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Late to the game: Parenting after 40

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Thu, 03/31/2022 - 09:27

 

As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

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As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

 

As they rolled me down the hallway to the OR, ceiling lights rhythmically passing above, I zoned out into a 1,000-mile stare. How did I get here? I started humming “Swing Low, Sweet Chariot,” praying for a miracle to happen. I thought back to my birth plan, meticulously crafted, a one-pager so that the no-nonsense labor and delivery nurses wouldn›t think me completely off my rocker. No C-section unless medically necessary. Those words laughed back at me – cackling, even. I’d planned out the whole birthing process and here we were, my team almost jogging me to the OR. I lay still, utterly gobsmacked and partially anesthetized.

If I squint my eyes and hallucinate just a bit, that is sort of what motherhood has been like.

It’s about knowing all the things that could go wrong and meeting the unplanned head-on. Motherhood has indeed been a whirlwind – so many physical, psychological, and emotional transformations. And to top it off, the added effort of giving birth in a pandemic. As an over-40 physician, you’d think I would have been better prepared.

I was, but in a sense, I was not. The knowledge, the wisdom, the experience of my medical training surrounded me, but even I panicked at times in the beginning: Am I feeding her correctly? Am I making enough food for her? Am I doing the best that I can for her? What more could I be doing for her?

Over time, I’ve learned to lighten up. Some. In those teachable moments with my daughter Gia, I’ve learned to not sugarcoat reality but encourage the hopeful. If Gia falls on the ground? “You’re okay, sweetie. Now get back up.” If Gia has a tantrum and starts hitting herself? “Honey, our hands are for hugs, not hurting ourselves. Let’s go play.” Eighty percent of motherhood right now is redirection and the other 20% is patience.

I remember this one time I was rushing out the door for work. After getting in the car with my keys, I realized I forgot my coffee back in the house. I left the car, went back in the house to grab the blessed joe, went back to the car, and couldn’t get in because it was locked. I panicked at that moment, went back inside the house, and found Gia playing with my extra key fob. My own daughter locked me out of my car. Of course, it wasn’t her fault. Deep breath and I offered her another kiss while simultaneously taking the key fob from her.

Before Gia could walk, she could climb the stairs in our home. Her father and I sometimes refer to her as “Lil Bamm-Bamm” because she is so strong. One day, Daddy was supposed to be watching her while Mommy was folding laundry upstairs. She was not allowed on the stairs, but what should I hear? Literally, the pitter-patter of little feet, running down the upstairs hallway. Her father had drifted off watching yet another episode of something Star Wars–related. My strong little girl made it up the stairs all by herself and Dad received a strong word. The Force was with me that day.

I would say that I feel like having a child ages you, but what does that really mean when you’re already old? I’ve become acutely aware of my lack of endurance, stamina, and bodily strength. My knees will creak when taking her upstairs to bed, an osseous dirge of a lullaby. Date nights become unintentionally less and less frequent. Friday night dress-up becomes Friday night dress-down. I’ve replaced stiletto heels with comfy sweats.

Once we put Gia down for the night, we are usually exhausted from the day, and the couch and TV are welcome respites. We exhale. As over-40 parents, we knew that having children late in life would bring its challenges. But I’d like to think that we are meeting them the best way that we can. Often I encourage my body to meet Gia at her eye level, see what she sees, play with her on her own terms, and match her energy. She absolutely loves it when I do this. I’m out of breath and my knees are sore by the end of our play session, but I wouldn’t have it any other way.

We are learning from each other. She has a bright and assertive personality, and I am protective of that innocence. Her innocence is without fear. I often wonder what she is thinking when I see her facial expressions. A side-eye, a fleeting giggle. Is she secretly contemplating the chronicity of the cosmos, or is it just gas? I look at her in stolen moments and still can’t believe that I grew a human inside me, and said human was extracted from me and is now walking around my house commanding her bidding. So surreal. The unromanticized, scientific ingredients that are at play from conception to delivery are nothing short of miraculous. And the miracles of parenting over 40 are present every day.

Dr. Tolliver is a family medicine physician at The Ohio State University Wexner Medical Center in Columbus. A version of this article first appeared on Medscape.com.

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Meet a fierce advocate for women’s health: Jen Gunter, MD

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Wed, 03/30/2022 - 14:31

Jen Gunter, MD, refuses to stay silent when she sees misleading claims about women’s health products.

In fact, the world’s most famous – and outspoken – ob.gyn. (as described by The Guardian), is on a social media mission to speak up whenever she sees companies or governments “prey on women’s health and vaginal shame.”

With nearly 400,000 followers, Dr. Gunter never shies away from a controversy.

Recently, she railed against vitamin and supplement maker Olly’s vaginal probiotic, taking the company to task for its product premise and objectionable ad copy.

This news organization caught up with the San Francisco–based doctor and author of two books, “The Vagina Bible” and “The Menopause Manifesto.” The following interview has been lightly edited for length and clarity.

Question: So these Olly capsules purport to be “Probiotics for Your Panty Hamster.” What was your reaction to this?

Answer:
Seeing the word “panty hamsters” is so egregious. I’m so used to baseline vaginal opportunism, but this was just absolutely egregious and I had to call it out.

Question: What are vaginal probiotics anyway?

Answer: These are one of these big wellness scams where companies try to sell you on somehow hacking your microbiome by taking them. They’re not inexpensive, either, and can range in price from $30 to $150 per month, depending on how bespoke they are. And yet the data isn’t good. There is little to no evidence of the value of these probiotics except to shareholders.

Question: What’s one claim made in the Olly probiotic packaging that bothers you the most?

Answer: The product claims to balance the vaginal pH. To say that is a gross misunderstanding of the vaginal ecosystem. If that tagline is what you’re leading with, what else don’t you know?

Also, if these things worked, we’d recommend them. Vaginitis is complex and often misdiagnosed, and it’s easy for a company to be predatory and swoop in and say they have a product for you.

If I think your product for the vagina is awful and you have not studied it in at least one quality clinical trial (never mind company-funded or not), and your marketing displays a stunning ignorance about vaginal health, don’t approach me about your product. Really.

Question: When there’s a pop culture reference to, say, menstruation, you’re quick to weigh in.

Answer:
I saw these viral messages from a boy mom (that’s what she called herself) where she wrote about being disgusted that there were mentions of periods in Turning Red, the animated movie.

Everything is here because of menstruation. If you didn’t menstruate, you wouldn’t have a kid, we wouldn’t have the person who had the intelligence to build the computer you’re spreading this message on. Menstruation is a vital part of human reproduction, and it’s far more complex than people think. For that reason alone, people should know about it.

Question: Do you ever get worried about being so “out there” on social media?

Answer: I have my stalkers I suppose, but the trolls don’t bother me. I don’t care if some whatever art dealer in New York thinks I have mental illness for promoting masks. That’s the best you’ve got? Honestly, this doesn’t even register with me. It’s like throwing a grain of sand at a car.

Question: You also got into an exchange with Dr. Leana Wen, CNN’s medical analyst, about mask wearing.

Answer: She obviously has a different opinion than I do. I think one of the biggest issues in the pandemic is the change in messaging and this idea that somehow people aren’t living their normal lives right now. I was sad to see her promote that concept.

This weekend I went out for lunch, I went furniture shopping, I went to the movies, I took a hike. My family and I wear masks everywhere. I fail to understand how wearing a mask means you’re not living a normal life when it’s clearly linked with the reduced spread of the virus.

Almost everything in medicine is about risk reduction. You can do things to lower your risk of heart disease. It’s not 100% guaranteed, but wouldn’t we want a lower risk of bad things? I’m going to keep wearing a mask forever!

Question: Do you wish more doctors were more vocal like you?

Answer:
I wish more doctors would have conversations about health outside of the office in ways they’re comfortable with. Like, you’re at the hairdresser and you share information, or you share information with 15 of your Facebook friends. If you’re a doctor and post an article about COVID-19 and how it impacts the heart, your 15 friends are more likely to read that article than if your friend who’s a lawyer puts that up.

As doctors, I believe we can often influence people in big and small ways.

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

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Jen Gunter, MD, refuses to stay silent when she sees misleading claims about women’s health products.

In fact, the world’s most famous – and outspoken – ob.gyn. (as described by The Guardian), is on a social media mission to speak up whenever she sees companies or governments “prey on women’s health and vaginal shame.”

With nearly 400,000 followers, Dr. Gunter never shies away from a controversy.

Recently, she railed against vitamin and supplement maker Olly’s vaginal probiotic, taking the company to task for its product premise and objectionable ad copy.

This news organization caught up with the San Francisco–based doctor and author of two books, “The Vagina Bible” and “The Menopause Manifesto.” The following interview has been lightly edited for length and clarity.

Question: So these Olly capsules purport to be “Probiotics for Your Panty Hamster.” What was your reaction to this?

Answer:
Seeing the word “panty hamsters” is so egregious. I’m so used to baseline vaginal opportunism, but this was just absolutely egregious and I had to call it out.

Question: What are vaginal probiotics anyway?

Answer: These are one of these big wellness scams where companies try to sell you on somehow hacking your microbiome by taking them. They’re not inexpensive, either, and can range in price from $30 to $150 per month, depending on how bespoke they are. And yet the data isn’t good. There is little to no evidence of the value of these probiotics except to shareholders.

Question: What’s one claim made in the Olly probiotic packaging that bothers you the most?

Answer: The product claims to balance the vaginal pH. To say that is a gross misunderstanding of the vaginal ecosystem. If that tagline is what you’re leading with, what else don’t you know?

Also, if these things worked, we’d recommend them. Vaginitis is complex and often misdiagnosed, and it’s easy for a company to be predatory and swoop in and say they have a product for you.

If I think your product for the vagina is awful and you have not studied it in at least one quality clinical trial (never mind company-funded or not), and your marketing displays a stunning ignorance about vaginal health, don’t approach me about your product. Really.

Question: When there’s a pop culture reference to, say, menstruation, you’re quick to weigh in.

Answer:
I saw these viral messages from a boy mom (that’s what she called herself) where she wrote about being disgusted that there were mentions of periods in Turning Red, the animated movie.

Everything is here because of menstruation. If you didn’t menstruate, you wouldn’t have a kid, we wouldn’t have the person who had the intelligence to build the computer you’re spreading this message on. Menstruation is a vital part of human reproduction, and it’s far more complex than people think. For that reason alone, people should know about it.

Question: Do you ever get worried about being so “out there” on social media?

Answer: I have my stalkers I suppose, but the trolls don’t bother me. I don’t care if some whatever art dealer in New York thinks I have mental illness for promoting masks. That’s the best you’ve got? Honestly, this doesn’t even register with me. It’s like throwing a grain of sand at a car.

Question: You also got into an exchange with Dr. Leana Wen, CNN’s medical analyst, about mask wearing.

Answer: She obviously has a different opinion than I do. I think one of the biggest issues in the pandemic is the change in messaging and this idea that somehow people aren’t living their normal lives right now. I was sad to see her promote that concept.

This weekend I went out for lunch, I went furniture shopping, I went to the movies, I took a hike. My family and I wear masks everywhere. I fail to understand how wearing a mask means you’re not living a normal life when it’s clearly linked with the reduced spread of the virus.

Almost everything in medicine is about risk reduction. You can do things to lower your risk of heart disease. It’s not 100% guaranteed, but wouldn’t we want a lower risk of bad things? I’m going to keep wearing a mask forever!

Question: Do you wish more doctors were more vocal like you?

Answer:
I wish more doctors would have conversations about health outside of the office in ways they’re comfortable with. Like, you’re at the hairdresser and you share information, or you share information with 15 of your Facebook friends. If you’re a doctor and post an article about COVID-19 and how it impacts the heart, your 15 friends are more likely to read that article than if your friend who’s a lawyer puts that up.

As doctors, I believe we can often influence people in big and small ways.

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

Jen Gunter, MD, refuses to stay silent when she sees misleading claims about women’s health products.

In fact, the world’s most famous – and outspoken – ob.gyn. (as described by The Guardian), is on a social media mission to speak up whenever she sees companies or governments “prey on women’s health and vaginal shame.”

With nearly 400,000 followers, Dr. Gunter never shies away from a controversy.

Recently, she railed against vitamin and supplement maker Olly’s vaginal probiotic, taking the company to task for its product premise and objectionable ad copy.

This news organization caught up with the San Francisco–based doctor and author of two books, “The Vagina Bible” and “The Menopause Manifesto.” The following interview has been lightly edited for length and clarity.

Question: So these Olly capsules purport to be “Probiotics for Your Panty Hamster.” What was your reaction to this?

Answer:
Seeing the word “panty hamsters” is so egregious. I’m so used to baseline vaginal opportunism, but this was just absolutely egregious and I had to call it out.

Question: What are vaginal probiotics anyway?

Answer: These are one of these big wellness scams where companies try to sell you on somehow hacking your microbiome by taking them. They’re not inexpensive, either, and can range in price from $30 to $150 per month, depending on how bespoke they are. And yet the data isn’t good. There is little to no evidence of the value of these probiotics except to shareholders.

Question: What’s one claim made in the Olly probiotic packaging that bothers you the most?

Answer: The product claims to balance the vaginal pH. To say that is a gross misunderstanding of the vaginal ecosystem. If that tagline is what you’re leading with, what else don’t you know?

Also, if these things worked, we’d recommend them. Vaginitis is complex and often misdiagnosed, and it’s easy for a company to be predatory and swoop in and say they have a product for you.

If I think your product for the vagina is awful and you have not studied it in at least one quality clinical trial (never mind company-funded or not), and your marketing displays a stunning ignorance about vaginal health, don’t approach me about your product. Really.

Question: When there’s a pop culture reference to, say, menstruation, you’re quick to weigh in.

Answer:
I saw these viral messages from a boy mom (that’s what she called herself) where she wrote about being disgusted that there were mentions of periods in Turning Red, the animated movie.

Everything is here because of menstruation. If you didn’t menstruate, you wouldn’t have a kid, we wouldn’t have the person who had the intelligence to build the computer you’re spreading this message on. Menstruation is a vital part of human reproduction, and it’s far more complex than people think. For that reason alone, people should know about it.

Question: Do you ever get worried about being so “out there” on social media?

Answer: I have my stalkers I suppose, but the trolls don’t bother me. I don’t care if some whatever art dealer in New York thinks I have mental illness for promoting masks. That’s the best you’ve got? Honestly, this doesn’t even register with me. It’s like throwing a grain of sand at a car.

Question: You also got into an exchange with Dr. Leana Wen, CNN’s medical analyst, about mask wearing.

Answer: She obviously has a different opinion than I do. I think one of the biggest issues in the pandemic is the change in messaging and this idea that somehow people aren’t living their normal lives right now. I was sad to see her promote that concept.

This weekend I went out for lunch, I went furniture shopping, I went to the movies, I took a hike. My family and I wear masks everywhere. I fail to understand how wearing a mask means you’re not living a normal life when it’s clearly linked with the reduced spread of the virus.

Almost everything in medicine is about risk reduction. You can do things to lower your risk of heart disease. It’s not 100% guaranteed, but wouldn’t we want a lower risk of bad things? I’m going to keep wearing a mask forever!

Question: Do you wish more doctors were more vocal like you?

Answer:
I wish more doctors would have conversations about health outside of the office in ways they’re comfortable with. Like, you’re at the hairdresser and you share information, or you share information with 15 of your Facebook friends. If you’re a doctor and post an article about COVID-19 and how it impacts the heart, your 15 friends are more likely to read that article than if your friend who’s a lawyer puts that up.

As doctors, I believe we can often influence people in big and small ways.

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

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You’re not on a ‘best doctor’ list – does it matter?

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Wed, 03/30/2022 - 13:26

 

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

 

 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

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Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

 

 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

 

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

 

 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

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As FDA OKs another COVID booster, some experts question need

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Tue, 04/05/2022 - 10:31

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

 

 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

 

 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

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The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

 

 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

 

 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

 

 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

 

 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

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Metformin use linked to birth defects in boys

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The widely used antidiabetic drug metformin may cause genital birth defects such as undescended testicles and urethral problems in the male offspring of men who take the medication, researchers have found.

The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.

“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”

Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”

For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.

Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.

The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.

Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.

The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.

In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”

Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”

The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.

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

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The widely used antidiabetic drug metformin may cause genital birth defects such as undescended testicles and urethral problems in the male offspring of men who take the medication, researchers have found.

The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.

“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”

Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”

For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.

Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.

The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.

Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.

The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.

In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”

Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”

The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.

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

The widely used antidiabetic drug metformin may cause genital birth defects such as undescended testicles and urethral problems in the male offspring of men who take the medication, researchers have found.

The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.

“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”

Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”

For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.

Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.

The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.

Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.

The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.

In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”

Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”

The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.

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

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Do ObGyns use intrapartum warm compresses to the perineum or perineal massage in their practices?

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Moderate-quality evidence demonstrates a decrease in obstetric anal sphincter injury (OASIS) with the use of intrapartum warm compresses to the perineum and perineal massage, reported Editor in Chief Robert L. Barbieri, MD, in his editorial, “Obstetric anal sphincter injury: Prevention and repair” (May 2021). He also said that warm compresses may enhance the positive sensory experience of women laboring in natural childbirth. A poll for readers asked, “Do you use intrapartum or warm compresses to the perineum or perineal massage in your practice?”

Poll results

A total of 200 readers cast their vote:

65.4% (129 readers)said yes

35.5% (71 readers)said no

 

 

 

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Moderate-quality evidence demonstrates a decrease in obstetric anal sphincter injury (OASIS) with the use of intrapartum warm compresses to the perineum and perineal massage, reported Editor in Chief Robert L. Barbieri, MD, in his editorial, “Obstetric anal sphincter injury: Prevention and repair” (May 2021). He also said that warm compresses may enhance the positive sensory experience of women laboring in natural childbirth. A poll for readers asked, “Do you use intrapartum or warm compresses to the perineum or perineal massage in your practice?”

Poll results

A total of 200 readers cast their vote:

65.4% (129 readers)said yes

35.5% (71 readers)said no

 

 

 

Moderate-quality evidence demonstrates a decrease in obstetric anal sphincter injury (OASIS) with the use of intrapartum warm compresses to the perineum and perineal massage, reported Editor in Chief Robert L. Barbieri, MD, in his editorial, “Obstetric anal sphincter injury: Prevention and repair” (May 2021). He also said that warm compresses may enhance the positive sensory experience of women laboring in natural childbirth. A poll for readers asked, “Do you use intrapartum or warm compresses to the perineum or perineal massage in your practice?”

Poll results

A total of 200 readers cast their vote:

65.4% (129 readers)said yes

35.5% (71 readers)said no

 

 

 

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OBG Management - 34(3)
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Going digital won’t fully fix prior authorizations, say medical groups

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Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

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Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

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ADHD link to prenatal opioid exposure shifts with other substances

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Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

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Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

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Fertility after tubal ligation – It’s a matter of ‘AGE’

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Mon, 03/28/2022 - 17:37

 

Despite the original intent of permanent contraception, tubal sterilization regret is experienced by 2%-26% of women as demonstrated by the United States Collaborative Review of Sterilization “CREST” 14-year study (Obstet Gynecol. 1999 Jun;93[6]:889-95). Regret appears to be higher in the United States than Europe and in resource-limited countries and is more common in women who are less than age 30, African-American, and unmarried. Nevertheless, requests for tubal reversal are estimated to be between 1% and 4% (Contraception. 1981 Jun;23[6]:579-89). The alternative option for fertility is in vitro fertilization (IVF) and this month’s column considers the pros and cons of both methods.

The procedure of tubal reanastomosis involves removing abnormal tissue and reapproximating the healthy tubal segments with attention to minimize adhesion formation through continued gentle irrigation. The surgery involves microsuturing using 6-0 to 10-0 sutures. Tubal patency can be confirmed during the procedure and with a subsequent hysterosalpingogram. While time from sterilization and the type of sterilization technique are factors that may influence the success rate of tubal reanastomosis, the age of the woman is the most predictive for pregnancy outcome.

Dr. Mark P. Trolice

In the original CREST study, the risk of ectopic pregnancy following tubal reanastomosis was contingent on the method of sterilization: Bipolar electrosurgery resulted in the highest probability of ectopic pregnancy (17.1 per 1,000 procedures at 10 years after permanent contraception), while postpartum partial salpingectomy resulted in the lowest (1.5 per 1,000 procedures at 10 years after permanent contraception) (N Engl J Med. 1997;336[11]:762). Comparatively, the ectopic pregnancy rate during an IVF cycle was 1.9% for pregnancies from transfers of fresh cleavage embryo, followed by transfers of frozen cleavage embryo (1.7%), transfers of fresh blastocyst (1.3%), and transfers of frozen blastocyst (0.8%) (Hum Reprod. 2015;30[9]:2048-54).

Reports vary regarding pregnancy rates from tubal reanastomosis. Prior use of rings and clips for sterilization appear to yield the highest outcomes as opposed to the use of electrocautery. In one large Canadian cohort study of over 300,000 women, those aged 15-30 years, 30-33 years, and 34-49 years had a conception rate of 73%, 64%, and 46%, respectively (Obstet Gynecol. 2003;101[4]:677-84). Most pregnancies were within 2 years after reversal and 48% of women achieved a delivery. Of interest, 23% of patients subsequently underwent another sterilization.

An Australian study of nearly 2,000 women found an overall cumulative live-delivery rate of 20% within the first year after reversal, 40% at 2 years, 51% at 5 years, and 52% at 10 years. As expected, the 5-year cumulative live-delivery rate was significantly lower in women who were aged 40-44 years (26%), compared with younger women. For all women below age 40 years, the live-delivery rate was approximately 50% within 5 years after tubal reanastomosis, while the rate halves after the age of 40 (Fertil Steril. 2015 Oct;104[4]:921-6).

To compare tubal reanastomosis with IVF, a retrospective cohort study of 163 patients demonstrated the cumulative delivery rate over 72 months was comparable for IVF vs. sterilization reversal (52% vs. 60%). The only significant difference was in a subset of patients aged <37 years (52% after IVF and 72% after reversal) and the lower cost of surgery. The authors advocated laparoscopic sterilization reversal in women younger than 37 years who have ≥4 cm of residual tube with IVF as the better alternative for all other women (Hum Reprod. 2007;22[10]:2660).

Indeed, tubal length is another important factor in successful reversal. The pregnancy rate after tubal anastomosis is 75% in women with tubal length of 4 cm or more, but only 19% in those with shorter tubes (Fertil Steril. 1987;48[1]:13-7). The literature does suggest equivalent pregnancy rates after laparoscopic tubal anastomosis and conventional microsurgical anastomosis. Although the laparoscopic approach may be more economical, it is more demanding technically than an open microsurgical procedure.

Tubal reanastomosis can also be performed using robot-assisted laparoscopy. In preliminary studies, robotic surgery appears to have a similar success rate and a shorter recovery time, but longer operative times and higher costs (Obstet Gynecol. 2007;109[6]:1375; Fertil Steril. 2008;90[4]:1175).

To educate women on the success of IVF based on individual characteristics, a valuable tool to approximate the cumulative outcome for a live birth following one cycle of IVF is offered by the Society for Assisted Reproductive Technology. To clarify, a cycle of IVF consists of one egg retrieval and the ultimate transfer of all embryos produced, i.e., fresh and frozen. The website also includes estimations of success following a second and third IVF cycle.

The woman’s age is a significant predictor of IVF success. Ovarian aging is currently best measured by combining chronologic age, antral follicle count (AFC) by transvaginal pelvic ultrasound, and serum anti-Müllerian hormone (AMH). Natural fecundity begins to decline, on average, above age 32-33 years. An AFC less than 11 reflects diminished ovarian reserve (DOR) and less than 6 is severe. AMH levels below 1.6 ng/mL have been shown to reduce the number of eggs retrieved with IVF, while levels below 0.4 ng/mL are very low. Very low AMH levels negatively affect the outcome of IVF cycles as demonstrated in the SART data study from a population of women with a mean age of 39.4 years: Cycle cancellation was 54%; of all retrieval attempts, no oocytes were obtained in 5.4%, and no embryo transfer occurred in 25.1% of cycles; the live birth rate per embryo transfer was 20.5% (9.5% per cycle start and 16.3% per retrieval) from a mean age of 36.8 years (Fertil Steril. 2016 Feb;105[2]:385-93.e3). The predictive ability of AMH on the live birth rate from IVF cycles was also shown in a study of over 85,000 women (Fertil Steril. 2018;109:258-65).

While low AMH has been shown to lessen a successful outcome from IVF, there appears to be no difference in natural pregnancy rates in women aged 30-44 years irrespective of AMH levels (JAMA. 2017;318[14]:1367-76). Of importance, the use of AMH in a population at low risk for DOR will yield a larger number of false-positive results (i.e., characterizing a woman as DOR when in fact she has normal ovarian reserve). Further, users of hormonal contraceptives have a 25.2% lower mean AMH level than nonusers.

When a patient is considering tubal reanastomosis vs. IVF, a useful acronym to remember is to check “AGE” – the A is for AMH because severely diminished ovarian reserve will reduce success with IVF as shown by the SART calculator; the G represents guy, i.e., ensuring a reasonably normal sperm analysis; and E stands for eggs representing ovulation function. In a woman who is anovulatory and who will require fertility medication, it would be reasonable to consider IVF given the need for ovarian stimulation. As in females, advanced paternal age has demonstrated a decline in fertility and sperm analysis parameters. Men above age 45 take approximately five times as long to achieve a pregnancy, compared with men less than 25 years of age. Further, there is evidence for advanced paternal age increasing risk of miscarriage, preterm birth, and birth defects. Men older than 40-45 years have twice the risk of an autistic child and five times the risk of having a child with schizophrenia (Transl Psychiatry 2017;7: e1019; Am J Psychiatry. 2002;159:1528-33).

To conclude, the data support consideration for sterilization reversal in women less than age 37 years with more than 4 cm of residual functional fallopian tube and the prior use of rings or clip sterilization. In other women, IVF may be the better option, particularly when ovulation dysfunction and/or male factor is present. IVF also offers the advantage of maintaining contraception and gender determination. However, given that AMH does not appear to reduce natural fertility, unlike during its effect during an IVF cycle, the option of tubal reversal may be more favorable in women with severe DOR.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

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Despite the original intent of permanent contraception, tubal sterilization regret is experienced by 2%-26% of women as demonstrated by the United States Collaborative Review of Sterilization “CREST” 14-year study (Obstet Gynecol. 1999 Jun;93[6]:889-95). Regret appears to be higher in the United States than Europe and in resource-limited countries and is more common in women who are less than age 30, African-American, and unmarried. Nevertheless, requests for tubal reversal are estimated to be between 1% and 4% (Contraception. 1981 Jun;23[6]:579-89). The alternative option for fertility is in vitro fertilization (IVF) and this month’s column considers the pros and cons of both methods.

The procedure of tubal reanastomosis involves removing abnormal tissue and reapproximating the healthy tubal segments with attention to minimize adhesion formation through continued gentle irrigation. The surgery involves microsuturing using 6-0 to 10-0 sutures. Tubal patency can be confirmed during the procedure and with a subsequent hysterosalpingogram. While time from sterilization and the type of sterilization technique are factors that may influence the success rate of tubal reanastomosis, the age of the woman is the most predictive for pregnancy outcome.

Dr. Mark P. Trolice

In the original CREST study, the risk of ectopic pregnancy following tubal reanastomosis was contingent on the method of sterilization: Bipolar electrosurgery resulted in the highest probability of ectopic pregnancy (17.1 per 1,000 procedures at 10 years after permanent contraception), while postpartum partial salpingectomy resulted in the lowest (1.5 per 1,000 procedures at 10 years after permanent contraception) (N Engl J Med. 1997;336[11]:762). Comparatively, the ectopic pregnancy rate during an IVF cycle was 1.9% for pregnancies from transfers of fresh cleavage embryo, followed by transfers of frozen cleavage embryo (1.7%), transfers of fresh blastocyst (1.3%), and transfers of frozen blastocyst (0.8%) (Hum Reprod. 2015;30[9]:2048-54).

Reports vary regarding pregnancy rates from tubal reanastomosis. Prior use of rings and clips for sterilization appear to yield the highest outcomes as opposed to the use of electrocautery. In one large Canadian cohort study of over 300,000 women, those aged 15-30 years, 30-33 years, and 34-49 years had a conception rate of 73%, 64%, and 46%, respectively (Obstet Gynecol. 2003;101[4]:677-84). Most pregnancies were within 2 years after reversal and 48% of women achieved a delivery. Of interest, 23% of patients subsequently underwent another sterilization.

An Australian study of nearly 2,000 women found an overall cumulative live-delivery rate of 20% within the first year after reversal, 40% at 2 years, 51% at 5 years, and 52% at 10 years. As expected, the 5-year cumulative live-delivery rate was significantly lower in women who were aged 40-44 years (26%), compared with younger women. For all women below age 40 years, the live-delivery rate was approximately 50% within 5 years after tubal reanastomosis, while the rate halves after the age of 40 (Fertil Steril. 2015 Oct;104[4]:921-6).

To compare tubal reanastomosis with IVF, a retrospective cohort study of 163 patients demonstrated the cumulative delivery rate over 72 months was comparable for IVF vs. sterilization reversal (52% vs. 60%). The only significant difference was in a subset of patients aged <37 years (52% after IVF and 72% after reversal) and the lower cost of surgery. The authors advocated laparoscopic sterilization reversal in women younger than 37 years who have ≥4 cm of residual tube with IVF as the better alternative for all other women (Hum Reprod. 2007;22[10]:2660).

Indeed, tubal length is another important factor in successful reversal. The pregnancy rate after tubal anastomosis is 75% in women with tubal length of 4 cm or more, but only 19% in those with shorter tubes (Fertil Steril. 1987;48[1]:13-7). The literature does suggest equivalent pregnancy rates after laparoscopic tubal anastomosis and conventional microsurgical anastomosis. Although the laparoscopic approach may be more economical, it is more demanding technically than an open microsurgical procedure.

Tubal reanastomosis can also be performed using robot-assisted laparoscopy. In preliminary studies, robotic surgery appears to have a similar success rate and a shorter recovery time, but longer operative times and higher costs (Obstet Gynecol. 2007;109[6]:1375; Fertil Steril. 2008;90[4]:1175).

To educate women on the success of IVF based on individual characteristics, a valuable tool to approximate the cumulative outcome for a live birth following one cycle of IVF is offered by the Society for Assisted Reproductive Technology. To clarify, a cycle of IVF consists of one egg retrieval and the ultimate transfer of all embryos produced, i.e., fresh and frozen. The website also includes estimations of success following a second and third IVF cycle.

The woman’s age is a significant predictor of IVF success. Ovarian aging is currently best measured by combining chronologic age, antral follicle count (AFC) by transvaginal pelvic ultrasound, and serum anti-Müllerian hormone (AMH). Natural fecundity begins to decline, on average, above age 32-33 years. An AFC less than 11 reflects diminished ovarian reserve (DOR) and less than 6 is severe. AMH levels below 1.6 ng/mL have been shown to reduce the number of eggs retrieved with IVF, while levels below 0.4 ng/mL are very low. Very low AMH levels negatively affect the outcome of IVF cycles as demonstrated in the SART data study from a population of women with a mean age of 39.4 years: Cycle cancellation was 54%; of all retrieval attempts, no oocytes were obtained in 5.4%, and no embryo transfer occurred in 25.1% of cycles; the live birth rate per embryo transfer was 20.5% (9.5% per cycle start and 16.3% per retrieval) from a mean age of 36.8 years (Fertil Steril. 2016 Feb;105[2]:385-93.e3). The predictive ability of AMH on the live birth rate from IVF cycles was also shown in a study of over 85,000 women (Fertil Steril. 2018;109:258-65).

While low AMH has been shown to lessen a successful outcome from IVF, there appears to be no difference in natural pregnancy rates in women aged 30-44 years irrespective of AMH levels (JAMA. 2017;318[14]:1367-76). Of importance, the use of AMH in a population at low risk for DOR will yield a larger number of false-positive results (i.e., characterizing a woman as DOR when in fact she has normal ovarian reserve). Further, users of hormonal contraceptives have a 25.2% lower mean AMH level than nonusers.

When a patient is considering tubal reanastomosis vs. IVF, a useful acronym to remember is to check “AGE” – the A is for AMH because severely diminished ovarian reserve will reduce success with IVF as shown by the SART calculator; the G represents guy, i.e., ensuring a reasonably normal sperm analysis; and E stands for eggs representing ovulation function. In a woman who is anovulatory and who will require fertility medication, it would be reasonable to consider IVF given the need for ovarian stimulation. As in females, advanced paternal age has demonstrated a decline in fertility and sperm analysis parameters. Men above age 45 take approximately five times as long to achieve a pregnancy, compared with men less than 25 years of age. Further, there is evidence for advanced paternal age increasing risk of miscarriage, preterm birth, and birth defects. Men older than 40-45 years have twice the risk of an autistic child and five times the risk of having a child with schizophrenia (Transl Psychiatry 2017;7: e1019; Am J Psychiatry. 2002;159:1528-33).

To conclude, the data support consideration for sterilization reversal in women less than age 37 years with more than 4 cm of residual functional fallopian tube and the prior use of rings or clip sterilization. In other women, IVF may be the better option, particularly when ovulation dysfunction and/or male factor is present. IVF also offers the advantage of maintaining contraception and gender determination. However, given that AMH does not appear to reduce natural fertility, unlike during its effect during an IVF cycle, the option of tubal reversal may be more favorable in women with severe DOR.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

 

Despite the original intent of permanent contraception, tubal sterilization regret is experienced by 2%-26% of women as demonstrated by the United States Collaborative Review of Sterilization “CREST” 14-year study (Obstet Gynecol. 1999 Jun;93[6]:889-95). Regret appears to be higher in the United States than Europe and in resource-limited countries and is more common in women who are less than age 30, African-American, and unmarried. Nevertheless, requests for tubal reversal are estimated to be between 1% and 4% (Contraception. 1981 Jun;23[6]:579-89). The alternative option for fertility is in vitro fertilization (IVF) and this month’s column considers the pros and cons of both methods.

The procedure of tubal reanastomosis involves removing abnormal tissue and reapproximating the healthy tubal segments with attention to minimize adhesion formation through continued gentle irrigation. The surgery involves microsuturing using 6-0 to 10-0 sutures. Tubal patency can be confirmed during the procedure and with a subsequent hysterosalpingogram. While time from sterilization and the type of sterilization technique are factors that may influence the success rate of tubal reanastomosis, the age of the woman is the most predictive for pregnancy outcome.

Dr. Mark P. Trolice

In the original CREST study, the risk of ectopic pregnancy following tubal reanastomosis was contingent on the method of sterilization: Bipolar electrosurgery resulted in the highest probability of ectopic pregnancy (17.1 per 1,000 procedures at 10 years after permanent contraception), while postpartum partial salpingectomy resulted in the lowest (1.5 per 1,000 procedures at 10 years after permanent contraception) (N Engl J Med. 1997;336[11]:762). Comparatively, the ectopic pregnancy rate during an IVF cycle was 1.9% for pregnancies from transfers of fresh cleavage embryo, followed by transfers of frozen cleavage embryo (1.7%), transfers of fresh blastocyst (1.3%), and transfers of frozen blastocyst (0.8%) (Hum Reprod. 2015;30[9]:2048-54).

Reports vary regarding pregnancy rates from tubal reanastomosis. Prior use of rings and clips for sterilization appear to yield the highest outcomes as opposed to the use of electrocautery. In one large Canadian cohort study of over 300,000 women, those aged 15-30 years, 30-33 years, and 34-49 years had a conception rate of 73%, 64%, and 46%, respectively (Obstet Gynecol. 2003;101[4]:677-84). Most pregnancies were within 2 years after reversal and 48% of women achieved a delivery. Of interest, 23% of patients subsequently underwent another sterilization.

An Australian study of nearly 2,000 women found an overall cumulative live-delivery rate of 20% within the first year after reversal, 40% at 2 years, 51% at 5 years, and 52% at 10 years. As expected, the 5-year cumulative live-delivery rate was significantly lower in women who were aged 40-44 years (26%), compared with younger women. For all women below age 40 years, the live-delivery rate was approximately 50% within 5 years after tubal reanastomosis, while the rate halves after the age of 40 (Fertil Steril. 2015 Oct;104[4]:921-6).

To compare tubal reanastomosis with IVF, a retrospective cohort study of 163 patients demonstrated the cumulative delivery rate over 72 months was comparable for IVF vs. sterilization reversal (52% vs. 60%). The only significant difference was in a subset of patients aged <37 years (52% after IVF and 72% after reversal) and the lower cost of surgery. The authors advocated laparoscopic sterilization reversal in women younger than 37 years who have ≥4 cm of residual tube with IVF as the better alternative for all other women (Hum Reprod. 2007;22[10]:2660).

Indeed, tubal length is another important factor in successful reversal. The pregnancy rate after tubal anastomosis is 75% in women with tubal length of 4 cm or more, but only 19% in those with shorter tubes (Fertil Steril. 1987;48[1]:13-7). The literature does suggest equivalent pregnancy rates after laparoscopic tubal anastomosis and conventional microsurgical anastomosis. Although the laparoscopic approach may be more economical, it is more demanding technically than an open microsurgical procedure.

Tubal reanastomosis can also be performed using robot-assisted laparoscopy. In preliminary studies, robotic surgery appears to have a similar success rate and a shorter recovery time, but longer operative times and higher costs (Obstet Gynecol. 2007;109[6]:1375; Fertil Steril. 2008;90[4]:1175).

To educate women on the success of IVF based on individual characteristics, a valuable tool to approximate the cumulative outcome for a live birth following one cycle of IVF is offered by the Society for Assisted Reproductive Technology. To clarify, a cycle of IVF consists of one egg retrieval and the ultimate transfer of all embryos produced, i.e., fresh and frozen. The website also includes estimations of success following a second and third IVF cycle.

The woman’s age is a significant predictor of IVF success. Ovarian aging is currently best measured by combining chronologic age, antral follicle count (AFC) by transvaginal pelvic ultrasound, and serum anti-Müllerian hormone (AMH). Natural fecundity begins to decline, on average, above age 32-33 years. An AFC less than 11 reflects diminished ovarian reserve (DOR) and less than 6 is severe. AMH levels below 1.6 ng/mL have been shown to reduce the number of eggs retrieved with IVF, while levels below 0.4 ng/mL are very low. Very low AMH levels negatively affect the outcome of IVF cycles as demonstrated in the SART data study from a population of women with a mean age of 39.4 years: Cycle cancellation was 54%; of all retrieval attempts, no oocytes were obtained in 5.4%, and no embryo transfer occurred in 25.1% of cycles; the live birth rate per embryo transfer was 20.5% (9.5% per cycle start and 16.3% per retrieval) from a mean age of 36.8 years (Fertil Steril. 2016 Feb;105[2]:385-93.e3). The predictive ability of AMH on the live birth rate from IVF cycles was also shown in a study of over 85,000 women (Fertil Steril. 2018;109:258-65).

While low AMH has been shown to lessen a successful outcome from IVF, there appears to be no difference in natural pregnancy rates in women aged 30-44 years irrespective of AMH levels (JAMA. 2017;318[14]:1367-76). Of importance, the use of AMH in a population at low risk for DOR will yield a larger number of false-positive results (i.e., characterizing a woman as DOR when in fact she has normal ovarian reserve). Further, users of hormonal contraceptives have a 25.2% lower mean AMH level than nonusers.

When a patient is considering tubal reanastomosis vs. IVF, a useful acronym to remember is to check “AGE” – the A is for AMH because severely diminished ovarian reserve will reduce success with IVF as shown by the SART calculator; the G represents guy, i.e., ensuring a reasonably normal sperm analysis; and E stands for eggs representing ovulation function. In a woman who is anovulatory and who will require fertility medication, it would be reasonable to consider IVF given the need for ovarian stimulation. As in females, advanced paternal age has demonstrated a decline in fertility and sperm analysis parameters. Men above age 45 take approximately five times as long to achieve a pregnancy, compared with men less than 25 years of age. Further, there is evidence for advanced paternal age increasing risk of miscarriage, preterm birth, and birth defects. Men older than 40-45 years have twice the risk of an autistic child and five times the risk of having a child with schizophrenia (Transl Psychiatry 2017;7: e1019; Am J Psychiatry. 2002;159:1528-33).

To conclude, the data support consideration for sterilization reversal in women less than age 37 years with more than 4 cm of residual functional fallopian tube and the prior use of rings or clip sterilization. In other women, IVF may be the better option, particularly when ovulation dysfunction and/or male factor is present. IVF also offers the advantage of maintaining contraception and gender determination. However, given that AMH does not appear to reduce natural fertility, unlike during its effect during an IVF cycle, the option of tubal reversal may be more favorable in women with severe DOR.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

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Even moderate exercise offers strong shield from COVID-19

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Mon, 03/28/2022 - 16:58

 Further support for the benefits of regular exercise in reducing severe COVID-19 outcomes has come from a large study, the first to directly measure physical activity in its participants.

Researchers identified 65,361 members of a South African private health plan who had a COVID-19 diagnosis from March 2020 to June 2021 and matched them with physical activity data during the 2 years prior to the country’s March 2020 lockdown captured by smart devices, and clocked gym attendance and mass event participation in a voluntary healthy lifestyle behavior program linked to the insurer.

UberImages/iStock/Getty Images

In all, 20.4% of participants had engaged in low levels of at least moderate-intensity physical activity per week (0-59 minutes), 34.5% in moderate levels (60-149 minutes), and 45.1% in high levels (150 minutes or more).

Overall, 11.1% were hospitalized as a result of COVID-19, 2.4% were admitted to the ICU, 1.3% required a ventilator, and 1.6% died.

As reported in the British Journal of Sports Medicine, analyses adjusted for demographic and other risk factors showed that, with COVID-19 infection, people with high versus low physical activity had a 34% lower risk for hospitalization (risk ratio, 0.66; 95% confidence interval, 0.63-0.70), a 41% lower risk for ICU admission (RR, 0.59; 95% CI, 0.52-0.66), a 45% lower risk of requiring ventilation (RR, 0.55; 95% CI, 0.47-0.64), and a 42% lower risk for death (RR, 0.58; 95% CI, 0.50-0.68).

Even moderate physical exercise, below the recommended guidelines of at least 150 minutes per week, was associated with several benefits, such as a 13% lower risk for hospitalization (RR, 0.87; 95% CI, 0.82-0.91), a 20% lower risk for ICU admission (RR, 0.80; 95% CI, 0.71-0.89), a 27% lower risk of requiring ventilation (RR, 0.73; 95% CI, 0.62-0.84), and a21% lower risk for death (RR, 0.79; 95% CI, 0.69-0.91).

“Should we come across further waves of this pandemic, our advice from a medical point of view should be to promote and facilitate exercise,” senior author Jon Patricios, MD, Wits Sport and Health, University of the Witwatersrand, Johannesburg, South Africa, said in an interview. “The likelihood is that exercise and vaccination are going to be the two most significant interventions in terms of helping to offload the health care system rather than face the catastrophic events endured a year or so ago.”

The study showed that males are at greater risk than females for severe COVID-19 outcomes, as were patients with essential hypertension, diabetes, and chronic renal disease.

It also suggests that the protective benefit of exercise extends to HIV-positive patients and those with rheumatoid arthritis, two groups previously not evaluated, the authors noted.

The results are comparable with previous reports of self-reported exercise and COVID-19 from the United States and South Korea, although the effect of even moderate exercise was more significant, possibly due to the use of direct measures of exercise rather than self-report, Dr. Patricios suggested.

Previous data suggest that regular physical activity may protect against many viral infections including influenza, rhinovirus, and the reactivation of latent herpes viruses, he noted. However, emerging evidence also points to significant decreases in physical activity during the pandemic.

“Regular physical activity should be a message that is strongly, strongly advocated for, particularly in less well-developed countries where we don’t have access or the resources to afford pharmacological interventions in many of these scenarios,” Dr. Patricios said. “It’s frustrating that the message is not driven strongly enough. It should be part of every government’s agenda.”

The cohort all being members of a medical insurance plan could imply some selection bias based on affordability and limit generalizability of the results, the authors noted. Other limitations include a lack of data on sociodemographic criteria such as education, income, and race, as well as behavioral risk factors such as smoking and diet.

Dr. Patricios and one coauthor are editors of the British Journal of Sports Medicine. Several coauthors are employees of Discovery Health, Johannesburg.

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

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 Further support for the benefits of regular exercise in reducing severe COVID-19 outcomes has come from a large study, the first to directly measure physical activity in its participants.

Researchers identified 65,361 members of a South African private health plan who had a COVID-19 diagnosis from March 2020 to June 2021 and matched them with physical activity data during the 2 years prior to the country’s March 2020 lockdown captured by smart devices, and clocked gym attendance and mass event participation in a voluntary healthy lifestyle behavior program linked to the insurer.

UberImages/iStock/Getty Images

In all, 20.4% of participants had engaged in low levels of at least moderate-intensity physical activity per week (0-59 minutes), 34.5% in moderate levels (60-149 minutes), and 45.1% in high levels (150 minutes or more).

Overall, 11.1% were hospitalized as a result of COVID-19, 2.4% were admitted to the ICU, 1.3% required a ventilator, and 1.6% died.

As reported in the British Journal of Sports Medicine, analyses adjusted for demographic and other risk factors showed that, with COVID-19 infection, people with high versus low physical activity had a 34% lower risk for hospitalization (risk ratio, 0.66; 95% confidence interval, 0.63-0.70), a 41% lower risk for ICU admission (RR, 0.59; 95% CI, 0.52-0.66), a 45% lower risk of requiring ventilation (RR, 0.55; 95% CI, 0.47-0.64), and a 42% lower risk for death (RR, 0.58; 95% CI, 0.50-0.68).

Even moderate physical exercise, below the recommended guidelines of at least 150 minutes per week, was associated with several benefits, such as a 13% lower risk for hospitalization (RR, 0.87; 95% CI, 0.82-0.91), a 20% lower risk for ICU admission (RR, 0.80; 95% CI, 0.71-0.89), a 27% lower risk of requiring ventilation (RR, 0.73; 95% CI, 0.62-0.84), and a21% lower risk for death (RR, 0.79; 95% CI, 0.69-0.91).

“Should we come across further waves of this pandemic, our advice from a medical point of view should be to promote and facilitate exercise,” senior author Jon Patricios, MD, Wits Sport and Health, University of the Witwatersrand, Johannesburg, South Africa, said in an interview. “The likelihood is that exercise and vaccination are going to be the two most significant interventions in terms of helping to offload the health care system rather than face the catastrophic events endured a year or so ago.”

The study showed that males are at greater risk than females for severe COVID-19 outcomes, as were patients with essential hypertension, diabetes, and chronic renal disease.

It also suggests that the protective benefit of exercise extends to HIV-positive patients and those with rheumatoid arthritis, two groups previously not evaluated, the authors noted.

The results are comparable with previous reports of self-reported exercise and COVID-19 from the United States and South Korea, although the effect of even moderate exercise was more significant, possibly due to the use of direct measures of exercise rather than self-report, Dr. Patricios suggested.

Previous data suggest that regular physical activity may protect against many viral infections including influenza, rhinovirus, and the reactivation of latent herpes viruses, he noted. However, emerging evidence also points to significant decreases in physical activity during the pandemic.

“Regular physical activity should be a message that is strongly, strongly advocated for, particularly in less well-developed countries where we don’t have access or the resources to afford pharmacological interventions in many of these scenarios,” Dr. Patricios said. “It’s frustrating that the message is not driven strongly enough. It should be part of every government’s agenda.”

The cohort all being members of a medical insurance plan could imply some selection bias based on affordability and limit generalizability of the results, the authors noted. Other limitations include a lack of data on sociodemographic criteria such as education, income, and race, as well as behavioral risk factors such as smoking and diet.

Dr. Patricios and one coauthor are editors of the British Journal of Sports Medicine. Several coauthors are employees of Discovery Health, Johannesburg.

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

 Further support for the benefits of regular exercise in reducing severe COVID-19 outcomes has come from a large study, the first to directly measure physical activity in its participants.

Researchers identified 65,361 members of a South African private health plan who had a COVID-19 diagnosis from March 2020 to June 2021 and matched them with physical activity data during the 2 years prior to the country’s March 2020 lockdown captured by smart devices, and clocked gym attendance and mass event participation in a voluntary healthy lifestyle behavior program linked to the insurer.

UberImages/iStock/Getty Images

In all, 20.4% of participants had engaged in low levels of at least moderate-intensity physical activity per week (0-59 minutes), 34.5% in moderate levels (60-149 minutes), and 45.1% in high levels (150 minutes or more).

Overall, 11.1% were hospitalized as a result of COVID-19, 2.4% were admitted to the ICU, 1.3% required a ventilator, and 1.6% died.

As reported in the British Journal of Sports Medicine, analyses adjusted for demographic and other risk factors showed that, with COVID-19 infection, people with high versus low physical activity had a 34% lower risk for hospitalization (risk ratio, 0.66; 95% confidence interval, 0.63-0.70), a 41% lower risk for ICU admission (RR, 0.59; 95% CI, 0.52-0.66), a 45% lower risk of requiring ventilation (RR, 0.55; 95% CI, 0.47-0.64), and a 42% lower risk for death (RR, 0.58; 95% CI, 0.50-0.68).

Even moderate physical exercise, below the recommended guidelines of at least 150 minutes per week, was associated with several benefits, such as a 13% lower risk for hospitalization (RR, 0.87; 95% CI, 0.82-0.91), a 20% lower risk for ICU admission (RR, 0.80; 95% CI, 0.71-0.89), a 27% lower risk of requiring ventilation (RR, 0.73; 95% CI, 0.62-0.84), and a21% lower risk for death (RR, 0.79; 95% CI, 0.69-0.91).

“Should we come across further waves of this pandemic, our advice from a medical point of view should be to promote and facilitate exercise,” senior author Jon Patricios, MD, Wits Sport and Health, University of the Witwatersrand, Johannesburg, South Africa, said in an interview. “The likelihood is that exercise and vaccination are going to be the two most significant interventions in terms of helping to offload the health care system rather than face the catastrophic events endured a year or so ago.”

The study showed that males are at greater risk than females for severe COVID-19 outcomes, as were patients with essential hypertension, diabetes, and chronic renal disease.

It also suggests that the protective benefit of exercise extends to HIV-positive patients and those with rheumatoid arthritis, two groups previously not evaluated, the authors noted.

The results are comparable with previous reports of self-reported exercise and COVID-19 from the United States and South Korea, although the effect of even moderate exercise was more significant, possibly due to the use of direct measures of exercise rather than self-report, Dr. Patricios suggested.

Previous data suggest that regular physical activity may protect against many viral infections including influenza, rhinovirus, and the reactivation of latent herpes viruses, he noted. However, emerging evidence also points to significant decreases in physical activity during the pandemic.

“Regular physical activity should be a message that is strongly, strongly advocated for, particularly in less well-developed countries where we don’t have access or the resources to afford pharmacological interventions in many of these scenarios,” Dr. Patricios said. “It’s frustrating that the message is not driven strongly enough. It should be part of every government’s agenda.”

The cohort all being members of a medical insurance plan could imply some selection bias based on affordability and limit generalizability of the results, the authors noted. Other limitations include a lack of data on sociodemographic criteria such as education, income, and race, as well as behavioral risk factors such as smoking and diet.

Dr. Patricios and one coauthor are editors of the British Journal of Sports Medicine. Several coauthors are employees of Discovery Health, Johannesburg.

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

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