.”
The study used evidence from the Adolescent Brain Cognitive Development Study, which the National Institutes of Health established in 2015 to study the brains and experiences of thousands of American children through early adulthood.
Brain scans revealed that Black children had less gray matter in 11 of 14 brain areas that were examined. Disparities in 8 of the 14 brain areas were affected by childhood adversity, particularly poverty.
A version of this article first appeared on WebMD.com.
Childhood stress can change the brain negatively, according to a new study that says Black children are affected more because they experience more poverty and adversity.
“The researchers analyzed MRI scans to identify small differences in the volume of certain brain structures, and said these could accumulate as children age and play a role in the later development of mental health problems,” STAT News reported. “The finding, part of an emerging research field looking at how racism and other social factors may affect the physical architecture of the brain, may help explain longstanding racial disparities in the prevalence of psychiatric disorders such as PTSD.”
The study was published in The American Journal of Psychiatry.
Brain development is affected by “disparities faced by certain groups of people,” even among children as young as 9 years old, said Nathaniel Harnett, an assistant professor of psychiatry at Harvard Medical School, Boston, and the study’s senior author. “If we’re going to treat the world as colorblind, we’re not going to create mental health solutions that are effective for all people.”
The study used evidence from the Adolescent Brain Cognitive Development Study, which the National Institutes of Health established in 2015 to study the brains and experiences of thousands of American children through early adulthood.
Brain scans revealed that Black children had less gray matter in 11 of 14 brain areas that were examined. Disparities in 8 of the 14 brain areas were affected by childhood adversity, particularly poverty.
A version of this article first appeared on WebMD.com.
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Cognitive testing for older drivers: Is there a benefit?
, according to results from a large population-based study using data from Japan.
But the same study, published in the Journal of the American Geriatrics Society, also reported a concurrent increase in pedestrian and cycling injuries, possibly because more older former drivers were getting around by alternative means. That finding echoed a 2012 study from Denmark, which also looked at the effects of an age-based cognitive screening policy for older drivers, and saw more fatal road injuries among older people who were not driving.
While some governments, including those of Denmark, Taiwan, and Japan, have implemented age-based cognitive screening for older drivers, there has been little evidence to date that such policies improve road safety. Guidelines issued in 2010 by the American Academy of Neurology discourage age-based screening, advising instead that people diagnosed with cognitive disorders be carefully evaluated for driving fitness and recommending one widely used scale, the Clinical Dementia Rating, as useful in identifying potentially unsafe drivers.
Japan’s national screening policy: Did it work?
The new study, led by Haruhiko Inada, MD, PhD, an epidemiologist at Johns Hopkins University in Baltimore, used national crash data from Japan, where since 2017 all drivers 75 and older not only must take cognitive tests measuring temporal orientation and memory at license renewal, but are also referred for medical evaluation if they fail them. People receiving a subsequent dementia diagnosis can have their licenses suspended or revoked.
Dr. Inada and his colleagues looked at national data from nearly 603,000 police-reported vehicle collisions and nearly 197,000 pedestrian or cyclist road injuries between March 2012 and December 2019, all involving people aged 70 and older. To assess the screening policy’s impact, the researchers calculated estimated monthly collision or injury incidence rates per 100,000 person-years. This way, they could “control for secular trends that were unaffected by the policy, such as the decreasing incidence of motor vehicle collisions year by year,” the researchers explained.
After the screening was implemented, cumulative estimated collisions among drivers 75 or older decreased by 3,670 (95% confidence interval, 5,125-2,104), while reported pedestrian or cyclist injuries increased by an estimated 959 (95% CI, 24-1,834). Dr. Inada and colleagues found that crashes declined among men but not women, noting also that more older men than women are licensed to drive in Japan. Pedestrian and cyclist injuries were highest among men aged 80-84, and women aged 80 and older.
“Cognitively screening older drivers at license renewal and promoting voluntary surrender of licenses may prevent motor vehicle collisions,” Dr. Inada and his colleagues concluded. “However, they are associated with an increase in road injuries for older pedestrians and cyclists. Future studies should examine the effectiveness of mitigation measures, such as alternative, safe transportation, and accommodations for pedestrians and cyclists.”
No definitive answers
Two investigators who have studied cognitive screening related to road safety were contacted for commentary on the study findings.
Anu Siren, PhD, professor of gerontology at Tampere (Finland) University, who in 2012 reported higher injuries after implementation of older-driver cognitive screening in Denmark, commented that the new study, while benefiting from a much larger data set than earlier studies, still “fails to show that decrease in collisions is because ‘unfit’ drivers were removed from the road. But it does confirm previous findings about how strict screening policies make people shift from cars to unprotected modes of transportation,” which are riskier.
In studies measuring driving safety, the usual definition of risk is incidents per exposure, Dr. Siren noted. In Dr. Inada and colleagues’ study, “the incident measure, or numerator, is the number of collisions. The exposure measure or denominator is population. Because the study uses population and not driver licenses (or distance traveled) as an exposure measure, the observed decrease in collisions does not say much about how the collision risk develops after the implementation of screening.”
Older driver screening “is likely to cause some older persons to cease from driving and probably continue to travel as unprotected road users,” Dr. Siren continued. “Similar to what we found [in 2012], the injury rates for pedestrians and cyclists went up after the introduction of screening, which suggests that screening indirectly causes increasing number of injuries among older unprotected road users.”
Matthew Rizzo, MD, professor and chair of the department of neurological sciences at the University of Nebraska Medical Center and codirector of the Nebraska Neuroscience Alliance in Omaha, Neb., and the lead author of the 2010 AAN guidelines on cognitive impairment and driving risk, cautioned against ageism in designing policies meant to protect motorists.
“We find some erratic/weak effects of age here and there, but the big effects we consistently find are from cognitive and visual decline – which is somewhat correlated with age, but with huge variance,” Dr. Rizzo said. “It is hard to say what an optimal age threshold for risk would be, and if 75 is it.”
U.S. crash data from the last decade points to drivers 80 and older as significantly more accident-prone than those in their 70s, or even late 70s, Dr. Rizzo noted. Moreover, “willingness to get on the road, number of miles driven, type of road (urban, rural, highway, commercial, residential), type of vehicle driven, traffic, and environment (day, night, weather), et cetera, are all factors to consider in driving risk and restriction,” he said.
Dr. Rizzo added that the 2010 AAN guidelines might need to be revisited in light of newer vehicle safety systems and automation.
Dr. Inada and colleagues’ study was funded by Japanese government grants, and Dr. Inada and his coauthors reported no financial conflicts of interest. Dr. Siren and Dr. Rizzo reported no financial conflicts of interest.
, according to results from a large population-based study using data from Japan.
But the same study, published in the Journal of the American Geriatrics Society, also reported a concurrent increase in pedestrian and cycling injuries, possibly because more older former drivers were getting around by alternative means. That finding echoed a 2012 study from Denmark, which also looked at the effects of an age-based cognitive screening policy for older drivers, and saw more fatal road injuries among older people who were not driving.
While some governments, including those of Denmark, Taiwan, and Japan, have implemented age-based cognitive screening for older drivers, there has been little evidence to date that such policies improve road safety. Guidelines issued in 2010 by the American Academy of Neurology discourage age-based screening, advising instead that people diagnosed with cognitive disorders be carefully evaluated for driving fitness and recommending one widely used scale, the Clinical Dementia Rating, as useful in identifying potentially unsafe drivers.
Japan’s national screening policy: Did it work?
The new study, led by Haruhiko Inada, MD, PhD, an epidemiologist at Johns Hopkins University in Baltimore, used national crash data from Japan, where since 2017 all drivers 75 and older not only must take cognitive tests measuring temporal orientation and memory at license renewal, but are also referred for medical evaluation if they fail them. People receiving a subsequent dementia diagnosis can have their licenses suspended or revoked.
Dr. Inada and his colleagues looked at national data from nearly 603,000 police-reported vehicle collisions and nearly 197,000 pedestrian or cyclist road injuries between March 2012 and December 2019, all involving people aged 70 and older. To assess the screening policy’s impact, the researchers calculated estimated monthly collision or injury incidence rates per 100,000 person-years. This way, they could “control for secular trends that were unaffected by the policy, such as the decreasing incidence of motor vehicle collisions year by year,” the researchers explained.
After the screening was implemented, cumulative estimated collisions among drivers 75 or older decreased by 3,670 (95% confidence interval, 5,125-2,104), while reported pedestrian or cyclist injuries increased by an estimated 959 (95% CI, 24-1,834). Dr. Inada and colleagues found that crashes declined among men but not women, noting also that more older men than women are licensed to drive in Japan. Pedestrian and cyclist injuries were highest among men aged 80-84, and women aged 80 and older.
“Cognitively screening older drivers at license renewal and promoting voluntary surrender of licenses may prevent motor vehicle collisions,” Dr. Inada and his colleagues concluded. “However, they are associated with an increase in road injuries for older pedestrians and cyclists. Future studies should examine the effectiveness of mitigation measures, such as alternative, safe transportation, and accommodations for pedestrians and cyclists.”
No definitive answers
Two investigators who have studied cognitive screening related to road safety were contacted for commentary on the study findings.
Anu Siren, PhD, professor of gerontology at Tampere (Finland) University, who in 2012 reported higher injuries after implementation of older-driver cognitive screening in Denmark, commented that the new study, while benefiting from a much larger data set than earlier studies, still “fails to show that decrease in collisions is because ‘unfit’ drivers were removed from the road. But it does confirm previous findings about how strict screening policies make people shift from cars to unprotected modes of transportation,” which are riskier.
In studies measuring driving safety, the usual definition of risk is incidents per exposure, Dr. Siren noted. In Dr. Inada and colleagues’ study, “the incident measure, or numerator, is the number of collisions. The exposure measure or denominator is population. Because the study uses population and not driver licenses (or distance traveled) as an exposure measure, the observed decrease in collisions does not say much about how the collision risk develops after the implementation of screening.”
Older driver screening “is likely to cause some older persons to cease from driving and probably continue to travel as unprotected road users,” Dr. Siren continued. “Similar to what we found [in 2012], the injury rates for pedestrians and cyclists went up after the introduction of screening, which suggests that screening indirectly causes increasing number of injuries among older unprotected road users.”
Matthew Rizzo, MD, professor and chair of the department of neurological sciences at the University of Nebraska Medical Center and codirector of the Nebraska Neuroscience Alliance in Omaha, Neb., and the lead author of the 2010 AAN guidelines on cognitive impairment and driving risk, cautioned against ageism in designing policies meant to protect motorists.
“We find some erratic/weak effects of age here and there, but the big effects we consistently find are from cognitive and visual decline – which is somewhat correlated with age, but with huge variance,” Dr. Rizzo said. “It is hard to say what an optimal age threshold for risk would be, and if 75 is it.”
U.S. crash data from the last decade points to drivers 80 and older as significantly more accident-prone than those in their 70s, or even late 70s, Dr. Rizzo noted. Moreover, “willingness to get on the road, number of miles driven, type of road (urban, rural, highway, commercial, residential), type of vehicle driven, traffic, and environment (day, night, weather), et cetera, are all factors to consider in driving risk and restriction,” he said.
Dr. Rizzo added that the 2010 AAN guidelines might need to be revisited in light of newer vehicle safety systems and automation.
Dr. Inada and colleagues’ study was funded by Japanese government grants, and Dr. Inada and his coauthors reported no financial conflicts of interest. Dr. Siren and Dr. Rizzo reported no financial conflicts of interest.
, according to results from a large population-based study using data from Japan.
But the same study, published in the Journal of the American Geriatrics Society, also reported a concurrent increase in pedestrian and cycling injuries, possibly because more older former drivers were getting around by alternative means. That finding echoed a 2012 study from Denmark, which also looked at the effects of an age-based cognitive screening policy for older drivers, and saw more fatal road injuries among older people who were not driving.
While some governments, including those of Denmark, Taiwan, and Japan, have implemented age-based cognitive screening for older drivers, there has been little evidence to date that such policies improve road safety. Guidelines issued in 2010 by the American Academy of Neurology discourage age-based screening, advising instead that people diagnosed with cognitive disorders be carefully evaluated for driving fitness and recommending one widely used scale, the Clinical Dementia Rating, as useful in identifying potentially unsafe drivers.
Japan’s national screening policy: Did it work?
The new study, led by Haruhiko Inada, MD, PhD, an epidemiologist at Johns Hopkins University in Baltimore, used national crash data from Japan, where since 2017 all drivers 75 and older not only must take cognitive tests measuring temporal orientation and memory at license renewal, but are also referred for medical evaluation if they fail them. People receiving a subsequent dementia diagnosis can have their licenses suspended or revoked.
Dr. Inada and his colleagues looked at national data from nearly 603,000 police-reported vehicle collisions and nearly 197,000 pedestrian or cyclist road injuries between March 2012 and December 2019, all involving people aged 70 and older. To assess the screening policy’s impact, the researchers calculated estimated monthly collision or injury incidence rates per 100,000 person-years. This way, they could “control for secular trends that were unaffected by the policy, such as the decreasing incidence of motor vehicle collisions year by year,” the researchers explained.
After the screening was implemented, cumulative estimated collisions among drivers 75 or older decreased by 3,670 (95% confidence interval, 5,125-2,104), while reported pedestrian or cyclist injuries increased by an estimated 959 (95% CI, 24-1,834). Dr. Inada and colleagues found that crashes declined among men but not women, noting also that more older men than women are licensed to drive in Japan. Pedestrian and cyclist injuries were highest among men aged 80-84, and women aged 80 and older.
“Cognitively screening older drivers at license renewal and promoting voluntary surrender of licenses may prevent motor vehicle collisions,” Dr. Inada and his colleagues concluded. “However, they are associated with an increase in road injuries for older pedestrians and cyclists. Future studies should examine the effectiveness of mitigation measures, such as alternative, safe transportation, and accommodations for pedestrians and cyclists.”
No definitive answers
Two investigators who have studied cognitive screening related to road safety were contacted for commentary on the study findings.
Anu Siren, PhD, professor of gerontology at Tampere (Finland) University, who in 2012 reported higher injuries after implementation of older-driver cognitive screening in Denmark, commented that the new study, while benefiting from a much larger data set than earlier studies, still “fails to show that decrease in collisions is because ‘unfit’ drivers were removed from the road. But it does confirm previous findings about how strict screening policies make people shift from cars to unprotected modes of transportation,” which are riskier.
In studies measuring driving safety, the usual definition of risk is incidents per exposure, Dr. Siren noted. In Dr. Inada and colleagues’ study, “the incident measure, or numerator, is the number of collisions. The exposure measure or denominator is population. Because the study uses population and not driver licenses (or distance traveled) as an exposure measure, the observed decrease in collisions does not say much about how the collision risk develops after the implementation of screening.”
Older driver screening “is likely to cause some older persons to cease from driving and probably continue to travel as unprotected road users,” Dr. Siren continued. “Similar to what we found [in 2012], the injury rates for pedestrians and cyclists went up after the introduction of screening, which suggests that screening indirectly causes increasing number of injuries among older unprotected road users.”
Matthew Rizzo, MD, professor and chair of the department of neurological sciences at the University of Nebraska Medical Center and codirector of the Nebraska Neuroscience Alliance in Omaha, Neb., and the lead author of the 2010 AAN guidelines on cognitive impairment and driving risk, cautioned against ageism in designing policies meant to protect motorists.
“We find some erratic/weak effects of age here and there, but the big effects we consistently find are from cognitive and visual decline – which is somewhat correlated with age, but with huge variance,” Dr. Rizzo said. “It is hard to say what an optimal age threshold for risk would be, and if 75 is it.”
U.S. crash data from the last decade points to drivers 80 and older as significantly more accident-prone than those in their 70s, or even late 70s, Dr. Rizzo noted. Moreover, “willingness to get on the road, number of miles driven, type of road (urban, rural, highway, commercial, residential), type of vehicle driven, traffic, and environment (day, night, weather), et cetera, are all factors to consider in driving risk and restriction,” he said.
Dr. Rizzo added that the 2010 AAN guidelines might need to be revisited in light of newer vehicle safety systems and automation.
Dr. Inada and colleagues’ study was funded by Japanese government grants, and Dr. Inada and his coauthors reported no financial conflicts of interest. Dr. Siren and Dr. Rizzo reported no financial conflicts of interest.
FROM THE JOURNAL OF THE AMERICAN GERIATRICS SOCIETY