MDedge ObGyn

Guilt reduction, now in deceptive and open-secret forms

Guilt plagues a lot of us, sometimes regularly. Maybe you felt bad about eating the leftovers that your partner was looking forward to eating at the end of the day. Or for not saving a seat for your friend who was running late to the movies. Maybe even hiding a secret that you know would hurt a person’s feelings. We’ve all felt it, and it doesn’t feel good.

Annie Spratt/Unsplash

But what if there was a pill that would make those feelings seem to hurt less? There’s already a pill for almost everything, right?

Well, researchers from the University of Basel are on the case and have conducted a study suggesting that a placebo might work. They asked participants to write down a time they felt super guilty about something, just to stir up those feelings again, then they were divided into three groups. One group was told they would receive real medication that was actually a placebo, one was told they would get a placebo, and one got nothing. The subjects’ guilty feelings were reduced in both the medication-that-was-really-a-placebo group and placebo-that-was-a-placebo group.

“Our study therefore supports the intriguing finding that placebos work even when they are administered openly, and that explanation of the treatment is key to its effectiveness,” lead author Dilan Sezer said in a written statement.

More research is needed, but the human mind is a very interesting place. It seems like we can convince ourselves of just about anything. Especially to feel less guilty.
 

It’s a mad, mad, mad, mad scientist’s world

Mad scientists. Life’s just more interesting with a few of them running around, but they’re mostly relegated to works of fiction. Real life is boring; we don’t actually have neurosurgeons going around claiming human brain transplant is technically feasible.

Oh, wait a minute.

Best of all, this isn’t even Dr. Sergio Canavero’s first rodeo with mad science: In 2015 he claimed human head transplants were technically feasible, and in the past few years has claimed to have rehearsed head transplants on cadavers and successfully repaired spinal cord injuries in animals. Lots of claims in there, but precious little evidence. And contrary to what everyone at the head enhancement clinic says, people will notice if you start going around with a new head.

But let’s get back to brains. Ignoring the fact that brain transplant sounds like a zombie with a PhD nibbling on your skull, the article does appear in a peer-reviewed journal. So surely there’s some level of legitimacy. After all, it’s not like Dr. Canavero is an editor for this journal. [Editor’s note: By that we mean he is an editor for the journal.]

Man, he’s taking all the fun out of this.

Anyway, now that we’ve prefaced this with the mother of all caveats, what exactly is Dr. Canavero proposing with his brain transplant? It’s pretty simple: Just have a robot scoop out the first brain and place it into a fresh body, either a donated but moribund younger body or a cloned body. Reconnect all the nerves and vasculature and you’re good to go. Enjoy your wine and laugh in the face of death.

Naturally, such a … bold proposal is lacking in the details, but who cares about details, anyway? This is mad science, not respectable science. Professionals have standards. And if we hear that a human brain transplant was successfully completed on a non–dark and stormy night and the doctor didn’t cackle madly “It’s alive! It’s alive!” then honestly, what even was the point?

Ambivalence rules!

As the office’s unofficial Sith lord/Star Wars nerd, LOTME takes notice when science extols the benefits of unhappiness: “It’s good to be grumpy: Bad moods make us more detail-oriented, study shows.”

Ryan Franco/Unsplash

The investigators manipulated the emotions of participants by having them watch a clip from “Sophie’s Choice” or one from “Friends.” Then the subjects listened to short, emotionally neutral stories, some of which contained inconsistencies, with the text displayed on a computer screen. Sorry to say, gang at Central Perk, but round one went to the sad movie.

“When people are in a negative mood, they are more careful and analytical. They scrutinize what’s actually stated in a text, and they don’t just fall back on their default world knowledge,” lead author Vicky Lai, PhD, of the University of Arizona said in a statement from the school.

Negative mood. Careful and analytical. Grumpy is good.

You’ve fallen into Darth Science’s little trap, and we have you now.

A study conducted at the University of Geneva offers a slightly different conclusion. And by slightly different, we mean completely different. People over age 65 who watched a series of short TV clips depicting people in a state of emotional suffering experienced excessive modification of their neuronal connections, compared with those who watched emotionally neutral videos.

The brains of these subjects remained “frozen in a negative state by relating the suffering of others to their own emotional memories,” lead author Sebastian Baez Lugo said in a written release from the university.

Emotional suffering. Frozen brains. Grumpy is … not good?

So there you have it. Darth Science’s lesson for the day: A negative mood makes you careful and analytical, but negative thoughts are bad for your brain.

Guilt reduction, now in deceptive and open-secret forms

Guilt plagues a lot of us, sometimes regularly. Maybe you felt bad about eating the leftovers that your partner was looking forward to eating at the end of the day. Or for not saving a seat for your friend who was running late to the movies. Maybe even hiding a secret that you know would hurt a person’s feelings. We’ve all felt it, and it doesn’t feel good.

Annie Spratt/Unsplash

But what if there was a pill that would make those feelings seem to hurt less? There’s already a pill for almost everything, right?

Well, researchers from the University of Basel are on the case and have conducted a study suggesting that a placebo might work. They asked participants to write down a time they felt super guilty about something, just to stir up those feelings again, then they were divided into three groups. One group was told they would receive real medication that was actually a placebo, one was told they would get a placebo, and one got nothing. The subjects’ guilty feelings were reduced in both the medication-that-was-really-a-placebo group and placebo-that-was-a-placebo group.

“Our study therefore supports the intriguing finding that placebos work even when they are administered openly, and that explanation of the treatment is key to its effectiveness,” lead author Dilan Sezer said in a written statement.

More research is needed, but the human mind is a very interesting place. It seems like we can convince ourselves of just about anything. Especially to feel less guilty.
 

It’s a mad, mad, mad, mad scientist’s world

Mad scientists. Life’s just more interesting with a few of them running around, but they’re mostly relegated to works of fiction. Real life is boring; we don’t actually have neurosurgeons going around claiming human brain transplant is technically feasible.

Oh, wait a minute.

Best of all, this isn’t even Dr. Sergio Canavero’s first rodeo with mad science: In 2015 he claimed human head transplants were technically feasible, and in the past few years has claimed to have rehearsed head transplants on cadavers and successfully repaired spinal cord injuries in animals. Lots of claims in there, but precious little evidence. And contrary to what everyone at the head enhancement clinic says, people will notice if you start going around with a new head.

But let’s get back to brains. Ignoring the fact that brain transplant sounds like a zombie with a PhD nibbling on your skull, the article does appear in a peer-reviewed journal. So surely there’s some level of legitimacy. After all, it’s not like Dr. Canavero is an editor for this journal. [Editor’s note: By that we mean he is an editor for the journal.]

Man, he’s taking all the fun out of this.

Anyway, now that we’ve prefaced this with the mother of all caveats, what exactly is Dr. Canavero proposing with his brain transplant? It’s pretty simple: Just have a robot scoop out the first brain and place it into a fresh body, either a donated but moribund younger body or a cloned body. Reconnect all the nerves and vasculature and you’re good to go. Enjoy your wine and laugh in the face of death.

Naturally, such a … bold proposal is lacking in the details, but who cares about details, anyway? This is mad science, not respectable science. Professionals have standards. And if we hear that a human brain transplant was successfully completed on a non–dark and stormy night and the doctor didn’t cackle madly “It’s alive! It’s alive!” then honestly, what even was the point?

Ambivalence rules!

As the office’s unofficial Sith lord/Star Wars nerd, LOTME takes notice when science extols the benefits of unhappiness: “It’s good to be grumpy: Bad moods make us more detail-oriented, study shows.”

Ryan Franco/Unsplash

The investigators manipulated the emotions of participants by having them watch a clip from “Sophie’s Choice” or one from “Friends.” Then the subjects listened to short, emotionally neutral stories, some of which contained inconsistencies, with the text displayed on a computer screen. Sorry to say, gang at Central Perk, but round one went to the sad movie.

“When people are in a negative mood, they are more careful and analytical. They scrutinize what’s actually stated in a text, and they don’t just fall back on their default world knowledge,” lead author Vicky Lai, PhD, of the University of Arizona said in a statement from the school.

Negative mood. Careful and analytical. Grumpy is good.

You’ve fallen into Darth Science’s little trap, and we have you now.

A study conducted at the University of Geneva offers a slightly different conclusion. And by slightly different, we mean completely different. People over age 65 who watched a series of short TV clips depicting people in a state of emotional suffering experienced excessive modification of their neuronal connections, compared with those who watched emotionally neutral videos.

The brains of these subjects remained “frozen in a negative state by relating the suffering of others to their own emotional memories,” lead author Sebastian Baez Lugo said in a written release from the university.

Emotional suffering. Frozen brains. Grumpy is … not good?

So there you have it. Darth Science’s lesson for the day: A negative mood makes you careful and analytical, but negative thoughts are bad for your brain.

Guilt reduction, now in deceptive and open-secret forms

Guilt plagues a lot of us, sometimes regularly. Maybe you felt bad about eating the leftovers that your partner was looking forward to eating at the end of the day. Or for not saving a seat for your friend who was running late to the movies. Maybe even hiding a secret that you know would hurt a person’s feelings. We’ve all felt it, and it doesn’t feel good.

Annie Spratt/Unsplash

But what if there was a pill that would make those feelings seem to hurt less? There’s already a pill for almost everything, right?

Well, researchers from the University of Basel are on the case and have conducted a study suggesting that a placebo might work. They asked participants to write down a time they felt super guilty about something, just to stir up those feelings again, then they were divided into three groups. One group was told they would receive real medication that was actually a placebo, one was told they would get a placebo, and one got nothing. The subjects’ guilty feelings were reduced in both the medication-that-was-really-a-placebo group and placebo-that-was-a-placebo group.

“Our study therefore supports the intriguing finding that placebos work even when they are administered openly, and that explanation of the treatment is key to its effectiveness,” lead author Dilan Sezer said in a written statement.

More research is needed, but the human mind is a very interesting place. It seems like we can convince ourselves of just about anything. Especially to feel less guilty.
 

It’s a mad, mad, mad, mad scientist’s world

Mad scientists. Life’s just more interesting with a few of them running around, but they’re mostly relegated to works of fiction. Real life is boring; we don’t actually have neurosurgeons going around claiming human brain transplant is technically feasible.

Oh, wait a minute.

Best of all, this isn’t even Dr. Sergio Canavero’s first rodeo with mad science: In 2015 he claimed human head transplants were technically feasible, and in the past few years has claimed to have rehearsed head transplants on cadavers and successfully repaired spinal cord injuries in animals. Lots of claims in there, but precious little evidence. And contrary to what everyone at the head enhancement clinic says, people will notice if you start going around with a new head.

But let’s get back to brains. Ignoring the fact that brain transplant sounds like a zombie with a PhD nibbling on your skull, the article does appear in a peer-reviewed journal. So surely there’s some level of legitimacy. After all, it’s not like Dr. Canavero is an editor for this journal. [Editor’s note: By that we mean he is an editor for the journal.]

Man, he’s taking all the fun out of this.

Anyway, now that we’ve prefaced this with the mother of all caveats, what exactly is Dr. Canavero proposing with his brain transplant? It’s pretty simple: Just have a robot scoop out the first brain and place it into a fresh body, either a donated but moribund younger body or a cloned body. Reconnect all the nerves and vasculature and you’re good to go. Enjoy your wine and laugh in the face of death.

Naturally, such a … bold proposal is lacking in the details, but who cares about details, anyway? This is mad science, not respectable science. Professionals have standards. And if we hear that a human brain transplant was successfully completed on a non–dark and stormy night and the doctor didn’t cackle madly “It’s alive! It’s alive!” then honestly, what even was the point?

Ambivalence rules!

As the office’s unofficial Sith lord/Star Wars nerd, LOTME takes notice when science extols the benefits of unhappiness: “It’s good to be grumpy: Bad moods make us more detail-oriented, study shows.”

Ryan Franco/Unsplash

The investigators manipulated the emotions of participants by having them watch a clip from “Sophie’s Choice” or one from “Friends.” Then the subjects listened to short, emotionally neutral stories, some of which contained inconsistencies, with the text displayed on a computer screen. Sorry to say, gang at Central Perk, but round one went to the sad movie.

“When people are in a negative mood, they are more careful and analytical. They scrutinize what’s actually stated in a text, and they don’t just fall back on their default world knowledge,” lead author Vicky Lai, PhD, of the University of Arizona said in a statement from the school.

Negative mood. Careful and analytical. Grumpy is good.

You’ve fallen into Darth Science’s little trap, and we have you now.

A study conducted at the University of Geneva offers a slightly different conclusion. And by slightly different, we mean completely different. People over age 65 who watched a series of short TV clips depicting people in a state of emotional suffering experienced excessive modification of their neuronal connections, compared with those who watched emotionally neutral videos.

The brains of these subjects remained “frozen in a negative state by relating the suffering of others to their own emotional memories,” lead author Sebastian Baez Lugo said in a written release from the university.

Emotional suffering. Frozen brains. Grumpy is … not good?

So there you have it. Darth Science’s lesson for the day: A negative mood makes you careful and analytical, but negative thoughts are bad for your brain.

Mothers with intellectual or developmental disabilities are less likely to initiate breastfeeding and to receive in-hospital breastfeeding support than are those without a disability, new data suggest.

In a population-based cohort study of more than 600,000 mothers, patients with an intellectual or developmental disability were about 18% less likely to have a chance to initiate breastfeeding during their hospital stay.

“Overall, we did see lower rates of breastfeeding practices and supports in people with intellectual and developmental disabilities, as well as those with multiple disabilities, compared to people without disabilities,” study author Hilary K. Brown, PhD, assistant professor of health and society at University of Toronto Scarborough in Ontario, told this news organization.

The study was published in The Lancet Public Health.
 

Disparities in breastfeeding

“There hasn’t been a lot of research on breastfeeding outcomes in people with disabilities,” said Dr. Brown, who noted that the study outcomes were based on the WHO-UNICEF Baby Friendly Hospital Initiative guidelines. “There have been a number of qualitative studies that have suggested that they do experience barriers accessing care related to breastfeeding and different challenges related to breastfeeding. But as far as quantitative outcomes, there has only been a handful of studies.”

To examine these outcomes, the investigators analyzed health administrative data from Ontario. They included in their analysis all birthing parents aged 15-49 years who had a single live birth between April 1, 2012, and March 31, 2018. Patients with a physical disability, sensory disability, intellectual or developmental disability, or two or more disabilities were identified via diagnostic algorithms and were compared with individuals without disabilities with respect to the opportunity to initiate breastfeeding, to engage in in-hospital breastfeeding, to engage in exclusive breastfeeding at hospital discharge, to have skin-to-skin contact, and to be provided with breastfeeding assistance.

The investigators considered a physical disability to encompass conditions such as congenital anomalies, musculoskeletal disorders, neurologic disorders, or permanent injuries. They defined sensory disability as hearing loss or vision loss. Intellectual or developmental disability was defined as having autism spectrum disorder, chromosomal anomaly, fetal alcohol spectrum disorder, or other intellectual disability. Patients with multiple disabilities had two or more of these conditions.

The study population included 634,111 birthing parents, of whom 54,476 (8.6%) had a physical disability, 19,227 (3.0%) had a sensory disability, 1,048 (0.2%) had an intellectual or developmental disability, 4,050 (0.6%) had multiple disabilities, and 555,310 (87.6%) had no disability.

The investigators found that patients with intellectual or developmental disabilities were less likely than were those without a disability to have an opportunity to initiate breastfeeding (adjusted relative risk [aRR], 0.82), to engage in any in-hospital breastfeeding (aRR, 0.85), to be breastfeeding exclusively at hospital discharge (aRR, 0.73), to have skin-to-skin contact (aRR, 0.90), and to receive breastfeeding assistance (aRR, 0.85) compared with patients without a disability.

They also found that individuals with multiple disabilities were less likely to have an opportunity to initiate breastfeeding (aRR, 0.93), to engage in any in-hospital breastfeeding (aRR, 0.93), to be exclusively breastfeeding at hospital discharge (aRR, 0.90), to have skin-to-skin contact (aRR, 0.93), and to receive breastfeeding assistance (aRR, 0.95) compared with patients without a disability.
 

An understudied population

Commenting on the study, Lori Feldman-Winter, MD, MPH, professor of pediatrics at Rowan University in Camden, N.J., said that one of its strengths is that it included patients who may be excluded from studies of breastfeeding practices. The finding of few differences in breastfeeding practices and supports for people with physical and sensory disabilities, compared with those without disabilities, was positive, she added.

“This is an understudied population, and it is important to call out that there may be practices related to breastfeeding care that suffer, due to implicit bias regarding persons with intellectual and multiple disabilities,” said Dr. Feldman-Winter. “The good news is that other disabilities did not show the same disparities. This study also shows how important it is to measure potential gaps in care across multiple sociodemographic and other variables, such as disabilities, to ensure equitable and inclusive care.”

Health care professionals need to be aware of disparities in breastfeeding care, she added. They need to be open to exploring potential biases when it comes to providing equitable care.

R. Douglas Wilson, MD, president of the Society of Obstetricians and Gynaecologists of Canada and professor emeritus of obstetrics and gynecology at the University of Calgary in Alberta, noted that the size of the cohort represents a strength of the study and that the findings suggest the possible need for closer follow-up of a new mother who is breastfeeding and who has an intellectual disability or multiple disabilities.

“You might keep that patient in hospital for an extra day, and then the home care nurse may look in on them more frequently than they would for someone who does not need that extra oversight,” said Dr. Wilson. When their patients are pregnant, obstetricians and gynecologists can find out whether their patients intend to breastfeed and put them in touch with nurses or lactation consultants to assist them, he added.

The study was funded by the National Institutes of Health and the Canada Research Chairs Program. Dr. Brown, Dr. Feldman-Winter, and Dr. Wilson reported no relevant financial relationships.

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

Mothers with intellectual or developmental disabilities are less likely to initiate breastfeeding and to receive in-hospital breastfeeding support than are those without a disability, new data suggest.

In a population-based cohort study of more than 600,000 mothers, patients with an intellectual or developmental disability were about 18% less likely to have a chance to initiate breastfeeding during their hospital stay.

“Overall, we did see lower rates of breastfeeding practices and supports in people with intellectual and developmental disabilities, as well as those with multiple disabilities, compared to people without disabilities,” study author Hilary K. Brown, PhD, assistant professor of health and society at University of Toronto Scarborough in Ontario, told this news organization.

The study was published in The Lancet Public Health.
 

Disparities in breastfeeding

“There hasn’t been a lot of research on breastfeeding outcomes in people with disabilities,” said Dr. Brown, who noted that the study outcomes were based on the WHO-UNICEF Baby Friendly Hospital Initiative guidelines. “There have been a number of qualitative studies that have suggested that they do experience barriers accessing care related to breastfeeding and different challenges related to breastfeeding. But as far as quantitative outcomes, there has only been a handful of studies.”

To examine these outcomes, the investigators analyzed health administrative data from Ontario. They included in their analysis all birthing parents aged 15-49 years who had a single live birth between April 1, 2012, and March 31, 2018. Patients with a physical disability, sensory disability, intellectual or developmental disability, or two or more disabilities were identified via diagnostic algorithms and were compared with individuals without disabilities with respect to the opportunity to initiate breastfeeding, to engage in in-hospital breastfeeding, to engage in exclusive breastfeeding at hospital discharge, to have skin-to-skin contact, and to be provided with breastfeeding assistance.

The investigators considered a physical disability to encompass conditions such as congenital anomalies, musculoskeletal disorders, neurologic disorders, or permanent injuries. They defined sensory disability as hearing loss or vision loss. Intellectual or developmental disability was defined as having autism spectrum disorder, chromosomal anomaly, fetal alcohol spectrum disorder, or other intellectual disability. Patients with multiple disabilities had two or more of these conditions.

The study population included 634,111 birthing parents, of whom 54,476 (8.6%) had a physical disability, 19,227 (3.0%) had a sensory disability, 1,048 (0.2%) had an intellectual or developmental disability, 4,050 (0.6%) had multiple disabilities, and 555,310 (87.6%) had no disability.

The investigators found that patients with intellectual or developmental disabilities were less likely than were those without a disability to have an opportunity to initiate breastfeeding (adjusted relative risk [aRR], 0.82), to engage in any in-hospital breastfeeding (aRR, 0.85), to be breastfeeding exclusively at hospital discharge (aRR, 0.73), to have skin-to-skin contact (aRR, 0.90), and to receive breastfeeding assistance (aRR, 0.85) compared with patients without a disability.

They also found that individuals with multiple disabilities were less likely to have an opportunity to initiate breastfeeding (aRR, 0.93), to engage in any in-hospital breastfeeding (aRR, 0.93), to be exclusively breastfeeding at hospital discharge (aRR, 0.90), to have skin-to-skin contact (aRR, 0.93), and to receive breastfeeding assistance (aRR, 0.95) compared with patients without a disability.
 

An understudied population

Commenting on the study, Lori Feldman-Winter, MD, MPH, professor of pediatrics at Rowan University in Camden, N.J., said that one of its strengths is that it included patients who may be excluded from studies of breastfeeding practices. The finding of few differences in breastfeeding practices and supports for people with physical and sensory disabilities, compared with those without disabilities, was positive, she added.

“This is an understudied population, and it is important to call out that there may be practices related to breastfeeding care that suffer, due to implicit bias regarding persons with intellectual and multiple disabilities,” said Dr. Feldman-Winter. “The good news is that other disabilities did not show the same disparities. This study also shows how important it is to measure potential gaps in care across multiple sociodemographic and other variables, such as disabilities, to ensure equitable and inclusive care.”

Health care professionals need to be aware of disparities in breastfeeding care, she added. They need to be open to exploring potential biases when it comes to providing equitable care.

R. Douglas Wilson, MD, president of the Society of Obstetricians and Gynaecologists of Canada and professor emeritus of obstetrics and gynecology at the University of Calgary in Alberta, noted that the size of the cohort represents a strength of the study and that the findings suggest the possible need for closer follow-up of a new mother who is breastfeeding and who has an intellectual disability or multiple disabilities.

“You might keep that patient in hospital for an extra day, and then the home care nurse may look in on them more frequently than they would for someone who does not need that extra oversight,” said Dr. Wilson. When their patients are pregnant, obstetricians and gynecologists can find out whether their patients intend to breastfeed and put them in touch with nurses or lactation consultants to assist them, he added.

The study was funded by the National Institutes of Health and the Canada Research Chairs Program. Dr. Brown, Dr. Feldman-Winter, and Dr. Wilson reported no relevant financial relationships.

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

Mothers with intellectual or developmental disabilities are less likely to initiate breastfeeding and to receive in-hospital breastfeeding support than are those without a disability, new data suggest.

In a population-based cohort study of more than 600,000 mothers, patients with an intellectual or developmental disability were about 18% less likely to have a chance to initiate breastfeeding during their hospital stay.

“Overall, we did see lower rates of breastfeeding practices and supports in people with intellectual and developmental disabilities, as well as those with multiple disabilities, compared to people without disabilities,” study author Hilary K. Brown, PhD, assistant professor of health and society at University of Toronto Scarborough in Ontario, told this news organization.

The study was published in The Lancet Public Health.
 

Disparities in breastfeeding

“There hasn’t been a lot of research on breastfeeding outcomes in people with disabilities,” said Dr. Brown, who noted that the study outcomes were based on the WHO-UNICEF Baby Friendly Hospital Initiative guidelines. “There have been a number of qualitative studies that have suggested that they do experience barriers accessing care related to breastfeeding and different challenges related to breastfeeding. But as far as quantitative outcomes, there has only been a handful of studies.”

To examine these outcomes, the investigators analyzed health administrative data from Ontario. They included in their analysis all birthing parents aged 15-49 years who had a single live birth between April 1, 2012, and March 31, 2018. Patients with a physical disability, sensory disability, intellectual or developmental disability, or two or more disabilities were identified via diagnostic algorithms and were compared with individuals without disabilities with respect to the opportunity to initiate breastfeeding, to engage in in-hospital breastfeeding, to engage in exclusive breastfeeding at hospital discharge, to have skin-to-skin contact, and to be provided with breastfeeding assistance.

The investigators considered a physical disability to encompass conditions such as congenital anomalies, musculoskeletal disorders, neurologic disorders, or permanent injuries. They defined sensory disability as hearing loss or vision loss. Intellectual or developmental disability was defined as having autism spectrum disorder, chromosomal anomaly, fetal alcohol spectrum disorder, or other intellectual disability. Patients with multiple disabilities had two or more of these conditions.

The study population included 634,111 birthing parents, of whom 54,476 (8.6%) had a physical disability, 19,227 (3.0%) had a sensory disability, 1,048 (0.2%) had an intellectual or developmental disability, 4,050 (0.6%) had multiple disabilities, and 555,310 (87.6%) had no disability.

The investigators found that patients with intellectual or developmental disabilities were less likely than were those without a disability to have an opportunity to initiate breastfeeding (adjusted relative risk [aRR], 0.82), to engage in any in-hospital breastfeeding (aRR, 0.85), to be breastfeeding exclusively at hospital discharge (aRR, 0.73), to have skin-to-skin contact (aRR, 0.90), and to receive breastfeeding assistance (aRR, 0.85) compared with patients without a disability.

They also found that individuals with multiple disabilities were less likely to have an opportunity to initiate breastfeeding (aRR, 0.93), to engage in any in-hospital breastfeeding (aRR, 0.93), to be exclusively breastfeeding at hospital discharge (aRR, 0.90), to have skin-to-skin contact (aRR, 0.93), and to receive breastfeeding assistance (aRR, 0.95) compared with patients without a disability.
 

An understudied population

Commenting on the study, Lori Feldman-Winter, MD, MPH, professor of pediatrics at Rowan University in Camden, N.J., said that one of its strengths is that it included patients who may be excluded from studies of breastfeeding practices. The finding of few differences in breastfeeding practices and supports for people with physical and sensory disabilities, compared with those without disabilities, was positive, she added.

“This is an understudied population, and it is important to call out that there may be practices related to breastfeeding care that suffer, due to implicit bias regarding persons with intellectual and multiple disabilities,” said Dr. Feldman-Winter. “The good news is that other disabilities did not show the same disparities. This study also shows how important it is to measure potential gaps in care across multiple sociodemographic and other variables, such as disabilities, to ensure equitable and inclusive care.”

Health care professionals need to be aware of disparities in breastfeeding care, she added. They need to be open to exploring potential biases when it comes to providing equitable care.

R. Douglas Wilson, MD, president of the Society of Obstetricians and Gynaecologists of Canada and professor emeritus of obstetrics and gynecology at the University of Calgary in Alberta, noted that the size of the cohort represents a strength of the study and that the findings suggest the possible need for closer follow-up of a new mother who is breastfeeding and who has an intellectual disability or multiple disabilities.

“You might keep that patient in hospital for an extra day, and then the home care nurse may look in on them more frequently than they would for someone who does not need that extra oversight,” said Dr. Wilson. When their patients are pregnant, obstetricians and gynecologists can find out whether their patients intend to breastfeed and put them in touch with nurses or lactation consultants to assist them, he added.

The study was funded by the National Institutes of Health and the Canada Research Chairs Program. Dr. Brown, Dr. Feldman-Winter, and Dr. Wilson reported no relevant financial relationships.

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

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

People who are overweight or have obesity appear to show a blunted response to vitamin D supplementation compared with normal-weight individuals in a new analysis of a randomized trial.

“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.

The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.

However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m²) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.

The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.

“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.

“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
 

New analysis examined vitamin D and biomarkers at baseline and 2 years

To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.

Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).

Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).

Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).

There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.

When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.

Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.

“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
 

Mechanisms?

Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.

“Our results are largely consistent with this hypothesis,” the authors noted.

They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.

Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.

Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.

“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.

The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.

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

People who are overweight or have obesity appear to show a blunted response to vitamin D supplementation compared with normal-weight individuals in a new analysis of a randomized trial.

“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.

The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.

However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m²) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.

The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.

“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.

“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
 

New analysis examined vitamin D and biomarkers at baseline and 2 years

To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.

Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).

Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).

Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).

There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.

When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.

Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.

“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
 

Mechanisms?

Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.

“Our results are largely consistent with this hypothesis,” the authors noted.

They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.

Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.

Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.

“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.

The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.

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

People who are overweight or have obesity appear to show a blunted response to vitamin D supplementation compared with normal-weight individuals in a new analysis of a randomized trial.

“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.

The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.

However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m²) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.

The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.

“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.

“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
 

New analysis examined vitamin D and biomarkers at baseline and 2 years

To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.

Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).

Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).

Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).

There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.

When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.

Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.

“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
 

Mechanisms?

Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.

“Our results are largely consistent with this hypothesis,” the authors noted.

They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.

Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.

Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.

“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.

The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.

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

A California woman developed skin cancer after getting a cut during a manicure. Now, she and her doctor are spreading the word about her ordeal as a lesson that speed and persistence in seeking treatment are the keys that make her type of cancer – squamous cell carcinoma – completely curable.

“She cut me, and the cut wasn’t just a regular cuticle cut. She cut me deep, and that was one of the first times that happened to me,” Grace Garcia, 50, told TODAY.com, recalling the November 2021 incident.

Ms. Garcia had been getting her nails done regularly for 20 years, she said, but happened to go to a different salon than her usual spot because she couldn’t get an appointment during the busy pre-Thanksgiving season. She doesn’t recall whether the technician opened packaging that signals unused tools.

She put antibiotic ointment on the cut, but it didn’t heal after a few days. Eventually, the skin closed and a darkened bump formed. It was painful. She went to her doctor, who said it was a “callus from writing,” she told TODAY.com. But it was on her ring finger, which didn’t seem connected to writing. Her doctor said to keep an eye on it. 

Five months after the cut occurred, she mentioned it during a gynecology appointment and was referred to a dermatologist, who also advised keeping an eye on it. A wart developed. She went back to her primary care physician and then to another dermatologist. The spot was biopsied.

Squamous cell carcinoma is a common type of skin cancer, according to the American Academy of Dermatology. It can have many causes, but the cause in Ms. Garcia’s case was both very common and very rare: human papillomavirus, or HPV. HPV is a virus that infects millions of people every year, but it’s not a typical cause of skin cancer.

“It’s pretty rare for several reasons. Generally speaking, the strains that cause cancer from an HPV standpoint tend to be more sexually transmitted,” dermatologist Teo Soleymani told TODAY.com. “In Grace’s case, she had an injury, which became the portal of entry. So that thick skin that we have on our hands and feet that acts as a natural barrier against infections and things like that was no longer the case, and the virus was able to infect her skin.”

Dr. Soleymani said Ms. Garcia’s persistence to get answers likely saved her from losing a finger.

“Your outcomes are entirely dictated by how early you catch them, and very often they’re completely curable,” he said. “Her persistence – not only was she able to have a great outcome, she probably saved herself from having her finger amputated.”

A California woman developed skin cancer after getting a cut during a manicure. Now, she and her doctor are spreading the word about her ordeal as a lesson that speed and persistence in seeking treatment are the keys that make her type of cancer – squamous cell carcinoma – completely curable.

“She cut me, and the cut wasn’t just a regular cuticle cut. She cut me deep, and that was one of the first times that happened to me,” Grace Garcia, 50, told TODAY.com, recalling the November 2021 incident.

Ms. Garcia had been getting her nails done regularly for 20 years, she said, but happened to go to a different salon than her usual spot because she couldn’t get an appointment during the busy pre-Thanksgiving season. She doesn’t recall whether the technician opened packaging that signals unused tools.

She put antibiotic ointment on the cut, but it didn’t heal after a few days. Eventually, the skin closed and a darkened bump formed. It was painful. She went to her doctor, who said it was a “callus from writing,” she told TODAY.com. But it was on her ring finger, which didn’t seem connected to writing. Her doctor said to keep an eye on it. 

Five months after the cut occurred, she mentioned it during a gynecology appointment and was referred to a dermatologist, who also advised keeping an eye on it. A wart developed. She went back to her primary care physician and then to another dermatologist. The spot was biopsied.

Squamous cell carcinoma is a common type of skin cancer, according to the American Academy of Dermatology. It can have many causes, but the cause in Ms. Garcia’s case was both very common and very rare: human papillomavirus, or HPV. HPV is a virus that infects millions of people every year, but it’s not a typical cause of skin cancer.

“It’s pretty rare for several reasons. Generally speaking, the strains that cause cancer from an HPV standpoint tend to be more sexually transmitted,” dermatologist Teo Soleymani told TODAY.com. “In Grace’s case, she had an injury, which became the portal of entry. So that thick skin that we have on our hands and feet that acts as a natural barrier against infections and things like that was no longer the case, and the virus was able to infect her skin.”

Dr. Soleymani said Ms. Garcia’s persistence to get answers likely saved her from losing a finger.

“Your outcomes are entirely dictated by how early you catch them, and very often they’re completely curable,” he said. “Her persistence – not only was she able to have a great outcome, she probably saved herself from having her finger amputated.”

A California woman developed skin cancer after getting a cut during a manicure. Now, she and her doctor are spreading the word about her ordeal as a lesson that speed and persistence in seeking treatment are the keys that make her type of cancer – squamous cell carcinoma – completely curable.

“She cut me, and the cut wasn’t just a regular cuticle cut. She cut me deep, and that was one of the first times that happened to me,” Grace Garcia, 50, told TODAY.com, recalling the November 2021 incident.

Ms. Garcia had been getting her nails done regularly for 20 years, she said, but happened to go to a different salon than her usual spot because she couldn’t get an appointment during the busy pre-Thanksgiving season. She doesn’t recall whether the technician opened packaging that signals unused tools.

She put antibiotic ointment on the cut, but it didn’t heal after a few days. Eventually, the skin closed and a darkened bump formed. It was painful. She went to her doctor, who said it was a “callus from writing,” she told TODAY.com. But it was on her ring finger, which didn’t seem connected to writing. Her doctor said to keep an eye on it. 

Five months after the cut occurred, she mentioned it during a gynecology appointment and was referred to a dermatologist, who also advised keeping an eye on it. A wart developed. She went back to her primary care physician and then to another dermatologist. The spot was biopsied.

Squamous cell carcinoma is a common type of skin cancer, according to the American Academy of Dermatology. It can have many causes, but the cause in Ms. Garcia’s case was both very common and very rare: human papillomavirus, or HPV. HPV is a virus that infects millions of people every year, but it’s not a typical cause of skin cancer.

“It’s pretty rare for several reasons. Generally speaking, the strains that cause cancer from an HPV standpoint tend to be more sexually transmitted,” dermatologist Teo Soleymani told TODAY.com. “In Grace’s case, she had an injury, which became the portal of entry. So that thick skin that we have on our hands and feet that acts as a natural barrier against infections and things like that was no longer the case, and the virus was able to infect her skin.”

Dr. Soleymani said Ms. Garcia’s persistence to get answers likely saved her from losing a finger.

“Your outcomes are entirely dictated by how early you catch them, and very often they’re completely curable,” he said. “Her persistence – not only was she able to have a great outcome, she probably saved herself from having her finger amputated.”

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.