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Docs become dog groomers and warehouse workers after COVID-19 work loss

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Thu, 03/04/2021 - 15:45

One of the biggest conundrums of the COVID-19 pandemic has been the simultaneous panic-hiring of medical professionals in hot spots and significant downsizing of staff across the country. From huge hospital systems to private practices, the stoppage of breast reductions and knee replacements, not to mention the drops in motor vehicle accidents and bar fights, have quieted operating rooms and emergency departments and put doctors’ jobs on the chopping block. A widely cited survey suggests that 21% of doctors have had a work reduction due to COVID-19.

For many American doctors, this is their first extended period of unemployment. Unlike engineers or those with MBAs who might see their fortunes rise and fall with the whims of recessions and boom times, physicians are not exactly accustomed to being laid off. However, doctors were already smarting for years due to falling salaries and decreased autonomy, punctuated by endless clicks on electronic medical records software.

Now, the twin shock of income loss and feeling unwanted in a pandemic – when, you know, medicine might seem especially essential – has doctors resorting to a bizarre array of side gigs, “fun-employment” activities, or outright career overhauls.

Stephanie Eschenbach Morgan, MD, a breast radiologist in North Carolina, trained for 10 years after college before earning a true physician’s salary.

“Being furloughed was awful. Initially, it was only going to be 2 weeks, and then it turned into 2 months with no pay,” she reflected.

Dr. Eschenbach Morgan and her surgeon husband, who lost a full quarter’s salary, had to ask for grace periods on their credit card and mortgage payments because they had paid a large tax bill right before the pandemic began. “We couldn’t get any stimulus help, so that added insult to injury,” she said.

With her time spent waiting in a holding pattern, Dr. Eschenbach Morgan homeschooled her two young children and started putting a home gym together. She went on a home organizing spree, started a garden, and, perhaps most impressively, caught up with 5 years of photo albums.

A bonus she noted: “I didn’t set an alarm for 2 months.”

Shella Farooki, MD, a radiologist in California, was also focused on homeschooling, itself a demanding job, and veered toward retirement. When one of her work contracts furloughed her (“at one point, I made $30K a month for [their business]”), she started saving money at home, teaching the kids, and applied for a Paycheck Protection Program loan. Her husband, a hospitalist, had had his shifts cut. Dr. Farooki tried a radiology artificial intelligence firm but backed out when she was asked to read 9,200 studies for them for $2,000 per month.

Now, she thinks about leaving medicine “every day.”

Some doctors are questioning whether they should be in medicine in the first place. Family medicine physician Jonathan Polak, MD, faced with his own pink slip, turned to pink T-shirts instead. His girlfriend manages an outlet of the teen fashion retailer Justice. Dr. Polak, who finished his residency just 2 years ago, didn’t hesitate to take a $10-an-hour gig as a stock doc, once even finding himself delivering a shelving unit from the shuttering store to a physician fleeing the city for rural New Hampshire to “escape.”

There’s no escape for him – yet. Saddled with “astronomical” student loans, he had considered grocery store work as well. Dr. Polak knows he can’t work part time or go into teaching long term, as he might like.

Even so, he’s doing everything he can to not be in patient care for the long haul – it’s just not what he thought it would be.

“The culture of medicine, bureaucracy, endless paperwork and charting, and threat of litigation sucks a lot of the joy out of it to the point that I don’t see myself doing it forever when imagining myself 5-10 years into it.”

Still, he recently took an 18-month hospital contract that will force him to move to Florida, but he’s also been turning himself into a veritable Renaissance man; composing music, training for an ultramarathon, studying the latest medical findings, roadtripping, and launching a podcast about dog grooming with a master groomer. “We found parallels between medicine and dog grooming,” he says, somewhat convincingly.

Also working the ruff life is Jen Tserng, MD, a former forensic pathologist who landed on news websites in recent years for becoming a professional dogwalker and housesitter without a permanent home. Dr. Tserng knows doctors were restless and unhappy before COVID-19, their thoughts wandering where the grass might be greener.

As her profile grew, she found her inbox gathering messages from disaffected medical minions: students with a fear of failing or staring down residency application season and employed doctors sick of the constant grind. As she recounted those de facto life coach conversations (“What do you really enjoy?” “Do you really like dogs?”) by phone from New York, she said matter-of-factly, “They don’t call because of COVID. They call because they hate their lives.”

Michelle Mudge-Riley, MD, a physician in Texas, has been seeing this shift for some time as well. She recently held a virtual version of her Physicians Helping Physicians conference, where doctors hear from their peers working successfully in fields like pharmaceuticals and real estate investing.

When COVID-19 hit, Dr. Mudge-Riley quickly pivoted to a virtual platform, where the MDs and DOs huddled in breakout rooms having honest chats about their fears and tentative hopes about their new careers.

“There has been increased interest in nonclinical exploration into full- and part-time careers, as well as side hustles, since COVID began,” she said. “Many physicians have had their hours or pay cut, and some have been laid off. Others are furloughed. Some just want out of an environment where they don’t feel safe.”

An ear, nose, and throat surgeon, Maansi Doshi, MD, from central California, didn’t feel safe – so she left. She had returned from India sick with a mystery virus right as the pandemic began (she said her COVID-19 tests were all negative) and was waiting to get well enough to go back to her private practice job. However, she said she clashed with Trump-supporting colleagues she feared might not be taking the pandemic seriously enough.

Finally getting over a relapse of her mystery virus, Dr. Doshi emailed her resignation in May. Her husband, family practice doctor Mark Mangiapane, MD, gave his job notice weeks later in solidarity because he worked in the same building. Together, they have embraced gardening, a Peloton splurge, and learning business skills to open private practices – solo primary care for him; ENT with a focus on her favorite surgery, rhinoplasty, for her.

Dr. Mangiapane had considered editing medical brochures and also tried to apply for a job as a county public health officer in rural California, but he received his own shock when he learned the county intended to open schools in the midst of the pandemic despite advisement to the contrary by the former health officer.

He retreated from job listings altogether after hearing his would-be peers were getting death threats – targeting their children.

Both doctors felt COVID-19 pushed them beyond their comfort zones. “If COVID hadn’t happened, I would be working. ... Be ‘owned.’ In a weird way, COVID made me more independent and take a risk with my career.”

Obstetrician Kwandaa Roberts, MD, certainly did; she took a budding interest in decorating dollhouses straight to Instagram and national news fame, and she is now a TV-show expert on “Sell This House.”

Like Dr. Doshi and Dr. Mangiapane, Dr. Polak wants to be more in control of his future – even if selling T-shirts at a mall means a certain loss of status along the way.

“Aside from my passion to learn and to have that connection with people, I went into medicine ... because of the job security I thought existed,” he said. “I would say that my getting furloughed has changed my view of the United States in a dramatic way. I do not feel as confident in the U.S. economy and general way of life as I did a year ago. And I am taking a number of steps to put myself in a more fluid, adaptable position in case another crisis like this occurs or if the current state of things worsens.”

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

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One of the biggest conundrums of the COVID-19 pandemic has been the simultaneous panic-hiring of medical professionals in hot spots and significant downsizing of staff across the country. From huge hospital systems to private practices, the stoppage of breast reductions and knee replacements, not to mention the drops in motor vehicle accidents and bar fights, have quieted operating rooms and emergency departments and put doctors’ jobs on the chopping block. A widely cited survey suggests that 21% of doctors have had a work reduction due to COVID-19.

For many American doctors, this is their first extended period of unemployment. Unlike engineers or those with MBAs who might see their fortunes rise and fall with the whims of recessions and boom times, physicians are not exactly accustomed to being laid off. However, doctors were already smarting for years due to falling salaries and decreased autonomy, punctuated by endless clicks on electronic medical records software.

Now, the twin shock of income loss and feeling unwanted in a pandemic – when, you know, medicine might seem especially essential – has doctors resorting to a bizarre array of side gigs, “fun-employment” activities, or outright career overhauls.

Stephanie Eschenbach Morgan, MD, a breast radiologist in North Carolina, trained for 10 years after college before earning a true physician’s salary.

“Being furloughed was awful. Initially, it was only going to be 2 weeks, and then it turned into 2 months with no pay,” she reflected.

Dr. Eschenbach Morgan and her surgeon husband, who lost a full quarter’s salary, had to ask for grace periods on their credit card and mortgage payments because they had paid a large tax bill right before the pandemic began. “We couldn’t get any stimulus help, so that added insult to injury,” she said.

With her time spent waiting in a holding pattern, Dr. Eschenbach Morgan homeschooled her two young children and started putting a home gym together. She went on a home organizing spree, started a garden, and, perhaps most impressively, caught up with 5 years of photo albums.

A bonus she noted: “I didn’t set an alarm for 2 months.”

Shella Farooki, MD, a radiologist in California, was also focused on homeschooling, itself a demanding job, and veered toward retirement. When one of her work contracts furloughed her (“at one point, I made $30K a month for [their business]”), she started saving money at home, teaching the kids, and applied for a Paycheck Protection Program loan. Her husband, a hospitalist, had had his shifts cut. Dr. Farooki tried a radiology artificial intelligence firm but backed out when she was asked to read 9,200 studies for them for $2,000 per month.

Now, she thinks about leaving medicine “every day.”

Some doctors are questioning whether they should be in medicine in the first place. Family medicine physician Jonathan Polak, MD, faced with his own pink slip, turned to pink T-shirts instead. His girlfriend manages an outlet of the teen fashion retailer Justice. Dr. Polak, who finished his residency just 2 years ago, didn’t hesitate to take a $10-an-hour gig as a stock doc, once even finding himself delivering a shelving unit from the shuttering store to a physician fleeing the city for rural New Hampshire to “escape.”

There’s no escape for him – yet. Saddled with “astronomical” student loans, he had considered grocery store work as well. Dr. Polak knows he can’t work part time or go into teaching long term, as he might like.

Even so, he’s doing everything he can to not be in patient care for the long haul – it’s just not what he thought it would be.

“The culture of medicine, bureaucracy, endless paperwork and charting, and threat of litigation sucks a lot of the joy out of it to the point that I don’t see myself doing it forever when imagining myself 5-10 years into it.”

Still, he recently took an 18-month hospital contract that will force him to move to Florida, but he’s also been turning himself into a veritable Renaissance man; composing music, training for an ultramarathon, studying the latest medical findings, roadtripping, and launching a podcast about dog grooming with a master groomer. “We found parallels between medicine and dog grooming,” he says, somewhat convincingly.

Also working the ruff life is Jen Tserng, MD, a former forensic pathologist who landed on news websites in recent years for becoming a professional dogwalker and housesitter without a permanent home. Dr. Tserng knows doctors were restless and unhappy before COVID-19, their thoughts wandering where the grass might be greener.

As her profile grew, she found her inbox gathering messages from disaffected medical minions: students with a fear of failing or staring down residency application season and employed doctors sick of the constant grind. As she recounted those de facto life coach conversations (“What do you really enjoy?” “Do you really like dogs?”) by phone from New York, she said matter-of-factly, “They don’t call because of COVID. They call because they hate their lives.”

Michelle Mudge-Riley, MD, a physician in Texas, has been seeing this shift for some time as well. She recently held a virtual version of her Physicians Helping Physicians conference, where doctors hear from their peers working successfully in fields like pharmaceuticals and real estate investing.

When COVID-19 hit, Dr. Mudge-Riley quickly pivoted to a virtual platform, where the MDs and DOs huddled in breakout rooms having honest chats about their fears and tentative hopes about their new careers.

“There has been increased interest in nonclinical exploration into full- and part-time careers, as well as side hustles, since COVID began,” she said. “Many physicians have had their hours or pay cut, and some have been laid off. Others are furloughed. Some just want out of an environment where they don’t feel safe.”

An ear, nose, and throat surgeon, Maansi Doshi, MD, from central California, didn’t feel safe – so she left. She had returned from India sick with a mystery virus right as the pandemic began (she said her COVID-19 tests were all negative) and was waiting to get well enough to go back to her private practice job. However, she said she clashed with Trump-supporting colleagues she feared might not be taking the pandemic seriously enough.

Finally getting over a relapse of her mystery virus, Dr. Doshi emailed her resignation in May. Her husband, family practice doctor Mark Mangiapane, MD, gave his job notice weeks later in solidarity because he worked in the same building. Together, they have embraced gardening, a Peloton splurge, and learning business skills to open private practices – solo primary care for him; ENT with a focus on her favorite surgery, rhinoplasty, for her.

Dr. Mangiapane had considered editing medical brochures and also tried to apply for a job as a county public health officer in rural California, but he received his own shock when he learned the county intended to open schools in the midst of the pandemic despite advisement to the contrary by the former health officer.

He retreated from job listings altogether after hearing his would-be peers were getting death threats – targeting their children.

Both doctors felt COVID-19 pushed them beyond their comfort zones. “If COVID hadn’t happened, I would be working. ... Be ‘owned.’ In a weird way, COVID made me more independent and take a risk with my career.”

Obstetrician Kwandaa Roberts, MD, certainly did; she took a budding interest in decorating dollhouses straight to Instagram and national news fame, and she is now a TV-show expert on “Sell This House.”

Like Dr. Doshi and Dr. Mangiapane, Dr. Polak wants to be more in control of his future – even if selling T-shirts at a mall means a certain loss of status along the way.

“Aside from my passion to learn and to have that connection with people, I went into medicine ... because of the job security I thought existed,” he said. “I would say that my getting furloughed has changed my view of the United States in a dramatic way. I do not feel as confident in the U.S. economy and general way of life as I did a year ago. And I am taking a number of steps to put myself in a more fluid, adaptable position in case another crisis like this occurs or if the current state of things worsens.”

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

One of the biggest conundrums of the COVID-19 pandemic has been the simultaneous panic-hiring of medical professionals in hot spots and significant downsizing of staff across the country. From huge hospital systems to private practices, the stoppage of breast reductions and knee replacements, not to mention the drops in motor vehicle accidents and bar fights, have quieted operating rooms and emergency departments and put doctors’ jobs on the chopping block. A widely cited survey suggests that 21% of doctors have had a work reduction due to COVID-19.

For many American doctors, this is their first extended period of unemployment. Unlike engineers or those with MBAs who might see their fortunes rise and fall with the whims of recessions and boom times, physicians are not exactly accustomed to being laid off. However, doctors were already smarting for years due to falling salaries and decreased autonomy, punctuated by endless clicks on electronic medical records software.

Now, the twin shock of income loss and feeling unwanted in a pandemic – when, you know, medicine might seem especially essential – has doctors resorting to a bizarre array of side gigs, “fun-employment” activities, or outright career overhauls.

Stephanie Eschenbach Morgan, MD, a breast radiologist in North Carolina, trained for 10 years after college before earning a true physician’s salary.

“Being furloughed was awful. Initially, it was only going to be 2 weeks, and then it turned into 2 months with no pay,” she reflected.

Dr. Eschenbach Morgan and her surgeon husband, who lost a full quarter’s salary, had to ask for grace periods on their credit card and mortgage payments because they had paid a large tax bill right before the pandemic began. “We couldn’t get any stimulus help, so that added insult to injury,” she said.

With her time spent waiting in a holding pattern, Dr. Eschenbach Morgan homeschooled her two young children and started putting a home gym together. She went on a home organizing spree, started a garden, and, perhaps most impressively, caught up with 5 years of photo albums.

A bonus she noted: “I didn’t set an alarm for 2 months.”

Shella Farooki, MD, a radiologist in California, was also focused on homeschooling, itself a demanding job, and veered toward retirement. When one of her work contracts furloughed her (“at one point, I made $30K a month for [their business]”), she started saving money at home, teaching the kids, and applied for a Paycheck Protection Program loan. Her husband, a hospitalist, had had his shifts cut. Dr. Farooki tried a radiology artificial intelligence firm but backed out when she was asked to read 9,200 studies for them for $2,000 per month.

Now, she thinks about leaving medicine “every day.”

Some doctors are questioning whether they should be in medicine in the first place. Family medicine physician Jonathan Polak, MD, faced with his own pink slip, turned to pink T-shirts instead. His girlfriend manages an outlet of the teen fashion retailer Justice. Dr. Polak, who finished his residency just 2 years ago, didn’t hesitate to take a $10-an-hour gig as a stock doc, once even finding himself delivering a shelving unit from the shuttering store to a physician fleeing the city for rural New Hampshire to “escape.”

There’s no escape for him – yet. Saddled with “astronomical” student loans, he had considered grocery store work as well. Dr. Polak knows he can’t work part time or go into teaching long term, as he might like.

Even so, he’s doing everything he can to not be in patient care for the long haul – it’s just not what he thought it would be.

“The culture of medicine, bureaucracy, endless paperwork and charting, and threat of litigation sucks a lot of the joy out of it to the point that I don’t see myself doing it forever when imagining myself 5-10 years into it.”

Still, he recently took an 18-month hospital contract that will force him to move to Florida, but he’s also been turning himself into a veritable Renaissance man; composing music, training for an ultramarathon, studying the latest medical findings, roadtripping, and launching a podcast about dog grooming with a master groomer. “We found parallels between medicine and dog grooming,” he says, somewhat convincingly.

Also working the ruff life is Jen Tserng, MD, a former forensic pathologist who landed on news websites in recent years for becoming a professional dogwalker and housesitter without a permanent home. Dr. Tserng knows doctors were restless and unhappy before COVID-19, their thoughts wandering where the grass might be greener.

As her profile grew, she found her inbox gathering messages from disaffected medical minions: students with a fear of failing or staring down residency application season and employed doctors sick of the constant grind. As she recounted those de facto life coach conversations (“What do you really enjoy?” “Do you really like dogs?”) by phone from New York, she said matter-of-factly, “They don’t call because of COVID. They call because they hate their lives.”

Michelle Mudge-Riley, MD, a physician in Texas, has been seeing this shift for some time as well. She recently held a virtual version of her Physicians Helping Physicians conference, where doctors hear from their peers working successfully in fields like pharmaceuticals and real estate investing.

When COVID-19 hit, Dr. Mudge-Riley quickly pivoted to a virtual platform, where the MDs and DOs huddled in breakout rooms having honest chats about their fears and tentative hopes about their new careers.

“There has been increased interest in nonclinical exploration into full- and part-time careers, as well as side hustles, since COVID began,” she said. “Many physicians have had their hours or pay cut, and some have been laid off. Others are furloughed. Some just want out of an environment where they don’t feel safe.”

An ear, nose, and throat surgeon, Maansi Doshi, MD, from central California, didn’t feel safe – so she left. She had returned from India sick with a mystery virus right as the pandemic began (she said her COVID-19 tests were all negative) and was waiting to get well enough to go back to her private practice job. However, she said she clashed with Trump-supporting colleagues she feared might not be taking the pandemic seriously enough.

Finally getting over a relapse of her mystery virus, Dr. Doshi emailed her resignation in May. Her husband, family practice doctor Mark Mangiapane, MD, gave his job notice weeks later in solidarity because he worked in the same building. Together, they have embraced gardening, a Peloton splurge, and learning business skills to open private practices – solo primary care for him; ENT with a focus on her favorite surgery, rhinoplasty, for her.

Dr. Mangiapane had considered editing medical brochures and also tried to apply for a job as a county public health officer in rural California, but he received his own shock when he learned the county intended to open schools in the midst of the pandemic despite advisement to the contrary by the former health officer.

He retreated from job listings altogether after hearing his would-be peers were getting death threats – targeting their children.

Both doctors felt COVID-19 pushed them beyond their comfort zones. “If COVID hadn’t happened, I would be working. ... Be ‘owned.’ In a weird way, COVID made me more independent and take a risk with my career.”

Obstetrician Kwandaa Roberts, MD, certainly did; she took a budding interest in decorating dollhouses straight to Instagram and national news fame, and she is now a TV-show expert on “Sell This House.”

Like Dr. Doshi and Dr. Mangiapane, Dr. Polak wants to be more in control of his future – even if selling T-shirts at a mall means a certain loss of status along the way.

“Aside from my passion to learn and to have that connection with people, I went into medicine ... because of the job security I thought existed,” he said. “I would say that my getting furloughed has changed my view of the United States in a dramatic way. I do not feel as confident in the U.S. economy and general way of life as I did a year ago. And I am taking a number of steps to put myself in a more fluid, adaptable position in case another crisis like this occurs or if the current state of things worsens.”

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

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FDA supports robotic device as hysterectomy helper

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Mon, 03/15/2021 - 13:28

Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

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Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.

The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.

The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.

RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.

“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.

The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.

The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.

“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.

The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.

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Vagisil offered teens a vaginal ‘glow up.’ Docs cry foul

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Thu, 03/04/2021 - 14:25

Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

 

 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

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Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

 

 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

Late one night in early February, Jen Gunter, MD, was scrolling online when she discovered a new “feminine hygiene” product being marketed for teen girls. The new vanilla clementine scented wipes and cleansers with confetti-colored packaging and a cute name (OMV!) irked Dr. Gunter because they are designed for girls to use to “freshen” their vaginal area.

Dr. Gunter, a San Francisco-based gynecologist and author of “The Vagina Bible,” has built a reputation as a fierce advocate for women’s health and debunker of pseudoscience. She has called out jade eggs and “detox pearls” and various other items that promise to improve the vagina but that she and other doctors warn could actually be harmful. And, in her view, this product is no different.

She fired off a tweet that became the first volley in a vociferous social media countercampaign: “Hey @vagisil going to call you out here for this predatory line of products aimed at teen girls. Why do you think teen vulvas need special cleaning? To be prepped for men? Because they are dirty. Anxiously awaiting your answer as are all my followers.”

Vagisil responded on Instagram that “we want to clarify any confusion or the underlying belief that OMV! was developed because there is something wrong with teens or that vulvas/vaginas are inherently dirty. That is not the case. All-Day Fresh Wash is an all-over body wash, that is safe, gentle, and pH-balanced for sensitive vulvar area skin.”

Dr. Gunter’s Feb. 4 tweet attracted more than 8,300 likes, 1,300 retweets and hundreds of comments, but that was just the beginning. Dr. Gunter has continued to tweet about the OMV! product line – and has inspired dozens of other gynecologists to join in.
 

‘Your vagina is fine’

Dr. Gunter and other gynecologists have long delivered the message that water alone is sufficient to cleanse the vulvar area and that the vagina itself is self-cleaning. Research into the vaginal microbiome reveals the role of lactobacilli in preventing urogenital diseases. “Disturbances in your vagina microbiome are hard to undo,” says Jocelyn Fitzgerald, MD, a urogynecologist and pelvic reconstructive surgeon at Magee-Womens Hospital at the University of Pittsburgh Medical Center.

To underscore that message, Dr. Fitzgerald recently tweeted in support of Dr. Gunter’s Twitter thread: “Honestly, the @vagisil marketing campaign is a brilliant one because using their products while your vagina is perfectly fine will destroy your microbiome, give you real Bacterial Vaginosis, and prompt you to buy more Vagisil. DON’T FALL FOR IT GIRLS YOUR VAGINA IS FINE.”

In an emailed response to this news organization, a Vagisil spokesperson said, “We follow industry best practices for testing and OMV! products are rigorously assessed for safety and quality. In addition, we work with respected, independent clinical labs that follow strict testing protocols, using board-certified gynecologists and dermatologists to test our products before launch.”

However, beyond the potential for irritation or misuse, the gynecologists zeroed in on the underlying message that girls would feel more confident if they used the wipes and cleanser. For example, the company suggested that teens could use the wipes to get rid of “period funk.”

“There is no such thing as period funk!” gynecologist Danielle Jones, MD, exclaimed in a video on YouTube, where she has a channel called Mama Doctor Jones – with 700,000 subscribers. “All you need is ordinary hygiene. Period funk is not a thing! And if you feel like something is going on because there’s an odor that is abnormal, you need to talk to your doctor.”

Adult women often use wipes and special cleansers in the vaginal area. An online survey of 1,435 Canadian women, published in BMC Women’s Health in 2018, found 42% had used vaginal wipes, 12% had used vaginal washes or cleansers – and 4% had used them internally.

When it launched OMV! in July, Vagisil said it had engaged 2,500 teens and their mothers in creating the product, which it said was “designed to meet the cleansing and care needs of a new generation of young women.”

That extension of a product most commonly used by adult women to teenagers – who often feel self-conscious about their bodies – is exactly what bothers Dr. Gunter. “BTW I am sorry I am subjecting you all to my @vagisil outrage, but preying on teens and amplifying patriarchal shame of normal bodily functions to sell an irritating product is not acceptable. I’m not stopping until they take that OMV! product line down everywhere,” she said in a Feb. 8 tweet that attracted more than 7,900 likes.
 

 

 

No ‘glow up’ needed

Dr. Gunter’s tweets tapped into collective anger over the shaming of women’s bodies. The OMV! marketing suggested that teens could get a “glow up” with the products.

“Your vulva doesn’t need a ‘glow up.’ It’s fine like it is. And if it’s not, talk to your doctor,” Dr. Jones said in her Feb. 8 video, which has had almost 350,000 views, with 28,000 likes and only 149 dislikes.

“They’re very clearly pathologizing normal physiology,” Dr. Jones says. “They’re creating language that makes people feel as though their normal bodily functions have to be somehow fixed or changed.”

Dr. Gunter says she specifically wanted to prevent Vagisil from leveraging social media to influence teen girls. With her stream of tweets and support from colleagues around the country, she has sparked a prolonged online conversation.

“I am encouraged by the strong response on social media from both other enraged ob.gyns. and health care professionals as well the response from a lot of women and men,” Dr. Gunter said in an interview. “We have effectively blocked [Vagisil] from using social media.”

In its response to this news organization, Vagisil noted, “We are a brand run by women with daughters of our own.” While defending the products, Vagisil acknowledged the criticisms: “We are always listening to our consumers and our expert partners so that we continuously evolve. We appreciate the perspective that our language choice surrounding periods may perpetuate an old idea and have already begun to make changes to address this.”

Dr. Gunter says she plans to stay on topic. “Given the number of people outraged, I suspect if they venture out on social media again the reaction will be swift,” she said. “Hopefully we have made OMV! toxic for influencers as well.”

In fact, she’s ready to take on “the entire predatory feminine hygiene market. I’m sick of their false claims about balancing pH and not-so-subtle suggestions that vaginas and vulvas and menstruation stink. These products cause psychological harm as well as physical harm from their irritants,” she said.

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

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Rural women receive antibiotics for longer than necessary for UTIs

Article Type
Changed
Thu, 03/04/2021 - 18:27

 

Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

 

 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.

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Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

 

 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.

 

Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

 

 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.

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Ovarian cancer prevention: How patients decide on surgery

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Changed
Thu, 03/04/2021 - 12:14

Patients consider the risk of cancer and menopause, as well as other factors, when making decisions about ovarian cancer prevention surgery, according to a small study.

Investigators interviewed 24 premenopausal women with BRCA mutations who were considering prophylactic surgery. Responses showed that women who prioritized cancer risk reduction opted for risk-reducing salpingo-oophorectomy (RRSO), while those who were more concerned about the effects of surgical menopause opted for risk-reducing early salpingectomy with delayed oophorectomy (RRESDO). Factors such as past surgical experience influenced patients’ decisions as well.

The women were participants in the PROTECTOR trial, which was designed to determine the impact of RRESDO on sexual function by comparing RRESDO, RRSO, and no surgery. Study participants made their own decisions regarding surgery, and the interviews with 24 participants provided insight into how patients made their decisions.

Faiza Gaba, MBBS, PhD, of Queen Mary University of London, and colleagues reviewed the results in the Journal of Medical Genetics.

“I think what is most important is that even though this is a tough decision women are being given, they are being given options that allow them to make up their own minds with support from health care providers,” said Barbara A. Goff, MD, of the University of Washington, Seattle, when asked to comment on this research.
 

Study details and results

The investigators interviewed 24 women aged 34-46 years. Fourteen patients were BRCA1 carriers, and 10 were BRCA2 carriers. Twenty-two women were White, and two were Asian. Nineteen women were married, and four were nulliparous.

The interviews lasted a mean of 55 minutes and were conducted with a predeveloped topic guide.

Eleven of the women interviewed opted for RRESDO, seven opted for RRSO, and six decided against prophylactic surgery. Four women who had previous breast cancer all opted for ovarian cancer prevention surgery.

Among the 18 women who chose surgery, 16 had completed childbearing, and 2 didn’t want children. Among the six women who decided against surgery, four had not completed childbearing, one was unsure of which procedure to choose, and the sixth had strong feelings against removing healthy tissue.

The 11 women who chose RRESDO did so because of concerns about early menopause following oophorectomy, particularly low mood, sexual dysfunction, and poorer quality of life. They were also more likely to have had a previous positive surgical experience, so they were not as concerned about a two-step surgery.

Women who chose RRSO were motivated by a strong family history of ovarian cancer, fear of dying, concurrent benign gynecological issues, lack of screening for ovarian cancer, and physician advice.

Nine women also opted for risk-reducing mastectomy (RRM), which was deemed a more difficult decision than prophylactic ovarian cancer surgery.

Women who decided against RRM did so because they hadn’t completed childbearing, they were concerned about recovery time and the psychological effects of the surgery, or they had confidence in breast cancer screening and treatment.

Among women who chose RRM, two highlighted lack of health care professional support for deciding against reconstruction. One interviewee regretted opting for flap reconstruction due to the resultant cosmetic appearance and chronic pain but did not regret RRM.

Fifteen women said they would have preferred combined RRM and ovarian cancer prevention in one surgery, due to less anxiety, less waiting, fewer appointments, less time off work, and a single surgical recovery.

The women advised fellow BRCA carriers to avoid time pressure with surgical decision-making, talk to other BRCA carriers, do personal research, and ask for second opinions if not satisfied. They also said the opportunity to ask experts questions and meet other BRCA carriers face-to-face was more helpful than online support groups. Women managed in specialist settings said they received better care, better access to hormone replacement therapy, and were more satisfied.

High-risk women need to be supported by a multidisciplinary team of geneticists, gynecologists/oncologists, oncoplastic surgeons, menopause specialists, fertility specialists, psychologists, and specialist nurses, the investigators wrote.

This study was funded by the Rosetrees Trust and Barts Charity. The authors disclosed relationships with AstraZeneca, Merck, Cancer Research UK, The Eve Appeal, Israel National Institute for Health Policy Research, and the UK National Health Service. Dr. Goff has no relevant disclosures.

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Patients consider the risk of cancer and menopause, as well as other factors, when making decisions about ovarian cancer prevention surgery, according to a small study.

Investigators interviewed 24 premenopausal women with BRCA mutations who were considering prophylactic surgery. Responses showed that women who prioritized cancer risk reduction opted for risk-reducing salpingo-oophorectomy (RRSO), while those who were more concerned about the effects of surgical menopause opted for risk-reducing early salpingectomy with delayed oophorectomy (RRESDO). Factors such as past surgical experience influenced patients’ decisions as well.

The women were participants in the PROTECTOR trial, which was designed to determine the impact of RRESDO on sexual function by comparing RRESDO, RRSO, and no surgery. Study participants made their own decisions regarding surgery, and the interviews with 24 participants provided insight into how patients made their decisions.

Faiza Gaba, MBBS, PhD, of Queen Mary University of London, and colleagues reviewed the results in the Journal of Medical Genetics.

“I think what is most important is that even though this is a tough decision women are being given, they are being given options that allow them to make up their own minds with support from health care providers,” said Barbara A. Goff, MD, of the University of Washington, Seattle, when asked to comment on this research.
 

Study details and results

The investigators interviewed 24 women aged 34-46 years. Fourteen patients were BRCA1 carriers, and 10 were BRCA2 carriers. Twenty-two women were White, and two were Asian. Nineteen women were married, and four were nulliparous.

The interviews lasted a mean of 55 minutes and were conducted with a predeveloped topic guide.

Eleven of the women interviewed opted for RRESDO, seven opted for RRSO, and six decided against prophylactic surgery. Four women who had previous breast cancer all opted for ovarian cancer prevention surgery.

Among the 18 women who chose surgery, 16 had completed childbearing, and 2 didn’t want children. Among the six women who decided against surgery, four had not completed childbearing, one was unsure of which procedure to choose, and the sixth had strong feelings against removing healthy tissue.

The 11 women who chose RRESDO did so because of concerns about early menopause following oophorectomy, particularly low mood, sexual dysfunction, and poorer quality of life. They were also more likely to have had a previous positive surgical experience, so they were not as concerned about a two-step surgery.

Women who chose RRSO were motivated by a strong family history of ovarian cancer, fear of dying, concurrent benign gynecological issues, lack of screening for ovarian cancer, and physician advice.

Nine women also opted for risk-reducing mastectomy (RRM), which was deemed a more difficult decision than prophylactic ovarian cancer surgery.

Women who decided against RRM did so because they hadn’t completed childbearing, they were concerned about recovery time and the psychological effects of the surgery, or they had confidence in breast cancer screening and treatment.

Among women who chose RRM, two highlighted lack of health care professional support for deciding against reconstruction. One interviewee regretted opting for flap reconstruction due to the resultant cosmetic appearance and chronic pain but did not regret RRM.

Fifteen women said they would have preferred combined RRM and ovarian cancer prevention in one surgery, due to less anxiety, less waiting, fewer appointments, less time off work, and a single surgical recovery.

The women advised fellow BRCA carriers to avoid time pressure with surgical decision-making, talk to other BRCA carriers, do personal research, and ask for second opinions if not satisfied. They also said the opportunity to ask experts questions and meet other BRCA carriers face-to-face was more helpful than online support groups. Women managed in specialist settings said they received better care, better access to hormone replacement therapy, and were more satisfied.

High-risk women need to be supported by a multidisciplinary team of geneticists, gynecologists/oncologists, oncoplastic surgeons, menopause specialists, fertility specialists, psychologists, and specialist nurses, the investigators wrote.

This study was funded by the Rosetrees Trust and Barts Charity. The authors disclosed relationships with AstraZeneca, Merck, Cancer Research UK, The Eve Appeal, Israel National Institute for Health Policy Research, and the UK National Health Service. Dr. Goff has no relevant disclosures.

Patients consider the risk of cancer and menopause, as well as other factors, when making decisions about ovarian cancer prevention surgery, according to a small study.

Investigators interviewed 24 premenopausal women with BRCA mutations who were considering prophylactic surgery. Responses showed that women who prioritized cancer risk reduction opted for risk-reducing salpingo-oophorectomy (RRSO), while those who were more concerned about the effects of surgical menopause opted for risk-reducing early salpingectomy with delayed oophorectomy (RRESDO). Factors such as past surgical experience influenced patients’ decisions as well.

The women were participants in the PROTECTOR trial, which was designed to determine the impact of RRESDO on sexual function by comparing RRESDO, RRSO, and no surgery. Study participants made their own decisions regarding surgery, and the interviews with 24 participants provided insight into how patients made their decisions.

Faiza Gaba, MBBS, PhD, of Queen Mary University of London, and colleagues reviewed the results in the Journal of Medical Genetics.

“I think what is most important is that even though this is a tough decision women are being given, they are being given options that allow them to make up their own minds with support from health care providers,” said Barbara A. Goff, MD, of the University of Washington, Seattle, when asked to comment on this research.
 

Study details and results

The investigators interviewed 24 women aged 34-46 years. Fourteen patients were BRCA1 carriers, and 10 were BRCA2 carriers. Twenty-two women were White, and two were Asian. Nineteen women were married, and four were nulliparous.

The interviews lasted a mean of 55 minutes and were conducted with a predeveloped topic guide.

Eleven of the women interviewed opted for RRESDO, seven opted for RRSO, and six decided against prophylactic surgery. Four women who had previous breast cancer all opted for ovarian cancer prevention surgery.

Among the 18 women who chose surgery, 16 had completed childbearing, and 2 didn’t want children. Among the six women who decided against surgery, four had not completed childbearing, one was unsure of which procedure to choose, and the sixth had strong feelings against removing healthy tissue.

The 11 women who chose RRESDO did so because of concerns about early menopause following oophorectomy, particularly low mood, sexual dysfunction, and poorer quality of life. They were also more likely to have had a previous positive surgical experience, so they were not as concerned about a two-step surgery.

Women who chose RRSO were motivated by a strong family history of ovarian cancer, fear of dying, concurrent benign gynecological issues, lack of screening for ovarian cancer, and physician advice.

Nine women also opted for risk-reducing mastectomy (RRM), which was deemed a more difficult decision than prophylactic ovarian cancer surgery.

Women who decided against RRM did so because they hadn’t completed childbearing, they were concerned about recovery time and the psychological effects of the surgery, or they had confidence in breast cancer screening and treatment.

Among women who chose RRM, two highlighted lack of health care professional support for deciding against reconstruction. One interviewee regretted opting for flap reconstruction due to the resultant cosmetic appearance and chronic pain but did not regret RRM.

Fifteen women said they would have preferred combined RRM and ovarian cancer prevention in one surgery, due to less anxiety, less waiting, fewer appointments, less time off work, and a single surgical recovery.

The women advised fellow BRCA carriers to avoid time pressure with surgical decision-making, talk to other BRCA carriers, do personal research, and ask for second opinions if not satisfied. They also said the opportunity to ask experts questions and meet other BRCA carriers face-to-face was more helpful than online support groups. Women managed in specialist settings said they received better care, better access to hormone replacement therapy, and were more satisfied.

High-risk women need to be supported by a multidisciplinary team of geneticists, gynecologists/oncologists, oncoplastic surgeons, menopause specialists, fertility specialists, psychologists, and specialist nurses, the investigators wrote.

This study was funded by the Rosetrees Trust and Barts Charity. The authors disclosed relationships with AstraZeneca, Merck, Cancer Research UK, The Eve Appeal, Israel National Institute for Health Policy Research, and the UK National Health Service. Dr. Goff has no relevant disclosures.

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Maternal chronic conditions predict cerebral palsy in offspring

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Wed, 03/03/2021 - 12:43

Several maternal chronic conditions increase the risk of giving birth to a child with cerebral palsy, based on data from more than 1.3 million Norwegian children.

Dr. Alastair MacLennan

Mothers with autoimmune disorders, such as diabetes and lupus, had the greatest risks, reported lead author Marianne S. Strøm, MD, of the University of Bergen (Norway) and colleagues.

“The etiologies of cerebral palsy are complex, and only a few prenatal risk factors have been identified,” the investigators wrote in Pediatrics. “Among these possible risk factors are maternal chronic conditions, although studies are typically underpowered and limited to one or two conditions.”

According to Dr. Strøm and colleagues, several components of maternal chronic conditions have been linked with cerebral palsy, including placental abnormalities, altered thrombotic state, and inflammation. Furthermore, mothers with chronic conditions are more likely to give birth prematurely and have children with congenital malformations, both of which have also been associated with cerebral palsy.

To date, however, “there has been no systematic description of maternal chronic conditions and risk of cerebral palsy in offspring,” the investigators noted.

The present, prospective cohort study aimed to meet this need with a population of 1,360,149 children born in Norway from 1990 to 2012, among whom 3,575 had cerebral palsy. Case data were extracted from the Norwegian Patient Registry and the National Insurance Scheme. Information about maternal chronic conditions was extracted from the Medical Birth Registry of Norway and the Norwegian Patient Registry, with the latter also providing information about paternal chronic conditions.

Using log binomial regression models, the investigators determined relative risks of having children with cerebral palsy among parents with chronic conditions versus parents from the general population. This revealed that chronic conditions in fathers had no correlation with cerebral palsy. In contrast, mothers with chronic conditions had a 30% increased risk (relative risk, 1.3; 95% confidence interval, 1.2-1.5), which could be further stratified by number of chronic conditions; mothers with one chronic condition, for instance, had a 20% increased risk (RR, 1.2; 95% CI, 1.1-1.4), while those with two chronic conditions had a 60% increased risk (RR, 1.6; 95% CI, 1.1-2.2), and those with more than two chronic conditions had triple the risk (RR, 3.1; 95% CI, 1.4-6.8)

“The lack of associations between the father’s chronic illness and cerebral palsy risk supports the interpretation that cerebral palsy risk in offspring is the direct result of the mother’s condition and not genetic predisposition or unmeasured situational factors,” the investigators wrote.

Maternal autoimmune conditions were particularly relevant, as they were associated with a 40% increased risk of cerebral palsy (RR, 1.4; 95% CI, 1.1-1.7), a rate that climbed dramatically, to 270%, among mothers with more than one autoimmune condition (RR, 2.7; 95% CI, 1.1-6.6).

“The role of autoimmune diseases in cerebral palsy risk (and maternal inflammation specifically) deserves closer attention,” the investigators wrote. “Using studies with larger sample sizes and a more clinical focus, including measures of placental structure and perinatal blood assays, researchers may be able to explore these possible connections between maternal autoimmune diseases and fetal neurodevelopment.”

Specifically, cerebral palsy in offspring was most strongly associated with maternal Crohn’s disease (RR, 2.1; 95% CI, 1.0-4.1), type 1 diabetes (RR, 2.2; 95% CI, 1.4-3.4), lupus erythematosus (RR, 2.7; 95% CI, 0.9-8.3), and type 2 diabetes (RR, 3.2; 95% CI, 1.8-5.4). Associations were also found for migraine (RR, 1.6; 95% CI, 1.2-2.2), multiple sclerosis (RR, 1.8; 95% CI, 0.8-4.4), and rheumatoid arthritis (RR, 2.0; 95% CI, 1.3-2.9). Several “weaker and less convincing associations” were detected for ulcerative colitis, thyroid disorder, epilepsy, asthma, anemia, and hypertension. Adjusting for parental education level, age, smoking status, and single-mother status did not significantly alter findings. Poisson and logistic regression models generated similar results.

In an accompanying editorial, Sandra Julsen Hollung, PhD, of the Cerebral Palsy Registry of Norway, Vestfold Hospital Trust, Tønsberg, and colleagues, advised that clinicians maintain perspective when discussing these findings with the general public.

“As the authors state, the absolute risk of cerebral palsy associated with at least one chronic maternal condition is low,” wrote Dr. Hollung and colleagues. “Among 1,000 pregnant women with any chronic and/or autoimmune disorder, more than 990 will deliver an infant who will not be diagnosed with cerebral palsy.”

They went on to emphasize that the study findings should not be viewed as firm evidence of causal relationships.

“Thus, the study cannot give clues to any specific preventive treatment,” wrote Dr. Hollung and colleagues. “However, if these disorders are part of a causal pathway, optimal treatment might reduce the risk of cerebral palsy.”

Although Dr. Hollung and colleagues advised that such efforts “would hardly affect the birth prevalence of cerebral palsy,” they also cited the Royal College of Obstetricians and Gynaecologists in the United Kingdom, noting that “each baby counts.”

Emeritus Professor Alastair MacLennan, AO, MB ChB, FRCOG, FRANZCOG, head of the Australian Collaborative Cerebral Palsy Research Group at the University of Adelaide (Australia) suggested that the findings may guide future research.

“An increasing proportion of cerebral palsy cases are being diagnosed by genome sequencing and other genetic techniques to have causative genetic variations,” Dr. MacLennan said. “The possibility of epigenetic interactions are also likely and are still to be investigated. Maternal disorders such as diabetes, lupus, or Crohn’s disease are possible epigenetic factors and this study helps to target these in future genetic and environmental studies of cerebral palsy causation. The days of attributing cerebral palsy to ‘birth asphyxia’ are over.”

The study was supported by the National Institutes of Health and the Western Norwegian Regional Health Authorities. The investigators reported no conflicts of interest.

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Several maternal chronic conditions increase the risk of giving birth to a child with cerebral palsy, based on data from more than 1.3 million Norwegian children.

Dr. Alastair MacLennan

Mothers with autoimmune disorders, such as diabetes and lupus, had the greatest risks, reported lead author Marianne S. Strøm, MD, of the University of Bergen (Norway) and colleagues.

“The etiologies of cerebral palsy are complex, and only a few prenatal risk factors have been identified,” the investigators wrote in Pediatrics. “Among these possible risk factors are maternal chronic conditions, although studies are typically underpowered and limited to one or two conditions.”

According to Dr. Strøm and colleagues, several components of maternal chronic conditions have been linked with cerebral palsy, including placental abnormalities, altered thrombotic state, and inflammation. Furthermore, mothers with chronic conditions are more likely to give birth prematurely and have children with congenital malformations, both of which have also been associated with cerebral palsy.

To date, however, “there has been no systematic description of maternal chronic conditions and risk of cerebral palsy in offspring,” the investigators noted.

The present, prospective cohort study aimed to meet this need with a population of 1,360,149 children born in Norway from 1990 to 2012, among whom 3,575 had cerebral palsy. Case data were extracted from the Norwegian Patient Registry and the National Insurance Scheme. Information about maternal chronic conditions was extracted from the Medical Birth Registry of Norway and the Norwegian Patient Registry, with the latter also providing information about paternal chronic conditions.

Using log binomial regression models, the investigators determined relative risks of having children with cerebral palsy among parents with chronic conditions versus parents from the general population. This revealed that chronic conditions in fathers had no correlation with cerebral palsy. In contrast, mothers with chronic conditions had a 30% increased risk (relative risk, 1.3; 95% confidence interval, 1.2-1.5), which could be further stratified by number of chronic conditions; mothers with one chronic condition, for instance, had a 20% increased risk (RR, 1.2; 95% CI, 1.1-1.4), while those with two chronic conditions had a 60% increased risk (RR, 1.6; 95% CI, 1.1-2.2), and those with more than two chronic conditions had triple the risk (RR, 3.1; 95% CI, 1.4-6.8)

“The lack of associations between the father’s chronic illness and cerebral palsy risk supports the interpretation that cerebral palsy risk in offspring is the direct result of the mother’s condition and not genetic predisposition or unmeasured situational factors,” the investigators wrote.

Maternal autoimmune conditions were particularly relevant, as they were associated with a 40% increased risk of cerebral palsy (RR, 1.4; 95% CI, 1.1-1.7), a rate that climbed dramatically, to 270%, among mothers with more than one autoimmune condition (RR, 2.7; 95% CI, 1.1-6.6).

“The role of autoimmune diseases in cerebral palsy risk (and maternal inflammation specifically) deserves closer attention,” the investigators wrote. “Using studies with larger sample sizes and a more clinical focus, including measures of placental structure and perinatal blood assays, researchers may be able to explore these possible connections between maternal autoimmune diseases and fetal neurodevelopment.”

Specifically, cerebral palsy in offspring was most strongly associated with maternal Crohn’s disease (RR, 2.1; 95% CI, 1.0-4.1), type 1 diabetes (RR, 2.2; 95% CI, 1.4-3.4), lupus erythematosus (RR, 2.7; 95% CI, 0.9-8.3), and type 2 diabetes (RR, 3.2; 95% CI, 1.8-5.4). Associations were also found for migraine (RR, 1.6; 95% CI, 1.2-2.2), multiple sclerosis (RR, 1.8; 95% CI, 0.8-4.4), and rheumatoid arthritis (RR, 2.0; 95% CI, 1.3-2.9). Several “weaker and less convincing associations” were detected for ulcerative colitis, thyroid disorder, epilepsy, asthma, anemia, and hypertension. Adjusting for parental education level, age, smoking status, and single-mother status did not significantly alter findings. Poisson and logistic regression models generated similar results.

In an accompanying editorial, Sandra Julsen Hollung, PhD, of the Cerebral Palsy Registry of Norway, Vestfold Hospital Trust, Tønsberg, and colleagues, advised that clinicians maintain perspective when discussing these findings with the general public.

“As the authors state, the absolute risk of cerebral palsy associated with at least one chronic maternal condition is low,” wrote Dr. Hollung and colleagues. “Among 1,000 pregnant women with any chronic and/or autoimmune disorder, more than 990 will deliver an infant who will not be diagnosed with cerebral palsy.”

They went on to emphasize that the study findings should not be viewed as firm evidence of causal relationships.

“Thus, the study cannot give clues to any specific preventive treatment,” wrote Dr. Hollung and colleagues. “However, if these disorders are part of a causal pathway, optimal treatment might reduce the risk of cerebral palsy.”

Although Dr. Hollung and colleagues advised that such efforts “would hardly affect the birth prevalence of cerebral palsy,” they also cited the Royal College of Obstetricians and Gynaecologists in the United Kingdom, noting that “each baby counts.”

Emeritus Professor Alastair MacLennan, AO, MB ChB, FRCOG, FRANZCOG, head of the Australian Collaborative Cerebral Palsy Research Group at the University of Adelaide (Australia) suggested that the findings may guide future research.

“An increasing proportion of cerebral palsy cases are being diagnosed by genome sequencing and other genetic techniques to have causative genetic variations,” Dr. MacLennan said. “The possibility of epigenetic interactions are also likely and are still to be investigated. Maternal disorders such as diabetes, lupus, or Crohn’s disease are possible epigenetic factors and this study helps to target these in future genetic and environmental studies of cerebral palsy causation. The days of attributing cerebral palsy to ‘birth asphyxia’ are over.”

The study was supported by the National Institutes of Health and the Western Norwegian Regional Health Authorities. The investigators reported no conflicts of interest.

Several maternal chronic conditions increase the risk of giving birth to a child with cerebral palsy, based on data from more than 1.3 million Norwegian children.

Dr. Alastair MacLennan

Mothers with autoimmune disorders, such as diabetes and lupus, had the greatest risks, reported lead author Marianne S. Strøm, MD, of the University of Bergen (Norway) and colleagues.

“The etiologies of cerebral palsy are complex, and only a few prenatal risk factors have been identified,” the investigators wrote in Pediatrics. “Among these possible risk factors are maternal chronic conditions, although studies are typically underpowered and limited to one or two conditions.”

According to Dr. Strøm and colleagues, several components of maternal chronic conditions have been linked with cerebral palsy, including placental abnormalities, altered thrombotic state, and inflammation. Furthermore, mothers with chronic conditions are more likely to give birth prematurely and have children with congenital malformations, both of which have also been associated with cerebral palsy.

To date, however, “there has been no systematic description of maternal chronic conditions and risk of cerebral palsy in offspring,” the investigators noted.

The present, prospective cohort study aimed to meet this need with a population of 1,360,149 children born in Norway from 1990 to 2012, among whom 3,575 had cerebral palsy. Case data were extracted from the Norwegian Patient Registry and the National Insurance Scheme. Information about maternal chronic conditions was extracted from the Medical Birth Registry of Norway and the Norwegian Patient Registry, with the latter also providing information about paternal chronic conditions.

Using log binomial regression models, the investigators determined relative risks of having children with cerebral palsy among parents with chronic conditions versus parents from the general population. This revealed that chronic conditions in fathers had no correlation with cerebral palsy. In contrast, mothers with chronic conditions had a 30% increased risk (relative risk, 1.3; 95% confidence interval, 1.2-1.5), which could be further stratified by number of chronic conditions; mothers with one chronic condition, for instance, had a 20% increased risk (RR, 1.2; 95% CI, 1.1-1.4), while those with two chronic conditions had a 60% increased risk (RR, 1.6; 95% CI, 1.1-2.2), and those with more than two chronic conditions had triple the risk (RR, 3.1; 95% CI, 1.4-6.8)

“The lack of associations between the father’s chronic illness and cerebral palsy risk supports the interpretation that cerebral palsy risk in offspring is the direct result of the mother’s condition and not genetic predisposition or unmeasured situational factors,” the investigators wrote.

Maternal autoimmune conditions were particularly relevant, as they were associated with a 40% increased risk of cerebral palsy (RR, 1.4; 95% CI, 1.1-1.7), a rate that climbed dramatically, to 270%, among mothers with more than one autoimmune condition (RR, 2.7; 95% CI, 1.1-6.6).

“The role of autoimmune diseases in cerebral palsy risk (and maternal inflammation specifically) deserves closer attention,” the investigators wrote. “Using studies with larger sample sizes and a more clinical focus, including measures of placental structure and perinatal blood assays, researchers may be able to explore these possible connections between maternal autoimmune diseases and fetal neurodevelopment.”

Specifically, cerebral palsy in offspring was most strongly associated with maternal Crohn’s disease (RR, 2.1; 95% CI, 1.0-4.1), type 1 diabetes (RR, 2.2; 95% CI, 1.4-3.4), lupus erythematosus (RR, 2.7; 95% CI, 0.9-8.3), and type 2 diabetes (RR, 3.2; 95% CI, 1.8-5.4). Associations were also found for migraine (RR, 1.6; 95% CI, 1.2-2.2), multiple sclerosis (RR, 1.8; 95% CI, 0.8-4.4), and rheumatoid arthritis (RR, 2.0; 95% CI, 1.3-2.9). Several “weaker and less convincing associations” were detected for ulcerative colitis, thyroid disorder, epilepsy, asthma, anemia, and hypertension. Adjusting for parental education level, age, smoking status, and single-mother status did not significantly alter findings. Poisson and logistic regression models generated similar results.

In an accompanying editorial, Sandra Julsen Hollung, PhD, of the Cerebral Palsy Registry of Norway, Vestfold Hospital Trust, Tønsberg, and colleagues, advised that clinicians maintain perspective when discussing these findings with the general public.

“As the authors state, the absolute risk of cerebral palsy associated with at least one chronic maternal condition is low,” wrote Dr. Hollung and colleagues. “Among 1,000 pregnant women with any chronic and/or autoimmune disorder, more than 990 will deliver an infant who will not be diagnosed with cerebral palsy.”

They went on to emphasize that the study findings should not be viewed as firm evidence of causal relationships.

“Thus, the study cannot give clues to any specific preventive treatment,” wrote Dr. Hollung and colleagues. “However, if these disorders are part of a causal pathway, optimal treatment might reduce the risk of cerebral palsy.”

Although Dr. Hollung and colleagues advised that such efforts “would hardly affect the birth prevalence of cerebral palsy,” they also cited the Royal College of Obstetricians and Gynaecologists in the United Kingdom, noting that “each baby counts.”

Emeritus Professor Alastair MacLennan, AO, MB ChB, FRCOG, FRANZCOG, head of the Australian Collaborative Cerebral Palsy Research Group at the University of Adelaide (Australia) suggested that the findings may guide future research.

“An increasing proportion of cerebral palsy cases are being diagnosed by genome sequencing and other genetic techniques to have causative genetic variations,” Dr. MacLennan said. “The possibility of epigenetic interactions are also likely and are still to be investigated. Maternal disorders such as diabetes, lupus, or Crohn’s disease are possible epigenetic factors and this study helps to target these in future genetic and environmental studies of cerebral palsy causation. The days of attributing cerebral palsy to ‘birth asphyxia’ are over.”

The study was supported by the National Institutes of Health and the Western Norwegian Regional Health Authorities. The investigators reported no conflicts of interest.

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Study clarifies who gets post–COVID-19 interstitial lung disease

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Changed
Thu, 08/26/2021 - 15:50

 

A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.

In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.

Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.

Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.

The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.

“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.

Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”

The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.

The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.

The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.

Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.

The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.

The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”

The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.

The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”

Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.

Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.

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A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.

In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.

Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.

Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.

The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.

“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.

Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”

The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.

The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.

The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.

Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.

The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.

The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”

The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.

The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”

Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.

Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.

 

A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.

In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.

Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.

Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.

The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.

“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.

Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”

The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.

The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.

The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.

Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.

The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.

The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”

The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.

The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”

Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.

Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.

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‘I think I’m transgender’: A clinician’s guide to next steps

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Tue, 03/02/2021 - 15:20

A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

 

 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxietysuicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

 

 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

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A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

 

 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxietysuicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

 

 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

 

 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxietysuicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

 

 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

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Armpit swelling after COVID-19 vaccine may mimic breast cancer

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Thu, 12/15/2022 - 17:30

 

Axillary adenopathy, or swelling under the armpit, has been reported by women after receiving the Pfizer-BioNTech and Moderna COVID-19 vaccines, but it is also a common symptom of breast cancer.

Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.

“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.

“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.

In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”

They hope they will decrease unnecessary biopsies and help reassure patients.

Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.

“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.

“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”

Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.

“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
 

New recommendations from SBI

The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.

“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.

“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.

In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.

“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”

If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
 

 

 

Differences between the vaccines?

The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.

For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.

For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.

The average duration of adenopathy was approximately 10 days.

Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.

However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.

In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.

In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.

The authors and Dr. Leung have disclosed no relevant financial relationships.

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

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Axillary adenopathy, or swelling under the armpit, has been reported by women after receiving the Pfizer-BioNTech and Moderna COVID-19 vaccines, but it is also a common symptom of breast cancer.

Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.

“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.

“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.

In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”

They hope they will decrease unnecessary biopsies and help reassure patients.

Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.

“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.

“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”

Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.

“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
 

New recommendations from SBI

The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.

“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.

“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.

In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.

“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”

If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
 

 

 

Differences between the vaccines?

The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.

For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.

For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.

The average duration of adenopathy was approximately 10 days.

Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.

However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.

In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.

In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.

The authors and Dr. Leung have disclosed no relevant financial relationships.

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

 

Axillary adenopathy, or swelling under the armpit, has been reported by women after receiving the Pfizer-BioNTech and Moderna COVID-19 vaccines, but it is also a common symptom of breast cancer.

Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.

“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.

“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.

In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”

They hope they will decrease unnecessary biopsies and help reassure patients.

Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.

“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.

“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”

Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.

“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
 

New recommendations from SBI

The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.

“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.

“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.

In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.

“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”

If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
 

 

 

Differences between the vaccines?

The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.

For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.

For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.

The average duration of adenopathy was approximately 10 days.

Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.

However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.

In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.

In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.

The authors and Dr. Leung have disclosed no relevant financial relationships.

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

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Fired for good judgment a sign of physicians’ lost respect

Article Type
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Thu, 08/26/2021 - 15:50

What happened to Hasan Gokal, MD, should stick painfully in the craws of all physicians. It should serve as a call to action, because Dr. Gokal is sitting at home today without a job and under threat of further legal action while we continue about our day.

Dr. Melissa Walton-Shirley
 

Dr. Gokal’s “crime” is that he vaccinated 10 strangers and acquaintances with soon-to-expire doses of the Moderna COVID-19 vaccine. He drove to the homes of some in the dark of night and injected others on his Sugar Land, Texas, lawn. He spent hours in a frantic search for willing recipients to beat the expiration clock. With minutes to spare, he gave the last dose to his at-risk wife, who has symptomatic pulmonary sarcoidosis, but whose age meant she did not fall into a vaccine priority tier.

According to the New York Times, Dr. Gokal’s wife was hesitant, afraid he might get into trouble. But why would she be hesitant? He wasn’t doing anything immoral. Perhaps she knew how far physicians have fallen and how bitterly they both could suffer.

In Barren County, Ky., where I live, a state of emergency was declared by our judge executive because of inclement weather. This directive allows our emergency management to “waive procedures and formalities otherwise required by the law.” It’s too bad that the same courtesy was not afforded to Dr. Gokal in Texas. It’s a shame that ice and snow didn’t drive his actions. Perhaps that would have protected him against the harsh criticism. Rather, it was his oath to patients and dedication to his fellow humans that motivated him, and for that, he was made to suffer.

Dr. Gokal was right to think that pouring the last 10 vaccine doses down the toilet would be an egregious act. But he was wrong in thinking his decision to find takers for the vaccine would be viewed as expedient. Instead, he was accused of graft and even nepotism. And there is the rub. That he was fired and charged with the theft of $137 worth of vaccines says everything about how physicians are treated in the year 2021. Dr. Gokal’s lawyer says the charge carried a maximum penalty of 1 year in prison and a fine of nearly $4,000.

Thank God a sage judge threw out the case and “rebuked” the office of District Attorney Kim Ogg. That hasn’t stopped her from threatening to bring the case to a grand jury. That threat invites anyone faced with the same scenario to flush the extra vaccine doses into the septic system. It encourages us to choose the toilet handle to avoid a mug shot.

And we can’t ignore the racial slant to this story. The Times reported that Dr. Gokal asked the officials, “Are you suggesting that there were too many Indian names in this group?”

“Exactly” was the answer. Let that sink in.

None of this would have happened 20 years ago. Back then, no one would have questioned the wisdom a physician gains from all our years of training and residency. In an age when anyone who conducts an office visit is now called “doctor,” respect for the letters “MD” has been leveled. We physicians have lost our autonomy and been cowed into submission.

But whatever his profession, Hasan Gokal was fired for being a good human. Today, the sun rose on 10 individuals who now enjoy better protection against a deadly pandemic. They include a bed-bound nonagenarian. A woman in her 80s with dementia. A mother with a child who uses a ventilator. All now have antibodies against SARS-CoV2 because of the tireless actions of Dr. Gokal.

Yet Dr. Gokal’s future is uncertain. Will we help him, or will we leave him to the wolves? In an email exchange with his lawyer’s office, I learned that Dr. Gokal has received offers of employment but is unable to entertain them because the actions by the Harris County District Attorney triggered an automatic review by the Texas Medical Board. A GoFundMe page was launched, but an appreciative Dr. Gokal stated publicly that he’d rather the money go to a needy charity.

 In the last paragraph of the Times article, Dr. Gokal asks, “How can I take it back?” referencing stories about “the Pakistani doctor in Houston who stole all those vaccines.”

Let’s help him take back his story. In helping him, perhaps we can take back a little control. We could start with letters of support that could be mailed to his lawyer, Paul Doyle, Esq., of Houston, or tweet, respectfully of course, to the district attorney @Kimoggforda.

We can also let the Harris County Public Health Department in Houston know what we think of their actions.

On Martin Luther King Day, Kim Ogg, the district attorney who charged Dr. Gokal, tweeted MLK’s famous quote: “Injustice anywhere is a threat to justice everywhere.”

Let that motivate us to action.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology. She enjoys locums work in Montana and is a champion of physician rights and patient safety. In addition to opinion writing, she enjoys spending time with her husband, daughters and parents, and sidelines as a backing vocalist for local rock bands. A version of this article first appeared on Medscape.com.

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What happened to Hasan Gokal, MD, should stick painfully in the craws of all physicians. It should serve as a call to action, because Dr. Gokal is sitting at home today without a job and under threat of further legal action while we continue about our day.

Dr. Melissa Walton-Shirley
 

Dr. Gokal’s “crime” is that he vaccinated 10 strangers and acquaintances with soon-to-expire doses of the Moderna COVID-19 vaccine. He drove to the homes of some in the dark of night and injected others on his Sugar Land, Texas, lawn. He spent hours in a frantic search for willing recipients to beat the expiration clock. With minutes to spare, he gave the last dose to his at-risk wife, who has symptomatic pulmonary sarcoidosis, but whose age meant she did not fall into a vaccine priority tier.

According to the New York Times, Dr. Gokal’s wife was hesitant, afraid he might get into trouble. But why would she be hesitant? He wasn’t doing anything immoral. Perhaps she knew how far physicians have fallen and how bitterly they both could suffer.

In Barren County, Ky., where I live, a state of emergency was declared by our judge executive because of inclement weather. This directive allows our emergency management to “waive procedures and formalities otherwise required by the law.” It’s too bad that the same courtesy was not afforded to Dr. Gokal in Texas. It’s a shame that ice and snow didn’t drive his actions. Perhaps that would have protected him against the harsh criticism. Rather, it was his oath to patients and dedication to his fellow humans that motivated him, and for that, he was made to suffer.

Dr. Gokal was right to think that pouring the last 10 vaccine doses down the toilet would be an egregious act. But he was wrong in thinking his decision to find takers for the vaccine would be viewed as expedient. Instead, he was accused of graft and even nepotism. And there is the rub. That he was fired and charged with the theft of $137 worth of vaccines says everything about how physicians are treated in the year 2021. Dr. Gokal’s lawyer says the charge carried a maximum penalty of 1 year in prison and a fine of nearly $4,000.

Thank God a sage judge threw out the case and “rebuked” the office of District Attorney Kim Ogg. That hasn’t stopped her from threatening to bring the case to a grand jury. That threat invites anyone faced with the same scenario to flush the extra vaccine doses into the septic system. It encourages us to choose the toilet handle to avoid a mug shot.

And we can’t ignore the racial slant to this story. The Times reported that Dr. Gokal asked the officials, “Are you suggesting that there were too many Indian names in this group?”

“Exactly” was the answer. Let that sink in.

None of this would have happened 20 years ago. Back then, no one would have questioned the wisdom a physician gains from all our years of training and residency. In an age when anyone who conducts an office visit is now called “doctor,” respect for the letters “MD” has been leveled. We physicians have lost our autonomy and been cowed into submission.

But whatever his profession, Hasan Gokal was fired for being a good human. Today, the sun rose on 10 individuals who now enjoy better protection against a deadly pandemic. They include a bed-bound nonagenarian. A woman in her 80s with dementia. A mother with a child who uses a ventilator. All now have antibodies against SARS-CoV2 because of the tireless actions of Dr. Gokal.

Yet Dr. Gokal’s future is uncertain. Will we help him, or will we leave him to the wolves? In an email exchange with his lawyer’s office, I learned that Dr. Gokal has received offers of employment but is unable to entertain them because the actions by the Harris County District Attorney triggered an automatic review by the Texas Medical Board. A GoFundMe page was launched, but an appreciative Dr. Gokal stated publicly that he’d rather the money go to a needy charity.

 In the last paragraph of the Times article, Dr. Gokal asks, “How can I take it back?” referencing stories about “the Pakistani doctor in Houston who stole all those vaccines.”

Let’s help him take back his story. In helping him, perhaps we can take back a little control. We could start with letters of support that could be mailed to his lawyer, Paul Doyle, Esq., of Houston, or tweet, respectfully of course, to the district attorney @Kimoggforda.

We can also let the Harris County Public Health Department in Houston know what we think of their actions.

On Martin Luther King Day, Kim Ogg, the district attorney who charged Dr. Gokal, tweeted MLK’s famous quote: “Injustice anywhere is a threat to justice everywhere.”

Let that motivate us to action.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology. She enjoys locums work in Montana and is a champion of physician rights and patient safety. In addition to opinion writing, she enjoys spending time with her husband, daughters and parents, and sidelines as a backing vocalist for local rock bands. A version of this article first appeared on Medscape.com.

What happened to Hasan Gokal, MD, should stick painfully in the craws of all physicians. It should serve as a call to action, because Dr. Gokal is sitting at home today without a job and under threat of further legal action while we continue about our day.

Dr. Melissa Walton-Shirley
 

Dr. Gokal’s “crime” is that he vaccinated 10 strangers and acquaintances with soon-to-expire doses of the Moderna COVID-19 vaccine. He drove to the homes of some in the dark of night and injected others on his Sugar Land, Texas, lawn. He spent hours in a frantic search for willing recipients to beat the expiration clock. With minutes to spare, he gave the last dose to his at-risk wife, who has symptomatic pulmonary sarcoidosis, but whose age meant she did not fall into a vaccine priority tier.

According to the New York Times, Dr. Gokal’s wife was hesitant, afraid he might get into trouble. But why would she be hesitant? He wasn’t doing anything immoral. Perhaps she knew how far physicians have fallen and how bitterly they both could suffer.

In Barren County, Ky., where I live, a state of emergency was declared by our judge executive because of inclement weather. This directive allows our emergency management to “waive procedures and formalities otherwise required by the law.” It’s too bad that the same courtesy was not afforded to Dr. Gokal in Texas. It’s a shame that ice and snow didn’t drive his actions. Perhaps that would have protected him against the harsh criticism. Rather, it was his oath to patients and dedication to his fellow humans that motivated him, and for that, he was made to suffer.

Dr. Gokal was right to think that pouring the last 10 vaccine doses down the toilet would be an egregious act. But he was wrong in thinking his decision to find takers for the vaccine would be viewed as expedient. Instead, he was accused of graft and even nepotism. And there is the rub. That he was fired and charged with the theft of $137 worth of vaccines says everything about how physicians are treated in the year 2021. Dr. Gokal’s lawyer says the charge carried a maximum penalty of 1 year in prison and a fine of nearly $4,000.

Thank God a sage judge threw out the case and “rebuked” the office of District Attorney Kim Ogg. That hasn’t stopped her from threatening to bring the case to a grand jury. That threat invites anyone faced with the same scenario to flush the extra vaccine doses into the septic system. It encourages us to choose the toilet handle to avoid a mug shot.

And we can’t ignore the racial slant to this story. The Times reported that Dr. Gokal asked the officials, “Are you suggesting that there were too many Indian names in this group?”

“Exactly” was the answer. Let that sink in.

None of this would have happened 20 years ago. Back then, no one would have questioned the wisdom a physician gains from all our years of training and residency. In an age when anyone who conducts an office visit is now called “doctor,” respect for the letters “MD” has been leveled. We physicians have lost our autonomy and been cowed into submission.

But whatever his profession, Hasan Gokal was fired for being a good human. Today, the sun rose on 10 individuals who now enjoy better protection against a deadly pandemic. They include a bed-bound nonagenarian. A woman in her 80s with dementia. A mother with a child who uses a ventilator. All now have antibodies against SARS-CoV2 because of the tireless actions of Dr. Gokal.

Yet Dr. Gokal’s future is uncertain. Will we help him, or will we leave him to the wolves? In an email exchange with his lawyer’s office, I learned that Dr. Gokal has received offers of employment but is unable to entertain them because the actions by the Harris County District Attorney triggered an automatic review by the Texas Medical Board. A GoFundMe page was launched, but an appreciative Dr. Gokal stated publicly that he’d rather the money go to a needy charity.

 In the last paragraph of the Times article, Dr. Gokal asks, “How can I take it back?” referencing stories about “the Pakistani doctor in Houston who stole all those vaccines.”

Let’s help him take back his story. In helping him, perhaps we can take back a little control. We could start with letters of support that could be mailed to his lawyer, Paul Doyle, Esq., of Houston, or tweet, respectfully of course, to the district attorney @Kimoggforda.

We can also let the Harris County Public Health Department in Houston know what we think of their actions.

On Martin Luther King Day, Kim Ogg, the district attorney who charged Dr. Gokal, tweeted MLK’s famous quote: “Injustice anywhere is a threat to justice everywhere.”

Let that motivate us to action.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology. She enjoys locums work in Montana and is a champion of physician rights and patient safety. In addition to opinion writing, she enjoys spending time with her husband, daughters and parents, and sidelines as a backing vocalist for local rock bands. A version of this article first appeared on Medscape.com.

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